Form 57.302 Hemovigilance Module Blood Product Incident Reporting -

OMB No. , 0920-0666

EXP. DATE: XX-XX-XXXX

Hemovigilance Module

Blood Product Incidents Reporting – Summary data

Facility ID#: _______________ Month __ __/ Year ___ ___ ___ ___

All reporting is facility-wide. Include numbers of individual reports in the totals.

*Process Point		*Total Number of Incidents	*# of Adverse Transfusion Reactions Associated w/ Incident
PC - Product Check-In (Products received from outside source)	PC 00 Detail not specified
	PC 01 Data entry incomplete/not performed/incorrect
	PC 02 Shipment incomplete/incorrect
	PC 03 Product & paperwork do not match
	PC 04 Shipped under inappropriate conditions
	PC 05 Inappropriate return to inventory
	PC 06 Product confirmation
	PC 07 Administrative check (2nd check)
PR - Product/Test Request (Clinical Service)	PR 00 Detail not specified
	PR 01 Order for wrong patient
	PR 02 Order incorrectly entered on-line
	+PR 03 Special needs not indicated on order (e.g., CMV negative, auto)
	PR 04 Order not done/incomplete/incorrect
	PR 05 Inappropriate/incorrect test ordered
	PR 06 Inappropriate/incorrect blood product ordered
SC – Sample Collection (Service collecting the samples)	SC 00 Detail not specified
	+SC 01 Sample labeled with incorrect patient name
	+SC 02 Not labeled
	+SC 03 Wrong patient collected
	SC 04 Collected in wrong tube type
	SC 05 Sample QNS
	SC 06 Sample hemolyzed
	+SC 07 Label incomplete/illegible/incorrect (other than patient name)
	SC 08 Sample collected in error
	SC 09 Requisition arrives without samples
	+SC 10 Wristband incorrect/not available
	SC 11 Sample contaminated

(Continued)

+Indicates high priority codes (individual incident report must be completed)

Assurance of Confidentiality: The 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 2 hours 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).

CDC 57.302

*Process Point		*Total Number of Incidents	*# of Adverse Transfusion Reactions Associated w/ Incident
SH – Sample Handling (Service collecting the samples)	SH 00 Detail not specified
	SH 01 Sample arrives without requisition
	SH 02 Requisition & sample label don’t match
	+SH 03 Patient ID incorrect/illegible on requisition
	SH 05 No phlebotomist/witness identification
	SH 06 Sample arrives with incorrect requisition
	SH 07 Patient information (other than ID) missing/incorrect on requisition
	SH 10 Sample transport issues
SR – Sample Receipt (Transfusion Service)	SR 00 Detail not specified
	SR 01 Sample processed in error
	SR 02 Historical review incorrect/not done
	SR 03 Demographic review/data entry incorrect/ not done
	SR 04 Sample incorrectly accessioned (test/product)
	SR 05 Duplicate sample sent
ST – Sample Testing (Transfusion Service)	ST 00 Detail not specified
	ST 01 Data entry incorrect/not performed
	ST 02 Appropriate sample checks not done
	+ST 03 Computer warning overridden
	ST 05 Sample tube w/ incorrect accession label
	+ST 07 Sample tubes mixed up
	+ST 09 Test tubes mislabeled (wrong patient name/number)
	ST 10 Equipment problem
	ST 12 Patient testing not performed
	ST 13 Incorrect testing method chosen
	ST 14 Testing performed incorrectly
	ST 15 Test result misinterpreted
	ST 16 Inappropriate/expired reagents used
	ST 17 ABO/Rh error caught on final check
	ST 18 Current & historical ABO/Rh don’t match
	ST 19 Additional testing not performed
	ST 20 Administrative check at time work performed
	ST 22 Sample storage incorrect/inappropriate
US – Product Storage (Transfusion Service)	US 00 Detail not specified
	US 01 Incorrect storage of unit in transfusion service
	US 02 Expired product in stock
	US 03 Inappropriate monitoring of storage device
	US 04 Unit stored on incorrect ABO shelf
AV - Available for Issue (Transfusion Service)	AV 00 Detail not specified
	AV 01 Inventory audits
	AV 02 Product status not/incorrectly updated in computer
	AV 03 Supplier recall
	AV 04 Product ordered incorrectly/not submitted
SE - Product Selection (Transfusion Service)	SE 00 Detail not specified
	SE 01 Incorrect product/component selected
	SE 02 Data entry incomplete/incorrect
	SE 03 Not checking/incorrect checking of product and/or patient information
	SE 05 Historical file misinterpreted/not checked
	SE 07 Special processing needs not checked
	SE 09 Special processing needs not understood or misinterpreted
	SE 11 Special processing not done
UM – Product Manipulation (Transfusion Service)	UM 00 Detail not specified
	UM 01 Data entry incomplete/incorrect
	UM 02 Record review incomplete/incorrect
	UM 03 Wrong component selected
	UM 04 Administrative check (at time of manipulation)
	UM 05 Labeling incorrect
	+UM 07 Special processing needs not checked
	+UM 08 Special processing misunderstood or misinterpreted
	+UM 09 Special processing not done/incorrectly done
RP - Request for Pick-up (Clinical 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 pt not available
	RP 05 Product requested for pick-up IV not ready
	RP 06 Request for pick-up incomplete
	RP 10 Product transport issues
UI – Product Issue (Transfusion Service)	UI 00 Detail not specified
	UI 01 Data entry incomplete/incorrect
	UI 02 Record review incomplete/incorrect
	UI 03 Pick-up slip did not match patient information
	UI 04 Incorrect unit selected (wrong person or right person wrong order)
	UI 05 Issue delayed
	+UI 06 LIS warning overridden
	UI 07 Computer issue not completed
	UI 09 Not checking/incorrect checking of unit and/or patient information
	UI 11 Unit delivered to incorrect location
	UI 19 Wrong product issued
	UI 20 Administrative review (self, 2nd check at issue)
	UI 22 Issue approval not obtained/documented
UT – Product Administra-tion (Clinical Service)	UT 00 Detail not specified
	+UT 01 Administered product to wrong patient
	+UT 02 Administered wrong product to patient
	UT 03 Product not administered
	UT 04 Incorrect storage of product on floor
	UT 05 Administrative review (unit/patient at bedside)
	UT 06 Administered product w/ incompatible IV fluid
	UT 07 Administration delayed
	UT 08 Wrong unit chosen from satellite refrigerator
	UT 10 Administered components in inappropriate order
	UT 11 Appropriate monitoring of patient not done
	UT 12 Floor/clinic did not check for existing products in their area
	UT 13 Labeling problem on unit
	UT 19 Transfusion protocol not followed
Other	MS 99
TOTAL Monthly Reports

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