Form 57.305 Hemovigilance Incident

Form Approved

OMB No. 0920-0666

Exp. Date: xx/xx/20xx

www.cdc.gov/nhsn

Hemovigilance Module

Incident

*Required for saving

*Facility ID#: _________________

NHSN Incident #: __________

Local Incident # or Log #: _________

Discovery

*Date of discovery: __ __ /__ __ / __ __ __ __

*Time of discovery: __ __ : __ __(HH:MM)

Time approximate

Time unknown

*Where in the facility was the incident discovered?

_____________________________________

*How was the incident first discovered? (check one)

Communication from lab to floor

Observation by staff of unit/plate/reagent/sample/equipment

Comparison of product label to patient information

Patient transfusion reaction

Comparison of product label to physician order

Repeat or sample re-testing

Comparison of sample to paperwork

Routine audit or supervisory review

Computer system alarm or warning

Visual inventory review

Historical record/previous type check

When checking patient ID band

Human ‘lucky catch’

When product/units returned to lab

Notification or complaint from floor (nurse, MD, etc.)

Other (specify) ________________________

*At what point in the process was the incident first discovered? (check one)

Product check-in

Sample receipt

Product selection

Product administration

Product/test request

Sample testing

Product manipulation

Post-transfusion review/audit

Sample collection

Product storage

Request for pick-up

Other (specify) ___________________________

Sample handling

Available for issue

Product issue

Occurrence

*Date incident occurred: __ __ /__ __ / __ __ __ __

*Time incident occurred: __ __ : __ __( (HH:MM)

Time approximate

Time unknown

*Where in the facility did the incident occur?

__________________________________________

Job function of the worker involved in the incident: (Use NHSN Occupation Codes on page 5.)

__ __ __

If Other (OTH), specify ___________________________

Worker unknown

Assurance of Confidentiality: The voluntarily provided information obtained in this surveillance system that would permit identification of any individual or institution is collected with a guarantee that it will be held in strict confidence, will be used only for the purposes stated, and will not otherwise be disclosed or released without the consent of the individual, or the institution in accordance with Sections 304, 306 and 308(d) of the Public Health Service Act (42 USC 242b, 242k, and 242m(d)). Public reporting burden of this collection of information is estimated to average 10 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to CDC, Reports Clearance Officer, 1600 Clifton Rd., MS D-74, Atlanta, GA 30333 ATTN: PRA (0920-0666).

*At what point in the process did the incident first occur? (check one)

Product check-in

Sample receipt

Available for issue

Request for pick-up

Product/test request

Sample testing

Product selection

Product issue

Sample collection

Product storage

Product manipulation

Product administration

Sample handling

Other (specify) ________________________________________________

*Incident code: __ __ __ __ (Use NHSN Incident Codes on page 4.)

Incident summary: (500 characters max) ____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

*Incident result: (check one)

1 – Product transfused, reaction

3 – No product transfused, unplanned recovery

2 – Product transfused, no reaction

4 – No product transfused, planned recovery

*Product action: (check all that apply)

Not applicable

Product retrieved

Product destroyed

^Single or multiple units destroyed?

Single unit:

Code system used:

ISBT-128

Codabar

Unit #: __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __

OR

Component code: __ __ __ __ __

Multiple units: (select code system used)

ISBT-128

Codabar

Component code: __ __ __ __ __

Number of units: ____

ISBT-128

Codabar

Component code: __ __ __ __ __

Number of units: ____

ISBT-128

Codabar

Component code: __ __ __ __ __

Number of units: ____

Product issued but not transfused

Product transfused

Was a patient reaction associated with this incident?

Yes

No

If Yes, Patient ID#(s):

__________

__________

__________

__________

*Record/other action: (check all that apply)
Record corrected			Floor/clinic notified					Attending physician notified
Additional testing			Patient sample re-collected					Other (specify) __________________
Investigation Results
*Did this incident receive root cause analysis?					Yes				No
If Yes, result(s) of analysis: (check all that apply)
Technical	Organizational			Human			Patient-related
Other (specify) ___________________________________________________________
Custom Fields
Label						Label
________________		__ __/__ __/__ __ __ __				________________				__ __/__ __/__ __ __ __
________________		___________________				________________				___________________
________________		___________________				________________				___________________
________________		___________________				________________				___________________
________________		___________________				________________				___________________
Comments
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________

CDC 57.305, Rev. 4, v8.0

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