Form 57.305 Hemovigilance Incident

Hemovigilance Incident OMB No. 0920-0666 Exp. Date: xx-xx-20xx

* Required for saving

Facility ID #:___________		Incident #: __________ [system generated] 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) Computer system alarm or warning Comparison of product label to patient information Comparison of sample and paperwork Comparison of product label to physician order Historical record/previous type check Human ‘lucky catch’ Observation by staff of unit/plate/reagent/sample/equipment Patient transfusion reaction Repeat or sample re-testing Routine audit or supervisory review Visual inventory review Other (specify)_____________________________________
*At what point in the process was the incident first discovered? (Check one) Product check-in Product/test request Sample collection Sample handling Sample receipt Sample testing Product storage Available for issue Product selection Product manipulation Request for pick-up Product issue Product administration Post-transfusion review/audit Other (specify) ___________________________
Occurrence
*Date the incident occurred: __ __/__ __/__ __ __ __	*Time the 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 CDC Occupation Type codes on page 5) ___ ___ ___ If Other (specify) _________________________
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 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). CDC 57.305
*Where in the process did the incident first occur? (Check one) Product check-in Product/test request Sample collection Sample handling Sample receipt Sample testing Product storage Available for issue Product selection Product manipulation Request for pick-up Product issue Product administration Other (specify) ________________________________ *Enter Incident Code (See Incident Codes on Page 4 of Form): __ __ __ __ OR Incident detail not specified Incident summary: ________________________________________________________________________________________ ________________________________________________________________________________________
*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) Product retrieved Product destroyed Code system used: (Check one) ISBT-128 Codabar Indicate whether single or multiple units were destroyed: *Single unit: a. Unit #: __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ OR b. Component Code: __ __ __ __ __ *Multiple units: Component Code(s) __ __ __ __ __ # of Units ____ Code __ __ __ __ __ # of Units ____ Code __ __ __ __ __ # of Units ____ (Add add’l) Product issued but not transfused Product transfused If the unit was transfused was a patient reaction associated with this incident? YES NO If YES, Patient ID#: _______________ Patient ID#: _______________
*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, indicate result of analysis: (Check all that apply) Technical Organizational Human Patient-related Other (specify) ____________________________					[Future] Severity Code: (check one) High Medium Low
Custom Fields
Label ______________________ ___/___/___ ______________________ ___________ ______________________ ___________ ______________________ ___________ ______________________ ___________ ______________________ ___________ ______________________ ___________			Label ______________________ ___/___/___ ______________________ ___________ ______________________ ___________ ______________________ ___________ ______________________ ___________ ______________________ ___________ ______________________ ___________
Comments

INCIDENT CODES Based on MERS-TM and TESS Product Check-In (Products Received from Outside Source) 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) Product/Test Request (Clinical Service) 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 Sample Collection 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 Sample Handling (Service Collecting Samples) 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 SH10 Sample transport issues

Sample Receipt (Transfusion Service) 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 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 Product Storage (Transfusion Service) 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 01 Inventory audits 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 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

Product Manipulation (Transfusion Service) 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 Request for Pick-up (Clinical Service) 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 Product Issue (Transfusion Service) 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 Product Administration (Clinical Service) 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 Type (Job Function) Codes

Lab

CLT	Clinical lab technician
IVT	IVT Team Staff
PHL	Phlebotomist/IV Team

Nursing Staff

CNA	Nurse Anesthetist
LPN	Licensed Practical Nurse
NMW	Nurse Midwife
NUA	Nursing Assistant
NUP	Nurse Practitioner
RNU	Registered Nurse

Physician

FEL	Fellow
MST	Medical Student
PHY	Physician
RES	Intern/Resident

Technicians

EMT	EMT/Paramedic
HEM	Hemodialysis Technician
ORS	OR/Surgery Technician
PCT	Patient Care Technician

Other Personnel

CLA	Clerical/administrative
TRA	Transport/Messenger/Porter

Additional Occupation Types

ATT	Attendant/orderly	PHA	Pharmacist
CSS	Central Supply	PHW	Public Health Worker
CSW	Counselor/Social Worker	PLT	Physical Therapist
DIT	Dietician	PSY	Psychiatric Technician
DNA	Dental Assistant/Tech	RCH	Researcher
DNH	Dental Hygienist	RDT	Radiologic Technologist
DNO	Other Dental Worker	RTT	Respiratory Therapist/Tech
FOS	Food Service	STU	Other Student
HSK	Housekeeper	VOL	Volunteer
ICP	Infection Control Professional
LAU	Laundry Staff
MNT	Maintenance/Engineering
MOR	Morgue Technician	OTH	Other (Specify)
OAS	Other Ancillary Staff
OFR	Other First Responder
OH	Occupational Health Professional
OMS	Other Medical Staff
OTT	Other Technician/Therapist

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