Form CDC 57.302 CDC 57.302 Hemovigilance Module Monthly Incident Summary

OMB No. 0920-0666

Exp. Date: XX-XX-XXXX

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 associated with Incidents
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 and 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 online
	+	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 arrived without samples
	+	SC 10 Wristband incorrect/not available
		SC 11 Sample contaminated
SH: Sample Handling (Service collecting the samples)		SH 00 Detail not specified
		SH 01 Sample arrived without requisition
		SH 02 Requisition and sample label don’t match
	+	SH 03 Patient ID incorrect/illegible on requisition
		SH 05 No phlebotomist/witness identification
		SH 06 Sample arrived with incorrect requisition
		SH 07 Patient information (other than ID) missing/incorrect on requisition
		SH 10 Sample transport issue
+ Indicates high-priority incidents; individual incident report must be completed for each.
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 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).
*Process Code	*Incident Code			*Total Incidents		*Total Adverse Reactions associated with Incidents
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 and 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 audit
		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/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 needs misunderstood or misinterpreted
	+	UM 09 Special processing not done/incorrectly done
+ Indicates high-priority incidents; individual incident report must be completed for each.
*Process Code	*Incident Code			*Total Incidents		*Total Adverse Reactions associated with Incidents
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, patient not available
		RP 05 Product requested for pick-up, IV not ready
		RP 06 Request for pick-up incomplete
		RP 10 Product transport issue
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 Product issue delayed
	+	UI 06 LIS warning overridden
		UI 07 Computer issue not completed
		UI 09 Not/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 Administration (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
MS: Other		MS 99 Other
	Total
+ Indicates high-priority incidents; individual incident report must be completed for each.

CDC 57.302 Rev. 1, v6.4

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