Form CDC 57.305 CDC 57.305 Hemovigilance Module Incident

OMB No. 0920-0666

Exp. Date: XX-XX-XXXX

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 - No recovery, harm

2 - No recovery, no harm

3 - Near miss, unplanned recovery

4 - Near miss, planned recovery

*Product action: (check all that apply)

Not applicable

Product retrieved

Product destroyed

Code system used:

ISBT-128

Codabar

Single or multiple units destroyed?

Single unit:

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

OR

Component code: __ __ __ __ __

Multiple units:

Component code: __ __ __ __ __

Number of units: ____

Component code: __ __ __ __ __

Number of units: ____

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
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
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NHSN Incident Codes

(Based on MERS-TM and TESS)

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) 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 Sample Collection 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 Sample Handling (Service Collecting 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 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

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 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 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 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 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/incorrectly done

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 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 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 Other MS 99

NHSN Occupation Codes

Laboratory		Additional Occupation Types
IVT	IVT Team Staff	ATT	Attendant/Orderly
MLT	Medical Laboratory Technician	CSS	Central Supply
MTE	Medical Technologist	CSW	Counselor/Social Worker
PHL	Phlebotomist/IV Team	DIT	Dietician
Physician		DNA	Dental Assistant/Technician
LPN	Licensed Practical Nurse	DNH	Dental Hygienist
CNA	Nurse Anesthetist	DNO	Other Dental Worker
CNM	Certified Nurse Midwife	DNT	Dentist
NUA	Nursing Assistant	DST	Dental Student
NUP	Nurse Practitioner	FOS	Food Service
RNU	Registered Nurse	HSK	Housekeeper
Nursing		ICP	Infection Control Professional
FEL	Fellow	LAU	Laundry Staff
MST	Medical Student	MNT	Maintenance/Engineering
PHY	Attending Physician	MOR	Morgue Technician
RES	Intern/Resident	OAS	Other Ancillary Staff
Technicians		OFR	Other First Responder
EMT	EMT/Paramedic	OH	Occupational Health Professional
HEM	Hemodialysis Technician	OMS	Other Medical Staff
ORS	OR/Surgery Technician	OTH	Other
PCT	Patient Care Technician	OTT	Other Technician/Therapist
Other Personnel		PAS	Physician Assistant
CLA	Clerical/Administrative	PHA	Pharmacist
TRA	Transport/Messenger/Porter	PHW	Public Health Worker
		PLT	Physical Therapist
		PSY	Psychiatric Technician
		RCH	Researcher
		RDT	Radiologic Technologist
		RTT	Respiratory Therapist/Technician
		STU	Other Student
		VOL	Volunteer

CDC 57.305, Rev. 1, v6.4

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