Form CDC 57.302 CDC 57.302 Hemovigilance Module Monthly Incident Summary

Form Approved

OMB No. 0920-0666

Exp. Date:12/31/2026

www.cdc.gov/nhsn

Hemovigilance Module

Monthly Incident Summary

*Required for saving

*Facility ID#: _______________		*Month: ______________	*Year: ______________
All reporting is facility-wide. Include numbers of individual incident reports in the totals.
*Process Code	*Incident Code			*Total Incidents	*Total Adverse Reactions
PC: Product Check-In (Transfusion Service) Events that occur during the shipment and receipt of products into the transfusion service from the supplier, another hospital site, satellite storage, or clinical area.	PC 00 Detail not specified
	PC 01 Data entry incomplete/incorrect/not performed
	PC 02 Shipment incomplete/incorrect
	PC 03 Products and paperwork do not match
	PC 04 Shipped/transported under inappropriate conditions
	PC 05 Inappropriate return to inventory
	PC 06 Product confirmation incorrect/not performed
	PC 07 Administrative check not incorrect/not performed (record review/audit)
	PC 08 Product label incorrect/missing
US: Product Storage (Transfusion Service) Events that occur during product storage by the transfusion service.	US 00 Detail not specified
	US 01 Incorrect storage conditions
	US 03 Inappropriate monitoring of storage device
	US 04 Unit stored on incorrect shelf (e.g., ABO/autologous/directed)
	US 05 Incorrect storage location
IM: Inventory Management (Transfusion Service) Events that involve quality management of the blood product inventory.	IM 00 Detail not specified
	IM 01 Inventory audit incorrect/not performed
	IM 02 Product status incorrectly/not updated online (e.g., available/discarded)
	IM 03 Supplier recall/traceback not appropriately addressed/not performed
	IM 04 Product order incorrectly/not submitted to supplier
	IM 05 Outdated product in available inventory
	IM 06 Recalled/quarantined product in available inventory
PR: Product/Test Request (Clinical Service) Events that occur when the clinical service orders patient tests or blood products for transfusion.	PR 00 Detail not specified
	PR 01 Order for wrong patient
	PR 02 Order incompletely/incorrectly ordered (online order entry)
	PR 03 Special processing needs not indicated (e.g., CMV negative, autologous)
	PR 04 Order not done
	PR 05 Inappropriate/unnecessary (intended) test ordered
	PR 06 Inappropriate/unnecessary (intended) blood product ordered
	PR 07 Incorrect (unintended) test ordered
	PR 08 Incorrect (unintended) blood product ordered
OE: Product/Test Order Entry (Transfusion Service) Events that occur when the transfusion service receives a patient order. This process may be excluded if clinical service uses online ordering.	OE 00 Detail not specified
	OE 01 Order entered for wrong patient
	OE 02 Order incompletely/incorrectly entered online
	OE 03 Special processing needs not entered (e.g., CMV-, autologous)
	OE 04 Order entry not done
	OE 05 Inappropriate/unnecessary (intended) test order entered
	OE 06 Inappropriate/unnecessary (intended) blood product order entered
	OE 07 Incorrect (unintended) test ordered
	OE 08 Incorrect (unintended) blood product ordered
*Process Code	*Incident Code			*Total Incidents	*Total Adverse Reactions
SC: Sample Collection (Service collecting the samples) Events that occur during patient sample collection.	SC 00 Detail not specified
	SC 01 Sample labeled with incorrect patient ID (intended patient drawn)
	SC 02 Sample not labeled
	SC 03 Wrong patient collected (sample labeled for intended patient)
	SC 04 Sample collected in wrong tube type
	SC 05 Sample quantity not sufficient (QNS)
	SC 06 Sample hemolyzed
	SC 07 Sample label incomplete/illegible for patient identifiers
	SC 08 Sample collected in error (e.g., unnecessary/duplicate)
	SC 09 Patient sample not collected (in error)
	SC 10 Patient wristband incorrect/not available
	SC 11 Sample contaminated
SH: Sample Handling (Service collecting the samples) Events that occur when a patient sample is sent for testing.	SH 00 Detail not specified
	SH 01 Sample sent without requisition
	SH 02 Requisition and sample label don’t match
	SH 03 Patient ID incomplete/illegible on requisition
	SH 04 No Patient ID on requisition
	SH 05 No phlebotomist/witness identification
	SH 06 Sample sent with incorrect requisition type
	SH 07 Patient information (other than ID) missing/incorrect on requisition
	SH 08 Requisition sent without sample
	SH 09 Data entry incorrect/incomplete/not performed
	SH 10 Sample transport issue (e.g., sample broken/inappropriate conditions)
	SH 11 Duplicate sample sent in error
SR: Sample Receipt (Transfusion Service) Events that occur when a sample is received by the transfusion service.	SR 00 Detail not specified
	SR 01 Sample accepted in error
	SR 02 Historical review incorrect/not performed
	SR 03 Demographic review/ data entry incorrect/not performed
	SR 04 Sample incorrectly accessioned
ST: Sample Testing (Transfusion Service) Events that occur during patient sample testing by the transfusion service.	ST 00 Detail not specified
	ST 01 Data entry incomplete/incorrect/not performed
	ST 02 Appropriate sample checks incomplete/incorrect/not performed
	ST 03 Computer warning overridden in error or outside SOP
	ST 05 Sample test tube incorrectly accessioned
	ST 07 Sample test tubes mixed up
	ST 09 Sample test tube mislabeled (wrong patient identifiers)
	ST 10 Equipment problem/failure/not properly QC’d
	ST 12 Sample testing not performed
	ST 13 Incorrect sample testing method chosen
	ST 14 Sample testing performed incorrectly
	ST 15 Sample test result misinterpreted
	ST 16 Reagents used were incorrect/inappropriate/expired/not properly QC’d
	ST 17 ABO/Rh error caught on final check
	ST 18 Current/historical ABO/Rh mismatch
	ST 19 Additional testing not performed
	ST 20 Confirmatory check incorrect/not performed (at time work performed)
	ST 21 Administrative check incorrect/not performed (record review/audit)
	ST 22 Sample storage incorrect/inappropriate
*Process Code	*Incident Code			*Total Incidents	*Total Adverse Reactions
UM: Product Manipulation/ Processing/Testing (Transfusion Service) Events that occur while testing, manipulating (e.g., pooling, washing, aliquoting, irradiating), processing, or labeling blood products.	UM 00 Detail not specified
	UM 01 Data entry incomplete/incorrect/not performed
	UM 02 Record review incomplete/incorrect/not performed
	UM 03 Incorrect product (type) selected
	UM 04 Incorrect product (patient) selected
	UM 05 Product labeled incorrectly (new/updated)
	UM 06 Computer warning overridden in error or outside SOP
	UM 07 Special processing needs not checked
	UM 08 Special processing needs misunderstood or misinterpreted
	UM 09 Special processing needs performed incorrectly
	UM 10 Special processing needs not performed
	UM 11 Equipment problem/failure/not properly QC’d
	UM 12 Reagents used were incorrect/inappropriate/expired/not properly QC’d
	UM 13 Confirmatory check incorrect/not performed (at time work performed)
	UM 14 Administrative check incorrect/not performed (record review/audit)
No Blood	NB 01 Inventory less than usual par level due to supplier unable to meet usual steady demand
	NB 02 Demand for blood product exceeding usual par inventory level
	NB 03 Incompatible/inappropriate units issued due to inventory constraints when demand for blood product exceeds usual par inventory levels.
	NB 04 Suboptimal dose (less than optimal quantity) transfusion or no transfusion due to inventory constraints when demand for blood product exceeds usual par inventory levels.
RP: Request for Pick-Up (Clinical Service) Events that occur when the clinical service requests pick-up of a blood product from the transfusion service.	RP 00 Detail not specified
	RP 01 Request for pick-up on wrong patient
	RP 02 Incorrect product requested for pick-up
	RP 03 Product requested prior to obtaining consent
	RP 04 Product requested for pick-up, but patient not available
	RP 05 Product requested for pick-up, but IV not ready
	RP 06 Request for pick-up incomplete (e.g., patient ID/product type missing)
	RP 07 Pick-up slip did not match patient information on product
UI: Product Issue (Transfusion Service) Events that occur when the transfusion service issues blood product to the clinical service.	UI 00 Detail not specified
	UI 01 Data entry incomplete/incorrect/not performed
	UI 02 Record review incomplete/incorrect/not performed
	UI 03 Product issued for wrong patient
	UI 04 Product issued out of order
	UI 05 Product issue delayed
	UI 06 LIS warning overridden in error or outside SOP
	UI 07 Computer issue not completed
	UI 08 Issued visibly defective product (e.g., clots/aggregates/particulate matter)
	UI 09 Not/incorrect checking of unit and/or patient information
	UI 10 Product transport issues (e.g., delayed) by transfusion service
	UI 11 Unit delivered to incorrect location by transfusion service
	UI 12 Product transport issue (from transfusion service to clinical area)
	UI 18 Wrong product issued for intended patient (e.g., incompatible)
	UI 19 Inappropriate product issued for patient (e.g., not irradiated, CMV+)
	UI 20 Confirmatory check incorrect/not performed (at time work performed)
	UI 21 Administrative check incorrect/not performed (record review/audit)
	UI 22 Issue approval not obtained/documented
	UI 23 Receipt verification not performed (pneumatic tube issue)

*Process Code	*Incident Code	*Total Incidents	*Total Adverse Reactions
CS: Satellite Storage (Clinical Service) Events that occur while product is stored and handled by the clinical service.	CS 00 Detail not specified
	CS 01 Incorrect storage conditions of product in clinical area
	CS 02 Incorrect storage location in the clinical area
	CS 03 Labeling issue (by clinical staff)
	CS 04 Floor/clinic did not check for existing products in their area
	CS 05 Product transport issues (to or between clinical areas)
	CS 06 Monitoring of satellite storage incorrect/incomplete/not performed
	CS 07 Storage tracking/documentation incorrect/incomplete/not performed
UT: Product Administration (Clinical Service) Events that occur during the administration of blood products.	UT 00 Detail not specified
	UT 01 Administered intended product to wrong patient
	UT 02 Administered wrong product to intended patient
	UT 03 Transfusion not performed in error
	UT 05 Bedside check (patient ID confirmation) incomplete/not performed
	UT 06 Transfused product with incompatible IV fluid
	UT 07 Transfusion delayed beyond pre-approved timeframe
	UT 09 Transfused unsuitable product (e.g., outdated/inappropriately stored)
	UT 10 Administered components in wrong order
	UT 11 Appropriate monitoring of patient not performed
	UT 14 Transfusion volume too low (per order or SOP)
	UT 15 Transfusion volume too high (per order or SOP)
	UT 16 Transfusion rate too slow (per order or SOP)
	UT 17 Transfusion rate too fast (per order or SOP)
	UT 18 Inappropriate preparation of product
	UT 19 Transfusion protocol not followed (not otherwise specified)
	UT 22 Order/consent check incorrect/not performed
	UT 23 Transfusion documentation incorrect/incomplete/not performed
	UT 24 Transfusion documentation not returned to transfusion service
	UT 26 Transfusion reaction protocol not followed
MS: Other	MS 99 Other
	Total

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 57.302 Rev. 4, v9.2

Public reporting burden of this collection of information is estimated to average 30 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).

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