Birth_ChildBiospecimenPickUpInstrument

OMB #: 0925-0593

OMB Expiration Date: 8/31/2014

Child Biospecimen Pick-Up Instrument, Phase 2g

OMB Specification

Child Biospecimen Pick-Up Instrument

Event Category:	Time-Based
Event:	Birth
Administration:	N/A
Instrument Target:	Child
Instrument Respondent:	Data Collector
Domain:	Biospecimen
Document Category:	Sample Collection
Method:	Data Collector Administered
Mode (for this instrument*):	In-Person, CAI
OMB Approved Modes:	In-Person, CAI
Estimated Administration Time:	0 minutes
Multiple Child/Sibling Consideration:	Per Event
Special Considerations:	N/A
Version:	1.0
MDES Release:	4.0

​*This instrument is OMB-approved for multi-mode administration but this version of the instrument is designed for administration in this/these mode(s) only.

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Child Biospecimen Pick-Up Instrument

TABLE OF CONTENTS

GENERAL PROGRAMMER INSTRUCTIONS: 1

CHILD BIOSPECIMEN PICK UP 3

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Child Biospecimen Pick-Up Instrument

GENERAL PROGRAMMER INSTRUCTIONS:

WHEN PROGRAMMING INSTRUMENTS, VALIDATE FIELD LENGTHS AND TYPES AGAINST THE MDES TO ENSURE DATA COLLECTION RESPONSES DO NOT EXCEED THOSE OF THE MDES. SOME GENERAL ITEM LIMITS USED ARE AS FOLLOWS:

DATA ELEMENT FIELDS	MAXIMUM CHARACTERS PERMITTED	DATA TYPE	PROGRAMMER INSTRUCTIONS
ADDRESS AND EMAIL FIELDS	100	CHARACTER
UNIT AND PHONE FIELDS	10	CHARACTER
_OTH AND COMMENT FIELDS	255	CHARACTER	Limit text to 255 characters
FIRST NAME AND LAST NAME	30	CHARACTER	Limit text to 30 characters
ALL ID FIELDS	36	CHARACTER
ZIP CODE	5	NUMERIC
ZIP CODE LAST FOUR	4	NUMERIC
CITY	50	CHARACTER
DOB AND ALL OTHER DATE FIELDS (E.G., DT, DATE, ETC.)	10	NUMERIC CHARACTER	DISPLAY AS MM/DD/YYYY STORE AS YYYY-MM-DD HARD EDITS: MM MUST EQUAL 01 TO 12 DD MUST EQUAL 01 TO 31 YYYY MUST BE BETWEEN 1900 AND CURRENT YEAR.
TIME VARIABLES	TWO-DIGIT HOUR AND TWO-DIGIT MINUTE, AM/PM DESIGNATION	NUMERIC	HARD EDITS: HOURS MUST BE BETWEEN 00 AND 12; MINUTES MUST BE BETWEEN 00 AND 59

Instrument Guidelines for Participant and Respondent IDs:

PRENATALLY, THE P_ID IN THE MDES HEADER IS THAT OF THE PARTICIPANT (E.G. THE NON-PREGNANT WOMAN, PREGNANT WOMAN, OR THE FATHER).

POSTNATALLY, A RESPONDENT ID WILL BE USED IN ADDITION TO THE PARTICIPANT ID BECAUSE SOMEBODY OTHER THAN THE PARTICIPANT MAY BE COMPLETING THE INTERVIEW. FOR EXAMPLE, THE PARTICIPANT MAY BE THE CHILD AND THE RESPONDENT MAY BE THE MOTHER, FATHER, OR ANOTHER CAREGIVER. THEREFORE, MDES VERSION 2.2 AND ALL FUTURE VERSIONS CONTAIN A R_P_ID (RESPONDENT PARTICIPANT ID) HEADER FIELD FOR EACH POST-BIRTH INSTRUMENT. THIS WILL ALLOW ROCs TO INDICATE WHETHER THE RESPONDENT IS SOMEBODY OTHER THAN THE PARTICIPANT ABOUT WHOM THE QUESTIONS ARE BEING ASKED.

A REMINDER:

ALL RESPONDENTS MUST BE CONSENTED AND HAVE RECORDS IN THE PERSON, PARTICIPANT, PARTICIPANT_CONSENT AND LINK_PERSON_PARTICIPANT TABLES, WHICH CAN BE PRELOADED INTO EACH INSTRUMENT. ADDITIONALLY, IN POST-BIRTH QUESTIONNAIRES WHERE THERE IS THE ABILITY TO LOOP THROUGH A SET OF QUESTIONS FOR MULTIPLE CHILDREN, IT IS IMPORTANT TO CAPTURE AND STORE THE CORRECT CHILD P_ID ALONG WITH THE LOOP INFORMATION. IN THE MDES VARIABLE LABEL/DEFINITION COLUMN, THIS IS INDICATED AS FOLLOWS: EXTERNAL IDENTIFIER: PARTICIPANT ID FOR CHILD DETAIL.

CHILD BIOSPECIMEN PICK UP

(TIME_STAMP_CBP_ST).

PROGRAMMER INSTRUCTIONS

• INSERT DATE/TIME STAMP

• PRELOAD PARTICIPANT ID (P_ID) FOR CHILD AND RESPONDENT ID (R_P_ID) FOR ADULT CAREGIVER.

• PRELOAD ​STAFF_ID.

DATA COLLECTOR INSTRUCTIONS

• COMPLETE WHEN AN NCS DATA COLLECTOR PICKS UP BIRTH BIOSPECIMENS FROM THE CHILD.

• IF BIOSPECIMENS FROM MULTIPLE CHILDREN ARE PICKED UP AT THE SAME LOCATION IN ONE ATTEMPT, A SEPARATE INSTRUMENT MUST BE COMPLETED FOR EACH CHILD.

CBP00100/(SPECIMEN_NUM_PU). HOW MANY SPECIMENS ARE BEING PICKED UP?

 

|___|

NUMBER

PROGRAMMER INSTRUCTIONS

• DISPLAY HARD EDIT IF SPECIMEN_NUM_PU > 5.

• LOOP THROUGH SPECIMEN_TYPE, SPECIMEN_SAME_DATE (IF APPLICABLE), CBP01000, CBP02000, SPECIMEN_ID, SPEC_STORED, SPEC_STORAGE_COND, AND SPECIMEN_PICKUP_COND UNTIL NUMBER OF LOOPS = SPECIMEN_NUM_PU.

CBP00200/(SPECIMEN_TYPE). WHICH SPECIMEN DID YOU PICK UP?

DATA COLLECTOR INSTRUCTIONS

• IF MORE THAN ONE SPECIMEN COLLECTED, SELECT ONE PER LOOP.

Label	Code	Go To
INFANT BLOOD SPOT CARD	1
CORD BLOOD - LAVENDER TOP TUBE	2
CORD BLOOD - RED TOP TUBE	3
PLACENTA 10	4
PLACENTA 11	5
FULL PLACENTA	6

PROGRAMMER INSTRUCTIONS

• IF SPECIMEN_NUM_PU = 1 OR IF THIS IS THE FIRST LOOP, GO TO CBP01000.

• OTHERWISE, GO TO SPECIMEN_SAME_DATE.

CBP00300/(SPECIMEN_SAME_DATE). DID YOU PICK UP THIS SPECIMEN AT THE SAME TIME AS {SPECIMEN_TYPE}?

Label	Code	Go To
YES	1	SPECIMEN_ID
NO	2

PROGRAMMER INSTRUCTIONS

• PRELOAD AND DISPLAY THE SPECIMEN_TYPE FROM THE FIRST LOOP:

• IF SPECIMEN_TYPE = 1, DISPLAY "INFANT BLOOD SPOT CARD."

• IF SPECIMEN_TYPE = 2, DISPLAY "CORD BLOOD - LAVENDER TOP TUBE."

• IF SPECIMEN_TYPE = 3, DISPLAY "CORD BLOOD - RED TOP TUBE."

• IF SPECIMEN_TYPE = 4, DISPLAY "PLACENTA 10."

• IF SPECIMEN_TYPE = 5, DISPLAY "PLACENTA 11."

• IF SPECIMEN_TYPE ​= 6, DISPLAY "FULL PLACENTA"

• IF SPECIMEN_SAME_DATE = 1, SET SPECIMEN_PICKUP_MM, SPECIMEN_PICKUP_DD, SPECIMEN_PICKUP_YYYY, SPECIMEN_PICKUP_TIME, AND SPECIMEN_PICKUP_TIME_UNIT = RESPONSES SELECTED FOR FIRST LOOP.

CBP01000. SPECIMEN PICK-UP DATE:

(SPECIMEN_PICKUP_MM) |___|___|

   M     M

(SPECIMEN_PICKUP_DD) |___|___|

   D    D

(SPECIMEN_PICKUP_YYYY) |2|0|___|___| 

 Y Y   Y     Y

CBP02000. SPECIMEN PICK-UP TIME:

(SPECIMEN_PICKUP_TIME) |___|___|:|___|___|

  H     H       M     M

(SPECIMEN_PICKUP_TIME_UNIT)

Label	Code	Go To
AM	1
PM	2

CBP03000/(SPECIMEN_ID). SPECIMEN ID FOR {SPECIMEN TYPE}

|__|__|__|__|__|__|__|__|__|-|__|__|__|__|

PROGRAMMER INSTRUCTIONS

• IF SPECIMEN_TYPE = 1, DISPLAY "INFANT BLOOD SPOT CARD" AS {SPECIMEN TYPE} AND FORMAT SPECIMEN ID AS TWO ALPHA, SEVEN NUMERIC CHARACTERS DASH HS01 (AA#######-HS01).

• IF SPECIMEN_TYPE = 2, DISPLAY "CORD BLOOD - LAVENDER TOP TUBE" AS {SPECIMEN TYPE} AND FORMAT SPECIMEN ID AS TWO ALPHA, SEVEN NUMERIC CHARACTERS DASH CL10 (AA#######-CL10). 

• IF SPECIMEN_TYPE = 3, DISPLAY "CORD BLOOD - RED TOP TUBE" AS {SPECIMEN TYPE} AND FORMAT SPECIMEN ID AS TWO ALPHA, SEVEN NUMERIC CHARACTERS DASH CS10 (AA#######-CS10). 

• IF SPECIMEN_TYPE = 4, DISPLAY "PLACENTA" AS {SPECIMEN TYPE} AND FORMAT SPECIMEN ID AS TWO ALPHA, SEVEN NUMERIC CHARACTERS DASH PC10 (AA#######-PC10). 

• IF SPECIMEN_TYPE = 5, DISPLAY "PLACENTA" AS {SPECIMEN TYPE} AND FORMAT SPECIMEN ID AS TWO ALPHA, SEVEN NUMERIC CHARACTERS DASH PC11 (AA#######-PC11). 

• IF SPECIMEN_TYPE = 6, DISPLAY "FULL PLACENTA" AS {SPECIMEN TYPE} AND FORMAT SPECIMEN ID AS TWO ALPHA, SEVEN NUMERIC CHARACTERS DASH PCXX (AA#######-PCXX). 

CBP04100/(SPEC_STORED). WAS THE SPECIMEN STORED BEFORE PICK-UP BY NCS STAFF?

Label	Code	Go To
YES	1
NO	2	SPECIMEN_PICKUP_COND

CBP04200/(SPEC_STORAGE_COND). IDENTIFY THE STORAGE CONDITION

Label	Code	Go To
REFRIGERAED	1
FROZEN	2
AMBIENT	3
DON'T KNOW	-2

CBP05000/(SPECIMEN_PICKUP_COND). CONDITION OF SPECIMEN UPON PICK-UP

Label	Code	Go To
PICKED UP OK	1
PICKED UP BROKEN	2
PICKED UP LEAKING	3
PICKED UP AT INCORRECT TEMPERATURE	4
MISSING SPECIMEN ID LABEL	5
SPECIMEN LOST	6
SPECIMEN NOT COLLECTED	7
NOT AVAILABLE	8
NOT APPLICABLE	-7

PROGRAMMER INSTRUCTIONS

• IF NUMBER OF LOOPS = SPECIMEN_NUM_PU, GO TO SPECIMEN_PICKUP_COMMENTS.

• OTHERWISE, GO TO SPECIMEN_TYPE.

CBP06000/(SPECIMEN_PICKUP_COMMENTS). DO YOU HAVE ANY COMMENTS ABOUT THE PICK-UP?

Label	Code	Go To
YES	1
NO	2	REMAINING_SPECIMEN

CBP07000/(SPECIMEN_PICKUP_COMMENTS_OTH). COMMENTS ABOUT PICK-UP: _________________________________________________________________

CBP08000/(REMAINING_SPECIMEN). ARE THERE ADDITIONAL BIOSPECIMEN SAMPLES THAT NEED TO BE PICKED UP?

Label	Code	Go To
YES	1
NO	2

PROGRAMMER INSTRUCTIONS

• IF REMAINING_SPECIMEN = 1, SET INSTRUMENT_STATUS = 3, AND BEGIN AT CBP00100 WHEN INSTRUMENT OPENED AGAIN.
  OTHERWISE, SET INSTRUMENT_STATUS = 4, AND CLOSE OUT OF THE INSTRUMENT COMPLETELY.

(TIME_STAMP_CBP_ET).

PROGRAMMER INSTRUCTIONS

INSERT DATE/TIME STAMP