DATA DEFINITIONS DONORHART TM. Knowledge Based Systems, Inc 1408 University Drive East Tel Fax

Transcription

1 DATA DEFINITIONS DONORHART TM Knowledge Based Systems, Inc 1408 University Drive East Tel Fax

2 TABLE OF CONTENTS Introduction 1 Data Elements and Formats 2 Lite Data Elements and Formats 6 Reaction Types & Reaction Categories 8 Reaction Categories & Sign and Symptoms 9 Reaction Categories & Other Adverse Events 14 Adverse Events 17 Denominator Dimensions 18 Definitions 23

3 INTRODUCTION This document contains information pertinent to the understanding, definition, format, and interchange of data within the DonorHART TM application BACKGROUND The focus of the application is to capture and analyze reaction information from the nation s blood centers. Though the components of a comprehensive Hemovigilance system include adverse transfusion events, infectious diseases monitoring, emerging infectious diseases, and hazards of donation, this research effort focuses on the donor aspect of Hemovigilance. Hemovigilance includes monitoring, analyzing, and researching the risks involved for a donor at the time of blood donation, or after the donation activity. Innovative approaches of the application include: 1. Gathering the information related to donor reactions that have occurred during blood donation using Web-based data capture methods; 2. Monitoring the key metrics related to the occurrence of reactions, and track them across facilities and regions, nationally; 3. Use the collected information for data mining and GIS-based visualization to analyze changes in trend differences in patterns and identify the underlying causalities; DATA ELEMENTS AND THEIR FORMAT The application will have the ability to accept data from Blood Establishments and Organizations in the form of CSV files on a frequent basis. The system currently supports importing CSV files for the following: 1. Donor Data 2. Donation Data 3. Reaction Data 4. Denominator Data 5. Delete Reaction Data 6. Collection Center Data Page 1

4 DATA ELEMENTS AND FORMATS DONOR DATA DATA ELEMENT DATA TYPE MAX LENGTH MANDATORY ORGANIZATION NAME Alpha-Numeric 100 Yes REGION Alpha-Numeric 50 No DONOR IDENTIFIER Alpha-Numeric 50 Yes DATE OF BIRTH MM/DD/YYYY 10 Yes GENDER Alpha-Numeric 10 Yes ETHNICITY Alpha-Numeric 10 Yes RACE Alpha-Numeric 28 Yes DONATION DATA DATA ELEMENT DATA TYPE MAX LENGTH MANDATORY ORGANIZATION NAME Alpha-Numeric 100 Yes REGION Alpha-Numeric 50 No DONOR IDENTIFIER Alpha-Numeric 50 Yes COLLECTION CENTER Alpha-Numeric 100 Yes DONATION IDENTIFIER Alpha-Numeric 50 Yes DONATION DATE MM/DD/YYY 10 Yes DONATION HISTORY Alpha-Numeric 10 No DONOR HEIGHT Decimal 10 No DONOR WEIGHT Decimal 10 No NUMBER OF DONATIONS Integer 3 No COLLECTION SITE Alpha-Numeric 25 No SPONSORING GROUP TYPE Alpha-Numeric 12 No INTENDED DONATION TYPE Alpha-Numeric 15 No INTENDED PROCEDURE TYPE Alpha-Numeric 50 No Page 2

5 DATA ELEMENT DATA TYPE MAX LENGTH MANDATORY TIME NEEDLE INSERTED Time in HH:MM 5 No TIME NEEDLE WITHDRAWN Time in HH:MM 5 No MANUFACTURER Alpha-Numeric 50 No MODEL Alpha-Numeric 50 No SOFTWARE Alpha-Numeric 50 No KIT MANUFACTURER Alpha-Numeric 50 No KIT TYPE Alpha-Numeric 50 No LOT NUMBER Alpha-Numeric 25 No COMPONENTS PRODUCED Alpha-Numeric 130 No VOLUME REMOVED Integer 9 No FLUID INFUSED Integer 9 No SUCCESSFUL DONATION Alpha-Numeric 10 No PLATELET COUNT Decimal 9 No DATE OF PLATELET COUNT MM/DD/YYYY 10 No TOTAL PROTEIN Decimal 9 No DATE OF TOTAL PROTEIN MM/DD/YYYY 10 No PULSE Integer 9 No SYSTOLIC PRESSURE Integer 9 No DIASTOLIC PRESSURE Integer 9 No HEMATOCRIT COUNT Decimal 9 No HEMOGLOBIN COUNT Decimal 9 No KIND OF SAMPLE Alpha-Numeric 10 No Page 3

6 REACTION DATA DATA ELEMENT DATA TYPE MAX LENGTH MANDATORY ORGANIZATION NAME Alpha-Numeric 100 Yes REGION Alpha-Numeric 50 No DONOR IDENTIFIER Alpha-Numeric 50 Yes COLLECTION CENTER Alpha-Numeric 100 Yes DONATION IDENTIFIER Alpha-Numeric 50 Yes DATE REACTION BEGAN MM/DD/YYYY 10 No TIME REACTION BEGAN Time in HH:MM 5 No TIME REACTION ENDED Time in HH:MM 5 No LOCATION REACTION BEGAN Alpha-Numeric 25 No REACTION TYPE Alpha-Numeric 40 Yes REACTION CATEGORY Alpha-Numeric 100 Yes REACTION BEGAN MORE THAN Boolean 30 MINUTES AFTER NEEDLE 1 No WITHDRAWAL RECOVERY MORE THAN 30 Boolean MINS 1 No HIGHEST PULSE Integer 9 No LOWEST PULSE Integer 9 No HIGHEST DIASTOLIC PRESSURE Integer 9 No LOWEST DIASTOLIC PRESSURE Integer 9 No SIGNS AND SYMPTOMS Alpha-Numeric 1400 No OTHER ADVERSE EVENTS Alpha-Numeric 500 No OTHER EVENTS Alpha-Numeric 1000 No RESOLUTION OF ACUTE Alpha-Numeric REACTION 40 No DATE OF RESOLUTION OF MM/DD/YYYY PROLONGED REACTION 10 No OUTCOME Alpha-Numeric 15 No OUTSIDE MEDICAL CARE Alpha-Numeric 75 No REACTION RELATED TO DONATION Boolean 1 No Page 4

7 DENOMINATOR DATA DATA ELEMENT DATA TYPE MAX LENGTH MANDATORY ORGANIZATION NAME Alpha-Numeric 100 Yes COLLECTION CENTER Alpha-Numeric 100 Yes MONTH Integer 2 Yes YEAR Integer 4 Yes DIMENSION NAME Alpha-Numeric 100 Yes DIMENSION CLASS Alpha-Numeric 100 Yes NO OF DONATIONS Integer 10 Yes Refer Denominator Dimensions for allowed dimension names and classes COLLECTION CENTER DATA DATA ELEMENT DATA TYPE MAX LENGTH MANDATORY COLLECTION CENTER Alpha-Numeric 100 Yes ORGANIZATION Alpha-Numeric 100 Yes USPHS REGION Alpha-Numeric 15 No IS ACTIVE Alpha-Numeric 3 Yes REGION Alpha-Numeric 50 No ADDRESS1 Alpha-Numeric 255 No ADDRESS2 Alpha-Numeric 255 No CITY Alpha-Numeric 100 No STATE CODE Alpha-Numeric 5 No ZIPCODE Alpha-Numeric 15 No COUNTRY Alpha-Numeric 100 No PHONE Alpha-Numeric 15 No FAX Alpha-Numeric 15 No URL Alpha-Numeric 100 No Page 5

8 LITE DATA ELEMENTS AND FORMATS DONOR DATA LITE DATA ELEMENT DATA TYPE MAX LENGTH MANDATORY ORGANIZATION NAME Alpha-Numeric 100 Yes REGION Alpha-Numeric 50 No DONOR IDENTIFIER Alpha-Numeric 50 Yes DATE OF BIRTH MM/DD/YYYY 10 Yes GENDER Alpha-Numeric 10 Yes DONATION DATA LITE DATA ELEMENT DATA TYPE MAX LENGTH MANDATORY ORGANIZATION NAME Alpha-Numeric 100 Yes REGION Alpha-Numeric 50 No DONOR IDENTIFIER Alpha-Numeric 50 Yes COLLECTION CENTER Alpha-Numeric 100 Yes DONATION IDENTIFIER Alpha-Numeric 50 Yes DONATION DATE MM/DD/YYY 10 Yes DONATION HISTORY Alpha-Numeric 10 No NUMBER OF DONATIONS Integer 3 No COLLECTION SITE Alpha-Numeric 25 No INTENDED DONATION TYPE Alpha-Numeric 15 No INTENDED PROCEDURE TYPE Alpha-Numeric 50 No SUCCESSFUL DONATION Alpha-Numeric 10 No KIND OF SAMPLE Alpha-Numeric 10 No Page 6

9 REACTION DATA LITE DATA ELEMENT DATA TYPE MAX LENGTH MANDATORY ORGANIZATION NAME Alpha-Numeric 100 Yes REGION Alpha-Numeric 50 No DONOR IDENTIFIER Alpha-Numeric 50 Yes COLLECTION CENTER Alpha-Numeric 100 Yes DONATION IDENTIFIER Alpha-Numeric 50 Yes DATE REACTION BEGAN MM/DD/YYYY 10 No LOCATION REACTION BEGAN Alpha-Numeric 25 No REACTION TYPE Alpha-Numeric 40 Yes REACTION CATEGORY Alpha-Numeric 100 Yes RESOLUTION OF ACUTE Alpha-Numeric REACTION 40 No DATE OF RESOLUTION OF MM/DD/YYYY PROLONGED REACTION 10 No OUTCOME Alpha-Numeric 15 No OUTSIDE MEDICAL CARE Alpha-Numeric 75 No Page 7

10 REACTION TYPES & REACTION CATEGORIES REACTION TYPE REACTION CATEGORY Vasovagal Prefaint, no LOC (uncomplicated or minor) LOC Local injury related to needle Nerve Irritation Hematoma / Bruise Arterial Puncture Painful Arm Delayed Bleeding Infection Apheresis Citrate Hemolysis Air Embolus Infiltration Allergic Local Systemic Anaphylaxis Injury Major Injury Minor Injury Major Cardiovascular Event Angina pectoris within 24 hours Cardiac arrest Cerebrovascular accident Myocardial infarction within 24 hours Transient ischemic attack within 24 hours (TIA) Other Other Page 8

11 REACTION CATEGORIES & SIGN AND SYMPTOMS VASOVAGAL REACTION CATEGORY SIGN & SYMPTOMS Prefaint, no LOC (uncomplicated or minor) 1. Cold extremities, chills 2. Feeling of warmth 3. Hypotension 4. Lightheaded / Dizziness 5. Nausea / vomiting 6. Normal pulse 7. Pallor, pale skin or lips 8. Rapid pulse 9. Slow pulse 10. Sweating 11. Twitching 12. Weakness LOC 1. Chest Pain 2. Cold extremities, chills 3. Convulsions 4. Feeling of warmth 5. Hypotension 6. Lightheaded / Dizziness 7. Loss of bladder, bowel control 8. Loss of consciousness < 60 seconds 9. Loss of consciousness >= 60 seconds 10. Nausea / vomiting Page 9

12 11. Normal pulse 12. Pallor, pale skin or lips 13. Rapid pulse 14. Slow pulse 15. Sweating 16. Tetany 17. Twitching 18. Weakness LOCAL INJURY RELATED TO NEEDLE REACTION CATEGORY SIGN & SYMPTOMS Nerve Irritation 1. Immediate intense pain at site, 2. Parasthesias, Numbness or tingling of fingers, hand or arm 3. Shooting pain down arm 4. Weakness of arm Hematoma / Bruise 1. Pain 2. Pressure, swelling, tenderness 3. Redness, warmth Arterial Puncture 1. Bright red blood 2. Pulse sensation in tubing 3. Pulsing blood flow 4. Rapid filling of bag (less than 4 minutes) 5. Rapid filling of bag (less than 4 minutes) Page 10

13 APHERESIS REACTION CATEGORY Citrate SIGN & SYMPTOMS 1. Bluish tint to skin (cyanosis) 2. Carpopedal spasms 3. Chills / Shivering 4. Circumoral paresthesia 5. Mental confusion 6. Muscle tightness or cramping, tetany 7. Nausea / vomiting 8. Normal Pulse 9. Pallor 10. Rapid pulse 11. Sharp chest pain 12. Shock - Low blood pressure 13. Shortness of breath 14. Slow Pulse 15. Tachycardia, irregular heart beat 16. Twitching / tremors (Sensation of vibration) Hemolysis 1. Back / Flank pain 2. Bluish tint to skin (cyanosis) 3. Hematuria 4. Mental confusion 5. Pallor 6. Red plasma 7. Shock - Low blood pressure 8. Shortness of breath Page 11

14 9. Tachycardia, irregular heart beat Air Embolus 1. Back / Flank pain 2. Bluish tint to skin (cyanosis) 3. Mental confusion 4. Nausea / vomiting 5. Sharp chest pain 6. Shock-low blood pressure 7. Shortness of breath 8. Tachycardia, irregular heart beat Infiltration 1. Pain 2. Swelling ALLERGIC REACTION CATEGORY Local SIGN & SYMPTOMS 1. Itching at insertion or bandage site 2. Rash / Hives at insertion or bandage site 3. Redness at needle insertion or bandage site Systemic 1. Anxiousness, restlessness 2. Arrhythmia 3. Cyanosis 4. Generalized hives 5. Generalized itching 6. Generalized rash 7. High blood pressure 8. Itching at insertion or bandage site 9. Laryngeal edema with stridor Page 12

15 10. Low blood Pressure 11. Normal Pulse 12. Pulmonary edema 13. Rapid Pulse 14. Rash / Hives at insertion or bandage site 15. Redness at needle insertion or bandage site 16. Scratchy feeling in throat 17. Shortness of breath 18. Slow Pulse 19. Sneezing and nasal congestion 20. Wheezing Anaphylaxis 1. Anxiousness, restlessness 2. Arrhythmia 3. Cyanosis 4. Generalized hives 5. Generalized itching 6. Generalized rash 7. High blood pressure 8. Itching at insertion or bandage site 9. Laryngeal edema with stridor 10. Low blood pressure 11. Normal Pulse 12. Pulmonary edema 13. Rapid Pulse 14. Rash / Hives at insertion or bandage site 15. Redness at needle insertion or bandage site Page 13

16 16. Scratchy feeling in throat 17. Shortness of breath 18. Slow Pulse 19. Sneezing and nasal congestion 20. Swollen tongue, throat, eyes and face 21. Wheezing OTHER REACTION CATEGORY Other SIGN & SYMPTOMS Signs and symptoms of all reaction types & categories Page 14

17 REACTION CATEGORIES & OTHER ADVERSE EVENTS REACTION TYPE REACTION CATEGORY ADVERSE EVENT CATEGORY Vasovagal Prefaint, no LOC (uncomplicated or minor) LOC LOC Local injury, related to needle Nerve Irritation Hematoma / Bruise Arterial Puncture Painful Arm Delayed Bleeding Infection Major Blood Vessel Injury Infection Major Blood Vessel Injury Apheresis Citrate Hemolysis Air Embolus Infiltration Allergic Local Systemic Anaphylaxis Injury Major Injury Injury Minor Injury Major Cardiovascular Event Angina pectoris within 24 hours Cardiac arrest Cerebrovascular accident Myocardial infarction within 24 hours Minor Injury Page 15

18 Transient ischemic attack within 24 hours (TIA) Other Other All other adverse events regardless of reaction types & categories Page 16

19 ADVERSE EVENTS ADVERSE EVENT GROUP Major Blood Vessel Injury ADVERSE EVENT 1. Arteriovenous fistula 2. Brachial artery pseudoaneurysm 3. Compartment syndrome 4. Deep vein thrombosis Injury 1. Closed head injury 2. Dental injury 3. Fracture 4. Laceration 5. Motor vehicle accident with imputability 6. Other 7. Soft Tissue Injury 8. Other 9. Soft tissue injury Minor Injury 1. Abrasion 2. Bruise 3. Hematoma 4. Pain Infection 1. Local infection Cellulitis 2. Thrombophlebitis LOC 1. < 60 seconds 2. >= 60 seconds 3. Complicated 4. Uncomplicated Page 17

20 DENOMINATOR DIMENSIONS DENOMIANTOR NAME DENOMINATOR CLASS NAME Age >= Other Blood Pressure 1. BP < BP BP > Other Collection Site 1. Mobile donor coach 2. Fixed site 3. Mobile inside-set-up 4. Other Donation History 1. First 2. Repeat 3. Other Donation Type 1. Allogeneic 2. Autologous Page 18

21 3. Directed 4. Source Plasma 5. Therapeutic 6. Other Ethnicity 1. Hispanic or Latino 2. Not Hispanic or Latino 3. Other Gender 1. Female 2. Male 3. Other Height 1. < > Other Procedure Type 1. Apheresis Double Red Cells 2. Apheresis Leukocytes 3. Apheresis Plasma 4. Apheresis Platelets 5. Apheresis Platelets and Plasma 6. Apheresis Platelets and Red Cells 7. Apheresis Platelet Plasma Red Cells 8. Apheresis Plasma Red Cells 9. Apheresis Stem Cells 10. Sample Only Page 19

22 11. Whole Blood 12. Apheresis Red Cells 13. Other Pulse 1. < > Other Race 1. African American or Black 2. Asian 3. American Indian/Alaska Native 4. Native Hawaiian/Other Pacific Islander 5. White 6. Other Sponsor Group Type 1. College 2. High School 3. Military 4. Work place 5. Other 6. NA Weight 1. < Page 20

23 >= Other Total Device Manufacturer 1. Total Donations (Any Manufacturer added to Organization profile. For example) 1. Caridian BCT 2. Haemonetics 3. Terumo Device Model (Value in CSV file should be semicolon separated in the format <manufactuer> ; <model>. For example) 1. CaridianBCT ; Refurbished Spectra CaridianBCT ; Spectra Haemonetics ; Cymbal Device Software (Value in CSV file should be semicolon separated in the format <manufactuer>;<model> ; <software>. For example) 1. CaridianBCT ; Refurbished Spectra ; CaridianBCT ; Spectra ; Haemonetics ; Cymbal ; B Page 21

24 Container Manufacturer (Any Manufacturer added to Organization profile. For example) 1. CaridianBCT 2. Fenwal 3. Gambro Container Kit Type (Value in CSV file should be semicolon separated in the format <manufacturer>;<kit Number> For example:) 1. CaridianBCT ; Fenwal ; 2B1323N 3. Haemonetics ; Page 22

25 DEFINITIONS DATA ELEMENT ORGANIZATION NAME REGION DONOR IDENTIFIER GENDER ETHNICITY RACE COLLECTION CENTER DONATION IDENTIFIER DONATION HISTORY DONOR HEIGHT DONOR WEIGHT NUMBER OF DONATIONS COLLECTION SITE SPONSORING GROUP TYPE DEFINITION An identifier that uniquely defines an organization. In the case when donor identifier is unique within a region (as in the case of ARC), the region name. In this case region is mandatory. An identifier that uniquely identifies a donor. Valid Values: Male, Female Valid Values: HISP, NOHISP HISP - Hispanic or Latino NOHISP - Not Hispanic or Latino Can specify multiple values separated by semicolon. Valid Values: AMIN, ASIAN, AAB, NH-PI, WHITE AMIN - American Indian/Alaska native AAB - African American or Black NH-PI - Native Hawaiian/Other Pacific Islander An identifier of the collection center where the donation happened. An identifier that uniquely identifies a donation. Valid Values: First, Repeat Height in inches Weight in lbs Donations made in the past 12 months. Valid Values: Fixed site, Mobile inside-set-up, Mobile donor coach Valid Values: High school, College, Work Place, Military, Other Page 23

26 INTENDED DONATION TYPE INTENDED PROCEDURE TYPE COMPONENTS PRODUCED SUCCESSFUL DONATION KIND OF SAMPLE LOCATION REACTION BEGAN REACTION TYPE REACTION CATEGORY REACTION BEGAN MORE THAN 30 MINUTES AFTER NEEDLE WITHDRAWAL RECOVERY MORE THAN 30 MINS SIGNS AND SYMPTOMS OTHER ADVERSE EVENTS Valid Values: Allogeneic, Autologous, Therapeutic, Directed, Source Plasma, Other Valid Values: Whole Blood, Apheresis Platelets, Apheresis Red Cells, Apheresis Plasma, Apheresis Platelets and Plasma, Apheresis Platelets and Red Cells, Sample only, Apheresis Leukocytes, Apheresi Platelet Plasma Red Cells, Apheresis Plasma Red Cells, Apheresis Stem Cells, Apheresis Doub Red Cells Component Produced by total. Can specify multiple combinations of component name and i number of units. Valid Values: Whole Blood, Platelets, Red Blood Cells, Plasma, Leukocyte, Stem cells. Valid Values: Yes, No Valid Values: Capillary, Venous Valid Values: Registration, Screening, Bed, Transit to canteen, Canteen, Other location on site, Off site Valid Values: See Reaction Types & Reaction Categories Valid Values: See Reaction Types & Reaction Categories Valid Values: 1 for Yes and 0 for No Valid Values: 1 for Yes and 0 for No Can specify multiple values separated by semicolon. Valid Values: See Reaction Categories & Sign and Symptoms Can specify multiple values separated by semicolon Valid Values: See Other REACTION CATEGORY SIGN & SYMPTOMS Page 24

27 Other Signs and symptoms of all reaction types & categories OTHER EVENTS RESOLUTION OF ACUTE REACTION OUTCOME OUTSIDE MEDICAL CARE REACTION RELATED TO DONATION MONTH YEAR DIMENSION NAME DIMENSION CLASS NO OF DONATIONS USPHS REGION IS ACTIVE REGION ADDRESS1 ADDRESS2 Reaction Categories & Other Adverse Events and Adverse Events Any other Events. Valid Values: Released, Released, escorted, Released to outside medical care, N/A Valid Values: Open, Resolved, Death, Disability. Can specify multiple values separated by semicolon. Valid Values: None, ER, EMT, Outpatient, Hospital Admission, Multiple clinic visits Indicates whether the reaction is related to donation or not Valid Values: 1 for Yes and 0 for No Month ( in number) to indicate the month for which denominator data is being reported Year ( in number) to indicate the year for which denominator data is being reported Name of the Dimension for which denominator data is being reported. See Error! Reference source not found. to view the valid values. Name of the Dimension Class for which denominator data is being reported. See Error! Refer source not found. to view the valid values. Number of donations An identifier that uniquely identifies a donor. Valid Values: REGION I, REGION II, REGION III, REGION IV, REGION V, REGION VI, REGION VII, REGION VIII, REGION IX, REGION X Indicates whether the Collection Center is active or not. Valid Values: Yes, No In the case when donor identifier is unique within a region (as in the case of ARC), the region name. In this case region is mandatory. Part 1 of the Collection Center s address Part 2 of the Collection Center s address Page 25

28 CITY STATE CODE ZIPCODE COUNTRY PHONE FAX URL Collection Center s city State Code of the state to which the Collection Center belongs Valid Values: All the standard codes for USA states and Other Zip Code of location where Collection Center is located Country where Collection Center is located. Valid Values: USA, Other Phone number of the Collection Center Fax of the Collection Center URL of the Collection Center Page 26