16.3 Survey

OMB #: 0925-0593

OMB Expiration Date: 07/31/ 2013

Biospecimen Child Blood Instrument, Phase 2e

Biospecimen Child Blood Instrument

Event:	12-Month
Participant:	Child
Respondent: Domain: Type of Document: Allowable Mode: Allowable Method:	Parent/Caregiver Biospecimen Instrument In Person CAPI
Recruitment Groups: Version: Release:	EH, PB, HI 1.0 MDES 3.0

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Biospecimen Child Blood Instrument

TABLE OF CONTENTS

Biospecimen Child Blood Instrument

1

Blood Collection 6

Blood Centrifugation 11

Preparation for Blood Tube Transport 16

Biospecimen Child Blood Instrument

(TIME_STAMP_1) PROGRAMMER INSTRUCTION:

• INSERT DATE/TIME STAMP.

BL0100/(BLOOD_INTRO). I would like to collect a sample of {CHILD’S NAME/ the child}’s blood. Before I do so, I will explain this collection and ask you some questions.

DATA COLLECTOR INSTRUCTIONS:

• EXPLAIN THE CHILD BLOOD COLLECTION PROTOCOL TO THE PARENT OR CAREGIVER .

• IF THE PARENT OR CAREGIVER REFUSED THE COLLECTION, SELECT REFUSED. OTHERWISE, SELECT CONTINUE.

CONTINUE 1

REFUSED -1

PROGRAMMER INSTRUCTIONS:

• PRELOAD PARTICIPANT ID (P_ID) FOR CHILD AND RESPONDENT ID (R_P_ID) FOR RESPONDENT (MOTHER, FATHER, OTHER).

• PRELOAD CHILD’S FIRST NAME (BABY_FNAME) AND DISPLAY NAME IN “CHILD’S NAME” THROUGHOUT DOCUMENT.

• USE “the child” IN APPROPRIATE FIELDS THROUGHOUT THE INSTRUMENT IF CHILD’S NAME IS REFUSED OR DON’T KNOW.

• PRELOAD CHILD_SEX.

• IF CHILD_SEX = 1, DISPLAY “his” AND “he” IN APPROPRIATE FIELDS THROUGHOUT INSTRUMENT.

• IF CHILD_SEX = 2, DISPLAY “her” AND “she” IN APPROPRIATE FIELDS THROUGHOUT INSTRUMENT.

DATA COLLECTOR COMPLETED QUESTION:

BL0100A/(RESP_REL). WHAT IS THE RELATIONSHIP OF THE PARENT OR CAREGIVER TO CHILD?

MOTHER 1

FATHER 2

OTHER -5

PROGRAMMER INSTRUCTIONS:

• IF BLOOD_INTRO = 1 AND RESP_REL = 1 OR 2, GO TO HEMOPHILIA.

• IF BLOOD_INTRO = -1 AND RESP_REL = 1 OR 2, GO TO REFUSAL_REASON.

• OTHERWISE, IF RESP_REL = -5, GO TO RESP_REL_OTH.

BL0100B/(RESP_REL_OTH).

SPECIFY__________________________________

PROGRAMMER INSTRUCTIONS:

• LIMIT TEXT TO 255 CHARACTERS.

• IF BLOOD_INTRO = 1, GO TO HEMOPHILIA.

• OTHERWISE, GO TO REFUSAL_REASON.

BL0100C/(REFUSAL_REASON). I am sorry that you have chosen not to participate in this collection. Can you tell me why?

DATA COLLECTOR INSTRUCTION:

• ENTER REASON FOR REFUSAL.

CHILD HAS FEVER/OTHER ILLNESS 1 (BL2000)

OTHER -5

REFUSED -1 (BL2000)

DON’T KNOW -2 (BL2000)

BL0100D/(REFUSAL_REASON_OTH).

SPECIFY________________________________________________(BL2000)

PROGRAMMER INSTRUCTION:

• LIMIT TEXT TO 255 CHARACTERS.

BL0200/(HEMOPHILIA). Has {CHILD’S NAME/the child} been diagnosed with hemophilia or any bleeding disorder?

DATA COLLECTOR INSTRUCTION:

• RESPONSE DETERMINES ELIGIBILITY OF CHILD FOR BLOOD DRAW.

YES 1 (BL1600)

NO 2

REFUSED -1 (BL1900)

DON’T KNOW -2 (BL1900)

BL0300/(BLOOD_THINNER). Has {CHILD’S NAME/the child} taken any blood thinning medication, such as Coumadin or Warfarin?

DATA COLLECTOR INSTRUCTION:

• RESPONSE DETERMINES ELIGIBILITY OF STUDY PARTICIPANT FOR BLOOD DRAW.

YES 1 (BL1600)

NO 2

REFUSED -1 (BL1900)

DON’T KNOW -2 (BL1900)

BL0400/(CHEMO). Has {CHILD’S NAME/the child} had cancer chemotherapy within the past 4 weeks?

DATA COLLECTOR INSTRUCTION:

• RESPONSE DETERMINES ELIGIBILITY OF STUDY PARTICIPANT FOR BLOOD DRAW.

YES 1 (BL1600)

NO 2

REFUSED -1 (BL1900)

DON’T KNOW -2 (BL1900)

BL0500/(BLOOD_DRAW). In the past, have there been any problems with taking blood from {CHILD’S NAME/the child}?

YES 1

NO 2 (LAST_EAT_ TIME/LAST_EAT_TIME_UNIT/LAST_EAT_DATE)

REFUSED -1 (LAST_EAT_ TIME/LAST_EAT_TIME_UNIT/LAST_EAT_DATE)

DON’T KNOW -2 (LAST_EAT_ TIME/LAST_EAT_TIME_UNIT/LAST_EAT_DATE)

BL0600/(BLOOD_DRAW_PROB). What problems did {he/she} have with taking blood in the past?

DATA COLLECTOR INSTRUCTIONS:

• SELECT ALL THAT APPLY.

• PROBE: Any others?

FAINTING 1

HEMATOMA 2

UNCOOPERATIVE/FIGETING/UNCONTROLLABLE CRYING 3

BRUISING 4

OTHER -5

REFUSED -1

DON’T KNOW -2

PROGRAMMER INSTRUCTIONS:

• IF BLOOD_DRAW_PROB = any combination of 1 through 4, go to LAST_EAT_ TIME/LAST_EAT_TIME_UNIT/LAST_EAT_DATE

• IF BLOOD_DRAW_PROB = any combination of 1 through 4, and -5, go to BLOOD_DRAW_OTH.

• IF BLOOD_DRAW_PROB = -5, go to BLOOD_DRAW_OTH.

• IF BLOOD_DRAW_PROB = -1 or -2, do not allow any other responses and go to LAST_EAT_ TIME/LAST_EAT_TIME_UNIT/LAST_EAT_DATE.

• BLOOD_DRAW_PROB can only = -1 or -2; not both.

BL0600A/(BLOOD_DRAW_OTH).

DATA COLLECTOR INSTRUCTION:

• IF THERE WERE ANY PROBLEMS WITH A PAST BLOOD DRAW THAT ARE NOT LISTED IN THE PREVIOUS QUESTION, RECORD THE PROBLEM BELOW.

SPECIFY:________________________________

PROGRAMMER INSTRUCTION:

• LIMIT TEXT TO 255 CHARACTERS.

BL0700/(LAST_EAT_TIME/LAST_EAT_TIME_UNIT/LAST_EAT_DATE). When was the last time {CHILD’S NAME/the child} had anything to eat or drink other than water?

DATA COLLECTOR INSTRUCTIONS:

• RECORD THE LAST TIME CHILD ATE OR DRANK ANYTHING OTHER THAN WATER.

• RECORD THE TIME AS HH:MM, BE SURE TO FILL THE SPACE WITH A ZERO WHEN NECESSARY AND TO MARK THE BOX TO CHOOSE “AM” OR “PM”. FOR EXAMPLE, IF THE LAST TIME CHILD ATE OR DRANK WAS AT 2:05 PM, RECORD “02:05” AND CHOOSE “PM”.

• RECORD THE DATE AS TWO-DIGIT MONTH, TWO-DIGIT DAY, AND FOUR-DIGIT YEAR.

BL0700A/(LAST_EAT_TIME). LAST TIME ATE OR DRANK – TIME

|___|___|:|___|___|

H H M M

REFUSED -1

DON’T KNOW -2

BL0700B/(LAST_EAT_TIME_UNIT). LAST TIME ATE OR DRANK – AM/PM

AM 1

PM 2

BL0700C/(LAST_EAT_DATE). LAST TIME ATE OR DRANK – DATE

|___|___| / |___|___| / |___|___|___|___|

M M D D Y Y Y Y

REFUSED -1

DON’T KNOW -2

PROGRAMMER INSTRUCTIONS:

• HARD EDIT: INCLUDE HARD EDIT IF HOURS, MINUTES, MONTH, OR DAY ARE NOT TWO DIGITS. (FILL THE SPACE WITH 0 AS NECESSARY).

• HARD EDIT: INCLUDE HARD EDIT IF HOUR OR MONTH IS NOT BETWEEN 01 AND 12.

• HARD EDIT: INCLUDE HARD EDIT IF MINUTES ARE NOT BETWEEN 00 AND 59.

• HARD EDIT: INCLUDE HARD EDIT IF DAY IS NOT BETWEEN 01 AND 31.

• HARD EDIT: INCLUDE HARD EDIT IF YEAR IS < 2012.

• HARD EDIT: INCLUDE HARD EDIT IF DATE AND TIME IS GREATER THAN CURRENT DATE AND TIME.

• FORMAT DATE AS YYYYMMDD.

BL1200/(VITAMIN). Has {CHILD’S NAME/the child} taken a dietary supplement such as vitamins or minerals in the last 8 hours?

YES 1

NO 2

REFUSED -1

DON’T KNOW -2

BL1500/(BLOOD_COMPLETE). Thank you for answering my questions. I am now going to prepare to draw blood.

CONTINUE 1 (TIME_STAMP_2)

REFUSED -1 (BL2000)

BL1600. Because {CHILD’S NAME/the child} {has been diagnosed with a bleeding disorder/uses blood thinners/had cancer chemotherapy}, we will not be able to draw {his/her} blood for this study. (TIME_STAMP_5)

PROGRAMMER INSTRUCTIONS:

• DISPLAY “has been diagnosed with a bleeding disorder” IF HEMOPHILIA=1.

• DISPLAY “uses blood thinners” IF BLOOD_THINNER=1.

• DISPLAY “had cancer chemotherapy” IF CHEMO=1.

BL1900. Because you do not know or declined to answer questions about {CHILD’S NAME/the child’s} {hemophilia/use of blood thinners/chemotherapy status}, we will not be able to draw {his/her} blood for this study. (TIME_STAMP_5)

PROGRAMMER INSTRUCTIONS:

• DISPLAY “hemophilia” IF HEMOPHILIA = -1 OR -2.

• DISPLAY “use of blood thinners” IF BLOOD_THINNER = -1 OR -2.

• DISPLAY “chemotherapy status” IF CHEMO = -1 OR -2.

BL2000. That’s fine. Thank you for your time. (TIME_STAMP_5)

BLOOD COLLECTION

(TIME_STAMP_2) PROGRAMMER INSTRUCTION:

• INSERT DATE/TIME STAMP.

BL2100/(BLOOD_INST). BLOOD DRAW INSTRUCTIONS

DATA COLLECTOR INSTRUCTIONS:

• CONFIRM THAT BLOOD TUBES ARE LABELED AND NOT EXPIRED PRIOR TO COLLECTION OF SPECIMEN.

• BE SURE TO EMPLOY UNIVERSAL PRECAUTIONS TO PREVENT EXPOSURE TO INFECTIOUS DISEASES AT ALL TIMES WHEN HANDLING BIOLOGICAL SPECIMENS.BE SURE TO EXPLAIN EACH PART OF PROCEDURE BEING PERFORMED DURING BLOOD COLLECTION.

• STOP DRAWING BLOOD IF BRUISING OCCURS.

• COLLECTION TUBES SHOULD BE DRAWN IN THE FOLLOWING ORDER:

• 3mL Lavender Top AA# # # # # # # - LV20

• 3mL Red top AA# # # # # # # - RD20

• 3mL Red top AA# # # # # # # - RD21

• 3mL Lavender top AA# # # # # # # - LV21

BL2100A/(COLLECTION_LOCATION). COLLECTION LOCATION

DATA COLLECTOR INSTRUCTION:

• RECORD WHERE BLOOD COLLECTION OCCURRED.

HOME 1 (CBLOOD_COLL_DATE)

CLINIC 2 (CBLOOD_COLL_DATE)

OTHER LOCATION -5

BL2100B/(COLLECTION_LOCATION_OTH).

SPECIFY______________________________________

PROGRAMMER INSTRUCTION:

• LIMIT TEXT TO 255 CHARACTERS.

BL2150/(CBLOOD_COLL_DATE). DATE CHILD BLOOD SPECIMEN COLLECTED

|___|___| / |___|___| / |___|___|___|___|

M M D D Y Y Y Y

BL2150A/(CBLOOD_COLL_TIME). TIME CHILD BLOOD SPECIMEN COLLECTED

|___|___|:|___|___|

H H M M

BL2150B/(CBLOOD_COLL_TIME_UNIT). TIME CHILD BLOOD SPECIMEN COLLECTED – AM/PM

AM 1

PM 2

DATA COLLECTOR INSTRUCTION:

• RECORD THE DATE AS TWO DIGIT MONTH, TWO DIGIT DAY, AND FOUR DIGIT YEAR.

PROGRAMMER INSTRUCTIONS:

• HARD EDIT: INCLUDE HARD EDIT IF HOURS, MINUTES, MONTH, OR DAY ARE NOT TWO DIGITS. (FILL THE SPACE WITH 0 AS NECESSARY).

• HARD EDIT: INCLUDE HARD EDIT IF HOUR OR MONTH IS NOT BETWEEN 01 AND 12.

• HARD EDIT: INCLUDE HARD EDIT IF MINUTES ARE NOT BETWEEN 00 AND 59.

• HARD EDIT: INCLUDE HARD EDIT IF DAY IS NOT BETWEEN 01 AND 31.

• HARD EDIT: INCLUDE HARD EDIT IF YEAR IS < 2012.

• HARD EDIT: INCLUDE HARD EDIT IF DATE AND TIME IS GREATER THAN CURRENT DATE AND TIME.

• FORMAT DATE AS YYYYMMDD.

BL2200. Thank you for {CHILD’S NAME/the child}’s blood sample.

DATA COLLECTOR INSTRUCTION:

• CHECK IF CLOTTING HAS OCCURRED AND APPLY BAND-AID OVER GAUZE.

BL2400/(TUBE_TYPE). ASSIGN TUBE_TYPE

PROGRAMMER INSTRUCTIONS:

• LOOP THROUGH TUBE_TYPE, SPECIMEN_ID, TUBE_STATUS, TUBE_COMMENTS (IFAPPLICABLE) AND TUBE_COMMENTS_OTH (IF APPLICABLE) SEQUENTIALLY FOR EACH OF THE FOUR (4) BLOOD TUBES. THEN GO TO COLLECTION_STATUS.

• DISPLAY CORRECT TUBE_TYPE FOR EACH LOOP:

• IF FIRST CYCLE OF the LOOP, THEN SET TUBE_TYPE = 1 AND DISPLAY “3mL Lavender top (LV20).”

• IF SECOND CYCLE OF THE LOOP, THEN SET TUBE_TYPE = 2 AND DISPLAY “3mL Red top (RD20).”

• IF THIRD CYCLE OF THE LOOP, THEN SET TUBE_TYPE = 3 AND DISPLAY “3mL Red top (RD21).”

• IF FOURTH CYCLE OF THE LOOP, THEN SET TUBE_TYPE = 4 AND DISPLAY “3mL Lavender top (LV21).”

BL2500/(SPECIMEN_ID). SPECIMEN_ID FOR {TUBE_TYPE}

DATA COLLECTOR INSTRUCTIONS:

• SCAN {TUBE_TYPE} BARCODE.

• IF THE BARCODE SCANNER IS NOT WORKING, MANUALLY ENTER THE INFORMATION.

• FORMAT SHOULD BE AA # # # # # # # - AA # #

|___|___|___|___|___|___|___|___|___| - |___|___|___|___|

PROGRAMMER INSTRUCTIONS:

• DISPLAY CORRECT TUBE_TYPE DESCRIPTION IN BRACKETS AND FORMAT FOR SPECIMEN_ID FOR EACH LOOP:

• IF TUBE_TYPE = 1, DISPLAY “3mL Lavender top, (LV20)” AND FORMAT
  AA# # # # # # # - LV20.

• IF TUBE_TYPE = 2, DISPLAY “3mL Red top (RD20),” AND FORMAT
  AA# # # # # # # - RD20.

• IF TUBE_TYPE = 3, DISPLAY “3mL Red top (RD21),” AND FORMAT

• AA# # # # # # # - RD21.

• IF TUBE_TYPE = 4, DISPLAY “3mL Lavender top (LV21),” AND FORMAT
  AA# # # # # # # - LV21.

BL2600/(TUBE_STATUS). {TUBE_TYPE} BLOOD TUBE COLLECTION STATUS

FULL DRAW 1

SHORT DRAW 2

NO DRAW 3

DATA COLLECTOR INSTRUCTIONS:

• ENTER STATUS OF {TUBE_TYPE} BLOOD TUBE.

• SELECT “FULL DRAW” TO INDICATE THAT THE BLOOD TUBE WAS FILLED TO AT LEAST 3/4 OF THE DESIRED CAPACITY. DESIRED CAPACITY IS DEFINED AS FILLED TO THE FILL LINE INDICATED ON THE BLOOD TUBE LABEL.

• SELECT “SHORT DRAW” TO INDICATE THAT THE BLOOD TUBE WAS FILLED TO LESS THAN 3/4 OF THE DESIRED CAPACITY.

• SELECT “NO DRAW” TO INDICATE THAT THE BLOOD TUBE WAS NOT COLLECTED.

PROGRAMMER INSTRUCTIONS:

• DISPLAY CORRECT TUBE_TYPE FOR LOOP:

• IF FIRST CYCLE OF the LOOP, THEN TUBE_TYPE = 1, DISPLAY ”3mL Lavender top (LV20)”.

• IF SECOND CYCLE OF THE LOOP, THEN TUBE_TYPE = 2, DISPLAY ”3mL Red top (RD20)”.

• IF THIRD CYCLE OF THE LOOP, THEN TUBE_TYPE = 3, DISPLAY ”3mL Red top (RD21)”.

• IF FOURTH CYCLE OF THE LOOP, THEN TUBE_TYPE = 4, DISPLAY ”3mL Lavender top (LV21)”.

• IF TUBE_STATUS = 2 OR 3, GO TO TUBE_COMMENTS.

• OTHERWISE, IF TUBE_STATUS = 1 AND

  • TUBE_TYPE = 1, 2, OR 3, GO TO TUBE_TYPE AND LOOP THROUGH REMAINING BLOOD SPECIMENS.

  • TUBE_TYPE = 4, GO TO OVERALL_COMMENTS.

BL2700/(TUBE_COMMENTS). REASON {TUBE_TYPE} BLOOD TUBE NOT COLLECTED OR DRAW WAS SHORT.

DATA COLLECTOR INSTRUCTION:

• ENTER REASONS {TUBE_TYPE} WAS NOT COLLECTED OR DRAW WAS SHORT. SELECT ALL THAT APPLY

EQUIPMENT FAILURE 1

FAINTING 2

LIGHT-HEADEDNESS 3

HEMATOMA 4

BRUISING 5

VEIN COLLAPSED DURING PROCEDURE 6

NO SUITABLE VEIN 7

UNCOOPERATIVE/FIDGETING/UNCOTROLLABLE CRYING 8

PARENT/CAREGIVER REFUSED 9

OTHER -5

PROGRAMMER INSTRUCTIONS:

• DISPLAY CORRECT TUBE_TYPE AS REFERENCE FOR LOOP:

• IF FIRST CYCLE OF the LOOP, THEN TUBE_TYPE = 1, DISPLAY ”3mL Lavender top (LV20)”.

• IF SECOND CYCLE OF THE LOOP, THEN TUBE_TYPE = 2, DISPLAY ”3mL Red top (RD20)”.

• IF THIRD CYCLE OF THE LOOP, THEN TUBE_TYPE = 3, DISPLAY ”3mL Red top (RD21)”.

• IF FOURTH CYCLE OF THE LOOP, THEN TUBE_TYPE = 4, DISPLAY ”3mL Lavender top (LV21)”.

• IF TUBE_TYPE = 1, 2, OR 3 AND

  • TUBE_COMMENTS = ANY COMBINATION OF 1 THROUGH 8, GO TO TUBE_TYPE AND LOOP THROUGH REMAINING BLOOD SPECIMENS.

  • TUBE_COMMENTS = -5 OR ANY COMBINATION OF 1 THROUGH 8 AND -5, GO TO TUBE_COMMENTS_OTH.

  • TUBE_COMMENTS = -1 OR -2, DO NOT ALLOW ANY OTHER RESPONSES, GO TO TUBE_TYPE AND LOOP THROUGH REMAINING BLOOD SPECIMENS.

• IF TUBE_TYPE = 4 AND

  • TUBE_COMMENTS = ANY COMBINATION OF 1 THROUGH 8, GO TO COLLECTION_STATUS.

  • TUBE_COMMENTS = -5 OR ANY COMBINATION OF 1 THROUGH 8 AND -5, GO TO TUBE_COMMENTS_OTH.

  • TUBE_COMMENTS = -1 OR -2, DO NOT ALLOW ANY OTHER RESPONSES AND GO TO COLLECTION_STATUS.

BL2700A/(TUBE_COMMENTS_OTH)

SPECIFY

PROGRAMMER INSTRUCTIONS:

• LIMIT TEXT TO 255 CHARACTERS.

• IF TUBE_TYPE = 1, 2, OR 3 GO TO TUBE_TYPE AND LOOP THROUGH REMAINING BLOOD SPECIMENS.

• IF TUBE_TYPE = 4, GO TO COLLECTION_STATUS.

BL2800/(COLLECTION_STATUS). BLOOD TUBE COLLECTION OVERALL STATUS

COLLECTED 1

PARTIALLY COLLECTED 2

NOT COLLECTED 3

PROGRAMMER INSTRUCTIONS:

• COLLECTION_STATUS = 1 IF EACH TUBE_TYPE HAS A TUBE_STATUS = 1.

• COLLECTION_STATUS = 2 IF AT LEAST 1 BUT LESS THAN 4 TUBES HAVE A TUBE_STATUS = 1 OR THAT ALL TUBES HAVE A TUBE_STATUS = 2.

• COLLECTION_STATUS = 3 IF EACH TUBE_TYPE HAS A TUBE_STATUS = 3

• IF COLLECTION STATUS = 1 OR 2, GO TO TIME_STAMP_3.

• OTHERWISE, GO TO OVERALL_COMMENTS.

BL2900/(OVERALL_COMMENTS). BLOOD COLLECTION OVERALL COMMENTS

DATA COLLECTOR INSTRUCTION:

• ENTER MAIN REASON BLOOD WAS NOT COLLECTED.

SAFETY EXCLUSION 1 (BLOOD_DRAW_COMMENT)

PHYSICAL LIMITATION 2 (BLOOD_DRAW_COMMENT)

CAREGIVER ILL/EMERGENCY 3 (BLOOD_DRAW_COMMENT)

QUANTITY NOT SUFFICIENT 4 (BLOOD_DRAW_COMMENT)

CHILD ILL/EMERGENCY 5 (BLOOD_DRAW_COMMENT)

NO TIME 6 (BLOOD_DRAW_COMMENT)

PARENT/CAREGIVER REFUSED 7 (BLOOD_DRAW_COMMENT)

OTHER -5

BL2900A/(OVERALL_COMMENTS_OTH)

SPECIFY (BLOOD_DRAW_COMMENT)

PROGRAMMER INSTRUCTION:

• LIMIT TEXT TO 255 CHARACTERS.

BLOOD CENTRIFUGATION

(TIME_STAMP_3) PROGRAMMER INSTRUCTION:

• INSERT DATE/TIME STAMP.

BL3000/(CENTRIFUGE_LOCATION). CENTRIFUGATION LOCATION

• DATA COLLECTOR INSTRUCTIONS: RECORD WHERE BLOOD WILL BE CENTRIFUGED.

DEFAULT COLLECTION LOCATION 1 (EQUIP_ID)

SPSC 2 (TIME_STAMP_4)

OTHER -5

BL3000A/(CENTRIFUGE_LOCATION_OTH).

SPECIFY_____________________

PROGRAMMER INSTRUCTION:

• LIMIT TEXT TO 255 CHARACTERS.

BL3100/(EQUIP_ID). EQUIPMENT ID FOR CENTRIFUGE

DATA COLLECTOR INSTRUCTION:

• ENTER EQUIPMENT ID FOR CENTRIFUGE.

_________________________________

BL3125/(CENTRIFUGE_START_DATE_TIME). DATE AND TIME CENTRIFUGATION BEGAN

DATA COLLECTOR INSTRUCTIONS:

• RECORD THE TIME THE BLOOD TUBES WERE PLACED IN THE CENTRIFUGE.

• RECORD THE TIME AS HH:MM, BE SURE TO FILL THE SPACE WITH A ZERO WHEN NECESSARY AND TO CHOOSE “AM” OR “PM.” FOR EXAMPLE, IF THE BLOOD TUBES WERE PLACED IN THE CENTRIFUGE AT 2:05 PM, RECORD “02:05” AND CHOOSE “PM.”

• RECORD THE DATE AS TWO-DIGIT MONTH, TWO-DIGIT DAY, AND FOUR-DIGIT YEAR.

BL3125A/(CENTRIFUGE_START_TIME). CENTRIFUGE START – TIME

|___|___|:|___|___|

H H M M

BL3125B/(CENTRIFUGE_START_TIME_UNIT). CENTRIFUGE START – AM/PM

AM 1

PM 2

BL3125C/(CENTRIFUGE_START_DATE). CENTRIFUGE START – DATE

|___|___| / |___|___| / |___|___|___|___|

M M D D Y Y Y Y

PROGRAMMER INSTRUCTIONS:

• HARD EDIT: INCLUDE HARD EDIT IF HOURS, MINUTES, MONTH, OR DAY ARE NOT TWO DIGITS. (FILL THE SPACE WITH 0 AS NECESSARY.)

• HARD EDIT: INCLUDE HARD EDIT IF HOUR OR MONTH IS NOT BETWEEN 01 AND 12.

• HARD EDIT: INCLUDE HARD EDIT IF MINUTES ARE NOT BETWEEN 00 AND 59.

• HARD EDIT: INCLUDE HARD EDIT IF DAY IS NOT BETWEEN 01 AND 31.

• HARD EDIT: INCLUDE HARD EDIT IF YEAR IS < 2012.

• HARD EDIT: INCLUDE HARD EDIT IF DATE AND TIME IS GREATER THAN CURRENT DATE AND TIME.

• FORMAT DATE AS YYYYMMDD.

BL3130/(CENTRIFUGE_END_DATE_TIME).TIME CENTRIFUGATION ENDED

DATA COLLECTOR INSTRUCTIONS:

• RECORD THE TIME CENTRIFUGATION WAS COMPLETED.

• RECORD THE TIME AS HH:MM, BE SURE TO FILL THE SPACE WITH A ZERO WHEN NECESSARY AND TO MARK THE BOX TO CHOOSE “AM” OR “PM.” FOR EXAMPLE, IF CENTRIFUGATION WAS COMPLETED AT 2:05 PM, RECORD “02:05” AND CHOOSE “PM.”

• RECORD THE DATE AS TWO-DIGIT MONTH, TWO-DIGIT DAY, AND FOUR-DIGIT YEAR.

BL3130A/(CENTRIFUGE_END_TIME). CENTRIFUGE END – TIME

|___|___|:|___|___|

H H M M

BL3130B/(CENTRIFUGE_END_TIME_UNIT). CENTRIFUGE END – AM/PM

AM 1

PM 2

BL3130C/(CENTRIFUGE_END_DATE). CENTRIFUGE END – DATE

|___|___| / |___|___| / |___|___|___|___|

M M D D Y Y Y Y

PROGRAMMER INSTRUCTIONS:

• HARD EDIT: INCLUDE HARD EDIT IF HOURS, MINUTES, MONTH, OR DAY ARE NOT TWO DIGITS. (FILL THE SPACE WITH 0 AS NECESSARY.)

• HARD EDIT: INCLUDE HARD EDIT IF HOUR OR MONTH IS NOT BETWEEN 01 AND 12.

• HARD EDIT: INCLUDE HARD EDIT IF MINUTES ARE NOT BETWEEN 00 AND 59.

• HARD EDIT: INCLUDE HARD EDIT IF DAY IS NOT BETWEEN 01 AND 31.

• HARD EDIT: INCLUDE HARD EDIT IF YEAR IS < 2011.

• HARD EDIT: INCLUDE HARD EDIT IF DATE AND TIME IS GREATER THAN CURRENT DATE AND TIME OR LESS THAN CENTRIFUGE_START_TIME AND/OR CENTRIFUGE_START_DATE.

• FORMAT DATE AS YYYYMMDD.

BL3140/(CENTRIFUGE_TEMP_MEASURE). TEMPERATURE OF CENTRIFUGE

DATA COLLECTOR INSTRUCTIONS:

• IF ABLE TO MEASURE CENTRIFUGE TEMPERATURE, SELECT “TEMPERATURE.”

• IF NOT ABLE TO MEASURE CENTRIFUGE TEMPERATURE, THEN SELECT “NOT ABLE TO MEASURE” AND THE REASON THE TEMPERATURE COULD NOT BE RECORDED.

• OTHERWISE, SELECT OTHER AND SPECIFY

TEMPERATURE 1 (CENTRIFUGE_TEMP/

CENT_TEMP_POSNEG)

NOT ABLE TO MEASURE – THERMOMETER BROKEN 2 (BLOOD_HEMOLYZE)

NOT ABLE TO MEASURE – THERMOMETER NOT AVAILABLE 3 (BLOOD_HEMOLYZE)

NOT ABLE TO MEASURE – OTHER -5

BL3140A/(CENTRIFUGE_TEMP_MEASURE_OTH).

SPECIFY ___________________(BLOOD_HEMOLYZE)

PROGRAMMER INSTRUCTION:

• LIMIT TEXT TO 255 CHARACTERS.

BL3150/(CENTRIFUGE_TEMP/CENT_TEMP_POSNEG). TEMPERATURE OF CENTRIFUGE

DATA COLLECTOR INSTRUCTIONS:

• RECORD THE TEMPERATURE READING ON THE DIGITAL THERMOMETER ATTACHED TO THE CENTRIFUGE AT THE TIME THAT THE BLOOD TUBES ARE REMOVED AFTER CENTRIFUGATION.

• ENTER TEMPERATURE IN DEGREES CELSIUS.

BL3150A/(CENTRIFUGE_TEMP). RECORD THE TEMPERATURE TO THE FIRST DECIMAL POINT.

|___|___| . |___| °C

PROGRAMMER INSTRUCTIONS:

• SOFT EDIT: DISPLAY SOFT EDIT IF TEMPERATURE IS < 15.0 ^oC OR > 25.0^oC

• SOFT EDIT: DISPLAY SOFT EDIT IF NO VALUE ENTERED IN THE FIRST DECIMAL POINT.

BL3150B/(CENT_TEMP_POSNEG). RECORD IF THE TEMPERATURE IS A POSITIVE OR NEGATIVE VALUE.

DATA COLLECTOR INSTRUCTIONS:

• If temperature is zero or above, record “Positive.”

• If temperature is below zero, record “Negative.”

POSITIVE 1

NEGATIVE 2

BL3160/(BLOOD_HEMOLYZE). did blood hemolyze?

DATA COLLECTOR INSTRUCTION:

• RECORD WHETHER HEMOLYSIS OCCURRED IN ONE OR MORE OF THE BLOOD TUBES.

YES, ALL TUBES HEMOLYZED 1

YES, AT LEAST ONE TUBE HEMOLYZED AND AT
LEAST ONE TUBE DID NOT HEMOLYZE 2

NO, NONE OF THE TUBES HEMOLYZED 3 (TIME_STAMP_4)

BL3170/(V1_TUBE_HEMOLYZE) INDICATE WHICH TUBE(S) HEMOLYZED.

DATA COLLECTOR INSTRUCTION:

• SELECT ALL THAT APPLY:

(TUBE_TYPE)= 1, 3mL Lavender top (LV20) 1

(TUBE_TYPE)= 2, 3mL Red top (RD20) .. 2

(TUBE_TYPE)= 3, 3mL Red top (RD21) 3

(TUBE_TYPE)= 4, 3mL Lavender top (LV21) 4

PROGRAMMER INSTRUCTION:

• DISPLAY THE FOLLOWING RESPONSE CATEGORIES:

(TUBE_TYPE)= 1, 3mL Lavender top (LV20) 1

(TUBE_TYPE)= 2, 3mL Red top (RD20) .. 2

(TUBE_TYPE)= 3, 3mL Red top (RD21) 3

(TUBE_TYPE)=4, 3mL Lavender top (LV21) 4

BL3180/(CENTRIFUGE_COMMENT). CENTRIFUGE OTHER COMMENTS

DATA COLLECTOR INSTRUCTION:

• ENTER CENTRIFUGE COMMENTS:

NO COMMENTS 1 (TIME_STAMP_4)

COMMENT 2

BL3185/(CENTRIFUGE_COMMENT_OTH).

DATA COLLECTOR INSTRUCTION:

• ENTER ANY CENTRIFUGE COMMENT.

SPECIFY __________________________

PROGRAMMER INSTRUCTION:

• LIMIT FREE TEXT TO 255 CHARACTERS.

PREPARATION FOR BLOOD TUBE TRANSPORT

(TIME_STAMP_4) PROGRAMMER INSTRUCTION:

• INSERT DATE/TIME STAMP.

BL3200/(COLD_TEMP_MEASURE). TEMPERATURE OF REFRIGERATED CHAMBER

DATA COLLECTOR INSTRUCTIONS:

• PREPARE THE TUBES FOR TRANSPORT IN EITHER THE REFRIGERATED CLAMSHELL OR IN THE AMBIENT TUBE HOLDER, DEPENDING ON THE TUBE TYPE AND LOCATION OF CENTRIFUGATION.

• PLACE A LOWER THRESHOLD (0.0C) MONITOR INSIDE THE REFRIGERATED CLAMSHELL AND INSIDE THE AMBIENT TUBE HOLDER (IF APPLICABLE).

• ACTIVATE AN UPPER THRESHOLD (20.0C) MONITOR AND AFFIX IT TO THE OUTSIDE OF THE REFRIGERATED CLAMSHELL.

• IF ABLE TO MEASURE TEMPERATURE, THEN SELECT “TEMPERATURE.” ENTER THE TEMPERATURE OF THE DIGITAL THERMOMETER IN THE TRANSPORT COOLER AT THE TIME THE DATA COLLECTOR PUTS THE SPECIMEN IN THE COOLER.

• IF NOT ABLE TO MEASURE TEMPERATURE, THEN SELECT “NOT ABLE TO MEASURE.”

• IF THERE ARE NOT ANY TUBES THAT REQUIRE REFRIGERATED TRANSPORT TEMPERATURES, THEN SELECT “NOT APPLICABLE.”

TEMPERATURE 1 (COLD_TEMP/

COLD_TEMP_POSNEG)

NOT ABLE TO MEASURE – THERMOMETER BROKEN 2 (COLD_THRESHOLD_LOW)

NOT ABLE TO MEASURE – THERMOMETER NOT AVAILABLE 3 (COLD_THRESHOLD_LOW)

NOT ABLE TO MEASURE – OTHER -5

NOT APPLICABLE -7 (COLD_THRESHOLD_LOW)

BL3200A/(COLD_TEMP_MEASURE_OTH).

SPECIFY (COLD_THRESHOLD_LOW)

PROGRAMMER INSTRUCTION:

• LIMIT TEXT TO 255 CHARACTERS.

BL3300/(COLD_TEMP/COLD_TEMP_POSNEG). RECORD TEMPERATURE OF REFRIGERATED CHAMBER

DATA COLLECTOR INSTRUCTION:

• RECORD THE TEMPERATURE OF THE REFRIGERATED CHAMBER OF THE TRANSPORT COOLER.

BL3300A/(COLD_TEMP). ENTER TEMPERATURE IN DEGREES CELSIUS.

|___|___| . |___| °C

3300B/COLD_TEMP_POSNEG). RECORD IF THE TEMPERATURE IS A POSITIVE OR NEGATIVE VALUE

DATA COLLECTOR INSTRUCTIONS:

• If temperature is zero or above, record “Positive.”

• If temperature is below zero, record “Negative.”

POSITIVE 1

NEGATIVE 2

PROGRAMMER INSTRUCTIONS:

• SOFT EDIT: DISPLAY SOFT EDIT IF TEMPERATURE IS ≥ 10.0^oC OR IF ≤ 0.0^oC.

• SOFT EDIT: DISPLAY SOFT EDIT IF NO VALUE ENTERED IN THE FIELD FOLLOWING THE DECIMAL POINT.

BL3400/(COLD_THRESHOLD_LOW). STATUS OF REFRIGERATED CHAMBER LOW THRESHOLD MONITOR

DATA COLLECTOR INSTRUCTION:

• RECORD STATUS OF THE LOW THRESHOLD MONITOR IN THE REFRIGERATED CHAMBER OF THE TRANSPORT COOLER.

YES, IN CHAMBER 1

NO, NOT REQUIRED 2

NO, NOT AVAILABLE 3

BL3500/(COLD_THRESHOLD_HIGH). STATUS OF REFRIGERATED CHAMBER HIGH THRESHOLD MONITOR

DATA COLLECTOR INSTRUCTION:

• RECORD STATUS OF THE HIGH THRESHOLD MONITOR IN THE REFRIGERATED COMPARTMENT OF THE COOLER.

YES, IN CHAMBER 1

NO, NOT REQUIRED 2

NO, NOT AVAILABLE 3

PROGRAMMER INSTRUCTIONS:

• IF 12-MONTH VISIT, GO TO TIME_STAMP_5.

• OTHERWISE, GO TO AMBIENT_THRESHOLD_LOW.

BL3600/(AMBIENT_THRESHOLD_LOW). STATUS OF AMBIENT LOW THRESHOLD MONITOR

DATA COLLECTOR INSTRUCTION:

• RECORD STATUS OF THE LOW THRESHOLD MONITOR IN THE AMBIENT COMPARTMENT OF THE COOLER.

YES, IN CHAMBER 1

NO, NOT REQUIRED 2

NO, NOT AVAILABLE 3

BL3650/(TRANSPORT_COMMENT). TRANSPORT COMMENT

NO COMMENTS 1 (TIME_STAMP_5)

COMMENT 2

BL3660/(TRANSPORT_COMMENT_OTH).

DATA COLLECTOR INSTRUCTION:

• ENTER ANY TRANSPORT COMMENT.

________________________________________________

PROGRAMMER INSTRUCTION:

• LIMIT TEXT TO 255 CHARACTERS.

BL3700/(BLOOD_DRAW_COMMENT). ADDITIONAL BLOOD DRAW COMMENT

DATA COLLECTOR INSTRUCTION:

• ENTER ANY ADDITIONAL BLOOD COLLECTION COMMENTS:

NO COMMENTS 1 (TIME_STAMP_5)

COMMENT 2

BL3750/(BLOOD_DRAW_COMMENT_OTH).

SPECIFY______________________________

(TIME_STAMP_5) PROGRAMMER INSTRUCTION:

• INSERT DATE/TIME STAMP.

Public reporting burden for this collection of information is estimated to average 15 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: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-0593). Do not return the completed form to this address.