Sub Sending List Specs

Pull List Specifications
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Document Name File Name Version Issue
Number Date
Pullist specs Pulllist_specs.doc 2
Missing vial update Missing_vial_specs.doc 1
Reselection screen Reselection_screen_specs.doc 1
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0-01 Initial draft All
Pull List Application: Sub-sending list

management
Design Specification
Version: 1.1
Changes since last version

Section Change Reason for change
Outstanding issues and omissions

Section Issue or Ommission
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Copyright of xxxx. All rights reserved.
Author:
Shelley Tworoger
Signature: Date:
Author: Shelly Tworoger Page 1 of 11 Date: 24/12/2008

Distribution List
Company Entity Recipient Name Action
Shelley Tworoger
Mark Magid
Helena Judge Ellis
Rachel DePasquale
Jeanne Sparrow
Eric Rimm
Sue Hankinson

Contents
1. Introduction 4
1.1 Purpose of document................................................................................4
1.2 Background................................................................................................4
1.3 Scope of the specification.........................................................................4
1.4 Input 4
1.5 Output 4
1.6 Glossary of Terms and Definitions.............................................................6
1.7 Contacts8
2. Functional Overview.................................................................................9
2.1 Business Objectives..................................................................................9
2.2 Functional Diagram...................................................................................9
2.3 Design Mock-up.......................................................................................10
2.4 Requirements..........................................................................................10
2.5 Non-Functional Requiremets...................................................................11
2.6 Outstanding Issues..................................................................................11

Document Title : [11632868.doc]
1.Introduction
1.1Purpose of document
The purpose of this document is to outline the specifications and management of the sub-sending list. This is a list of all the
IDs accessed for a particular assay request.
1.2Background
It is important to track all of the changes that occur while preparing an assay request to send out to a laboratory. Changes can
occur such that some participants cannot be sent and/or that new participants are added. The sub-sending list will keep a
record of these changes and will ultimately provide the end-user with a final list of IDs/vials sent to the laboratory.
1.3Scope of the specification

The concern of this specification is to define the parameters of the sub-sending list and note how it will be updated and
accessed by the end-user.
1.4Input
This is based on the sending list(s) that are entered for a specific assay request.
1.5Output
The output will be a table accessible by the user that contains information about the vials/participants handled in the course of
preparing an assay request to send to a laboratory. The table will have a number of fields (see example below):
ID Caco status (if Match ID (if Sent to Reason not Reselected Date
applicable) applicable) laboratory sent ID change
# 1 or 2 # Yes or No See below #, if Date
applicable
/var/www/apps/scribd/scribd/tmp/scratch2/11632868.doc
Description of fields:
1. ID: the participant ID of interest
2. Caco status: for a case-control study, note if it is a case (1) or control (2)
3. Match ID: The ID of the matched case for a case-control study
4. Sent to laboratory: Yes or no, will be updated throughout the process
5. Reason not sent: if an ID was not sent to the laboratory then a reason must be specified:
a. Low volume
b. Control of a case that was not sent
c. Reselected
d. OTHERS??
6. Reselected ID: if a participant was reselected, note the ID that replaced it.
7. Date: Date of last change to that record.

1.6Glossary of Terms and Definitions

Term Definition
Reselection This occurs when for some reason a participant who was selected
for a project (e.g. a control) needs to be excluded from the data set
and a replacement added. The blood programmers will be
responsible for choosing the new participant and uploading the
relevant information to Healthtrack.
Vial A tube filled with biological specimen to be used in an assay request
or as part of a pull list.
Pull List General term for the functionality that generates the all the vial lists
used to pull biospecimens from the freezer for a set of assay
requests.
STAGES OF PULL
LIST
Initialization Entering the initial data for a pull list, choosing assay requests,
setting parameters. Includes making decisions about appropriate
parameter settings and changing those parameters to get the best
list.
Active Approved and finalized the pull list, all final parameter settings
selected. Vials are reserved in the database. Pull list has been
generated and blood lab personnel are actively pulling samples out
of the freezer. Includes updating the freezer file when an incorrect
tube is found, getting new locations of alternate vials, and noting
what new subvials have been created.
Completed and After all vials have been pulled for a particular pull list, finalized
Updated updates are made to the freezer file, including removal of original
and subvials, addition of newly made subvials. Also includes final
update to the sub-sending list that notes which vials were sent for
which assay requests.
TYPES OF LISTS IN
PULL LIST
FUNCTIONALITY
Original vial list List of original vials, separated by vial type (i.e. vial size), with
locations in the freezer and other information (see appendix) to be
Author: Shelly Tworoger used for pulling vials
Page 7 offor
11 a Pull List. Generated by the pull list24/12/2008
Date:
1.7Contacts
Name Job Title/ Position/ Signoff Telephone E-mail
Role
Shelley Project Lead 5-2087 nhsst@channing.ha
Tworoger rvard.edu
Mark Magid Project 5-0074 mgmagi@hotmail.c
Development om
Helena Lab Manager 617-732-5781 nhhje@channing.ha
Judge Ellis rvard.edu
End User
Rachel Lab Manager hprap@channing.h
DePasquale arvard.edu
End User
Jeanne Data Manager 5-4220 nhjms@channing.h
Sparrow arvard.edu
Rakesh

2.Functional Overview
2.1Business Objectives
2.2Functional Diagram
Enter Assay Request Enter Assay Request Enter Assay Request
*if replace/delete participants

**if need to change parameters
Conduct tally to find cases/controls
that may need to be removed,
update sending lists.
Create Pull List Request
* **
See Intermediate Results (Put “hold” on potential vials)

Finalize Pull List
Generate Freezer Pull List(s)

***if a vial is Generate Pull Box Labels
missing in
freezer, pull (Blood Lab RA Pulls Tubes***)
alternate vial if
one exists, if Generate Sub-Sending List by Assay Request
not remove from to note which ID’s will actually be set.
list + any matched
controls if a case Sorting Lists Information Defined (e.g. Box size, aliquot volumes)
Sort Lists Generated

-Aliquot sort list, separated Final sort list, separate by assay

by original vial volume request , notes where subvials are
-Generates labels for newly placed into sending boxes. Make
aliquoted tubes QC labels
Actual aliquots recorded Add QCS w/ labels that have fake ID’s
in healthtrack Put subvials into
sending box
New aliquots into Computer generates a box list/ASCII file

sending box Double check, give sub-sending list to programmer
2.3Design Mock-up
N/A
2.4Requirements
The sub-sending list will be generated when a sending list is uploaded to an assay request. Changes to the sub-sending list will
occur in the following situations:
1. A case or control is dropped during the pull list process because of low volume
2. A control(s) whose case was dropped due to low volume
3. A case or control was eliminated because no appropriate vial was located (in the missing vial update screen)
4. A control(s) whose case was dropped due to a missing vial
5. A control or ID was reselected, added, or deleted (in the reselection screen), in this situation removed ID(s) will be marked as
not sent and new ID(s) will be added to the sub-sending list

* Note that this list will be sent to the programmer the conducted the case –control selection before the samples are sent out the
lab for final confirmation that everything looks correct. Also, the information about IDs not sent to the lab will be included in the
README or fail file on the Unix system.
* Another functionality that should be added is the ability of the end user to select a pull list ID and then healthtrack will merge
the sub-sending lists from the assay requests in that pull list to form the following type of table:
ID Caco Match ID Sent assay Sent assay Sent assay

request A request B request C…
Participant ID If applicable If applicable Yes / No Yes / No Yes / No
2.5Non-Functional Requiremets
Research Assistants and Lab Technicians generally have not used oracle databases. The user interface of this and any part
of Htrack needs to accommodate for their skill set and ensure usability by making the product as easy to use for non-technical
people as possible.
2.6Outstanding Issues
None.


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Pull List Specifications

Pull List Application: Sub-sending list

Changes since last version

Outstanding issues and omissions

Author: Shelly Tworoger Page 1 of 11 Date: 24/12/2008

Author: Shelly Tworoger Page 2 of 11 Date: 24/12/2008

Author: Shelly Tworoger Page 3 of 11 Date: 24/12/2008

1.3Scope of the specification

Author: Shelly Tworoger Page 5 of 11 Date: 24/12/2008

1.6Glossary of Terms and Definitions

Author: Shelly Tworoger Page 6 of 11 Date: 24/12/2008

Author: Shelly Tworoger Page 8 of 11 Date: 24/12/2008

*if replace/delete participants

Create Pull List Request

See Intermediate Results (Put “hold” on potential vials)

Generate Freezer Pull List(s)

Sort Lists Generated

-Aliquot sort list, separated Final sort list, separate by assay

New aliquots into Computer generates a box list/ASCII file

Author: Shelly Tworoger Page 10 of 11 Date: 24/12/2008

ID Caco Match ID Sent assay Sent assay Sent assay

Author: Shelly Tworoger Page 11 of 11 Date: 24/12/2008

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