Form CDC 57.305 CDC 57.305 Hemovigilance Module Incident

F orm Approved

OMB No. 0920-0666

Exp. Date: 12/31/2026

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?					_____________________________________
*At what point in the process was the incident first discovered? (check one)
Product check-in	Order entry			Sample testing				Satellite storage
Product storage	Sample collection			Product manipulation				Product administration
Inventory management	Sample handling			Request for pick-up				Post-transfusion review/audit
Product/test request	Sample receipt			Product issue				Other ___________________
*How was the incident first discovered? (check one)
Visual inventory review			Observation by staff of unit/reagent/sample/equipment
Routine audit or supervisory review			Comparison of product label to patient information
Computer system alarm or warning			Comparison of product label to physician order
Comparison of sample to paperwork			When checking patient ID band
Repeat or sample re-testing			Notification or complaint from floor (nurse, MD, etc.)
Historical record/previous type check			When product/units returned to lab
Communication from lab to floor			Patient transfusion reaction
Human ‘lucky catch’			Other (specify) _________________________________
Occurrence
*Date initial incident occurred: __ __ /__ __ / __ __ __ __
*Time initial incident occurred: __ __ : __ __(HH:MM)						Time approximate			Time unknown
Incident summary: (500 characters max) _____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________ _______________________________________________________________________________

*Incident code(s): (max 20) Use NHSN incident codes in the surveillance protocol.

Incident Code

Occurrence Location

Incident Code

Occurrence Location

1

__ __ __ __

______________________

11

__ __ __ __

______________________

2

__ __ __ __

______________________

12

__ __ __ __

______________________

3

__ __ __ __

______________________

13

__ __ __ __

______________________

4

__ __ __ __

______________________

14

__ __ __ __

______________________

5

__ __ __ __

______________________

15

__ __ __ __

______________________

6

__ __ __ __

______________________

16

__ __ __ __

______________________

7

__ __ __ __

______________________

17

__ __ __ __

______________________

8

__ __ __ __

______________________

18

__ __ __ __

______________________

9

__ __ __ __

______________________

19

__ __ __ __

______________________

10

__ __ __ __

______________________

20

__ __ __ __

_____________________

MS 99

Miscellaneous, specify _________________________________________________

Job function of the worker(s) involved in the incident: (max 6) Use NHSN occupation codes in the protocol.

__ __ __

__ __ __

__ __ __

__ __ __

__ __ __

__ __ __

Other

Other (OTH), specify __________________________

Worker unknown

*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 and returned to inventory

Product retrieved and 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

^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
Custom Fields
Label				Label
________________	__ __/__ __/__ __ __ __			________________			__ __/__ __/__ __ __ __
________________	___________________			________________			___________________
________________	___________________			________________			___________________
________________	___________________			________________			___________________
________________	___________________			________________			___________________
Comments (2000 characters max)
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________

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)). CDC 57.305, Rev. 7, v9.2

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 H21-8, Atlanta, GA 30333, ATTN: PRA (0920-0666).

Page 1 of 11