Access 2 Operator's Guide
Access 2 Operator's Guide
Access 2 Operator's Guide
Operator’s Guide
P/N 105330F
September 2003
Printed in U.S.A.
© 2003 Beckman Coulter, Inc.
BECKMAN COULTER, INC. • FULLERTON, CA 92835
Publication Notes
Each page of the Access 2 Operator’s Guide is identified with its revision and release date. For pages other than
the title page, revision information is located at the bottom of the page.
This guide includes pages from five revision releases. The pages listed below are issued as P/N 105330F, release
date 9/03.
• Title page and Publication Notes
• Preface: pages 2 through 6, 11, 12, and 15
• Chapter 1: pages 1-6, 1-8, 1-15, and1- 22
• Chapter 2: pages 2-1, 2-2, 2-5, 2-8, 2-11, 2-21, 2-22, 2-25 through 2-28, 2-31, 2-35, and 2-39
• Chapter 3: pages 3-10 through 3-12, 3-23, 3-47, and 3-48
• Chapter 4: page 4-28
• Chapter 5: pages 5-5, 5-6, 5-9 through 5-11, 5-19, 5-20, and 5-43
• Chapter 6: pages 6-5, 6-6, and 6-22
• Chapter 7: pages 7-1, 7-2, 7-4, 7-10, 7-12 through 7-19, 7-23 through 7-26, 7-28 through 7-30, and 7-35
through 7-38
• Chapter 8: 8-1, 8-2, 8-7, 8-17, 8-20, 8-21, 8-27 through 8-34, 8-38 through 8-40, 8-51, 8-52,8-55
through 8-57, 8-62, 8-63, and 8-66
• Appendix A: A-2, A-3, A-6, and A-9
The pages listed below are issued as P/N 105330E, release date 6/02.
• Chapter 1: pages 1-2, 1-14, 1-17, and 1-28
• Chapter 2: page2-12
• Chapter 3: pages 3-1, 3-19, 3-20, and 3-36
• Chapter 5: pages 5-1, 5-4, 5-7, 5-32, 5-34, 5-35, and 5-41, 5-42, and 5-44
• Chapter 6: pages 6-11 and 6-15
The pages listed below are issued as P/N 105330D, release date 1/02.
• Chapter 2: pages 2-13, 2-45, and 2-46
• Chapter 3: page 3-7
• Chapter 4: pages 4-16, 4-18, and 4-25
• Chapter 5: pages 5-14, 5-22, 5-23, 5-30, 5-33, and 5-45 through 5-48
• Chapter 6: pages 6-23 and 6-24
• Chapter 7: pages 7-8 and 7-9
• Chapter 8: page 8-54
The pages listed below are issued as P/N 105330C, release date 10/01.
• Chapter 1: page 1-18
• Chapter 2: page 2-9
• Chapter 4: pages 4-14 and 4-15
• Chapter 8: pages 8-16, and 8-36
• Appendix A: page A-10
All other pages in this guide are issued as P/N 105330B, release date 4/01.
This guide is intended for use with the Access 2 Immunoassay System.
From time to time, the documentation for the Access 2 Immunoassay System will need to be updated.
Beckman Coulter, Inc. will make every attempt to distribute these updates to you in electronic
format, such as an updated Help system with manuals; however, that is not always feasible. At times,
you may receive these updates in paper format, which must be used in conjunction with the
electronic documentation. These changes will be incorporated into a later version of the electronic
documentation and distributed to you with the Access 2 system software.
Access and the BECKMAN COULTER logo are trademarks of Beckman Coulter, Inc.
Operator’s Guide Table of Contents
Table of Contents
Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1
2 Supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
2.1 Supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
2.2 Wash Buffer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8
2.3 Liquid Waste . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11
2.4 Substrate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-15
2.5 Reaction Vessels (RVs) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-20
2.6 Reaction Vessel Waste Bag . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-24
2.7 Reagent Packs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-27
2.8 Reagent Inventory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-36
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I-1
Table A-1 Sample Containers with Corresponding Rack and Rack IDs . . . .A-3
Figure A-2 Rack Bar Code Label Placement. . . . . . . . . . . . . . . . . . . . . . . . . .A-4
Figure A-3 Sample Bar Code Label Placement. . . . . . . . . . . . . . . . . . . . . . . .A-7
Figure A-4 Loading Insert Cups . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-8
Table A-5 Sample Containers with Rack and Volume Requirements . . . . . .A-9
Preface
About This Manual .............................................................................................. 2
About This This Operator’s Guide provides the step-by-step information needed for everyday
Manual operation of the Access 2 system. The Operator’s Guide contains the following
chapters:
Other In addition to this Operator’s Guide, the Access 2 system includes the following
Access 2 printed and online documentation.
System
Documen- Reference Manual
tation
The Reference Manual provides background, theory, troubleshooting, and advanced
maintenance information. The Reference Manual contains the following chapters:
The Quick Reference Guide contains short instructions for everyday use and routine
maintenance. It also contains general information about the Access 2 instrument, such
as theory of operation, system specifications, safety labeling, and troubleshooting.
Ordering information for reagents and system supplies is provided in an Appendix.
Help System
The Access 2 Help system provides all of the information contained in the Operator’s
Guide and Reference Manual in a convenient online format that you can access from
within the Access 2 system software.
The following books (or pages) are contained in the Help Topics window, which can
be viewed by using the Contents tab:
About the Access 2 General information about how to use the system,
Immunoassay System what you can do from the Main Menu, and
information about the warranty.
About Help Information about the Access 2 Help system and how
to use it.
Publication Notes Information about changes to the Access 2
Immunoassay System documentation.
Access 2 Manuals Links to electronic copies of the English language
versions of the Operator’s Guide and Reference
Manual in Adobe* Acrobat* (.pdf) format.
Glossary An alphabetical list of terms and definitions specific to
the Access 2 system.
Operator’s All of the procedural information from the Operator’s
Procedures Guide. Chapter information is divided into separate
books.
Reference Information All of the reference information from the Reference
Manual. Chapter information is divided into separate
books.
Flowcharts All procedure overviews and procedure flowcharts,
sorted alphabetically by subject.
Forms/Logs/ Illustrations of all suggested forms and worksheets
Worksheets you can use to record Access 2 activity.
Reports Illustrations of all system reports in alphabetical order.
Screens/Menus/ Illustrations and field descriptions of all screens and
Windows menus (alphabetized in one book) and complex
windows (alphabetized in another book).
Online Manuals
The Access 2 Help system contains links to electronic copies of the English language
versions of the Operator’s Guide and Reference Manual in Adobe Acrobat (.pdf)
format. The Access 2 PC comes with the Acrobat Reader* installed. When you
display the online manuals in the Reader, you can search, view, and print individual
pages or the full manual.
* Adobe, Acrobat, and Reader are trademarks of Adobe Systems Inc.
Online versions of the Assay Manual and the LIS Vendor Information document are
provided on CDs, to be used on a PC that is not connected to the Access 2 instrument.
NOTE
In Japan, the Assay Manual CD is unavailable. In Japan only, see alternative
local information.
NOTE
In Japan, the Material Safety Data Sheet (MSDS) manual is unavailable. In
Japan only, see alternative local information.
For Japan only, the Japanese Data Entry document contains instructions for entering
and reporting information using Katakana characters.
From time to time, the Access 2 system documentation may include charts, graphs, or
other supplementary printed materials.
Using the To make information easier for you to find and use, Access 2 system documentation
Manual uses the following standards and styles.
Chapter Organization
Most of the chapters in the Operator’s Guide and Reference Manual contain
flowcharts, screen and window captures, tables of screen or window item
descriptions, and procedural or informational sections.
Screens and complex windows are illustrated in the manuals if you need explanations
of their contents to understand how to perform a procedure. Simple windows that are
self-explanatory are not included.
For a list of system status button names and descriptions, see Chapter 1: System
Overview in this manual.
NOTES
• For consistency as illustrated in the previous examples, whether you touch
the screen, point and click with the mouse, or press [Tab] to select a text
button, system command button, or an option in a field, this documentation
uses the term select.
• For information about how to navigate through the Help system, see the
System Navigation topic in Chapter 1: System Overview of this manual.
Keys
When you perform an action exclusively with the keyboard, the key name or
description is provided in bold type, in brackets. For example:
Required Steps
Required steps in a procedure are indicated by sequentially numbered lists in the
Help, and by numbered boxes in the manuals. For example:
Optional Steps
Optional steps in a procedure are indicated by an asterisk and the word (Optional) in
the Help. Small, unnumbered boxes and the word (Optional) are used in the manuals.
For example:
Optional steps provide information about how to perform a task that you only need to
do under some circumstances. For example, required steps in the Printing Reagent
Inventory Report procedure tell you how to print the report including all reagent
packs. The optional step tells you how to print the report for selected packs only.
Using the Help The Access 2 Help system provides all of the information contained in the Reference
System Manual and Operator’s Guide in an online format that you can access from within the
Access 2 system software.
When you select the Help from any Access 2 system software screen, a Help window
is displayed. From the Help window, you can use the Help window button bar to
perform operations (print or copy) on the currently displayed topic or to navigate to a
different topic.
You can access the Help system from any system software screen and from some
system software windows by pressing a Help button or [F12] Help on the keyboard.
Help
Description
Access
On screens, the Help button is the round system status button with a
question mark (?).
Help
A screen also has function buttons, a Menu tab, system command
from a
Screen buttons, and system status buttons. For more information about
screens, see Chapter 1: System Overview in the Operator’s Guide.
When you select Help from a screen, the Help system displays
information about the screen you are on and provides a button you can
select to view the screen and its description.
In windows, the Help button is the rectangular Help F12 function
button in the lower right corner.
A window may provide information about the status of the system or
Help
ask you a question that requires your response. For more information
from a
Window about windows, see Chapter 1: System Overview in the Operator’s
Guide.
When you select Help from a window, the Help system displays
procedural information related to the window you are in. Sometimes
you can view the window and its description from the Help, and
sometimes you can view a flowchart of the procedure.
From any displayed Help topic, you can go to other topics using Help
Help
navigational features such as Help link buttons, the Help window
from
Help
button bar, the Help Topics window (tabs), the [F12] Help key on the
keyboard, and the highlighted text (green).
Button Description
Button Description
Help Windows
The Help for the Access 2 system uses standard window types to display different
types of information:
• Procedure (narrow window displaying on the right of the screen, usually lists
steps to perform)
• Main (widest window displaying in the center of the screen, usually includes
a column of arrow buttons on the left to link to more information)
• Picture (wide window displaying on the left of the screen, usually shows a
screen, window, flowchart, or a picture of a portion of the instrument)
• Glossary (narrow window displaying on the right of the screen, usually lists
items to link to, such as term definitions or event information)
• Popup (window displaying anywhere on the screen, usually provides a brief
definition or description of an item and has no button bar or scroll bar)
When you display a Help window, it continues to be displayed until you display
another window of the same type, select any part of the UI software visible beyond
the edges of a Help window, or exit the Help system.
Exit the Help system by selecting Exit from the Help window button bar.
NOTE
Select Exit only when you are finished using the Help system. When you select
Exit, all Help windows close.
0862b.bmp
Figure 6 Help Window Button Bar
Find (Button) Displays the Help Find tab in the Help Topics window, which allows you
to search for a topic by keywords.
For more information on the Find feature, see the Help Find Feature topic later in
this preface.
Help Topics (Button) Displays the Help Topics window. From this window, you can search the
entire Help system and go directly to any topic.
For more information, see the Help Topics Window topic.
Back (Button) Select to return to the last displayed topic in the same type of window
(such as a procedure window or a picture window).
This button is unavailable if the topic displayed is the first topic for that type of
window.
Print (Button) Select to print the displayed topic.
Glossary (Button) Select to display the Help system glossary.
This button is only available from main (large) Help windows.
Exit (Button) Select to exit the Help system.
Help Window Menu The Help window menu contains features that are duplicates of others found in the
Help system and features that can change Help appearance and performance. The
Help system has been optimized for your use. You should not access the features
in the Help window menu.
Select a topic
to display
Select a book
to display the
contents
0603b.bmp
Figure 8 Help Topics Window (Contents View)
Contents (Tab) Select to display the table of contents for the Help
system. The Help Contents are organized like the table of
contents of a combined Operator’s Guide and Reference
Manual.
From the table of contents, you can:
• Select a topic page (the white icon with ? inside) to
display Help about the topic.
• Select a topic book, which expands to list more available
topic pages and books related to the topic book.
Index (Tab) Select to locate information by typing the first few
letters of a keyword, and then by selecting one of the
available topics. The Help index is organized like a
combined Operator’s Guide and Reference Manual index.
Find (Tab) Select to search for a topic by keywords.
For more information on the Help Find feature, see the
Help Find Feature topic in this preface.
search feature. If you enter a word that is contained in multiple topics, Find is capable
of displaying a list of every topic that contains the word.
The first time you use the Find feature, the Find Setup Wizard window is displayed.
Before you can use this feature, the Help system must create a database to search from
available database options.
• When you select Minimize database size, the Find feature displays a list of
the main topics containing the word you enter. Minimum is the default and
the recommended choice.
• When you select Maximize search capabilities, the Find feature displays a
list of every topic containing the word you enter. When you select this
option, the Find feature may operate at a slower rate.
• When you select Customize search capabilities, you select the
characteristics of the Find feature in response to questions provided by the
Find Setup Wizard.
After you select a database option, select Next and then select Finish. The Help
system creates the database and displays the Find window.
0857b.bmp
NOTE
The Help system creates the Find database only the first time you select the
Find feature.
Notes, The Access 2 system documentation uses notes, cautions, and warnings to draw your
Cautions, and attention to important information, instrument operation instructions, and safety
Warnings information.
Help Manual
Description
Icon Graphic
Technical For technical assistance with the Access 2 Immunoassay System contact:
Support • Beckman Coulter Technical Support at 800-854-3633 (in the U.S.A.)
• Your technical support representative (outside the U.S.A.)
System Overview
1.1 System Overview ........................................................................................... 1-3
Installation......................................................................................................... 1-5
Warranty............................................................................................................ 1-5
1.1
System Overview
The Access 2 Immunoassay System is an automated instrument that performs a wide
variety of immunoassays on body fluid samples.
The system processes patient, quality control, and calibration samples in individual,
disposable, plastic tubes called reaction vessels (RVs) with reagent from up to 24
on-board reagent packs.
The Access 2 system provides random, continuous, and STAT access. Random access
allows you to perform any assay on any sample, using the on-board reagent packs.
Continuous and STAT access allow you to schedule additional or STAT samples,
replenish most supplies, and change waste containers while the instrument is
processing samples. The system schedules assays as defined by the assay protocol file
(APF) for each assay, and ensures adequate supplies to complete the assays. When a
STAT assay is added, the instrument automatically reschedules other samples in a run
to process the STAT sample first.
The Access 2 system can operate in workgroups of 1-4 instruments, depending upon
your lab requirements.
For information about the Access 2 system, instrument, and assay technology, see
Chapter 1: Technology Overview in the Reference Manual.
1.2
Instrument Overview
The Access 2 system uses the following six instrument hardware modules to
accomplish sample processing:
• The carousel module includes the sample carousel, reagent carousel, cup/tube
detector, and internal bar code reader. The sample carousel holds the racks.
The reagent carousel holds the reagent packs. The cup/tube detector
identifies if a sample container is present in each position on the rack. The
internal bar code reader scans bar coded rack and sample container
information.
• The main pipettor module includes the pipettor gantry, main pipettor,
precision pump, and ultrasonic transducer. This module transfers samples,
reagents, and wash buffer (for dilutions, if necessary) to the reaction vessels.
• The analytical module includes the reaction vessel loader, incubator belt, and
wash/read carousel. This module transports reaction vessels through
incubation, washing, addition of substrate, luminometer reading, and
transmits the reading to the electronics module.
• The fluidic module includes the probe wash tower, vacuum pump, vacuum
reservoir, substrate pump, wash pump, waste pump, and fluids tray. This
module works together with the main pipettor module and the analytical
module to dispense reagents and samples, wash the samples and the probes,
dispense substrate, and store liquid waste.
• The electronics module includes a power supply, reset button, interlock
switch, reaction vessel load door alarm, internal hard drive, 3.5-inch disk
drive for troubleshooting the system, and printed circuit boards.
• The peripherals module includes the external computer, keyboard, pointing
device (mouse), monitor, printer, and hand-held bar code wand. The external
computer has its own hard disk, 3.5-inch disk drive, CD-ROM drive, modem,
and tape drive. You use the peripheral components to direct and monitor the
Access 2 system through the system software, to make a backup tape of your
system data, and to print reports.
For more information about instrument technology, see Section 1.2: Instrument
Technology in the Reference Manual.
Warranty The Access 2 Immunoassay System is covered by and subject to the provisions of the
warranty included in your contractual agreement for the system and/or its reagents.
Safety The Access 2 Immunoassay System is designed to meet U.S. and international safety
Features standards. Safety labels are affixed to the instrument to alert you to safety
considerations, and an interlock switch stops the movement of the main pipettor to
protect you from injury if you were to open the instrument’s front panel while the
system is running.
Safety Labels
A label with an exclamation point (see Figure 1-1) calls attention to important
information to read. The information is located either on the label or in an Access 2
manual. In this manual, text following the label example provides additional
information regarding safety conditions.
0209B.eps
Figure 1-1 Safety Label Exclamation Point
CAUTIONS
• The Access 2 system generates, uses, and can radiate radio frequency
energy. If the system is not installed and operated properly, this energy
can cause interference with other equipment. In addition, other
equipment can radiate radio frequency energy to which the system is
sensitive. The Access 2 system has been tested and shown to be
compliant with the requirements of part 15 of FCC rules for a Class A
digital device. These requirements are intended to provide reasonable
protection from interference when the instrument is operated in a
commercial environment.
• If you suspect interference between the Access 2 system and other
equipment, you must take whatever action is required to correct the
interference. Beckman Coulter suggests the following actions:
1. Move the equipment so there is a greater distance between the
equipment and the Access 2 system.
2. Re-orient the equipment with respect to the Access 2 system.
3. Be sure the equipment is operating from a different power service
connector than that of the Access 2 system.
• The Access 2 system contains high leakage electrical current and should
always be plugged into an outlet with a third grounding hole. DO NOT
bypass the grounding prong on the plug.
C US
2186A.eps
Figure 1-2 Canadian Standards Association Label
The Canadian Standards Association label (see Figure 1-2) indicates that the Access 2
Immunoassay System meets all U.S. and Canadian requirements for electrical safety.
0171A.eps
Figure 1-3 General Electrical Safety Label
The general electrical safety label (see Figure 1-3) indicates an electrical shock
hazard.
• The system uses high voltage to operate the ultrasonic probe.
• The luminometer contains a high voltage power supply that presents a shock
hazard. The power supply box does not contain operator-serviceable parts.
• The electronics module contains high voltage circuitry that operates the
ultrasonic probe. This circuitry presents a shock hazard if you open the
electronics module. The electronics module does not contain
operator-serviceable parts.
0223A.eps
Figure 1-4 Biohazard Label
The biohazard symbol (see Figure 1-4) indicates areas of the instrument and
associated fluid handling equipment that can contain potentially infectious human
serum or blood products. Follow good laboratory practices in handling and disposing
of materials from these areas.
0176E.eps
Figure 1-5 CE Mark Label
A label with the CE mark of conformity (see Figure 1-5) is attached to the back panel
of Access 2 Immunoassay System instruments. This label signifies that the Access 2
Immunoassay System complies with applicable EU directives. The instrument
Declaration of Conformity lists the directives with which the Access 2 system
complies.
2195A.eps
Figure 1-5a C-Tick Mark Label
A label with the C-Tick mark indicates that the instrument complies with applicable
Australian Communications Authority requirements.
Interlock Switch
The Access 2 system is equipped with an interlock switch to protect you from injury.
If you open the front panel of the instrument, the interlock switch stops the movement
of the main pipettor. Other mechanical devices will continue to operate with the front
panel open. If you open the front panel while the system is processing samples, the
system may cancel tests.
WARNING
The Access 2 instrument has moving parts and uses high voltage in the ultrasonic
transducer. Both present an injury hazard. You should not operate the Access 2
instrument with the covers open.
1.3
Software Overview
The Access 2 system software consists of a real-time operating system in the
instrument and a PC-based user interface (UI) software. The instrument software
controls all of the processing functions. The UI software allows you to interface with
and direct the instrument software. It also contains database, sample, calibration,
quality control, and LIS information, as well as the assay protocol files (APFs). The
APFs contain assay-specific information about sample processing and calculating test
results. The UI software is located on the hard drive of the external computer (PC).
The instrument software, UI software, and APFs are installed on the system through
the PC’s CD-ROM drive.
The system software functions are organized into a set of screens that have common
elements. From any screen, you can run, pause, or stop the instrument, monitor its
system mode, access the Help system, view the Event Log, select options to operate
the system, and go to other screens.
NOTES
• Your ability to perform these functions can depend upon the instrument’s
system mode. For example, it is not possible to select Run when the
instrument is in the Not Ready mode.
• You cannot select Run from a limited number of screens, such as the
Diagnostics screen.
The system will sometimes display a smaller window on top of a screen to prompt
you to perform an action, confirm that you want the system to perform an action,
display a message, or allow you to enter information. When entering information in a
window, you can use basic keyboard commands, such as Ctrl+C (copy) or Ctrl+V
(paste), to transfer information between windows. For example, you can copy a
comment from the Sample Comments window and paste it in the same window for
another sample, or copy and paste a formula when setting up derived results.
The software also comes with a Laboratory Information System (LIS) feature, which
allows an external LIS to communicate with a workgroup through one LIS serial line.
Test requests entered at the LIS are transmitted to the workgroup for processing. Once
processing is complete, the test results are sent back to the LIS system. The
workgroup data is managed from a single computer acting as the workgroup server.
For more information about system modes, see Table 1-10 in this section. For more
information about the system mode required to perform a specific procedure, see
Appendix B: System and Mode Availability Tables in the Reference Manual.
For more information about instrument technology or the LIS system, see Chapter 1:
Technology Overview in the Reference Manual.
For more information about setting up an LIS system, see section 4.9 LIS Setup in the
Reference Manual.
Running Other Only the Access 2 software should be installed on your PC. If a software application
Applications other than the authorized Access 2 Immunoassay System software is detected on your
PC, it must be removed.
Main Menu The Main Menu is the first screen you see when the system is installed or initialized.
To get to this menu from any screen, press [F9].
You can navigate everywhere through the Access 2 system using the eight function
buttons across the bottom of the Main Menu (see Figure 1-6). These buttons are direct
routes to the functions you perform most frequently.
The Main Menu function buttons are available from other screens when you use the
Menu tab. The Menu tab displays along the right edge of every screen except the
Main Menu.
0622A.bmp
Figure 1-6 Main Menu
Sample Manager F1 Select to display the Sample Manager screen. You use this screen to:
• Define racks in the system, load or unload them, or delete them from
the system
• Add samples to, or remove samples from racks
• Display the Test Request screen to enter test requests and check on their
progress
• Request maintenance routines
• Review tests on the Work Pending screen
For more information see Chapter 3: Sample Management, and Chapter 4,
Sample Processing.
Test Results F2 Select to display the Test Results screen. You use this screen to:
• View test results and associated result flags
• Print test result reports or copy test result data to a disk
• Rerun a test after reviewing its results
For more information about Test Results, see Chapter 5: Test Results.
Supplies F3 Select to display the Supplies screen. You use this screen to:
• Check the status of all system supplies
• Replenish bulk supplies
• Load and unload reagent packs and review the reagent inventory
For more information about Supplies, see Chapter 2: Supplies.
Quality Control F4 Select to display the Quality Control screen. You use this screen to:
• Set up quality controls
• Review, compare, or print quality control information
For more information, see Chapter 7: Quality Controls.
Calibration F5 Select to display the Calibration screen. You use this screen to:
• Set up calibrators
• View the results of assay calibrations
• Print calibration reports
For more information, see Chapter 6: Assay Calibrations.
Maintenance Review F6 Select to display the Maintenance Review screen. You use this screen to:
• Review system temperatures
• Run or disable the Utility Assay
• Review system check results
For more information, see Chapter 8: Routine Maintenance.
Diagnostics F7 Select to display the Diagnostics menu. You use this menu to:
• Initialize the system or align and home devices
• View information from various instrument sensors
• Perform diagnostic or troubleshooting procedures as instructed in
system documentation or by Technical Support
For more information, see Chapter 5: Diagnostics in the Reference
Manual.
Configure F8 Select to display the Configure menu. You use this menu to:
• Set up system and LIS information, test result ranges, test panels,
derived results, and reflex tests for your laboratory
• Enable and disable tests and test panels
• Set up or change the system password
• Back up and restore system data
For more information, see Chapter 4: System Configuration in the
Reference Manual.
Main Menu Select one of the Main Menu function buttons to display its associated screen. Across
Workflow the bottom of the screen you will see another row of function buttons. You can select
these buttons to perform an action or display a menu with additional function buttons.
The following flowchart (see Figure 1-8) outlines the workflow for each of the Main
Menu function buttons.
F1 Load Rack /
Get/Edit Rack
F2 Delete Sample
F3 Show/Hide
F1 Load a Rack
Test Menu
F2 Work Pending
F4 Test Results
F3 Test Request
Sample Manager F5 Request QC
F4 Maintenance Request
F1 F6 Request
F6 Get Selected Rack
Calibration
F7 Clear Selected Rack
F7 Clear All
F8 Change Rack ID
Samples
F8 More Options F1 Filter
F2 Review Data
Calibration
F5 Calibrator Setup
F5
F6 Delete
F7 Print
F1 Filter
F2 Find
F3 Rerun Test
F4 Sample Details
F5 Send to LIS
Test Results
F6 Copy to Disk
F2 F1 Report
F7 Print
F2 Completed Samples
F1 Refresh Screen
F2 Configure Screen F2 System Checks
F8 More Options
F3 Delete Data F5 Run Utility Assay
Maintenance Review
F6 Enable/Disable Utility
F6
Assay
F7 Print
F1 System Revisions
F1 Filter F2 Bar Code
F2 Review Chart Reader Setup
and Data F1 System Setup F3 Set Workgroup
Quality Control
F3 Compare Charts Date/Time
F4
F4 Delete Comparison F5 Password Setup
F5 QC Setup F7 Reports Setup
F7 Print
F1 Filter
F2 Edit Units
F3 Ranges
Configure F2 Tests F4 Gray Zone
F8 F5 Special
F7 Print
F8 Update APF
F3 Test Panels
F4 Derived Results
F1 Scheduled Backup
F5 Reflex Tests
F2 Immediate Backup
F6 LIS
F3 Eject Tape
F7 PC Admin
F4 Restore
F8 About Access 2
F5 Auto-Delete Setup
F8 Shut Down PC
0863D.wmf
Figure 1-8 Main Menu Work Flow
Common The Access 2 system displays certain elements on every screen so you can
Screen continuously monitor the system’s status (see Figure 1-9). The labels in the example
Elements screen below are described in the following sections.
System
Command
Buttons
Scroll
Bar
Back
Tab
Menu
Tab
Status
Line
Function
Buttons
0711B.bmp
Figure 1-9 Common Access 2 System Screen Elements
System The Access 2 system has four system modes (see Table 1-10) that indicate the
Modes operating state of the system. The current mode is displayed in the upper left corner of
each screen. When the system is in the Running mode, the estimated completion time
for the requested function displays as a text line above the three system command
buttons.
System You use the three system command buttons (see Table 1-11) to run, pause, and stop
Command the Access 2 instrument.
Buttons
Button Screen Description
Display
System Status There are ten system status buttons. You can use these buttons to:
Buttons • Monitor the status of on-board supplies
• Review quality control results
• Display test requests that are on the work pending list
• View the Event Log for information about an event that occurred during
processing
• Access the Help system
Most buttons are color coded to alert you if a supply level requires your attention, a
sample processing issue exists, or if the instrument has recorded a system event.
Under normal operating conditions the button color will be neutral. The color of some
buttons can change to yellow to indicate a caution condition, or red to indicate a
warning condition. The Help button color is always neutral.
System Status
Description Button Colors
Button
System Status
Description Button Colors
Button
System Status
Description Button Colors
Button
System Status
Description Button Colors
Button
Help Select to display specific information The Help button color is always neutral.
about the screen you are on, or to
navigate to a picture with descriptions
for the screen, to a list of related topics,
or to any topic within Help.
Scroll Bar The scroll bar displays along the right side or bottom of some screens. Use the scroll
bar to view areas that are out of the normal viewing area of the screen. Select the
arrows at either end of the scroll bar to move through the screen line-by-line, or drag
the icon within the scroll bar to pass through the screen rapidly.
Back and The Back and Menu tabs (see ) are on all screens except the Main Menu. Select the
Menu Tabs Back tab to display the previous screen. Select the Menu tab to display the Main
Menu function buttons.
0649A.bmp 0650A.bmp
Function The Access 2 system displays a row of eight function buttons across the bottom of
Buttons each screen. Selecting a function button performs an action or displays a menu of
additional function buttons.
Function buttons vary from screen to screen, according to the operations you can
perform on each screen.
Information Some screens require that you enter pertinent information into a field. You can only
Fields enter information if the field is available.
Status Line The status line displays the system ID and the current date and time. It may also
display other information, such as what activity the system is currently performing, or
what to enter in a selected field.
System The Access 2 system has three navigation methods that you can use in any
Navigation combination:
• Touching part of the screen using the tip of your finger or fingernail.
• Clicking the left mouse button to select an item on the screen.
• Pressing a keyboard equivalent such as a function key, tab key, or arrow key
to select a field or other item on the screen.
Keyboard Equivalents
The following table lists the equivalent keystrokes you can use to perform common
functions on the Access 2 system.
The word enter is applied throughout the system documentation to signify putting
information into a field. Depending on the options available for the field, you can
enter information using one of the following methods:
• Type the information from the keyboard.
• Select the information by checking a box or choosing an item from a list.
This will enter the information you selected into the appropriate field.
• Scan bar coded information with the hand-held bar code wand.
Common The Access 2 system displays a window to provide information, ask you to respond to
Windows a question, prompt you to perform an action, or confirm that you want the system to
perform an action. Illustrations of many windows, particularly those that are
complicated, are included in the Help procedures.
0920A.bmp.
Figure 1-17 OK/Cancel/Help Window Example
The OK F1, Cancel F8, and Help F12 buttons are common buttons. This section
provides an explanation of these buttons. Common buttons will not be explained
again in the remaining chapters of the Operator’s Guide or Reference Manual.
Reports You can print reports as well as the displayed screen or window from the Access 2
system software.
NOTE
If a report breaks a page in the middle of a sample or patient, the system repeats
the sample or patient ID at the top of the next page.
For more information about setting up report header information, see Section 4.2:
System Setup in the Reference Manual.
2001 Copyright Beckman Coulter, Inc. 1-25
P/N 105330B 4/01
1.3: Software Overview Operator’s Guide
4 5
3 Laboratories, Inc.
Laboratory A 6
Report Name
123 Lake Street
Townsville, ST 3333 7
Access 2 Immunoassay System
S/N 501240
101-555-2323 ext. 109 8 Jane Smith
2
1 9
10
QNS = sample quantity not sufficient, ORL = result below reference range, ORH = result above reference range,
LEX = reagent pack lot expired 11
13 12
Page 1 of 1
Technologist Printed 10-10-00 2:43pm
0745B.eps
Supplies
2.1 Supplies ........................................................................................................... 2-2
2.1
Supplies
Access 2 system supplies are the consumables and waste containers that you must
change to continue operating the system. Consumables consist of wash buffer,
substrate, reaction vessels (RVs), and reagent packs. Waste containers consist of the
liquid waste bottle and the RV waste bag.
The system keeps track of the following supply status information during processing:
• When the wash buffer reservoir is empty
• When the liquid waste bottle is full
• When the substrate bottle was opened, when it will expire, and how many
tests can be processed with the current supply
• How many RVs are available
• How many RVs will fit in the RV waste bag
• Which reagent packs are on board and off board, when each reagent pack was
first punctured, when the reagent lot will expire, how many tests can be
processed with the current supply in each pack, and which packs are in use.
• When each calibration will expire
• Which reagent packs are in inventory for all instruments in a workgroup
The system displays and continuously updates supply status information during
processing.
The system status buttons for supply conditions at the top of every screen change
color to indicate the current supply status. You can select them to get detailed supply
information and load supplies or change waste containers.
For more information about system status buttons, see Chapter 1: System Overview.
For information about ordering supplies, see the Quick Reference Guide.
Supply Status
The system status buttons for supply conditions are located at the top of every
Access 2 system screen. These buttons alert you to the status of on-board supplies and
waste containers, by changing color if a supply level requires your attention. When a
button changes color, you can select it to show the screen or window you will use to
change the supply or change the waste container.
For more information about the system status buttons, see Section 1.3: Software
Overview.
NOTE
You do not use the system screens, windows, or function buttons when you
change the wash buffer or liquid waste bottles. You do need to use the system
screens, windows, or function buttons according to the procedures, when you
change the substrate or RV waste bag, or load reaction vessels (RVs) or reagent
packs.
Scanning Bar Use this procedure to scan a bar code with the external bar code wand. You use the
Codes external bar code wand to enter information provided on bar code labels. Scanning the
bar codes eliminates the need for you to type the information into a field.
1 Be sure that the cursor is positioned in the appropriate field before scanning the
bar code.
2 Place the tip of the wand at an angle on the quiet zone of the bar code. For more
information, see Section 2.3: Performance Characteristics in the Reference
Manual. When the wand is properly angled, you will see a small, oval pattern of
light extending from the tip of the wand within the quiet zone.
3 Move the tip of the wand smoothly and rapidly across the bar code to the quiet
zone on the other side. The system beeps after it successfully reads the bar code.
4 Keep the light focused within the lines of the bar code. If the light extends
across the edge of either side of the bar code, the bar code may not be read
successfully.
5 Look at the screen and verify that the bar code is correctly displayed in the
appropriate field.
Supplies Screen
You use the Supplies screen to:
• Check the status of all system supplies
• Replenish the supply of substrate and RVs
• Change the RV waste bag
• Load and unload reagent packs
• Display the Reagent Inventory screen
To get to this screen from the Main Menu, select Supplies F3, or from any screen,
select the Substrate, RVs, or RV Waste Bag button.
0631B.bmp
Figure 2-1 Supplies Screen
Reagent Pack (24 Buttons) Correspond to the 24 available slots in the reagent carousel of the
Button instrument. Sorted alphabetically by pack name down a column, then from left to
right. For each on-board reagent pack, the button displays the following
information:
• Reagent Pack Name
(Button label) The same as the test name, except in the case of multi-constituent
tests, such as Folate and RBC Folate. The RBC Folate test uses the Folate
reagent pack, so there is no Reagent Pack button for RBC Folate.
• Tests Left
(Field) The number of tests remaining in the pack, updated as the system uses
the reagent. This field turns yellow when there are 10 tests or fewer remaining
for all on-board packs with the same lot number, or if the open pack expiration
date is within three days. The field turns red when there are zero tests left, or the
pack is past the open pack expiration date.
• Lot Number
(Field) The lot number of the reagent pack. This field turns yellow when the
pack lot or the calibration for the lot will expire within three days. The field
turns red when the calibration for the lot is expired or if no calibration exists.
The system tracks both lot and open pack expiration dates.
NOTE
For assay calibrations that expire within three days of being generated, such
as Chlamydia, the field does not turn yellow. The field goes straight to red
when the calibration is expired.
• In-Use Icon
(Padlock) If the system is processing samples and the reagent pack is
scheduled for use, the system displays a padlock icon and disables the
Unload Reagent Pack F2 button to prevent you from removing the
pack. You cannot remove in-use packs until the system aspirates the reagent for
the current run.
The system updates the Reagent Pack buttons when you load and unload packs.
RV Supply (Field) Displays the number of RVs available. The system updates this number as
it uses RVs.
This field turns yellow when there are 60 or fewer RVs available. This field turns
red when there are 28 or fewer RVs available.
RV Waste (Field) Displays the number of RVs that can fit in the waste bag. The system
updates this number as it ejects RVs.
This field turns yellow when there is room for 60 or fewer RVs in the waste bag.
The field turns red when the waste bag is full.
For more information about loading reagent packs, see Section 2.7: Reagent Packs.
Unload Reagent (Button) Select to unload a reagent pack.
Pack F2
When the system presents the pack, you can remove it from the reagent carousel.
The system removes the Reagent Pack button from the Supplies screen and
retains the lot number, expiration date, and number of tests left for the pack, so you
can reload the pack on any instrument in the workgroup. If the pack is empty, the
system automatically deletes the pack from inventory.
For more information about unloading reagent packs, see Section 2.7: Reagent
Packs.
Load RVs F4 (Button) Select to load RVs.
The system displays a message to wait while it prepares for RV loading. It retracts
the rake, releases the latch on the RV load door, then displays the message that you
can load a cartridge of RVs. When you are done, the system updates the RV count
on the Supplies screen.
For more information about loading RVs, see Section 2.5: Reaction Vessels (RVs).
2.2
Wash Buffer
Wash buffer is buffered solution the Access 2 system uses to clean the main pipettor
and probes, and to remove unbound material during test processing. The system
monitors the volume of on-board wash buffer with a float level sensor.
The wash buffer bottle drains into an internal wash buffer reservoir. When the wash
buffer bottle is visibly empty, but before the Wash Buffer button turns red, you
should change the empty bottle with a full one. There will still be some buffer in the
reservoir. If you wait until the button is red, the system schedules no new tests
because the internal reservoir is almost empty. The Wash Buffer button does not turn
yellow.
Wash Buffer
0573A.bmp
You can change the wash buffer bottle at any time. Because of the internal reservoir,
the system continues processing samples even when you remove the wash buffer
bottle.
For information about ordering supplies, see the Quick Reference Guide.
For more information about the system status buttons, see Section 1.3: Software
Overview.
Remove dispense
cap assembly from
empty bottle
0588B.wmf
Figure 2-3 Changing the Wash Buffer Bottle Flowchart
Changing the Use this procedure to change the wash buffer bottle (see Figure 2-4).
Wash Buffer 1 Mix the contents of the new wash buffer bottle by gently inverting the sealed
Bottle bottle 3 or 4 times.
2 Remove the cap and the inner seal from the new bottle.
3 Lift the empty bottle from the reservoir in the fluids tray on the left side of the
instrument.
CAUTION
To avoid contaminating the wash buffer, do not touch any part of the
dispense cap assembly that enters the reservoir. Handle the dispense cap
assembly only by screw cap, not the nozzle.
4 Unscrew the wash buffer dispense cap assembly from the empty bottle.
6 Turn the new bottle upside down and place the dispense cap assembly into the
reservoir receptacle.
NOTES
• The wash buffer will flow into the wash buffer reservoir as needed. DO
NOT squeeze the bottle or excess buffer may be forced into the reservoir
causing it to overflow.
• The sides of the bottle may cave in as it drains. This is normal.
2b 2
2a
4
3
0225F.eps
2.3
Liquid Waste
Liquid waste is any fluid removed from the Access 2 system.
WARNING
Consider the liquid waste potentially infectious. Handle and dispose of the liquid
waste according to proper laboratory procedures. Proper hand, eye, and facial
protection is required.
The liquid waste bottle collects liquid waste. Each instrument ships with two waste
bottles. This allows you to cycle containers, with one installed on the instrument
while you decontaminate the other. For your convenience, you can order more waste
bottle assemblies.
The system monitors the volume in the on-board liquid waste bottle with a weight
sensor. The Liquid Waste button turns red when the waste bottle is full. The system
will not schedule any new tests until you change the liquid waste bottle. You can
change the liquid waste bottle any time, even during processing, and preferably before
it is full. The Liquid Waste button does not turn yellow.
Liquid Waste
0574A.bmp
For information about ordering supplies, see the Quick Reference Guide.
For more information about system status buttons, see Section 1.3: Software
Overview.
Stopped
Remove bottle cap and
Processing No
insert in clean bottle
samples?
Yes
Connect quick
disconnects to empty
liquid waste bottle
Decontaminate
contents of full liquid
waste bottle
0589C.wmf
Figure 2-5 Changing the Liquid Waste Bottle Flowchart
Changing the Use this procedure to change the liquid waste bottle. To minimize contact with liquid
Liquid Waste waste, do not change the liquid waste bottle while the system is processing samples.
Bottle
WARNING
Consider the liquid waste potentially infectious. Handle and dispose of the
liquid waste according to proper laboratory procedures.
1 Loosen the liquid waste bottle cap slightly to release any pressure.
2 If the system is not processing samples, press the button on the quick
disconnects while pulling on the tubing to detach the tubing from the liquid
waste bottle cap (see Figure 2-6). Immediately, connect the quick disconnects to
the cap of a clean liquid waste bottle.
Y (Optional) If the system is processing samples, remove the liquid waste bottle
cap and immediately attach it to a clean liquid waste bottle.
NOTE
If a clean liquid waste bottle is not immediately available, put the liquid waste
bottle cap into a temporary container to prevent spills.
3 Remove the full liquid waste bottle and place the clean liquid waste bottle in the
fluids tray.
4 Decontaminate the contents of the full liquid waste bottle according to proper
laboratory procedures before disposing of the liquid waste.
6 Rinse the just-emptied liquid waste bottle thoroughly by filling it with tap water
and discarding the contents to remove any traces of the decontaminant.
WARNING
Thoroughly flush any decontaminant from the liquid waste bottle before
you store the liquid waste bottle. If you reinstall the liquid waste bottle
before you flush it, any remaining decontaminants may react with chemicals
pumped into the liquid waste bottle and the resulting chemical reactions can
create gases harmful to you or the instrument.
0229C.eps
2.4
Substrate
In Access 2 assays, the substrate is a dioxetane-based chemiluminescent compound
that emits light in response to the amount of alkaline phosphatase (enzyme) it is
exposed to. The system monitors the volume in the on-board substrate bottle. Each
bottle contains 130 mL of substrate, which can be used to perform up to 600 tests.
When the system can process 60 or fewer tests with the current supply of substrate, or
when the substrate will expire within three days, the Substrate button turns yellow.
When the substrate bottle is empty or the substrate is expired, the button turns red, and
the system cannot start processing samples until you connect a new bottle of substrate.
You can only change the substrate bottle while the system is in the Ready mode.
The fluids tray can accommodate two substrate bottles. The bottle in use is connected
to the substrate supply line. Another bottle can be stored in the tray to equilibrate to
room temperature prior to use, for the time specified in the substrate product insert.
The substrate bottle in use can occupy either the left or right tray position (see Figure
2-10).
All Access substrate bottles are labeled with a bar code. The Access 2 system tracks
the lot number, open bottle expiration date, serial number, and tests left. The system
also checks the substrate quantity and expiration date prior to sample processing, and
notifies you if supplies are required. You can override an expired supply condition,
but any test results generated with expired substrate are flagged.
For more information about checking and overriding supply conditions, in Section
4.2: Supply and Calibration Conditions.
For more information about system status buttons, see Chapter 1: System Overview.
any screen
Supplies
Change Substrate
F5
Change Substrate
Done
F1
Yes
F1
0505A.wmf
Figure 2-7 Changing the Substrate Bottle Flowchart
1 Be sure the system is in the Ready mode, then go to the Supplies screen. To get
to this screen from any screen, select the Substrate button.
0662A.bmp
Figure 2-8 Change Substrate Window
Bar Code (Field) Using the bar code wand or using the keyboard,
enter the bar code ID of the substrate bottle.
Lot Number (Field) Displays the lot number of the substrate bottle.
Serial Number (Field) Displays the unique serial number of the substrate
bottle.
Expiration Date (Field) Displays the expiration date of the substrate
bottle.
Tests Left (Field) Displays the number of tests that can be run using
the substrate bottle.
3 Pick up the equilibrated (new) substrate bottle and enter the bar code by
scanning the bottle with the bar code wand or by typing the characters in the
Bar Code field.
The window displays the lot number, serial number, expiration date, and
number of tests left.
NOTE
To avoid contaminating the substrate, do not combine partial bottles, touch the
supply line or the inside of the substrate cap, or allow the supply line to come in
contact with any surface. Also, combining partial bottles would cause improper
monitoring of the substrate supply.
For information on scanning the bar code, see the Scanning Bar Codes
procedure in Section 2.1: Supplies.
4 Remove the cap from the new, equilibrated substrate bottle and discard it (see
Figure 2-10).
5 Unscrew the substrate supply cap from the bottle in use and immediately screw
it onto the new bottle.
1 2
0228B.eps
9 Remove the empty substrate bottle from the fluids tray and discard it.
NOTE
Do not store substrate at room temperature for longer than the limits specified in
the product insert. Do not loosen or remove the cap on the substrate bottle while
it is equilibrating.
G (Optional) To track the stability of the substrate, monitor the Substrate fields
on the Supplies screen.
2.5
Reaction Vessels (RVs)
During an Access 2 test, the chemical reaction occurs in a container called a reaction
vessel (RV). Each test uses one or two RVs. RVs come in cartridges of 98. You can
load up to 3 cartridges at a time for a maximum capacity of 294 RVs.
• When there are 60 or fewer RVs available, the RVs button turns yellow.
• When there are 28 or fewer RVs available, the RVs button turns red.
• When no RVs are available, the system cannot process another sample until
you load a new RV cartridge onto the instrument.
For more information about system status buttons, see Section 1.3: Software
Overview.
any screen
Supplies
Load RVs
F4
Load RVs
Remove cartridge
cover, load cartridge,
remove empty spine
Done
F1
0504A.wmf
Figure 2-11 Loading RVs Flowchart
Loading RVs Use this procedure to load a cartridge of RVs onto the instrument.
NOTES
• You can load only full cartridges of RVs. If you try to load RVs when the
instrument only has room for a partial cartridge, the system displays a
message.
• If the system is processing samples and has one row or fewer RVs left when
you try to load more, the system displays a message. You must wait until the
instrument stops before you load the new cartridge.
• RVs can fall between the rake and the wall of the incubator if you do not
load RVs properly by selecting Load RVs F4 from the Supplies or Supplies
Required screen.
1 Go to the Supplies screen. To get to this screen from any screen, select the RVs
button.
3 Peel back and remove the protective covering from the RV cartridge.
4 To be sure that all 98 RVs are firmly seated in the cartridge spine, press down
on the spine before you load the cartridge.
5 Open the supplies door on the front of the instrument (see Figure 2-12).
0013A.eps
1 Supplies Door
2 RV Load Door
9 Open the RV load door and remove the empty spine. Do not leave the RV load
door open longer than necessary when the system is processing.
CAUTION
Remove the empty cartridge spine to prevent possible damage to the RV
rake.
2.6
Reaction Vessel Waste Bag
When a test is complete, the instrument ejects the reaction vessel (RV) through the
waste chute into the RV waste bag. The RV waste bag holds up to 300 RVs. The
system monitors the number of RVs ejected into the waste bag, and warns you when
the waste bag is nearing capacity.
When the waste bag has room for 60 or fewer RVs, the RV Waste Bag button
(represented by a biohazard symbol) turns yellow. When the RV waste bag is full, the
button turns red and the system will not start processing samples. You must change
the RV waste bag.
RV Waste Bag
0577A.bmp
When you install a new RV waste bag, the system resets the RV counter.
For more information about system status buttons, see Section 1.3: Software
Overview.
For more information about how RVs move through the system, see Section 3.1:
Sample Processing Theory in the Reference Manual.
any screen
Supplies
Done
F1
0507A.wmf
Figure 2-13 Changing the RV Waste Bag Flowchart
NOTES
• The system will not start sample processing without a waste bag in place.
• Always use the Change RV Waste Bag window to change the waste bag to
be sure the system can properly monitor RV waste bag capacity.
1 Go to the Supplies screen. To get to this screen from any screen, select the RV
Waste Bag button.
4 Unfold a new waste bag, grasp its sides, and pull gently to expand it.
NOTE
If the instrument is ejecting RVs, wait until you hear an RV ejected. You then
have 36 seconds to remove the old waste bag and install the new one before the
instrument ejects the next RV.
CAUTION
If the system is in the Running mode when you change the RV waste bag,
the system may try to eject an RV when the plastic collar on the waste bag
is blocking the ejection chute. This will cause a jam.
6 Place the new bag into position by sliding the plastic collar on the bag into the
slot on the waste chute. Press down firmly to be sure that the collar is
completely seated.
NOTE
If the next RV in line sticks out from the ejection chute slightly, it may prevent
the plastic collar on the new waste bag from sliding into the slot on the waste
chute. Gently push the top of the RV back slightly and out of the way of the
plastic collar.
CAUTION
To prevent damaging the system, DO NOT push an RV that is sticking out
from the ejection chute all the way back into the chute.
2.7
Reagent Packs
A reagent pack is a container that holds up to five assay-specific reagents. Reagents
include:
• Conjugate
• Paramagnetic particles with analyte-specific antigens or antibodies attached
• Stripping agents
• Buffered protein solutions
The Access 2 system monitors the number of tests processed using each reagent pack.
When an on-board reagent pack does not contain enough reagent to process requested
tests, the system assigns those tests the Supplies Required status and the Supplies
Required button (represented by a checklist) turns yellow. When you load a new pack
onto the instrument, the system takes the requested tests out of Supplies Required
status and begins processing them.
Supplies Required
0578A.bmp
For reagent packs in inventory, the Access 2 system also tracks the lot expiration date
and the number of days the pack has been open.
For more information about sample processing and supplies required, in Section 4.1:
Sample Processing.
For more information about system status buttons, see Section 1.3: Software
Overview.
Retrieving For the Access 2 system to accurately track the proper locations of reagent packs on
Misplaced the reagent carousel, the packs must be loaded and unloaded using the appropriate
Packs system windows. If you load a pack and do not use the Load Reagent Pack window,
or if you use the Unload Reagent Pack window, but do not remove the pack, you will
have a misplaced pack on your system.
Use this procedure to retrieve a misplaced reagent pack.
WARNING
You will come in contact with potentially infectious materials during this
procedure. Handle and dispose of biohazard materials according to proper
laboratory procedures. Proper hand, eye, and facial protection is required.
1 Be sure the system is in the Ready or Not Ready mode, and then unload all
reagent packs from the reagent carousel. For more information, see the
Unloading a Reagent Pack procedure.
2 Go to the Mechanics screen. To get to this screen from the Main Menu, select
Diagnostics F7 to display the Diagnostics menu, then
Select Device Diagnostics F4 to display the Device Diagnostics screen, then
Select Mechanics F1.
4 Slide the carousel door to the left to open it, and then open the reagent carousel
door.
5 Gently turn the reagent carousel one rotation. If you find any reagent packs
remaining on the carousel, remove them as they come into position at the
reagent carousel door.
6 After verifying that all packs are removed, close the reagent carousel door and
then slide the carousel door to the right to close it.
8 Home the reagent carousel. For more information, see the Homing a Device
procedure in Section 5.5: Mechanics and Device Diagnostics of the Reference
Manual.
9 When homing is complete, initialize the system. For more information, see the
Initializing the System procedure in Section 5.2: Initialize System of the
Reference Manual.
10 When system initialization is complete, reload all of the packs you removed
from the reagent carousel. For more information, see the Loading a Reagent
Pack procedure.
Supplies
F3
You can also load a
Supplies reagent pack from the
Supplies Required Reagent Inventory
screen
Done
Done F1
F1
Done
F1
0502A.wmf
Figure 2-14 Loading a Reagent Pack Flowchart
Loading a Use this procedure to load a reagent pack onto the instrument.
Reagent Pack
NOTES
• If you try to load an empty reagent pack, the system displays a message and
prevents you from loading it.
• If you load an expired reagent pack, the system displays a message. You can
only use the pack if you override the expired condition. For information
about using expired reagent packs, see the Overriding Supply Conditions
procedure in Section 4.2: Supply and Calibration Conditions.
1 Go to the Supplies screen. To get to this screen from the Main Menu, select
Supplies F3.
You can also load reagent packs from the Reagent Inventory screen or the
Supplies Required screen.
For information about the Reagent Inventory screen, see Section 2.8: Reagent
Inventory.
For information about the Supplies Required screen, see Chapter 4: Sample
Processing.
0663A.bmp
Figure 2-15 Load Reagent Pack Window
Bar Code (Field) Using the bar code wand or using the keyboard,
enter the bar code ID of the reagent pack.
Test Name (Field) Displays the test name of the reagent pack.
If a pack is used for more than one test, the system
displays the primary test for that pack. For example, the
Folate pack is used to run a primary test (Folate) and a
secondary test (RBC Folate). The system displays the
primary test (Folate).
Lot Number (Field) Displays the lot number of the reagent pack.
Serial Number (Field) Displays the unique serial number of the reagent
pack.
Expiration Date (Field) Displays the expiration date of the reagent pack.
Tests Left (Field) Displays the number of tests that can be run using
the reagent pack.
NOTE
You must always use the Load Reagent Pack window to load a reagent pack to
be sure the system can monitor the location of and tests left in the reagent pack.
3 Mix the new, unpunctured reagent pack by gently inverting the pack to remove
any magnetic particles from the top. Never invert a punctured pack.
WARNING
If you are reloading a partially used reagent pack, it must be returned to the
same stand-alone system or Access 2 workgroup from which it was removed. If a
partially used reagent pack is loaded on a different system or workgroup, it will
be inventoried as a full pack and inaccurate results may occur.
6 Insert the reagent pack into the empty slot directly under the reagent carousel
door. Angle the narrow end of the pack down into the slot, pressing forward
gently as you lower the pack into position (see Figure 2-17). Press down on the
back of the pack until it snaps into place, then gently pull the pack back toward
the outer rim of the reagent carousel. A spring on the front of the pack and a
small plastic anchor on the back of the pack hold it securely in place.
2 1
4 5
6
0764B.eps
1 Reagent Pack
2 Reagent Carousel Door
3 Spring
4 Empty Slot
5 Angle pack into empty slot
6 Press pack into place
CAUTION
To prevent damaging the reagent pack, be sure it is properly seated in the
reagent carousel.
7 Enter the reagent pack bar code by scanning the reagent pack with the bar code
wand (see Figure 2-18) or by typing the characters above the reagent pack bar
code in the Bar Code field.
The system displays the reagent pack bar code, pack name, lot number, serial
number, expiration date, and number of tests that the system can process using
the reagent pack in the Load Reagent Pack window.
For more information on scanning the bar code, see the Scanning Bar Codes
procedure in Section 2.1: Supplies.
a
b
E
c tal Ig
d
To 8T
3F
6D
WM
e
0019F.eps
Figure 2-18 Scanning a Reagent Pack Bar Code
The Supplies screen displays a button for that reagent pack in the list of
on-board reagent packs.
Main Menu
Supplies
F3
Done
F1
Done
F1
0503A.wmf
Figure 2-19 Unloading a Reagent Pack Flowchart
Unloading a Use this procedure to unload a reagent pack from the instrument.
Reagent Pack
NOTES
• If the system is using a reagent pack to process tests, you cannot unload it
(identified by the in-use [padlock] icon on the Supplies screen).
• When you unload a partially full reagent pack, the system keeps track of the
number of tests left in the pack until you reload it or manually delete it from
inventory.
WARNING
You will come in contact with potentially infectious materials during this
procedure. Handle and dispose of biohazard materials according to proper
laboratory procedures. Proper hand, eye, and facial protection is required.
1 Go to the Supplies screen. To get to this screen from the Main Menu, select
Supplies F3.
2 Select the button for the reagent pack you want to unload.
3 Select Unload Reagent Pack F2. The Unload Reagent Pack window displays
the pack information for the reagent pack you selected.
NOTE
Even if the reagent pack you want to unload is already in the unloading position
in the reagent carousel, you must use the Unload Reagent Pack window to
unload the pack to be sure the system can properly monitor the reagent
inventory.
6 Remove the reagent pack from the slot directly under the reagent carousel door.
Press forward gently as you lift the back end of the reagent pack. Slide the pack
back slightly to release the spring on the front before completely removing it
from the carousel.
11 If you intend to use the unloaded pack again, store it upright in the refrigerator.
Use the pack before it expires.
2.8
Reagent Inventory
The Access 2 system keeps an inventory of all on-board and off-board reagent packs
for every instrument in the workgroup. When you load a reagent pack, you scan a bar
code label on the pack. The bar code label contains the following information:
• Pack name
• Lot number
• Serial number
• Lot expiration date
The system also tracks the following non-bar coded information for each pack:
• Tests left
• Number of days the pack has been open (and the open pack expiration date)
• Pack expiration date (the earlier of two dates: the lot expiration date printed
on the label and the open pack expiration date)
• Calibration expiration date (for assays that are calibrated)
• Slot number (for packs on board the instrument the PC is attached to)
• Instrument the pack is on (for packs on board an instrument in the
workgroup)
You can remove a reagent pack from the instrument, store it, and reload it when
needed.
To maintain the reagent pack inventory, the system automatically deletes empty packs
when you unload them. You can manually delete full or partially full packs, if
necessary.
NOTE
You cannot reload a reagent pack after you have deleted it.
For more information about how to delete reagent packs, see the Deleting a Reagent
Pack procedure in this section.
For information on scanning the bar code, see the Scanning Bar Codes procedure in
Section 2.1: Supplies.
For information about how to load and unload reagent packs, see Section 2.7: Reagent
Packs.
For detailed information about open pack stability and expiration, see the product
insert in the Assay Manual.
For more information about system status buttons, see Section 1.3: Software
Overview.
0587A.bmp
Figure 2-20 Reagent Inventory Screen
NOTE
To refresh the information displayed in this column, you must exit the screen
and redisplay it.
Days Open (Column) Displays the number of days since the system first punctured the reagent
packs.
Pack Expiration (Column) Displays the dates the reagent packs expire.
The pack expiration date is the lot expiration date or the open pack expiration date,
whichever is earliest.
For a specific reagent pack, this field turns yellow when the reagent pack expires
within three days. This field turns red when the reagent pack is expired.
To calculate the open pack expiration, the system records the date the primary
probe first punctures the reagent pack and adds a number of days past that date,
based on limits specified in the assay protocol file (APF).
Calib. Expiration (Column) For on-board packs, displays the expiration dates of the current assay
calibrations. For off-board packs, displays Unloaded.
For a specific reagent pack, this field turns yellow when the calibration expires
within three days. This field turns red when the calibration is expired.
Assay calibrations can be completed while you are reviewing this screen. To
refresh the information displayed in this column, exit the screen and redisplay it.
For more information about calibrations, see Chapter 6: Assay Calibrations.
Slot (Column) Displays the position of on-board reagent packs on their instrument’s
reagent carousel. Slot positions are from 1 to 24.
If the pack is off board, the field is blank.
Instrument (Column) Displays the instrument the reagent pack is loaded on.
If the pack is off board, the field is blank.
Load Reagent Pack (Button) Select to load a reagent pack. When the instrument presents an empty
F1 pack position on the reagent carousel, you can load a reagent pack.
For more information on loading a reagent pack, see the Loading a Reagent Pack
procedure in Section 2.7: Reagent Packs.
Unload Reagent (Button) Select to unload a reagent pack. When the instrument presents the reagent
Pack F2 pack, you can unload it from the reagent carousel.
For more information on unloading a reagent pack, see the Unloading a Reagent
Pack procedure in Section 2.7: Reagent Packs.
This button is unavailable if the selected rack is already off board, or if it is on
board another instrument in the workgroup.
Delete Reagent (Button) Select to delete an off-board reagent pack from inventory. When you
Pack F5 delete a reagent pack, the system removes pack information from screens and
reports, but keeps it in the database. You can delete full or partially full off-board
reagent packs.
NOTE
You cannot reload a reagent pack after you have deleted it.
Applying a A filter is a set of parameters you can change to increase or decrease the number of
Filter to the reagent packs that display on the Reagent Inventory screen. A filter is always applied.
Reagent The default filter at system installation is all packs sorted by pack name on the
Inventory instrument the PC is attached to. Use this procedure to apply a different filter to the
Screen Reagent Inventory screen.
NOTE
The system uses the selected filter until you apply a different one.
0664A.bmp
Figure 2-22 Filter (Reagent Inventory) Window
Filter (List) Select a filter that limits the packs that display on
the Reagent Inventory screen.
Values are: All, On-Board, and Off-Board.
Instruments (List) Displays the instruments in the workgroup. Select
one or more workgroup instrument to display the packs
on the selected instruments only.
NOTE
This field is disabled when you select Off-Board in
the Filter field.
Sort Order (Options) Select to change the default sort order of the
packs.
Values are: Pack Name, Tests Left, Days Open, Pack
Expiration, Carousel Slot, and Instrument.
Ascending (Box) Displays the default sort order of the packs. Select
to sort the packs in the ascending order and clear to sort
in descending order.
The system sorts the packs in the following order:
• Pack Name and Instrument are sorted alphabetically
• Tests Left, Days Open, and Carousel Slot are sorted
numerically
• Pack Expiration is sorted by date
3 Select OK F1.
The Reagent Inventory screen displays the reagent packs according to the filter
criteria, sort order, and instrument you selected.
Main Menu
Supplies
F3
Supplies
Reagent Inventory
F7
Reagent Inventory
Yes
Delete Pack
F5
0508A.wmf
Figure 2-24 Deleting a Reagent Pack Flowchart
Deleting a Use this procedure to delete full or partially full off-board reagent packs from
Reagent Pack inventory.
NOTES
• You cannot reload a reagent pack after you have deleted it.
• You cannot unload or delete a reagent pack that is in use.
• You must unload a reagent pack before you can delete it.
• The system automatically deletes an empty reagent pack from inventory
when you unload it from the instrument.
1 Go to the Reagent Inventory screen. To get to this screen from any screen,
select the Substrate, RVs, or RV Waste Bag button to display the Supplies
screen, then select Reagent Inventory F7.
Y (Optional) To easily locate the pack you want to delete, apply a filter to reduce
the number of packs displayed. For help on how to do this, see the Applying a
Filter to the Reagent Inventory Screen procedure in this section.
3 Check to see if the reagent pack you selected is off board by verifying that the
slot and instrument fields are blank for this reagent pack.
Y (Optional) If the reagent pack is on board an instrument, find and unload the
reagent pack. For help on how to do this, see the Unloading a Reagent Pack
procedure in Section 2.7: Reagent Packs.
Printing the Use this procedure to print the Pack Inventory Report, containing all selected packs or
Pack all packs in the current filter.
Inventory
1 Go to the Reagent Inventory screen. To get to this screen from any screen,
Report
select the Substrate, RVs, or RV Waste Bag button to display the Supplies
screen, then select Reagent Inventory F7.
Y (Optional) To print the Pack Inventory Report for one or more selected packs,
select the packs you want to print. If you do not select any packs, the system
prints the report for all packs displayed on the Reagent Inventory screen.
Laboratories, Inc.
Laboratory A
123 Lake Street
Townsville, ST 33333
Pack Inventory Report 101-555-2323 ext. 109
Access 2 Immunoassay System Jane Smith
Page 1 of 1
Technologist______________________________ Printed 04/04/01 02:43 PM
0746B.bmp
Figure 2-25 Pack Inventory Report
Sample Management
3.1 Sample Management................................................................................... 3-3
Adding Test Requests to On-Board Samples Using the Pause Button ........... 3-54
Deleting Test Requests from On-Board Samples Using the Pause Button..... 3-56
3.1
Sample Management
Sample management is the process of placing patient, maintenance, quality controls,
or calibration samples in racks, entering test requests, and loading the racks onto the
Access 2 instrument for processing.
A test request includes a unique sample ID, information about the sample such as
patient ID and priority, and the tests you want to run on that sample.
You load samples onto the instrument in racks. Each rack is identified by a unique
bar-coded rack ID. When you load a rack onto the instrument, the system uses the
rack ID to identify the type of sample containers. In addition, the system displays
real-time summary information for each defined rack including:
• Location of the rack (on or off board the instrument)
• Estimated time until the instrument completes aspirating all samples in the
rack
• Estimated time until the instrument completes processing all samples in the
rack
• Sample container positions in the rack
• Any sample management errors, such as an illegible bar code or no test
requests for a sample on board the instrument
You can set up patient samples with or without a Laboratory Information System
(LIS). If you are using an LIS, the system downloads test request information
automatically after you load the rack. You cannot use an LIS to set up calibration,
quality control, or maintenance samples.
For information about how to process samples, see Chapter 4: Sample Processing.
Place samples
on racks
Main Menu
Sample Manager
F1
Sample Manager
Using
internal BCR Test Request
to read sample No Enter a rack ID
F3
IDs?
Test Request
Yes
Load rack
Test Request
Using LIS? No F3
Test Request
Yes
No Using LIS?
Yes
All racks
No loaded?
All racks
loaded?
No
Yes
Run
Yes
Run
0619B.wmf
Figure 3-1 Sample Management Flowchart
To get to this screen from the Main Menu, select Sample Manager F1.
0586B.bmp
Figure 3-2 Sample Manager Screen
On Board (List) Displays a rack button for each rack that is on board the instrument. You can
load up to six racks. Displays the most recently loaded rack button at the top. When
you unload the rack, the system moves the rack button to the Off Board list.
Off Board (List) Displays a rack button for each rack that is defined for the instrument, but is
currently off board. Displays the most recently unloaded rack button at the top.
When you load the rack, the system moves the rack button to the On Board list.
Rack Button (Button) Displays information for each rack. Each of the rack buttons contains the
following data:
• Rack ID number
• Number and position of the samples on the rack (graphically displayed using an
image of a rack with blue sample tubes)
• Rack status
• Aspiration and completion time for the rack
• Any bar code errors or QNS errors
Possible rack status values are: No Tests, Requested, Supply Wait, In Progress,
Aspirated, Done, and *Done*.
The rack status is determined by the status of the least progressed, individual
samples. For example, if 9 samples have been aspirated, but one has not been
aspirated, the rack status is In Progress. Once the final sample has been aspirated,
the status changes to Aspirated.
For more information about rack statuses, see Chapter 4: Sample Processing.
You must select a rack button before you can do anything with it. You can select a
rack in the following ways:
• Touching the screen or using the mouse to select the rack you want
• Using the 4 directional arrow keys
• Typing the rack button ID in the Rack ID field and pressing the [Enter] key
Rack Icon (Indicator) Displays the position of each sample container in the rack. Indicates
any sample errors that occur after you load the rack. If any of the following errors
occur, the system displays a red sample container in the corresponding position of
the rack icon:
• The internal bar code reader could not read the bar code on the sample container.
• There is no sample container in a position you entered a test request for.
• There are two or more loaded samples with the same sample ID on the same
instrument.
After you select Run, and if there is not enough sample to complete the ordered
tests, the system displays a red sample container in the corresponding position of
the rack icon and associates a QNS flag to the result.
Rack ID (Indicator) Displays the rack ID of the selected rack.
To define a new rack in the system, enter the rack ID or load the rack and wait for
the internal bar code reader to scan the rack ID label.
NOTES
• Rack IDs are shared across the Access 2 system. Each rack ID must be
unique across all instruments in a workgroup.
• To define a maintenance rack, you must enter the rack ID. If you load the
rack and wait for the internal bar code reader to scan the rack ID, the rack
is designated for sample processing and cannot be used for maintenance.
Asp. (Field) Displays the rack aspiration status.
When the rack status is In Progress, displays the estimated time until the
instrument finishes aspirating all tests for all samples in the rack.
When the rack status is Aspirated, displays Done. You can then get or unload the
rack.
When the rack status is No Tests, Requested, Supply Wait, Done, or *Done*, the
system displays the status instead of the Asp. and Comp. fields.
Comp. (Field) Displays the rack completion time.
When the rack status is In Progress or Aspirated, displays the estimated time until
the instrument completes all tests selected for all samples in the rack.
When the rack status is No Tests, Requested, Supply Wait, Done, or *Done*, the
system displays the status instead of the Asp. and Comp. fields.
Load a Rack F1 (Button) Select to load a rack onto the instrument.
When the instrument presents an empty rack position on the sample carousel, you
can load the rack.
Work Pending F2 (Button) Select to display the Work Pending screen. You use this screen to view:
• Reflex tests for samples not on board any instrument in a workgroup
• LIS test requests for samples not on board any instrument in a workgroup
• Re-ordered tests from Test Results (Rerun test)
For more information about this screen, see Chapter 4: Sample Processing.
Test Request F3 (Button) Select to display the Test Request screen. You use this screen to:
• Enter test requests for patient samples if you are not using an LIS
• Enter test requests for calibration and quality control samples
• Edit or delete test requests
• Monitor processing of specific samples
Maintenance (Button) Select to display the Request Maintenance window. You use this window
Requests F4 to request one or a combination of the following maintenance routines:
• Daily Clean System
• Special Clean
• System Check
For more information about maintenance requests, see Chapter 8: Routine
Maintenance in the Operator’s Guide.
Get Selected Rack (Button) After you select a rack from the On Board list, select to get the rack from
F6 the instrument. The system displays the Get Selected Rack window and presents
the selected rack. You can then add, remove, or rearrange samples or unload the
rack from the instrument.
NOTE
This button is only displayed when you select a rack from the On Board list.
Clear Selected Rack (Button) After you select a rack from the Off Board list, select to delete all
F7 information for the rack from the system. Clearing a rack removes the rack button
from the Sample Manager screen and any associated sample information from all
other screens, but does not delete the sample information from the database.
• You must clear a rack before you can reuse it.
• You cannot clear a rack from the On Board list.
The system prompts you to clear the rack when you unload a rack with a status of
Done or *Done*.
The system automatically clears racks with no test requests when you unload them.
NOTE
This button is only displayed when you select a rack from the Off Board list.
Change Rack ID F8 (Button) After you select a rack from the Off Board list, select Change Rack ID F8
to edit the rack ID.
NOTE
This button is only displayed when you select a rack from the Off Board list.
Placing Place all samples to be tested on the Access 2 system in racks before loading them
Sample onto the instrument. The rack ID on each rack identifies what type of sample
Containers in containers you may use in that rack. Each rack holds up to ten sample containers.
Racks Place all sample containers except insert cups directly in the rack. Place insert cups
into another sample container appropriate for the rack you are using.
WARNINGS
• You will come in contact with potentially infectious materials during this
procedure. Handle and dispose of biohazard materials according to proper
laboratory procedures. Proper hand, eye, and facial protection is required.
• Air bubbles in samples can affect level sensing by the Access 2 system and
compromise the integrity of test results. Avoid creating bubbles when
transferring samples to a secondary container. Always inspect samples before
loading on the instrument, and remove or break any bubbles.
CAUTION
Use only recommended sample containers and place them in a rack with a
rack ID defined for that type of sample container. Using containers other
than those specified for use with a particular rack ID may damage the
system and compromise the integrity of test results.
For more information about appropriate sample containers, corresponding rack IDs,
calculating sufficient sample volumes, and using insert cups, see Appendix A: Racks
and Sample Containers.
For information about supported bar code symbologies, see Chapter 2: System
Specifications in the Reference Manual. For information about enabling, disabling,
and configuring the internal bar code reader, see Chapter 4: System Configuration in
the Reference Manual.
Loading Use this procedure to load an off-board rack onto the instrument.
Racks
WARNING
You will come in contact with potentially infectious materials during this
procedure. Handle and dispose of biohazard materials according to proper
laboratory procedures. Proper hand, eye, and facial protection is required.
NOTES
• Be sure the rack ID bar code label is in good condition and is properly
affixed to the rack. For more information about properly applying rack ID
bar code labels, see Section A.1: Racks.
• You cannot load two racks with the same rack ID bar code label onto an
instrument.
• Within a workgroup, each instrument must use racks with unique ID bar
code labels. The same rack ID cannot be used on more than one instrument
in the workgroup.
1 Go to the Sample Manager screen. To get to this screen from the Main Menu,
select Sample Manager F1.
(Optional) To load a maintenance rack, go to the Maintenance Request screen.
To get to this screen from the Sample Manager screen, type the rack ID and
select [Enter], then select Maintenance Requests F4.
2 Select Load a Rack F1.
3 Open the sample carousel door, then pick up the rack by the handle and lower it
onto the sample carousel (see Figure 3-4).
Be sure the rack is within the guides of the carousel, and allow the lip of the
rack to guide it into position. The peg below the rack handle (under the lip)
should rest in the notch on the sample carousel.
0011D.eps
1 Go to the Sample Manager screen. To get to this screen from the Main Menu,
select Sample Manager F1.
4 Open the sample carousel door, then unload the rack by holding onto the rack
handle and lifting upward.
The system scans the sample carousel for any changes and moves any unloaded
rack buttons from the On Board list to the Off Board list on the Sample
Manager screen.
The system reports aspirated sample progress on the rack button in the Off
Board list and on the Test Request screen.
NOTE
You can view the maintenance sample progress from the Maintenance Requests
screen. For more information about maintenance samples, see Section 8.1:
Routine Maintenance.
Resolving If a sample error occurs after you load a rack, the system turns the affected sample
Sample Errors container red in the rack icon on the Sample Manager and Test Request screens, and
displays a specific error message or indicator in the corresponding Status field on the
Test Request screen.
Use this procedure to resolve any sample management errors that occur after you load
a rack.
1 Go to the Sample Manager screen. To get to this screen from the Main Menu,
select Sample Manager F1.
2 In the On Board list, look for red sample containers in the rack icon and select a
rack icon with a sample error.
4 Look for error messages in the Status field of the sample in error.
5 Take the necessary action to resolve the sample error. For more information,
see Appendix A: Troubleshooting in the Reference Manual.
1 Go to the Sample Manager screen. To get to this screen from the Main Menu,
select Sample Manager F1.
2 In the Off Board list, select the rack you want to change.
NOTE
A manually entered rack ID will override a scanned ID. As you type rack IDs,
be sure the numbers you enter into the appropriate field are correct.
5 Select OK F1.
A confirmation window is displayed.
Clearing Use this procedure to clear a rack button from the Off Board list on the Sample
Racks Manager screen and all of the rack’s associated sample information from the Test
Request or Maintenance Requests screen.
NOTES
• You must clear a rack before you can reuse it.
• You cannot clear an on-board rack.
• The system prompts you to clear the rack when you unload a rack that is
Done or *Done*.
• The system automatically clears racks with no test requests when you
unload them.
• Clearing a rack does not delete sample information, test results, or the rack
ID associated with the test results from the database.
1 Go to the Sample Manager screen. To get to this screen from the Main Menu,
select Sample Manager F1.
2 In the Off Board list, select the rack you want to clear.
Entering Use this procedure to enter, edit, or delete comments for patient or quality control
Sample samples on the Test Request screen.
Comments
1 Select the Pen or Notepad button to display the Sample Comment window.
Changing the Use this procedure to select a different reagent lot number for calibration or quality
Reagent Lot control tests.
Number
1 You can access the Change Lot Number window by selecting Sample Manager
F1, Test Request F3, and either Request QC F5 or Request Calibration F6.
2 Select the calibrator or quality control lot to be changed, then select Change
Reag. Lot.
NOTE
You can change to an off-board lot, but you must first load the reagent pack
onto the instrument.
3 Select the lot number from the Reagent Lot list and select OK F1.
The system returns you to either the Request Calibration or Request QC
window.
Requesting Technical Support representatives use service assays for instrument diagnostics.
Service
Assays NOTE
Use this window only as directed by your technical support representative.
3.2
Patient Test Requests
Before you can request a test for any sample, you must configure the test in the
system. When configuring tests, you can modify system default values, such as the
test ID, sample type, and reflex test conditions. For each patient test request, you must
enter a unique sample ID per instrument and a list of tests to run. For all tests, the
system supplies default values, including priority (routine) and dilution factor (1).
You can edit any of these fields and also enter sample comments.
If you use an LIS to download patient test and sample information, you load the rack
to begin test requests. The system automatically scans the rack ID and sample IDs,
and downloads test request information. You can verify or modify the information,
and then start processing. If you are using a bar-coded sample container, the system
scans the sample ID and any other bar-coded information and enters the information
in the appropriate fields and positions.
If you do not use an LIS or bar-coded sample containers, you select or enter test
request information manually before processing.
To simplify entering test requests manually, you can use the Auto Sample ID option
to automatically assign sequential sample IDs and use the Batch Request option to
automatically request the same tests for each sample.
For information about how to configure tests, see Chapter 4: System Configuration in
the Reference Manual.
For more information about how to edit or delete patient test requests,see Section 3.5:
Working with On-Board Samples.
For information about how to review patient test results, see Chapter 5: Test Results.
To get to this screen from the Main Menu, select Sample Manager F1, then select
Test Request F3.
Position
Selected
Sample
Selected
Tests
0583C.bmp
Figure 3-6 Test Request Screen
Rack Icon (Indicator - Rack Icon) Displays the rack ID and position of each sample container
in the rack.
If any of the following sample management errors occur after loading, the system
turns the affected sample container red:
• The internal bar code scanner could not read the bar code on the sample
container
and • A sample container is missing or is not in the correct position (for manual
requests only)
• There is not enough sample to complete one or more tests
For more information about resolving sample management errors, see Section A.4:
Assay Troubleshooting in the Reference Manual.
Rack ID (Field - Rack ID ) Displays the ID of the rack selected on the Sample Manager
screen. If you want to change the selected rack, you must go back to the Sample
Manager screen, select a different rack, then select Test Request F3.
Rack Location (Field) Displays the location of the rack.
Values are: Unloaded, Loaded, and Scanned/Loaded.
Rack Status (Field) Displays the sample processing status for the rack as determined by the
least processed sample in the rack.
Values are: No Tests, Requested, Supply Wait, In Progress, Aspirated, Done,
or *Done*.
For more information about rack statuses, see Section 4.4: Monitoring Sample
Progress.
Batch Request (Indicator) Displays to the left of the rack location when you turn Batch Request
on. When turned off, this indicator is not shown.
For more information about Batch Request, see the Using Batch Request procedure
in this section.
Auto Sample ID (Indicator) Displays to the right of the rack status when you turn Auto Sample ID
on. When turned off, this indicator is not shown.
For more information about Auto Sample ID, see the Using Auto Sample ID
procedure in this section.
Position (Button) Select to enter information about the sample in rows numbered 1-10. The
rows correspond to the ten positions in the selected rack, from left to right with the
convex side of the rack facing you.
The fields in each sample position row pertain to the sample in that position on the
rack.
Sample ID (Field) For patient samples, enter a unique sample ID. Sample IDs are unique for
loaded samples on the same instrument.
NOTES
• You can use a maximum of 15 characters, numbers 0 through 9,
uppercase and lowercase letters A through Z, slash (/), plus (+), and
minus (-).
• Spaces, punctuation marks, and special characters are not accepted.
For quality control samples, select Request QC F5 to select the quality control
name. For calibration samples, select Request Calibration F6 to select the
calibrator set name.
If you are using bar-coded sample containers, the system scans the sample ID and
any other bar-coded information after you load the rack and enter the information
in the appropriate fields and positions.
Patient ID/Lot (Field) For patient samples, enter an optional patient ID (1-15 alphanumeric
Number characters).
NOTE
A patient ID is required for LIS test requests.
For quality control or calibration samples, you can select one of the available lots
from the list.
For more information about QC setup, see Chapter 7: Quality Controls.
For more information about calibration setup, see Chapter 6: Assay Calibrations.
Dilution (Field) For patient samples, enter the dilution factor for any sample you dilute prior
to loading onto the system. The default value is 1 (no dilution 1/1). You can change
the default to a new value from 1-999. The system multiplies the test result by the
number you enter.
For quality control and calibration samples, this field is unavailable.
Sample Type (Field) For patient samples, select the type of fluid in the sample container.
Before you enter or download test requests for a sample, the default is Serum.
After you enter or download test requests, the default changes to the sample type
configured for the first selected test. To change it, select another sample type.
Values are: Serum, Urine, CSF, W. Blood, Plasma, Other, Amniotic, Urethral,
Cervical, or Synovial.
If you want to process more than one sample type for the same patient, you must
enter separate test requests using a unique sample ID for each sample type.
For quality control and calibration samples, the system supplies the sample type
configured for the quality control or calibrator.
STAT (Box) For patient samples, select to process the sample with STAT priority (before
all other samples). Clear to process the sample with routine priority.
Because STAT samples are processed before calibrations, verify that all tests
requested for a STAT sample have an active assay calibration (see Chapter 6:
Assay Calibrations).
Comment (Pen or Notepad Button) For patient and quality control samples, select to display
the Sample Comment window and add, edit, or delete sample comments.
If there are no comments associated with the sample, the system displays
the Pen button.
If a comment has been entered for a sample, the system displays the
Notepad button.
The system displays sample comments on test result reports and on the Quality
Control screen and reports.
Completion (Field) Displays the estimated time the system will finish processing all tests
requested for the sample. The format of this field is defined when you configure
the system.
If the system has not started processing any of the tests, this field is blank. If the
system schedules a reflex test for the sample, the system recalculates the
completion time.
Status (Field) Displays the sample status, as determined by the least processed test
requested for the sample. For more information, see the Sample Status topic in
Section 4.4: Monitoring Sample Progress.
If the system cancels a test, it records the test name and sample ID on the Event
Log screen and the Event Log button turns red.
Selected Tests (Field) Displays a list of all tests requested for the sample. The tests requested for
the sample are also called the test list.
For patient, quality control, and calibration samples, the system indicates replicates
by a number in parentheses after the test name. For calibration and quality control
samples, the system displays the reagent lot number in parentheses after the test
name.
To add, delete, or edit tests from the selected tests list, use the Test menu.
For more information about using the Test menu, see the Entering Patient Test
Requests Manually procedure in this section.
Load Rack X F1 (Button) X is the rack ID of the rack selected on the Sample Manager screen. If the
or selected rack is off board, select Load Rack X F1 to load it. If the selected rack is
Get/Edit Rack X F1 on board, select Get/Edit Rack X F1 to present the rack at the sample carousel
door, where you can unload the rack, add, remove, or rearrange samples.
Delete Sample F2 (Button) Select to delete all selected sample information from the Test Request
screen.
You can only delete a sample when the rack is off board, the sample status is
Requested or Supply Wait, or when all of the test statuses are Requested or
Supply Wait.
Show / Hide Test (Button) Select Show Test Menu F3 to display the Test menu. Select Hide Test
Menu F3 Menu F3 to hide the Test menu.
You use the Test menu to request tests to run on the selected sample. The menu
moves up and down as you select a different sample position so it does not overlap
the position you are entering information for. You do not have to hide the Test
menu.
Test Results F4 (Button) Select to display the Test Results screen, filtered to display results for all
samples on the selected rack. The sample selected on the Test Request screen is
also selected on the Test Results screen.
NOTE
When you select Test Results F4, the On-Board Patient Sample filter is
automatically applied to the Test Results screen. Therefore, if you select an
off-board rack on the Test Requests screen, the results for that rack will not
be displayed.
Request QC F5 (Button) For quality control samples, select to display the Request QC window.
You use the Request QC window to select the name of the quality control you want
to run from a list of quality controls defined across all systems in a workgroup.
When the selected sample position contains a patient sample or calibration request,
the system displays an error message.
Request Calibration (Button) For calibration samples, select to display the Request Calibration window.
F6 You use the Request Calibration window to select the calibrator you want to run
from a list of calibrators defined across all systems in a workgroup.
When the selected sample position contains a patient sample or quality control
request, the system displays an error message.
Clear All Samples (Button) Select to clear all sample fields for the current rack.
F7
Navigating If you are using the keyboard to navigate the Test Request screen, the cursor
the Test movement on this screen is different from other screens.
Request
When you go to the Test Request screen, the cursor will be in the Sample ID field for
Screen
the first position on the rack. You can press [Tab] to move the cursor through the
subsequent fields. Pressing [Tab] moves the cursor through the fields in this order:
• Patient ID/Lot Number
• Test Menu
• Dilution
• Sample Type
• STAT
You can press [Enter] to validate information you enter into a field, and to move the
cursor through a limited number of fields. From the Sample ID field, pressing [Enter]
moves the cursor through the fields in this order:
• Patient ID/Lot Number
• Test Menu
• To the next Sample ID field
NOTE
To access the Comment window you must select the Pen or Notepad button.
You cannot navigate to this window using the [Tab] or [Enter] keys.
You can use the up and down arrow keys to move the cursor vertically through the
sample positions.
You can use the left and right arrow keys to move the cursor through the fields in the
same order as the [Tab] key. However, once you enter information into an editable
field, these arrow keys move the cursor through the field by individual characters until
you reach the end of the field.
Main Menu
Sample Manager
F1
Sample Manager
Load a Rack
F1
Load rack
Done
F1
All racks
No loaded?
Yes
System downloads
test requests from LIS
Verify downloaded
sample and test
information and make
any necessary changes
Run
0621B.wmf
Figure 3-8 Processing LIS Test Requests Flowchart
Processing LIS If you are using bar-coded sample containers and are downloading test requests from
Patient Test an LIS, use this procedure to load racks and run the tests. You can load up to six racks
Requests at one time.
NOTES
• If you want to load another rack after you select Run (the last step of the
procedure), you must wait for the system to update all of the tests before you
continue. You can avoid waiting if you load all the racks at the same time.
• Be sure that the rack and sample ID bar code label is in good condition and
is properly affixed to the rack. For more information about properly
applying rack ID bar code labels, see Section A.1: Racks.
• Be sure the appropriate tests are enabled before entering test requests. The
system will reject an LIS test request if the associated test has not been
enabled. For more information about enabling tests, see Section 4.4: Test
Setup in the Reference Manual.
1 Go to the Sample Manager screen. To get to this screen from the Main Menu,
select Sample Manager F1.
2 Place the samples in the rack(s). For information about how to do this, see the
Placing Sample Containers in Racks procedure in this chapter.
For information about sample containers and volumes, see Appendix A: Racks
and Sample Containers in this manual. For assay-specific sample volume
information, see the product inserts.
NOTE
After the system starts scanning, you can interrupt the scan to load another rack.
The system cancels the scan as soon as you select Load a Rack F1. However,
there is a slight delay before it presents the rack position.
7 Verify scanned and downloaded sample and test request information and make
any necessary changes.
NOTE
If you already entered sample IDs on the Test Request screen, and the sample
IDs scanned do not match the IDs you entered, the system uses the sample IDs
you entered.
For more information about sample processing, see the Starting Sample Processing
procedure in Chapter 4: Sample Processing of the Operator’s Guide.
Main Menu
Sample Manager
F1
Sample Manager
Enter rack ID
or select rack button
from Off Board list
Test Request
F3
Test Request
Place samples
in racks
Load Rack X
F1
Load rack
All racks
loaded? No Back
Yes
Run
0618B.wmf
Figure 3-9 Entering Patient Test Requests Manually Flowchart
Entering If you have disabled sample bar code scanning, or need to enter test requests and
Patient Test sample information manually, use this procedure to manually enter test requests.
Requests
Manually NOTES
• If you want to load another rack after you select Run (the last step of the
procedure), you must wait for the system to update all of the tests before you
continue. You can avoid waiting if you load all the racks at the same time.
• To add test requests to samples in an on-board rack, see Section 3.5:
Working with On-Board Samples.
• You can use other procedures in this chapter to enter test requests for
calibration or quality control samples, and place these samples in the same
rack with patient samples.
• Be sure that the rack ID bar code label is in good condition and is properly
affixed to the rack.
1 Go to the Sample Manager screen. To get to this screen from the Main Menu,
select Sample Manager F1.
2 Select the rack button from the Off Board list, or enter the rack ID in the Rack
ID field and press [Enter].
NOTE
If you will be entering additional samples, you can use the Auto Sample ID
option to simplify entering this information. For more information, see the
Using Auto Sample ID procedure in this chapter.
6 Using the Test menu, select the tests you want to run on the sample.
If the Test menu is not shown, select Show Test Menu F3 to display the menu.
NOTE
If you will be entering additional samples, you can use the Batch Request
option to simplify entering this information. For more information, see the
Using Batch Request procedure in this chapter.
0697A.bmp
Figure 3-10 Test Menu (Patient Samples)
Tests Requested for (List) Displays test names selected to run on the sample (X is the selected sample
Sample X position). Displays the number of selected replicates in parentheses after the test
name.
Test (Field) Displays the test ID or test name for the selected test. You can type a test ID
or test name in this field to request the test instead of using the test buttons. You
can add a test replicate with the [+] key, or subtract a test replicate with the [-] key.
Remove (Button) Select this button to remove one replicate of the test selected in the Tests
Requested for Sample X list.
Test Buttons (Buttons) Each button displays the test name and test ID for an available test or test
panel. Select to add one replicate of the test. If you select a button for a test panel,
one replicate of each individual test associated with that panel is added to the Tests
Requested list.
7 Review the values for the Dilution, Sample Type, STAT, and Comment fields
and edit them if necessary.
G (Optional) To enter additional samples, repeat steps 4-7 for each additional
sample.
NOTE
If you are entering a STAT sample, verify that the tests requested have active
calibrations.
G (Optional) To delete a test for a sample, select the test in the menu list and select
Remove.
8 Place the samples in the rack. For information about how to do this, see the
Placing Sample Containers in Racks procedure in this chapter.
For information about sample containers and volumes, see Appendix A: Racks
and Sample Containers in this manual. For assay-specific sample volume
information, see the product inserts.
G (Optional) To load another rack, select Back to return to the Sample Manager
screen, then repeat steps 2-9.
NOTES
• When configuring the system, you can disable sample ID bar code scanning,
but tube detection and rack ID scanning are always enabled. If the internal
bar code reader cannot read a rack ID, you must relabel the rack with a
readable label or use a different rack.
• If the rack ID you entered does not match the rack ID scanned, the system
displays an error message. You must return to the Sample Manager screen,
unload the rack, and either load the right one or change the rack ID.
• If the tube detector does not detect a sample container in a position that has
requested tests, the system deletes the sample from the Test Request screen.
Main Menu
Sample Manager
F1
Sample Manager
Test Request
F3
Test Request
Enter sample ID
for first sample
More Options
F8
Turn Auto Sample ID On
F2
Yes Run
The system
automatically enters
the sample ID
0512B.wmf
Figure 3-12 Using Auto Sample ID Flowchart
Using Auto The Auto Sample ID option simplifies test request entry when you are not using
Sample ID bar-coded sample IDs, and your sample IDs are consecutive. After you enter the first
sample ID, the system enters sample IDs automatically for subsequent samples. Each
ID will be numerically increased by 1.
For example, if the first sample ID is PAT11, the next sample ID will be PAT12, and
so on. If the first sample ID ends with a non-numeric character, the system adds a 1 to
the next sample ID and then increments subsequent sample IDs. For example, if the
initial sample is SampleA, the next sample ID will be SampleA1, the next will be
SampleA2 and so on.
Use this procedure to turn the Auto Sample ID option on or off during the Entering
Patient Test Requests Manually procedure.
1 Go to the Test Request screen. To get to this screen from the Main Menu, select
Sample Manager F1.
3 Select Test Request F3. Type the sample ID for the first sample and press
[Enter].
4 Select More Options F8, then select Turn Auto Sample ID On F2.
5 Enter the rest of the test request information for the sample.
The system continues to supply an incremented sample ID for each sample until
you turn off the option or exit the Test Request screen.
G (Optional) To turn off Auto Sample ID, select More Options F8, then select
Turn Auto Sample ID Off F2.
Main Menu
Sample Manager
F1
Sample Manager
Test Request
F3
Test Request
Type sample ID for the first
sample and select tests to
run
More Options
F8
Turn Batch Request On
F1
Test Request
The system
automatically selects
same tests for
next sample
Done entering
samples?
No
Yes
Run
0513B.wmf
Figure 3-13 Using Batch Request Flowchart
Using Batch The Batch Request option simplifies test request entry when you are not using an LIS
Request to download test requests. You can use this option if you are manually entering
sample IDs, but it is most effective if you use it along with bar-coded sample IDs.
After you request tests for the initial sample, the system assigns the same tests to
subsequent samples.
1 Go to the Test Request screen. To get to this screen from the Main Menu, select
Sample Manager F1.
3 Select Test Request F3. Type the sample ID and enter the tests you want to
run, then press [Enter].
5 Enter the rest of the test request information for the sample.
6 Select the next sample position, enter the sample ID, and press [Enter].
The system automatically selects the same tests for the sample in the position
you selected.
Reusing You must delete a sample ID from the system before it can be reused.
Sample IDs
In order to reuse a sample ID, you must first complete the following steps.
1 On each instrument in the workgroup, unload and clear all racks that contain the
sample ID. For more information, see Section 3.1: Sample Management.
2 Delete all test results associated with the sample ID. For more information, see
Section 5.3: Managing Test Results. To configure the system to automatically
delete test results, see Section 4.10: PC Administration Setup in the Reference
Manual.
3 Be sure each test you will request for the reused sample ID is enabled. For more
information, see Section 4.4: Test Setup in the Reference Manual.
4 Delete all work pending tests associated with the sample ID. For more
information, see Section 4.3: Work Pending.
3.3
Calibration Test Requests
Calibrators, calibration controls, or controls are samples of known reactivity specific
for calibrating an assay on the Access 2 system. You run calibration samples on the
Access 2 system to establish values the system uses to assess test results for patient
and quality control samples. The system requires an active (accepted, not expired)
assay calibration for each requested test.
You can run a calibration at any time, or when the system prompts you. Beckman
Coulter recommends that you perform assay calibration under the following
circumstances:
• When you switch to a new reagent lot, or to a new reagent shipment within
the same lot
• When the active calibration has expired
• When quality control data indicates calibration is necessary
• When a major system component has been repaired or replaced
NOTES
• You must configure each new lot of calibrators, calibration controls, or
controls before you can use them for a calibration.
• Although the calibration sample may be prepared from bottles named
calibrators, calibration controls, or controls, the system uses the generic term
calibrator on Access 2 screens, buttons, and windows to refer to all of these
calibration examples.
For information about how to edit or delete calibration test requests, see Section 3.5:
Working with On-Board Samples.
For information about how to load a new reagent pack, see Chapter 2: Supplies.
For information about how to review calibration data and determine if a test has an
active assay calibration, see Chapter 6: Assay Calibrations.
Main Menu
Sample Manager
F1
Sample Manager
Test Request
Request Calibration
F6
Request Calibration
OK
F1
Test Request
Run
0510B.wmf
Figure 3-14 Entering Calibration Test Requests Flowchart
Entering Use this procedure to enter test requests for a set of calibration samples.
Calibration
Test Requests NOTES
• The system processes calibration samples before quality controls and
routine patient samples.
• You must set up each new calibrator before you can perform a calibration
using that lot.
1 Go to the Sample Manager screen. To get to this screen from the Main Menu,
select Sample Manager F1.
2 Select the rack button from the Off Board list, or enter the rack ID in the Rack
ID field and press [Enter].
0698B.bmp
Figure 3-15 Test Menu (Calibration)
Reagent (List) Displays the test name associated with the selected calibrator, calibration
control, or control.
Reagent Lot (List) Displays the selected reagent lot number associated with each selected test.
Test (Field) Displays the test ID or test name for the selected test.
Change Reag. Lot (Button) Select to display the Change Lot Number window and choose a different
reagent lot.
NOTE
You can only change the reagent lot if the sample status is Requested.
G (Optional) To change the reagent lot for a calibrator, select the calibrator set,
then select Change Reag. Lot. For more information about changing the
reagent lot, see the Changing the Reagent Lot Number procedure in this
chapter.
G (Optional) To change the calibration test, select Delete Sample F2, then return
to step 4.
G (Optional) To hide the Test menu, select Hide Test Menu F3.
6 Place the samples in the rack(s). For information about how to do this, see the
Placing Sample Containers in Racks procedure in this chapter.
NOTE
Be sure that each calibrator in the set is in the same type of sample container,
then place the calibration samples for the entire calibration set in the same rack.
For information about sample containers and volumes, see Appendix A: Racks
and Sample Containers in this manual. For assay-specific sample volume
information, see the product inserts.
7 Load the rack (see the Loading Racks procedure in this chapter).
G (Optional) To request additional calibration sets, repeat steps 2-6. Or, use other
procedures in this chapter to request patient or quality control samples.
For more information about sample processing, see Section 4.1: Sample
Processing.
3.4
Quality Control Test Requests
Quality control samples are commercially available samples of known reactivity. You
run quality control samples along with patient samples to monitor analytical variation
on your Access 2 instrument and to ensure the validity of patient sample results.
You run quality controls by entering a quality control test request for a quality control
sample or set of samples. When you enter a quality control test request, you select a
specific quality control lot number from the Request QC window.
You should run quality control samples as recommended in the product insert and
after any scheduled or unscheduled maintenance to verify assay calibration. Also,
after successfully installing new software, Beckman Coulter recommends running
quality controls for all assays you use to report patient results, then recalibrating any
assays with out of range QC results.
To best simulate the characteristics of patient samples, use quality control samples
prepared from material similar to the patient samples you are testing. For example, if
testing serum, use serum-based quality control samples.
NOTE
You must set up each new quality control lot in the Access 2 system before you
can select it during test request entry.
For information about how to edit or delete quality control test requests, see Section
3.5: Working with On-Board Samples.
For information about how to review quality control data, see Section 7.2: Reviewing
Quality Control Charts and Data.
Main Menu
Sample Manager
F1
Sample Manager
Test Request
F3
Test Request
Request QC
F5
Request QC
Test Request
Load Rack X
F1
Run
0511B.wmf
Figure 3-17 Entering Quality Control Test Requests Flowchart
Entering Use this procedure to enter a test request for a quality control sample or set of
Quality samples.
Control Test
1 Go to the Sample Manager screen. To get to this screen from the Main Menu,
Requests
select Sample Manager F1.
2 Select the rack button from the Off Board list, or enter the rack ID in the Rack
ID field and press [Enter].
3 Select Test Request F3 to display the Test Request screen, then select Request
QC F5.
NOTE
The Request QC window displays the quality controls set up on all systems in a
workgroup.
0699B.bmp
Figure 3-18 Test Menu (QC)
Reagent (List) Displays the tests selected to run on the quality control sample.
Reagent Lot (List) Displays the reagent lot number if you have changed the lot number for the
selected test.
If you do not change the reagent lot number, no reagent lot is listed. The system
selects a lot number when processing begins.
Test (Field) Displays the test ID for the selected test. You can use this field to enter the
test to run on the quality control sample instead of using the test buttons.
Change Reag. Lot (Button) Select a test from the Reagent list, then select this button to display the
Change Lot Number window and choose a different reagent lot.
NOTE
You can only change the reagent lot when the sample status is Requested.
Remove (Button) Select a test from the Reagent list, then select this button to remove one
replicate.
Test Buttons (Buttons) Each button displays the test name and test ID for an available test or test
panel. Select to add one replicate of the test. If you select a button for a test panel,
one replicate of each individual test associated with that panel is added to the
Reagent list.
5 Select the tests you want to run on the QC sample. The Reagent list in the Test
menu displays the selected tests.
G (Optional) To change the reagent lot for a test, select the test, then select
Change Reag. Lot. For more information, see the Changing the Reagent Lot
Number procedure in this chapter.
G (Optional) To hide the Test menu, select Hide Test Menu F3.
G (Optional) To enter or edit comments, select the Pen or Notepad button. For
more information, see the Entering Sample Comments procedure in this
chapter.
6 Place the QC samples in the rack(s). For more information, see the Placing
Sample Containers in Racks procedure in this chapter.
For information about sample containers and volumes, see Appendix A: Racks
and Sample Containers in this manual. For assay-specific sample volume
information, see the product inserts.
7 Load the rack(s). For more information, see the Loading Racks procedure in
this chapter.
3.5
Working with On-Board
Samples
The Access 2 system allows continuous access to sample information. You can edit
active test request fields, select additional tests, cancel selected tests, delete tests, and
add, remove, or rearrange samples while the system continues processing.
If the sample rack containing the sample you want to work with is on board, and the
system is in the Running mode, you must stop aspiration activity before working with
the on-board sample by pausing the instrument or getting the rack. Pausing the
instrument does not affect tests already in progress.
NOTE
In general, if you use an LIS to download test requests, you should use the LIS
to add, edit, or delete test requests. The LIS expects to receive results from the
Access 2 system for all tests downloaded for a sample. If you use the Test menu
to delete a downloaded test request, the Access 2 system does not inform the
LIS of the deletion, and the LIS continues to expect a result for the test.
Likewise, if you use the Test menu to add a test request, the LIS may not
recognize uploaded results for the added test. See your LIS documentation or
contact your LIS vendor for details.
For information about how to load, unload, and clear racks, and to change rack IDs,
see Section 3.1: Sample Management.
Main Menu
Sample Manager
F1
Sample Manager
Done
F1
Run
0848B.wmf
Figure 3-20 Adding, Removing, and Rearranging On-Board Samples Flowchart
Adding, Use this procedure to access an on-board rack so you can add, remove, or rearrange
Removing, samples.
and
Rearranging WARNING
On-Board You will come in contact with potentially infectious materials during this
Samples procedure. Handle and dispose of biohazard materials according to proper
laboratory procedures. Proper hand, eye, and facial protection is required.
NOTES
• If you are using the internal bar code reader to scan sample IDs, you should
only work with on-board samples without unloading the rack.
• If sample ID scanning is disabled, you can unload the rack, add, remove, or
rearrange samples as you edit the necessary information on the Test Request
screen, and then reload the rack.
1 Go to the Sample Manager screen. To get to this screen from the Main Menu,
select Sample Manager F1.
2 Select the rack you want to work with from the On Board list.
CAUTION
If the rack status is Aspirated, the system displays a warning message that
reflex tests could be scheduled for samples on that rack. If you choose to
remove samples scheduled for reflex tests from the rack, the system will
display the scheduled reflex tests on the Work Pending screen. You will
have to reload the sample(s) to run the reflex tests.
4 Open the sample carousel door and add, remove, or rearrange samples. You do
not need to unload the rack.
The internal bar code reader scans the rack(s) for changes. If you added samples
and are using an LIS and bar-coded sample IDs, the system downloads patient
test requests for the new samples.
(Optional) To add, remove, or rearrange samples on another on-board rack,
repeat steps 2-5.
Main Menu
Sample Manager
F1
Sample Manager
Test Request
F3
Test Request
Get/Edit Rack X F1
System
No processing
samples?
Yes
System enters
Paused mode
Test Request
All samples
No
edited?
Yes
Done
F1
Run
0514B.wmf
Figure 3-21 Editing Test Requests for On-Board Samples Flowchart
Editing Test Use this procedure to edit a test request for a sample in an on-board rack.
Requests for
1 Go to the Sample Manager screen. To get to this screen from the Main Menu,
On-Board
select Sample Manager F1.
Samples
2 In the On Board list, select the rack with the test request to be edited.
NOTE
If you edit the sample ID for a test request, all information associated with that
sample, including the tests you have requested, is removed from the test request.
G (Optional) To edit tests, select Show Test Menu F3. Select the test you want to
edit.
7 To start or continue sample processing, select Done F1, then select Run.
For more information about sample processing, see Section 4.1: Sample
Processing.
Main Menu
Sample Manager
F1
Sample Manager
Test Request
F3
Test Request
Get/Edit Rack X
F1
Specify sample
containing the test
request to delete
Remove
F2
Done
F1
Run
0517B.wmf
Figure 3-22 Deleting Test Requests for On-Board Samples Flowchart
Deleting Test Use this procedure to delete a test request for a sample in an on-board rack.
Requests for
On-Board NOTE
Samples You can delete a test request only if the sample status is Requested, In
Progress, or Supply Wait.
1 Go to the Sample Manager screen.To get to this screen from the Main Menu,
select Sample Manager F1.
2 In the On Board list, select the rack containing the sample with the test request
to be deleted.
6 In the Test menu, select the test to be deleted from the Tests Requested for
Sample X list.
8 To start or continue sample processing, select Done F1, then select Run.
For more information about sample processing, see Section 4.1: Sample
Processing.
Main Menu
Sample Manager
F1
Sample Manager
Test Request
F3
Test Request
Pause
Run
0934A.wmf
Figure 3-23 Adding Test Requests to On-Board Samples Using the Pause Button Flowchart
Adding Test Use this procedure to add a test request for a sample in an on-board rack using the
Requests to Pause button.
On-Board
Samples NOTE
Using the The instrument must be in the Running mode to use this procedure.
Pause Button
1 Go to the Sample Manager screen. To get to this screen from the Main Menu,
select Sample Manager F1.
2 In the On Board list, select the rack containing the sample that requires
additional test requests.
4 Select Pause.
The system enters the Paused mode, but does not present the selected rack.
Main Menu
Sample Manager
F1
Sample Manager
Test Request
F3
Test Request
Pause
Select sample
containing the test
request to be deleted
Remove
F2
Run
0935A.wmf
Figure 3-24 Deleting Test Requests from On-Board Samples Using the Pause Button Flowchart
Deleting Test Use this procedure to delete a test request for a sample in an on-board rack using the
Requests from Pause button.
On-Board
Samples NOTE
Using the The instrument must be in the Running mode to use this procedure.
Pause Button
1 Go to the Sample Manager screen. To get to this screen from the Main Menu,
select Sample Manager F1.
2 In the On Board list, select the rack containing the sample with the test requests
to be deleted.
NOTE
You cannot delete test requests if the rack status is In Progress, Aspirated,
*Done*, or Done.
4 Select Pause.
The system enters the Paused mode, but does not present the selected rack.
6 In the Test menu, select the test to delete from the sample.
NOTES
• You cannot delete test requests from samples that have any of the following
sample statuses: In Progress, Aspirated, or Done.
• If the sample has test requests that are Requested and In Progress, you can
delete any test requests with the Requested status. If you delete all
Requested test requests, the sample status changes to In Progress.
Sample Processing
4.1 Sample Processing ........................................................................................ 4-2
4.1
Sample Processing
Sample processing begins after you verify supplies, load samples, enter or verify test
request information, and select Run.
The Access 2 system is dynamic. When you select Run, the system automatically
determines the optimal sample processing order and immediately begins to process
the samples it can. The system alerts you if you need to replenish supplies, calibrate
any test, or respond to the system in any other way. For the most efficient throughput,
verify that the instrument has the supplies and valid calibrations needed to process all
samples before you select Run.
NOTE
You cannot change the substrate bottle while the system is in the Running
mode.
If you are using an LIS to enter patient test requests and the system is in the Running
mode, the system automatically downloads the requests as they are received.
• If the sample for downloaded test requests is on board, the system adds the
requests to the current run. If supplies and calibrations are sufficient, the
system automatically processes the downloaded tests. You do not need to
select Run again. If supplies or calibrations require attention, the system
assigns the Supply Wait status to the tests it cannot process, and the
Supplies Required button turns yellow. You must load supplies, change
waste containers, or recalibrate before the system can process the tests with
Supply Wait status.
• If the sample for downloaded test requests is not on board, the system puts
the test requests in the work pending list, and the Work Pending button turns
yellow. You must load the sample before the system can process the
downloaded test requests.
While the system is processing tests, you can monitor the progress of each on-board
sample and requested test.
You can process multiple containers with the same sample ID on multiple
instruments. However, you cannot process multiple containers with the same sample
ID concurrently on the same instrument.
The Access 2 system allows continuous access, so you can add or remove most
supplies, add or remove samples or racks, or change waste containers during
processing. You can also pause processing to add or delete test requests.
If you configured your system with reflex testing enabled, the system orders reflex
tests automatically when the defined conditions are met and the sample is on board an
instrument in the workgroup.
To be sure the Access 2 system continues to run efficiently, you must perform routine
daily and weekly maintenance procedures.
For information about how to load samples and enter or verify test request
information, see Chapter 3: Sample Management.
For more information about reflex testing, see Chapter 4: System Configuration in the
Reference Manual.
(optional) (optional)
Monitor progress Supplies or
Samples Monitor progress
View results No calibration No
required? View results
Print results required?
Print results
Yes Yes
Override
F8
Yes
(optional)
Override Apply filter
Correct the Load samples
No expired supply/ No condition now?
calibration? Delete samples
Print report
Yes
Load supply,
change waste
container, or
request calibration
0518B.wmf
Figure 4-1 Processing Samples Flowchart
Starting Use this procedure to begin processing samples after you verify supplies, load
Sample samples, and enter or verify test request information.
Processing
1 Select Run.
The Access 2 system determines the testing sequence and begins the tests it can
complete under current conditions.
NOTE
You cannot select Run from a limited number of screens, such as Diagnostics
screens.
2 If a test requires calibration or the system needs any supplies, the Supplies
Required button turns yellow. If the system requires samples, the Work
Pending button turns yellow. If the system detects an operational error, the
Event Log button turns yellow or red. Select the button to display the
corresponding screen.
For information about Supplies Required, see Section 4.2: Supply and
Calibration Conditions.
For information about Work Pending, see Section 4.3: Work Pending.
For information about the Event Log, see Chapter 6: Event Log in the Reference
Manual.
NOTES
• When the system has completed or cancelled the last test on the last
on-board rack, it automatically rinses the aspirate probes by running the
Utility Assay.
• Unless there is an emergency, let the Utility Assay run to completion.
Pausing Use this procedure to temporarily pause the instrument when it is in the Running
Sample mode.
Processing
NOTES
• You cannot pause the instrument during a maintenance routine.
• You can make changes to on-board samples and test requests while the
system is in the Paused mode. For more information, see Section 3.5:
Working with On-Board Samples.
For detailed information about the Utility Assay, see Chapter 8: Routine
Maintenance.
Sample When you start sample processing, the system determines the optimal processing
Processing order using the following criteria, and begins processing the samples with the highest
Order priority first.
Priority Criteria
1 Type:
1st STAT patient samples
2nd Calibration samples
3rd Quality control samples and routine
patient samples
2 Date and time the rack was loaded (first on, first
processed)
3 Assay (depends on the assay protocol file [APF])
4 Sample position within the rack (in order from
first position to tenth position)
5 Maintenance routines
The system processes all STAT samples first, in the order you loaded them onto the
instrument. Next, the system processes calibration samples. Then, the system
processes routine patient samples and quality control samples with the same priority,
in the order you loaded them onto the instrument. Last, the system runs maintenance
routines.
NOTE
If a STAT patient sample has a requested test that is not calibrated, you must
calibrate the assay before you load and run the STAT sample.
Within a rack, the system typically processes all tests of a given type together to
maximize throughput. For example, the system will process all Cortisol tests
requested for samples in a rack, then all Theophylline tests, and so on.
If your system is set up to automatically print reports, the result reports for patient
samples print when testing is complete, according to the priority criteria. For more
information about result reports, see Chapter 5: Test Results.
LIS Request When the system receives an LIS test request, it uses a set of rules to determine which
Container instrument and sample container it will assign the request to. If a test request is not
Assignment assigned to a sample container right away, the system stores it in the LIS workpool,
and the Work Pending button turns yellow. The test request in the LIS workpool can
be viewed on the Work Pending screen. When one of the rules is satisfied, the system
assigns the pending test request to the appropriate sample container.
NOTE
Be sure the appropriate tests are enabled. The system will reject an LIS test
request if the associated test is not enabled on at least one instrument in the
workgroup.
If the LIS interface is enabled (configured on), the Access 2 system is always open to
receive broadcast downloads of test requests. When a rack is loaded, the system
searches the LIS workpool for test requests for sample IDs scanned by the bar code
reader, and repeats the search every few seconds when in the Running mode.
You can also enable or disable host query for each instrument. If host query is
enabled, the Access 2 system can ask the LIS for new test requests, instead of waiting
for a broadcast. When a rack is loaded and the system finds no test requests in the
workpool for any of the loaded sample IDs, the system queries the LIS for test
requests. A test request received by host query is always assigned to the instrument
that generated the query, if the test is enabled.
The rules for assigning a test request to a sample container differ depending on:
• How many instruments are in the workgroup
• How many of the instruments in the workgroup have the test enabled
• How many sample containers exist for the sample ID
Just loaded onto the The system searches the test list for test requests for the
instrument samples in the rack.
• If the test requests are not in the test list, the system
searches the LIS workpool.
• If the test requests are not in the workpool, and Host
Query is enabled, the system queries the LIS.
On board, and the The system assigns downloaded test requests to the
instrument is in the appropriate sample containers and automatically
Running mode schedules them to run on the instrument.
On board, but the Downloaded test requests remain in the LIS workpool
instrument is not in the until you either:
Running mode
• Select Run, or
• Get the rack and select Done F1 (reload it)
When you select Run, the rules for the Running mode
apply.
All sample containers are off board The test remains in the LIS workpool
all instruments in the workgroup until you load one of the sample
containers.
The rules for one instrument (see Table
4-3) then apply.
One sample container is on board Every other sample The test remains in the LIS workpool
an instrument that is not in the container is off board all until you:
Running mode instruments in the • Select Run, or
workgroup
• Get the rack and select Done F1
(reload it), or
• Load the rack onto another
instrument
The rules for one instrument (see Table
4-3) then apply.
One sample container is on board The test is enabled on all The system assigns the test requests to
an instrument that is in the instruments the instrument that is in the Running
Running mode and all other mode.
sample containers are on board
instruments that are not in the
Running mode
All sample containers are on board The test is enabled on all The system assigns the test requests to
instruments that are in the Running instruments the instrument that searches the LIS
mode workpool or queries the LIS first.
4.2
Supply and Calibration
Conditions
Before running requested tests, the Access 2 system does the following verifications
of supply quantities and expiration dates:
• Compares the requested tests to the number of tests that it can process with
the on-board substrate, reaction vessels (RVs), and reagent packs
• Compares the requested tests to the remaining capacity for RV waste
• Checks if there is wash buffer available and if there is remaining capacity for
liquid waste
• Checks the expiration dates of the substrate, reagent packs, reagent lots, and
calibrations
• Verifies that an active calibration exists for each of the tests requested
You can manage supply and calibration requirements in the following ways:
• Manually verify supply levels and calibrations at least once a day to be sure
the system can process all requested tests immediately when you start
processing.
• Request the system to verify supplies and calibrations after all of the tests are
requested (by you or the LIS), and before you select Run.
• Wait for the system to automatically verify supplies and calibrations after
you select Run. The Supplies Required button turns yellow if the system
requires supplies or calibrations.
If supply or calibration conditions are not OK for all of the tests requested, the system
processes the tests it can. The system does not schedule additional tests when the
current supplies are gone, calibrations are needed, or the waste containers are almost
full.
You can start sample processing using expired supplies or calibrations by overriding
current conditions. The system flags the results of tests using expired supplies or
calibrations in the Event Log and on result reports.
For more information about how to verify supply levels, load supplies, and change
waste containers, see Chapter 2: Supplies.
For more information about how to review calibrations, see Chapter 6: Assay
Calibrations.
For more information about how to enter calibration test requests, see Chapter 3:
Sample Management.
0692A.bmp
Tests Requested (Field) Displays the total number of tests requested for loaded samples with test
statuses of Requested or Supply Wait. The number includes reflex tests and tests
requested by the LIS.
Tests to Run (Field) Displays the number of tests requested for loaded samples that the system
can process with the current supply levels and active calibrations.
Required (Column) Displays the action or quantity needed.
• When a reagent is low or expired, displays number of packs (X Packs) needed.
• When RVs are low, displays the number of cartridges (X Cartridges) needed.
• When there is no calibration, displays Calibrate.
• When the calibration is expired, displays Recalibrate.
• When substrate is low or expired, the RV waste bag is full, or the wash buffer is
low, displays Change.
• When the liquid waste bottle is full, displays Empty.
• When no tests are requested or no supplies are needed, displays None.
Supply (Column) Displays the name of the supply required and the icon that represents the
supply. Supply names are: Substrate, RVs, RV Waste Bag, Wash Buffer, Liquid
Waste, and XXX, where XXX is the name of the reagent pack. For reagent packs
with primary and secondary tests, secondary tests display in parentheses after the
reagent pack name for the primary test. For example: Folate (RBC Folate).
Lot Number (Column) Displays the lot number associated with the supply condition, if
applicable. Otherwise, this column is blank.
Status (Column) Displays the calibration, lot, or substrate expiration status.
• When a reagent pack is expired, displays Pack Expired.
• When a reagent lot is expired, displays Lot Expired.
• When the substrate is expired, displays Expired.
• When there is no calibration, displays No Calibration.
• When the calibration is expired, displays Calibration Expired.
Load Reagent Pack (Button) Select to load a reagent pack onto the instrument. For information about
F1 loading reagent packs, see Chapter 2: Supplies.
Reagent Inventory (Button) Select to display the Reagent Inventory screen to see a list of on-board
F2 and off-board reagent packs, including the following information:
• Test name
• Lot number
• Serial number
• Tests left
• Days the reagent pack has been open
• Reagent pack expiration date
• Calibration expiration date
• Slot number (if the pack is on board the instrument)
• Instrument the reagent pack is on (if it is on board the instrument)
For information about the Reagent Inventory screen, see Chapter 2: Supplies.
Load RVs F4 (Button) Select to load RVs. For information about loading RVs, see Chapter 2:
Supplies.
Change Substrate (Button) Select to change the substrate bottle. You cannot change the substrate
F5 bottle when the system is in the Running mode.
For information about changing the substrate bottle, see Chapter 2: Supplies.
Change RV Waste (Button) Select to change the RV waste bag. For information about changing the
Bag F6 RV waste bag, see Chapter 2: Supplies.
Print F7 (Button) Select to print the Supplies Required Report (see Figure 4-8).
Override F8 (Button) Select to continue sample processing. This button is only available when
you can override a supply condition that is preventing the processing of new tests.
You can override the following supply conditions:
• Expired calibrations
• Expired substrate
• Expired reagent packs or lots
• No calibration
Requesting Before starting sample processing, you can display the Supplies Required screen to
Verification of get detailed information about any supply and calibration conditions that will prevent
Supplies and the processing of new tests.
Calibrations
Use this procedure to verify supplies and calibrations.
1 Go to the Supplies Required screen. To get to this screen from any screen, select
the Supplies Required button.
The system compares the number of requested tests to the number of tests that it
can process with the on-board supplies and the remaining capacity for liquid
waste and used RVs. The system also verifies the status of all requested assay
calibrations and checks the expiration dates of calibrations, reagent packs,
reagent lots, and substrate.
The screen lists the actions or quantities needed.
For information about overriding conditions, see the Overriding Supply Conditions
procedure in this section.
Overriding You can start sample processing using expired calibrations, substrate, reagent packs,
Supply or reagent lots by overriding the current conditions. The system applies appropriate
Conditions flags to test results and logs a corresponding event in the Event Log.
You can also override a reagent pack that is not calibrated, but no test results will be
generated for the assay.
NOTE
If you are recalibrating an expired calibration and running STAT tests for the
assay at the same time, you must override the expired calibration. Until you
select Override F8, the STAT test requests stay in the Supply Wait status.
1 Go to the Supplies Required screen. To get to this screen from any screen, select
the Supplies Required button.
Y (Optional) To override some supply conditions but not others, first correct the
conditions you do not want to override.
For example, you may have an expired Theophylline reagent pack and a Cortisol
pack with an expired calibration, and you only want to override the Cortisol
calibration. You unload the expired Theophylline pack and load an unexpired
Theophylline pack. You then return to the Supplies Required screen and perform
the override procedure. Cortisol will be removed from the list on the Supplies
Required screen and the subsequent Cortisol test results will be flagged.
NOTE
If the system is in the Running mode, you do not need to select Run. The
system pauses briefly and then runs the tests, using overridden expired supplies
or calibrations.
Laboratories, Inc.
Laboratory A
123 Lake Street
Supplies Required Report Townsville, ST 33333
Access 2 Immunoassay System 101-555-2323 ext. 109
S/N 500135 Jane Smith
Tests Requested 36
Tests to Run 0
Page 1 of 1
Technologist ________________________ Printed 04/04/01 03:16 PM
0823C.bmp
Figure 4-8 Supplies Required Report
4.3
Work Pending
The Access 2 system verifies that all necessary samples are on board while scheduling
tests.
When the system requests a reflex test, accepts a downloaded LIS test request, or
when you rerun a test, the system tries to find the sample on board any instrument in
the workgroup.
Tests that the system cannot schedule because it cannot find an on-board sample are
called work pending. When the system fails to find an on-board sample, the sample is
added to the work pending list, and the Work Pending button turns yellow. You must
either load the appropriate sample or delete the test request using the Delete F6 button
on the Work Pending screen.
Work Pending only lists test requests for tests that are enabled on the instrument
attached to the PC displaying the Work Pending screen. These test requests can
originate from any system in the workgroup.
Because the system automatically deletes manually entered, unscheduled test requests
if you unload and clear the sample, the system never displays manually entered test
requests in the work pending list.
For information about reflex tests, see Chapter 4: System Configuration in the
Reference Manual.
For information about rerunning tests with fatally flagged results, see Chapter 5: Test
Results.
To get to this screen from the Main Menu, select Sample Manager F1 to display the
Sample Manager screen, then select Work Pending F2. Or, select the Work Pending
button from any screen.
0700A.bmp
Figure 4-10 Work Pending Screen
Filter (Field) Displays the filter and sort order currently in effect.
Samples Requested (Field) Displays the number of samples the system needs in order to complete the
requested tests.
LIS Workpool (Field) Displays the number of samples in the LIS Workpool. The workpool is a
list of tests that have been requested by the LIS, but that the system cannot
schedule because the associated samples are not on board any instrument in the
workgroup.
Sample ID (Column) Displays the sample ID of the requested sample.
Patient ID (Column) Displays the patient ID, if one exists, for the requested sample.
NOTE
A patient ID is required for LIS test requests.
Requested (Column) Displays the date and time that the sample was requested.
Tests Pending (Column) Displays the test names of all tests pending for the sample.
Origin (Column) Displays the origin of the test request. Values are: Reflex, LIS, Manual
(Rack/Instrument) Rerun.
In parentheses, displays the rack ID and the instrument name the sample is
associated with. If the sample is not associated with a rack, the rack is blank. If the
sample was never loaded on an instrument, the instrument is Unknown.
Filter F1 (Button) Select to display the Filter window and apply a filter and a sort order to
the Work Pending screen. The system displays the filter and sort order you select in
the Filter field.
The default filter is all pending tests (all filters selected) sorted in ascending
Sample ID order.
For more information about the Filter window, see the Applying a Filter to Work
Pending procedure in this section.
Sample Manager F2 (Button) Select to display the Sample Manager screen to see a list of on-board and
off-board racks, to load a rack, or to add a sample to an on-board rack.
For more information about loading samples and racks, see Chapter 3: Sample
Management.
Delete F6 (Button) Select to display the Delete window and delete tests from the work
pending list.
Print F7 (Button) Select to print the Work Pending Report.
Table 4-11 Work Pending Screen Descriptions
Applying a A work pending filter is a set of parameters you can change to reduce or expand the
Filter to Work number of samples displayed on the Work Pending screen.
Pending
Use this procedure to apply a different filter to the Work Pending screen.
1 Go to the Filter window. To get to this window from any screen, select the
Work Pending button to display the Work Pending screen, then select Filter F1.
0826B.bmp
Figure 4-12 Filter (Work Pending) Window
• To include off-board samples with pending LIS test requests, select the
Off-board LIS Requests box.
G (Optional) Select or clear the Ascending box to sort the samples in ascending
or descending order.
3 Select OK F1.
The system displays all samples with tests that meet the selected filter
parameters on the Work Pending screen.
NOTES
• The system uses the selected filter until you apply a different one.
• The Work Pending button turns yellow only when a pending test that fits
the filter criteria is added to the work pending list.
Deleting Work Use this procedure to delete selected tests or all tests from the Work Pending screen.
Pending Tests
1 Go to the Work Pending screen. To get to this screen from any screen, select the
Work Pending button.
3 Select OK F1.
A confirmation window is displayed.
Printing Work Use this procedure to print a list of samples associated with pending test requests.
Pending
1 Go to the Work Pending screen. To get to this screen from any screen, select the
Work Pending button.
Laboratories, Inc.
Laboratory A
123 Lake Street
Work Pending Report Townsville, ST 33333
Access 2 Immunoassay System 101-555-2323 ext. 109
S/N 501240 Jane Smith
Page 1 of 1
Technologist ______________________________________ Printed 10/10/01 11:05 PM
0824B.bmp
Figure 4-14 Work Pending Report
4.4
Monitoring Sample Progress
You can monitor sample progress by looking at the rack status, sample status, or test
status:
• Rack Status
Progress of all samples on a rack.
• Sample Status
Progress of individual samples.
• Test Status
Progress of requested tests.
Rack Status You can monitor the testing progress of an entire rack by looking at the rack status,
displayed on the Sample Manager screen. The system displays the rack status in the
center of the rack button in the On Board or Off Board list.
The rack status depends on the progress of each sample in the rack. After the rack
reaches the status of Requested, the sample in the earliest stage of testing determines
the status. For example, if nine samples in a rack are In Progress but the tenth sample
is Requested, the rack status is Requested.
You can use the rack status to determine when you can unload a rack from the
instrument. You can unload a rack with the Aspirated status without affecting testing,
unless a reflex test is requested after aspiration is complete. If you attempt to unload a
rack before the Aspirated status, the system displays a confirmation window before
you can unload it.
If a reflex test begins processing, the rack status can revert to an earlier status.
For more information about the Sample Manager screen, see Chapter 3: Sample
Management.
For more information about reflex testing, see Chapter 4: System Configuration in the
Reference Manual.
No Tests The rack is empty or has samples associated with it, but none of
the samples has requested tests.
Requested At least one test has been entered or downloaded for at least one
sample in the rack.
Supply Wait At least one test requested for at least one sample in the rack
requires you to load supplies or calibrate assays before it can
run.
In Progress All tests requested for all samples in the rack have been
scheduled for processing.
The Asp. and Comp. fields replace the rack status. The Asp.
field displays the estimated time until aspiration is complete
and the Comp. field displays the estimated time until all
processing is complete for the rack.
If the rack is being used for a maintenance routine, the Asp. and
Comp. fields are displayed as applicable.
Aspirated All tests requested for all samples in the rack have been
pipetted. You can remove the rack without affecting
processing, unless a reflex test is requested after aspiration is
complete.
The Asp. field displays Done, and the Comp. field displays the
estimated time until all processing is complete for the rack.
Done All tests requested for all samples in the rack have been
processed. The Done rack status replaces the Asp. and Comp.
fields.
*Done* All tests requested for all samples in the rack have been
processed, but at least one test was cancelled. The *Done* rack
status replaces the Asp. and Comp. fields.
Sample Status For an individual sample, you can monitor sample progress by looking at the Status
column on the Test Request screen. For more information about the Test Request
screen, see Chapter 3: Sample Management.
Test Status You can monitor individual test status by looking at the Result column on the Test
Results screen. During test processing, the system displays the test status instead of a
result in this column. For more information about this screen, see Chapter 5: Test
Results.
Status Description
Test Results
5.1 Test Results ...................................................................................................... 5-2
Specifying a Date and Time Range for a Test Result Filter ........................... 5-19
5.1
Test Results
Test results are data the Access 2 system creates and stores for every test the system
runs. As the system completes sample processing, the test results become available
for you to review, manage, and print. Test results include:
You can review the test results on the Test Results screen, or print the test results in
one of several report formats.
You use the function buttons on the screen to perform these procedures:
For more information about filters, see Section 5.2: Reviewing Test Results.
0591B.wmf
Figure 5-1 Test Results Flowchart
To get to this screen from the Main Menu, select Test Results F2.
0627C.bmp
Figure 5-2 Test Results Screen
NOTE
A patient ID is required for LIS test requests.
Sample ID (Required column) Displays the sample ID associated with the result.
Rack (Optional column) Displays the number of the rack the sample is loaded on.
Verify (Optional column) Displays the status of the test results. When the LIS is set up to
send only auto-verified results to the LIS, the system compares the test results to
the LIS ranges you defined. For more information, see Section 4.9: LIS Setup.
Also see Section 4.7: Ranges Setup in the Reference Manual. Values are:
• <blank> - The system has not compared the test result to the set LIS ranges. If
the column is blank, it usually means the result has not been calculated yet.
• Pass - The test result was within the set LIS ranges. The system sent the result
to the LIS.
• Fail - The test result was not within the set LIS ranges and the system cannot
send it to the LIS. The system displays the word Fail in red.
• Not Verified - The LIS is not set up to verify results.
Test Name (Required column) Displays the test name associated with the result.
Result (Required column) Displays the result of the test, including the value, units, and
interpretation. No Value is displayed if the result is associated with a fatal flag, if
the result was run using an uncalibrated reagent lot, or if a calibrator result is
outside the upper or lower limits of the curve.
If test processing is incomplete, displays the test status. For more information
about test status, see Section 4.4: Monitoring Sample Progress in the Operator’s
Guide.
The system displays the test result in red for the following conditions:
• Quantitative and Semi-Quantitative - For controls, if the results are outside of
the control range.
• Qualitative - If the result is reactive, confirmed, or associated with a GRY flag.
Flags (Required column) Displays any flags associated with the result. If there are no
flags, the field is blank.
LIS (Optional column) Displays the LIS status of the test result.
Values are:
• <blank> - Either the system has not calculated the result, or the result will not be
sent to the LIS.
• Sending - The system is sending the result to the LIS.
• Accepted - The system sent the result and the LIS received it.
• Failed - The system sent the result, but the LIS did not receive it.
• Idle - The system attempted to send the test result to the LIS while the global
LIS interface was offline.
RLU (Optional column) Displays the actual RLUs for the test result.
Comp. Time (Optional column - not shown) Displays the date and completion time of the test.
Instrument (Optional column - not shown) Displays the ID of the instrument that ran the test.
Pipettor (Optional column - not shown) Displays N/A. This column is reserved for future
use.
Filter F1 (Button) Select to apply, edit, or delete filters and sort orders to the Test Results
screen. The system displays the selected filter and sort order in the Filter field.
For information about test result filters, see Section 5.2: Reviewing Test Results.
Find F2 (Button) Select to search the filtered results for a specific test result.
Rerun Test F3 (Button) Select to re-request the selected test. If the sample is on board an
instrument, the test is automatically assigned and runs at the next opportunity. If
the sample is off board, the system displays it on the Work Pending screen (see
Chapter 4 in this manual for more information on Work Pending).
Sample Details F4 (Button) Select to display demographic information, comments, and flag
interpretations for the sample.
Send to LIS F5 (Button) Select to send test results to the LIS.
Copy to Disk F6 (Button) Select to copy all test results or selected test results to a disk.
Print F7 (Button) Select to display a menu of the following options:
Report F1
Select to print test result reports.
Completed Samples F2
Select to manually print results as samples are completed. The results print on the
Continuous Sample Report.
More Options F8 (Button) Select to display a menu of the following options:
Refresh Screen F1
Select to re-apply the filter and display new results that match the filter parameters.
Configure Screen F2
Select to choose optional columns and change column order of the test result data.
Delete Data F3
Select to remove test result data from the system and the database.
Selecting Test Use this procedure to select one or more test results on the Test Result screen.
Results 1 Go to the Test Result screen. To get to this screen from the Main Menu, select
Test Results F2.
2 Select a test result by selecting the row. An arrow displays at the beginning of
the selected row.
NOTES
• Use the scroll bar on the right side of the screen to view the results that are
out of the normal viewing range.
• Press the [Ctrl] key while you press the [Home] or [End] key to go to the
beginning or end of the test result list, respectively.
G (Optional) Select a different row by touching it. The arrow displays at the new
row you selected and is cleared from the previous selection.
G (Optional) To make multiple selections, you use the [Ctrl] or [Shift] key.
To select test results that are not contiguous, press the [Ctrl] key while you
select multiple rows. For example, press the [Ctrl] key and then select 3 results.
Each of the rows is selected.
To select contiguous test results, press the [Shift] key while you select the first
and last of the contiguous rows. For example, to select the first 5 results, press
the [Shift] key and then select the first and fifth results. Release the [Shift] key.
All five results are selected.
G (Optional) If you want to clear a selection, select the result again. The result is
no longer selected.
5.2
Reviewing Test Results
When test results become available, you can review them. The system displays test
results for all samples currently on board the instrument and sorts them by sample ID,
then by test name. This is the default filter the system applies to the test result data.
You can limit the number of test results that display on the screen by applying a
different filter. You can also choose the columns you want to display and customize
the column order.
You can find a specific test result using the sample ID, patient ID, rack ID, or test
name.You can also view test result flags and descriptions. Flags are codes the
Access 2 system associates with test results when a special circumstance requires
attention.
When reviewing results for a particular sample, you can rerun any tests on that
sample.
Test Result A test result filter is a set of parameters you can manipulate to limit the number of
Filters results displayed on the Test Results screen to only those you want to see at any given
time.
The Test Results screen is always filtered. The default filter is On-board Samples -
Sorted by Sample ID Then by Test Name.
The system displays the test results based on the filter parameters. You can adjust the
number and type of test results displayed by selecting a different system-defined
filter, defining a new filter, or editing the parameters of one of your laboratory’s
defined filters.
You define a new filter by determining all of the parameters for the filter. For
example, you can create a filter that only displays patient samples with a sample ID
that begins with the digits 1234.
You can also edit the laboratory-defined filter parameters to display different test
results, or you can use a system-defined filter as a basis for creating a new filter. For
example, you can select the system-defined All Patient Samples (Last 30 Days)
filter, change the parameters, and save the filter with a new name.
When you change any of the parameters of a filter, you can either save the changes as
a new filter or apply the changes without saving them. If you do not save the changes,
the system retains the unnamed filter only until you apply a different one. You would
have to redefine the filter to use it again.
The last filter you apply becomes the default filter for the next time you display the
Test Results screen. The Access 2 system automatically uses that default filter until
you apply a new one.
A sort order determines the order test results are listed in, and you can include both
primary and secondary sort orders in a filter. For example, you can sort test results by
Sample ID, then by Completion Time in ascending order.
Main Menu
Test Results
F2
Test Results
Filter
F1
Filter
Select filter
and sort orders
OK
F1
0522A.wmf
Figure 5-4 Applying a Test Result Filter Flowchart
Applying a Use this procedure to apply one of the available test result filters. The following test
Test Result result filters are system-defined:
Filter
Filter Default 1st Order Default 2nd Order
1 Go to the Filter window. To get to this window from the Main Menu, select
Test Results F2 to display the Test Results screen, then select Filter F1.
2037A.bmp
Figure 5-6 Filter (Test Results) Window
2nd Sort Order (Option) Select to change the secondary sort order. The sort order default is
dependent on the filter (see Table 5-5).
Values are: No second sort, Sample ID, Patient ID, Test Name, Rack ID, and
Completion Time.
Ascending (Box) Select to sort the results in the ascending, alphabetic order and clear to sort
by descending, alphabetic order.
Description (Field) Displays a description of the selected filter.
New Filter F2 (Button) Select to display the New Filter window and define a new filter.
Edit Filter F3 (Button) Select to display the Edit Filter window. The fields and options in the Edit
Filter window reflect the selected filter parameters. In this window, you can edit
the existing filter parameters and save the changes as a new filter or apply the new
filter without saving it.
Delete Filter F4 (Button) Select to delete the filter selected in the Filter list box.
NOTE
You cannot delete a system-defined filter.
G (Optional) To display the results in descending order, clear the Ascending box.
3 Select OK F1.
The system displays all test results that meet the selected filter parameters on
the Test Results screen. The applied filter becomes the default filter until you
apply a different saved filter.
NOTE
If you select the system-defined filters All Patient Samples Loaded
Between... or All Samples Loaded Between..., or a laboratory-defined filter
that asks for the date and time, the system prompts you to enter the date range.
For more information, see the Specifying a Date and Time Range for a Test
Result Filter procedure in this section.
Main Menu
Test Results
F2
Test Results
Filter
F1
Filter
Select filter
and sort orders
Filter Parameters
Edit Filter
F3 Filter Name
Description
Ask for Date & Time
Edit Filter Instruments
Test Result Status
LIS State
Sample ID
Edit filter parameters
Test Name
Auto-Verify
Rack ID
Patient ID
Result
Population
Filter
Clear Parameters
F3
No parameters
OK?
Yes
OK
F1
No Cancel
F4
No Save Filter? No F8
OK
F1
0647B.wmf
Figure 5-8 Editing a Test Result Filter Flowchart
Editing a Test Use this procedure to edit an existing filter and apply it to the Test Results screen.
Result Filter
NOTE
If you change the system ID for an instrument in your workgroup, the
instruments selected in the existing filters may also change. Test and update the
filters to make sure they operate as expected.
1 Go to the Filter window. To get to this window from the Main Menu, select
Test Results F2 to display the Test Results screen, then select Filter F1.
2 Select the filter you want to edit from the Filter list.
The system displays a description of the filter in the Description field and the
default sort orders in the 1st and 2nd Sort Order columns.
0605B.bmp
Figure 5-9 Edit Filter (Tests Results) Window
Filter Name (Field) Displays the name of the filter selected in the Filter window. You can delete
the name and type a new name.
Description (Field) Displays the description of the filter selected in the Filter window. You can
delete the description and type a new description.
Ask for Date and (Box) Select to have the system ask for date and time parameters time you apply
Time the filter.
To set the date and time, see the Specifying a Date and Time Range for a Test
Result Filter procedure in this section.
Instruments (Boxes) Select the instrument(s) to include in the filter.
If your Access 2 system is connected to a workgroup, there could be up to 4
systems to choose from.
Test Result Status (Boxes) Select the test result statuses to include in the filter.
Values are:
• Completed
• Not Completed
• On Board
• Off Board
• STAT
• Routine
• Flagged
• Not Flagged
LIS State (List) Select to include the status of the LIS in your filter.
Values are:
• All
• Idle
• Sending
• Failed
• Accepted
• Not Sent
Sample ID (List) Select the sample IDs to include in the filter. In the first field, select a
relationship from the list.
Values are: all, =, <, >, <=, >=.
In the second field, enter a sample ID value.
Test Name (List) Select the enabled tests to include in the filter. The list contains all enabled
test names.
Auto-Verify (List) Select the status of the test results to include in the filter.
Values are: pass, fail, or all results.
Rack ID (List) Select the rack IDs to include in the filter. The list contains all racks defined
in the database.
Patient ID (List) Select the patient IDs to include in the filter. In the first field, select a
relationship.
Values are: all, =, Begins With, Ends With, Contains.
In the second field, enter a patient ID value.
Result (List) Select to enter a numeric relationship to filter results. For example, if you set
the value in the first box to >, and the value in the next box is 4.00, then the filter
locates results > 4.00.
Values for the first box are all, +, <, >, <=, >=, outside of, and between.
Population (Boxes) Select the result population to include in the filter.
Values are: Patients, Controls, Calibrators.
Save As F2 (Button) Select to save the new or edited filter with a new name. For
laboratory-defined filters, you can keep the same name and overwrite the previous
filter. When you save the filter, it is applied.
Clear Parameters (Button) Select to clear all of the fields and reset the parameters to the current filter
F3 parameters.
4 Enter the information and select or clear boxes and options to define the
parameters for the filter.
5 Select OK F1.
The system prompts you to save the filter.
G (Optional) To save your changes to a system-defined filter, select Yes F1 to
display the Save As window. Enter a name for the filter in the Save Filter As
field, then select OK F1.
NOTE
If you are editing one of the system-defined filters, you must save it as a
different name.
G (Optional) To continue without saving changes to the filter, select No F4. The
system applies the filter.
G (Optional) To continue without saving the filter, select Cancel F8. The system
does not save or apply the filter.
Main Menu
Test Results
F2
Test Results
Filter
F1
Filter
Yes
OK
F1
No
F4
No Save Filter?
OK
F1
0610B.wmf
Figure 5-11 Defining a New Test Result Filter Flowchart
Defining a Use this procedure to define a new filter and apply it to the Test Results screen.
New Test
1 Go to the New Filter window. To get to this window from the Main Menu,
Result Filter
select Test Results F2 to display the Test Results screen, then
Select Filter F1 to display the Filter window, then
Select New Filter F2.
The New and Edit Filter windows are the same, but the fields in the New Filter
window are blank.
2 Enter information and select or clear the boxes and options to define the
parameters for the new filter.
NOTE
Every new filter has the default sort orders Sample ID and Test Name.
G (Optional) To save and apply the filter, select Yes F1 to display the Save As
window. Enter a name for the filter in the Save Filter As field, then select
OK F1.
If the filter requires a date or time range, the Specify a Date Range window is
displayed. Select the appropriate ranges or enter information in the fields, then
select OK F1. For more information, see the Specifying a Date and Time Range
for a Test Result Filter procedure in this section.
The system displays the test results that meet the filter parameters on the Test
Results screen.
G (Optional) To apply a filter without saving it, select No F4. The unnamed filter
remains the default filter until you apply a different one.
The system displays the test results that meet the filter parameters on the Test
Results screen.
Deleting a Use this procedure to delete any new or edited filters. You cannot delete
Test Result system-defined filters.
Filter
1 Go to the Filter window. To get to this window from the Main Menu, select
Test Results F2 to display the Test Results screen, then select Filter F1.
3 Select Delete Filter F4. This button is unavailable for system-defined filters.
The system displays a confirmation message.
5 Select Cancel F8 to exit the Filter window without changing the applied filter.
Specifying a Use this procedure to specify date and time parameters when applying a test result
Date and filter that asks for date and time ranges.
Time Range
1 Go to the Filter window. To get to this window from the Main Menu, select
for a Test
Test Results F2 to display the Test Results screen, then select Filter F1.
Result Filter
2 Select a filter that requires you to specify a date and time range (the Ask for
Date and Time box was selected when the filter was defined).
0927B.bmp
Figure 5-12 Specify a Date Range Window
Date and Time (Options and field) Select one of the following options to
Range display the test results from that date range:
• Past 24 hours - display all of the test results that were
obtained in the past 24 hours and fit the filter criteria
• Past 7 days - display all of the test results that were
obtained in the past 7 days and fit the filter criteria
• Past # days - display all of the test results that were
obtained during the days you enter and that fit the filter
criteria
• Past # hours - display all of the test results that were
obtained in the past number of hours you enter and that fit
the filter criteria
If you select one of the options with a # sign, enter a number in
the field below the options.
Specify Date (Option and fields) Select the Date and Time Range option
and Time and specify the starting and ending dates and times.
Range
NOTE
The date format follows the format you set up on the System Setup screen. The
system displays a message if the incorrect format is used. For more information
about setting the date format, see Chapter 4: System Configuration in the
Reference Manual.
Main Menu
Test Results
F2
Find
F2
Find
(Optional)
Select a search
direction, up or down
Find Next
F1
Result(s)
selected? No
Yes
Cancel
F8
0520B.wmf
Figure 5-14 Finding a Test Result Flowchart
Finding a Test Use this procedure to search filtered results for a specific test result.
Result
NOTE
This procedure will only find test results that fit the filter criteria. If you are
having difficulty finding a specific test result, apply a different new filter.
1 Go to the Test Results screen. To get to this screen from the Main Menu, select
Test Results F2.
0609A.bmp
Figure 5-15 Find (Test Result) Window
Sample ID (Field) Enter the sample ID of the result you want to find.
You do not need to enter complete information in the field. For example, if you are
searching for sample ID 123456789, enter 1234. The system will select the first
sample ID starting with 1234.
Rack ID (List and Field) Select from a list of known rack IDs or enter a rack ID.
Patient ID (Field) Enter the patient ID.
Test Name (List and Field) Select from a list of test names or enter a test name.
Direction (Option) Select Up or Down to change the direction of the search. If you select
Down, the system begins the search at the current result and continues down the
list. If you select Up, the system begins the search at the current result and
continues up the list.
When a search reaches the top or bottom of the list, the search continues from the
opposite end.
Find Next F1 (Button) Select to find the next result included in the filter that fits the search
criteria.
3 Enter information in one of the Sample ID, Patient ID, Rack ID, or Test Name
fields for the sample you want to find.
G (Optional) To change the direction of the search, select the Up or Down option.
4 Select Find Next F1. The closest match to the search parameters you entered
becomes the selected result.
NOTES
• If the system does not find a match, the system displays a message in the
status line.
• If any of the filtered results have been deleted, a message displays that
directs you to refresh the screen. To refresh the screen, select More Options
F8 and then select Refresh Screen F1. Repeat step 4.
G (Optional) To find the next result that fits the search criteria, select Find Next F1.
Rerunning a Use this procedure to rerun a test. If the sample is on board an instrument, the system
Test automatically assigns the test and runs it at the next opportunity. If the sample is off
board, the system assigns it to the instrument and displays it on the Work Pending
screen (see Chapter 4: Sample Processing in this manual).
NOTE
You can only rerun tests for patient and quality control samples. To rerun tests
for other kinds of samples, request the tests again.
1 Go to the Test Results screen. To get to this screen from the Main Menu, select
Test Results F2.
G (Optional) To locate a specific test result associated with the sample, select
Find F2. For information about how to do this, see the Finding a Test Result
procedure in this section.
Main Menu
Test Results
F2
Select a single
test result
Sample Details
F4
Details
Review sample
demographic
information and flag
explanations (if any)
OK
F1
0643B.wmf
Figure 5-17 Viewing Sample Details Flowchart
Viewing Use this procedure to view details about the sample the result is associated with,
Sample including demographic information, comments, and result flag explanations (if
Details applicable).
1 Go to the Test Results screen. To get to this screen from the Main Menu, select
Test Results F2.
G (Optional) To find a specific test result, select Find F2. For information about
how to do this, see the Finding a Test Result procedure in this section.
0747B.bmp
Figure 5-18 Sample Details Window
Patient ID (Field) Displays the patient ID, if one exists, for the patient sample. This
demographic information is sent from the LIS.
First Name (Field) Displays the first name of the patient that is associated with the sample.
This demographic information is sent from the LIS.
Last Name (Field) Displays the last name of the patient that is associated with the sample. This
demographic information is sent from the LIS.
Sex (Field) Displays the sex of the patient that is associated with the sample. This
demographic information is sent from the LIS.
Birth Date (Field) Displays the birth date of the patient that is associated with the sample.
This demographic information is sent from the LIS.
NOTE
The system displays birth dates before 1900 incorrectly.
Doctor Name (Field) Displays the doctor’s name that is associated with the patient sample. This
demographic information is sent from the LIS.
Sample ID (Field) Displays the sample ID of the patient sample.
Sample Type (Field) Displays the type of fluid in the sample container.
Dilution (Field) Displays the dilution factor of the patient sample.
Test Name (Field) Displays the name of the test that was run on the patient sample.
Reference Range (Field) Displays the reference range used for the test. The reference range is
defined in the ranges windows (see Section 4.7: Ranges Setup in the Reference
Manual).
Result (Field) Displays the results of the test run on the sample.
Sample Comment (Field) Displays any comments that are associated with the sample.
Flags (List) Displays the flags applied to the result and a description of each flag.
Troubleshoot F2 (Button) Displays troubleshooting Help about flags.
NOTE
This button is unavailable for results without flags.
4 Select OK F1.
Test Result If something occurs while a test is running or if the system needs supplies, the system
Flags associates a flag to the sample.
You can use the Sample Details window to read a description of the flags associated
with a particular result. You then select Troubleshoot F2 to find troubleshooting
information about each flag.
For the result flag description and troubleshooting information, see in Section A.4:
Assay Troubleshooting of the Reference Manual.
Main Menu
Test Results
F2
Test Results
More Options
F8
Configure Screen
F2
Configure Screen
OK
F1
0611B.wmf
Figure 5-20 Configuring the Test Results Screen
Configuring Use this procedure to change the columns and rearrange the order of the columns
the Test displayed on the Test Results screen. The system displays the following default
Results Screen columns for all filters except for the Failed Auto-Verify and Not Sent to LIS filter:
• Patient ID • Result
• Sample ID • Completion Time
• Rack • Flags
• Test Name • LIS
For the Failed Auto-Verify and Not Sent to LIS filter, the system displays the Verify
column and does not display the Patient ID column. You can change the default
column configurations for any filter.
1 Go to the Configure Screen window. To get to this window from the Main
Menu, select Test Results F2 to display the Test Results screen, then
Select More Options F8, then
Select Configure Screen F2.
The Configure Screen window displays the columns as they appear on the Test
Results screen. There are four required columns: Sample ID, Test Name,
Result, and Flags. You can change the order of the required columns, but you
cannot remove them from the Test Results screen.
Column Order
Buttons
0602A.bmp
Figure 5-21 Configure Screen Window
Column Order (Row) Displays the columns currently included on the Test Results screen and in
their respective order.
Optional Columns (Boxes) Select the optional columns to include on the Test Results screen.
Values are: Patient ID, Rack, Verify, Comp. Time, LIS, Instrument, and RLU.
For more information about these values, see Table 5-3.
Column Order (Buttons) Select the right or left arrow button to rearrange the columns in the
Buttons Column Order row.
You can select a column from the Column Order row before selecting an arrow
button to move that column right or left. If you do not select a column, before
selecting an arrow button, the first column is selected by default.
2 In the Optional Columns list, select the additional columns you want to
include.
You can add optional columns, depending on the combination of columns, until
you reach the maximum width of the screen.
G (Optional) To rearrange the order of the columns, select a column and use the
right and left arrow column buttons to move it.
3 Select OK F1.
The Test Result screen displays the new options you selected.
5.3
Managing Test Results
For help in managing your test results, you can use the Access 2 system to:
• Send test results to the LIS
• Copy test results to a disk
• Delete test results
If you are using an LIS, the system automatically sends the test results with their
associated flags to the LIS when sample processing is complete.
NOTE
For a list of circumstances that require you to manually send test results to the
LIS, see the Sending Test Results to the LIS procedure in this section.
You can copy selected test results or all test results to a high-density, 3.5-inch
DOS-formatted disk. Copying test results to a disk does not remove them from the
system database.
You can also permanently delete test results from the system.
For information about how to automatically transmit test results to the LIS and how to
enable host query of the LIS, see Chapter 4: System Configuration in the Reference
Manual.
Main Menu
Test Results
F2
Test Results
Filter
Apply filter
and sort orders
Selected
Filter
results No F1
displayed?
Yes
(Optional)
Select a group of
results or a single result
Send to LIS
F5
Send to LIS
OK
F1
0644A.wmf
Figure 5-23 Sending Test Results to the LIS Flowchart
Sending Test Use this procedure to manually send test results to the LIS if one or more of the
Results to the following circumstances applies:
LIS • The Auto Send to LIS option is set to Off or to Send Only Auto-Verified
Results. For more information about the Auto Send to LIS or Send Only
Auto-Verified Results options, see Section 4.9: LIS Setup in the Reference
Manual.
• The LIS fails to receive a transmission of test results.
• The test results were on hold while the LIS was off-line, and now it is back
on-line.
1 Go to the Test Results screen. To get to this screen from the Main Menu, select
Test Results F2.
G (Optional) To locate a group of test results to send to the LIS, apply a filter to
reduce the number of displayed results. For information about how to do this,
see the Applying a Test Result Filter procedure in Section 5.2: Reviewing Test
Results.
G (Optional) To locate a specific test result to send, select Find F2. For
information about how to do this, see the Finding a Test Result procedure in
Section 5.2: Reviewing Test Results.
2 Select a single test result or a group of results to send the LIS. For more
information about selecting test results, see the Selecting Test Results procedure
in Section 5.1: Test Results.
0626A.bmp
Figure 5-24 Send to LIS Window
Current Result (Option) Select to send the selected test result to the LIS.
Current (Option) Select to send the one or more selected test results to
Selection the LIS.
Resend LIS (Option) Select to resend all of the test results with an LIS
Fail status of Fail to the LIS.
All (filtered (Option) Select to send all the test results in the current filter to
results) the LIS.
5 Select OK F1.
NOTE
If any of the filtered results have been deleted, a message displays that directs
you to refresh the screen. To refresh the screen, select More Options F8 and
then select Refresh Screen F1. Then repeat this procedure, beginning at step 2.
6 Monitor the transmission by viewing the statuses in the LIS column of the Test
Results screen.
• If the LIS successfully receives results, the LIS status changes to Accepted.
• If the LIS does not successfully receive the results, the LIS status changes to
Failed.
Main Menu
Test Results
F2
Test Results
Filter
Apply filter
and sort orders
Correct set
Filter
of results No F1
selected?
Yes
Copy to Disk
F6
Copy to Disk
(Optional)
Select Format disk
OK
F1
0645B.wmf
Figure 5-26 Copying Test Results to a Disk Flowchart
Copying Test Use this procedure to copy test results to a disk. Use a 3.5" high-density,
Results to a DOS-formatted disk. The Access 2 system writes the following data into a
Disk comma-separated field format that you can import into a PC-based spreadsheet
program:
NOTE
Copying test result data does not remove it from the database.
1 Be sure the system is in the Ready or Not Ready mode, then go to the Test
Results screen. To get to this screen from the Main Menu, select Test Results
F2.
G (Optional) To locate a group of test results to copy, apply a filter to limit the
number of results to include only the results you want to copy. For information
about how to do this, see the Applying a Test Result Filter procedure in Section
5.2: Reviewing Test Results.
G (Optional) To locate a specific test result to copy, select Find F2. For
information about how to do this, see the Finding a Test Result procedure in
Section 5.2: Reviewing Test Results.
2 Select a single test result or a group of results. For more information about
selecting test results, see the Selecting Test Results procedure in Section 5.1:
Test Results.
3 Insert a 3.5" disk into the 3.5-inch disk drive of the PC.
CAUTION
Be sure you insert the disk into the 3.5-inch disk drive of the PC, not the
Access 2 instrument.
0604A.bmp
Figure 5-27 Copy to Disk (Test Results) Window
File name (Field) Displays the default file name and extension of the test
result to be copied. You can delete the name and type a new
name.
Current Result (Option) Select to copy the selected test result to a disk.
Current (Option) Select to copy one or more selected test results to a
Selection disk.
All (filtered (Option) Select to send all the test results in the current filter to
results) a disk.
Format disk (Box) Select to format a disk. Formatting a disk prepares it for
reading and writing data.
7 Select OK F1.
A progress window is displayed. Select Cancel F8 to stop the copy process at
any time. When the copy process is complete, the system displays a status
message.
G To copy multiple files to one disk, see the Copying Multiple Files to One Disk
procedure in this section.
G To copy one file to multiple disks, see the Copying One File to Multiple Disks
procedure in this section.
8 Remove the disk from the drive. Label it with the data file name(s).
1 Write down the current file name in preparation for disk labeling.
2 Repeat steps 2-7 (see the Copying Test Results to a Disk procedure in this
section) for the next file, and write down the file name.
4 Remove the disk from the drive. Label it with the data file name(s).
1 When the original disk is full, the system displays a status message.
2 Remove the disk from the drive. Label it with the data file name(s).
The system automatically names the file on the new disk the same as the file on
the first disk, only with the disk number on the end. For example, mydata.csv =
disk 1 and mydata(2).csv = disk 2.
4 Remove the disk from the drive. Label it with the data file name(s).
Main Menu
Test Results
F2
Test Results
Find Filter
Yes
More Options
F8
Delete Data
F3
Password
Enter your
password
OK
F1
Delete Data
OK
F1
0646B.wmf
Figure 5-29 Deleting a Test Result Flowchart
Deleting a Use this procedure to permanently delete test results from the database. You need the
Test Result system password in order to delete test results.
CAUTION
Deleting test results removes the data permanently from the database.
1 Be sure the system is in the Ready or Not Ready mode, then go to the Test
Results screen. To get to this screen from the Main Menu, select Test Results
F2.
G (Optional) To locate a group of test results to delete, apply a filter to limit the
number of results displayed. For information about how to do this, see the
Applying a Test Result Filter procedure in Section 5.2: Reviewing Test Results.
G (Optional) To locate a specific test result to delete, select Find F2. For
information about how to do this, see the Finding a Test Result procedure in
Section 5.2: Reviewing Test Results.
2 Select a single test result or a group of results to delete. For more information
about selecting test results, see the Selecting Test Results procedure in Section
5.1: Test Results.
4 In the Password field, enter the system password, then select OK F1.
For information about passwords, see Chapter 4: System Configuration in the
Reference Manual.
The Delete Data window is displayed.
6 Select OK F1.
The system displays a warning message.
5.4
Test Result Reports
You can print test result data in report format. You can print reports manually, or use
the auto-print option on the Report Setup window to print STAT and continuous
sample reports automatically.
You can display and print the following test result reports:
Report Description
Report Description
Continuous Sample To print this report, set up the automatic print option.
Report This report prints automatically when there are enough
test results to fill a page, or when the run is complete.
Alternatively, you can manually print the report as
samples are completed.
This report includes test results for all of the samples
associated with a particular run. The report displays the
results on the page continuously when they are
completed.
Calibration and maintenance routine results are not
included on this report.
For information about how to apply a filter to test results you want to print, see the
Applying a Test Result Filter procedure in Section 5.2: Reviewing Test Results.
For information about how to automatically print test result reports, see Chapter 4:
System Configuration in the Reference Manual.
Main Menu
Test Results
F2
Test Results
System Configuration
Is For information about how to
Are you
printing from
Continuous automatically print test result
Set up the Auto Print
a completed No Sample Report No option
reports, see Chapter 4: System
Filter run?
set to Configuration in the Reference
print? Manual.
Yes
(Optional)
Select a group of
displayed results
Print
F7
Report
F1
OK
F1
0519C.wmf
Figure 5-31 Printing Test Result Reports Flowchart
0623B.bmp
Figure 5-32 Print (Test Result Reports) Window
6 Select the appropriate option from the Print What list (based on your selection
in Step 2).
7 Select OK F1.
The system sends the report to the printer. A progress window is displayed.
Select Cancel F8 to stop the print job at any time.
Laboratories, Inc.
Laboratory A
123 Lake Street
Townsville, ST 33333
Patient Report 101-555-2323 ext. 109
Access 2 Immunoassay System R. Goldman
**STAT**
Sample ID: 23345128Dil Sample Type: Plasma Dilution: 10
Test Name Result Ref. Range Flags Completed
CKMB 939.0 ng/mL 0.000 - 4.000 10-10-01 08:18 PM
Comments: Sample slightly cloudy.
**STAT**
Sample ID: 23345128 Sample Type: Plasma
Test Name Result Ref. Range Flags Completed
CKMB >293 ng/mL 0.000 - 4.000 OVR 10-10-01 07:30 PM
cTnI(2) No Value 0.000-0.030 QNS 10-10-01 07:27 PM
cTnI 2.08 ng/mL 0.000-0.030 10-10-01 07:27 PM
0660C.bmp
Figure 5-34 Patient Report
Laboratories, Inc.
Laboratory A
123 Lake Street
Townsville, ST 33333
Sample Report 101-555-2323 ext. 109
Access 2 Immunoassay System B. Beaulieu
**STAT**
Instrument: 501240
Test Name Result Ref. Range Flags Dilution Completed
CKMB >293 ng/mL 0.000 - 4.000 OVR 1 10-10-01 07:30 PM
cTnI(2) No Value 0.000 - 0.030 QNS 1 10-10-01 07:27 PM
cTnI 2.08 ng/mL 0.000 - 0.030 1 10-10-01 07:16 PM
Instrument: 500135
Test Name Result Ref. Range Flags Dilution Completed
FreePSA% 16.6
freePSA 1.58 ng/mL 1 08-08-01 02:45 PM
PSA-Hyb 9.53 ng/mL 0.000 - 4.000 1 08-08-01 02:15 PM
Comments: Cloudy sample.
0748C.bmp
Laboratories, Inc.
Laboratory A
123 Lake Street
Selected Test Results Report Townsville, ST 33333
Access 2 Immunoassay System 101-555-2323 ext 109
S/N 501240 V. Flores
0749B.bmp
5-48
Laboratory A
123 Lake Street
Continuous Sample Report Townsville, ST 33333
Access 2 Immunoassay System 101-555-2323 ext. 109
S/N 501240 Jane Smith
___________________________________________________________________________________________________________________________________
5.4: Test Result Reports
Rack/Pos Sample ID Type Test Result Ref. Range Flags RLUs Completion
Patient/Lot ID Dilution
___________________________________________________________________________________________________________________________________
515/1 435D8S Cervical
99847438-01 1 Chl-Ag Reactive 9.62 S/CO 1098168 10-10-01 05:26 PM
ChlBlock Confirmed 99.58% Supp RFX 11028 10-10-01 05:27 PM
___________________________________________________________________________________________________________________________________
122/1 23345128 Plasma
**STAT** 555-56-9898 1 CKMB >293 ng/mL 0.000 - 4.000 OVR 18445200 10-10-01 06:01 PM
cTnI 2.08 ng/mL 0.000 - 0.030 337183 10-10-01 05:58 PM
cTnI(2) No Value 0.000 - 0.030 QNS No Value 10-10-01 05:48 PM
Dig 853012 RLU NCR 853012 10-10-01 06:07 PM
Comments: This sample comment was entered in the Test Request screen.
___________________________________________________________________________________________________________________________________
115/1 236-79 Serum
126-00-544 1 PSA-Hyb 14.82 ng/mL 0.000 - 4.000 2606765 10-10-01 06:01 PM
freePSA 12.24 ng/mL 6390525 10-10-01 06:00 PM
FreePSA% 82.6 No Value 10-10-01 06:01 PM
Comments: This sample comment was entered in the Test Request screen.
___________________________________________________________________________________________________________________________________
115/2 999 Serum
Assay Calibrations
6.1 Assay Calibrations ......................................................................................... 6-2
Switching the Active with the Previous Active Calibration ........................... 6-18
6.1
Assay Calibrations
You periodically calibrate assays on an Access 2 instrument to establish values that
the system uses to correctly report test results for patient and quality control samples
on that instrument. There are three types of assay calibrations. The calibrations differ
in the way they calculate and report test results.
• Quantitative assay calibrations establish a calibration curve that the system
uses to convert sample RLU (relative light unit) readings into concentrations.
• Semi-quantitative assay calibrations are also supported by the Access 2
system, but the calibration curve is calculated the same as for a quantitative
assay.
• Qualitative assay calibrations establish a cutoff that the system uses to
classify samples as reactive or non-reactive.
NOTE
Regardless of the type of calibration, the system reports the calibration with
either a quantitative curve or a qualitative cutoff, according to the parameters
defined in the assay protocol file (APF).
When you run calibration samples, the system evaluates the test results using
acceptance criteria defined by the APF. The calibration either passes or fails.
The system requires an active calibration for each requested test. If the calibration for
the requested test has not been performed or is expired, the system prompts you to
perform a calibration. If you process samples with an expired calibration, the system
flags the test results. If a new calibration fails, the system calculates the test results
using the previous active calibration.
For information about how to enter calibration test requests, see Chapter 3: Sample
Management in the Operator’s Guide.
For information about reviewing test results and result flags, see Chapter 5: Test
Results in the Operator’s Guide.
For information about calibration theory and qualitative or quantitative assays, see
Chapter 3: Theory of Operation in the Reference Manual.
0521A.wmf
Figure 6-1 Calibration Flowchart
Calibration Screen
You use the Calibration screen to:
• View the results of the active, previous active, or last run calibrations
• Print calibration reports
• View the calibration status of all calibrated assays
• Add, edit, and delete calibrators
NOTE
Although you may use calibrators, calibration controls, or controls to calibrate
an assay, the system uses the term calibrator to refer to all of these components.
To get to this screen from the Main Menu, select Calibration F5.
0766B.bmp
Figure 6-2 Calibration Screen
NOTES
• Calibration buttons only exist for calibrations that have run. If you want
to review the calibrators that are configured for the workgroup, select
Calibrator Setup F5.
• You can choose a button by touching it, selecting it with the mouse, or by
using the [Tab] key.
Filter F1 (Button) Select to modify the applied filter or the sort order.
Review Data F2 (Button) Select to display the Calibration Data screen for a selected calibration
button. You can view the active curve or cutoff from this screen. If there is no
active calibration (no calibration has passed), the system displays the last
calibration that has been run.
Calibrator Setup F5 (Button) Select to go to the Calibration Setup screen. You can set up the
calibrators, edit existing calibrators, or delete calibrators from this screen for all
instruments in the workgroup.
Delete F6 (Button) Select to delete a selected calibration button. The calibration button is
removed from the Calibration screen.
For information about deleting calibrations, see the Deleting Calibrations
procedure in this chapter.
Print F7 (Button) Select to print the calibration report, which lists all the calibrations for the
instrument.
For more information about how to print a report, see Section 6.3: Calibration
Reports in this chapter.
Applying a Use this procedure to apply a filter to the calibration buttons on the Calibration screen.
Calibration You can choose a filter and specify the direction of the sort order.
Filter
1 Go to the Calibration screen. To get to this screen from the Main Menu, select
Calibration F5.
850C.bmp
Figure 6-4 Filter (Calibration) Window
Filter (Options) Select either the filter that displays all assay
calibrations or the filter that displays only those assay
calibrations with reagent on board the instrument.
Ascending (Box) Select to have the filter sort the calibrations in
ascending, alphabetic order (A - Z). Leave the box
clear to sort the calibrations in descending, alphabetic
order (Z - A).
The calibrations are sorted by test name, then by
reagent lot.
4 Select the Ascending box if you want the system to display the calibrations in
ascending, alphabetic order (A - Z). If you want to display the calibrations in
descending, alphabetic order (Z - A), leave the box blank.
NOTE
The calibrations are sorted by test name, then by reagent lot.
5 Select OK F1.
The system applies the filter and displays the results on the Calibration screen.
Deleting Use this procedure to delete the stored data for an assay calibration and reagent lot.
Calibrations You would delete a calibration that is expired or one that you do not use anymore.
NOTE
You cannot delete the calibration data if the instrument is in the Running or
Paused mode.
1 Go to the Calibration screen. To get to this screen from the Main Menu, select
Calibration F5.
2 Select the button for the assay calibration and reagent lot you want to delete.
4 Select OK F1.
The calibration and all of the stored data associated with the reagent lot listed on
the button are deleted from the instrument.
6.2
Reviewing Calibration Data
The system creates and stores calibration data for each calibration you run. Depending
on the type of assay calibration, the system generates an associated calibration curve
or cutoff. You can view this information and print it in a report format.
Calibrations using different reagent pack lots can be run for the same assay. When
reviewing calibration data, be sure to select the calibration button and the reagent
pack lot number of the calibration you want to view.
You can also view the associated calibration curve or cutoff. A calibration curve plots
the measured RLUs of each replicate versus the concentration of analyte. Calibration
cutoffs show the acceptance limits for individual replicates and for the mean of the
replicates.
Stored For calibrations with a cutoff, the system stores calibration data for the active and last
Calibration run calibrations. For calibrations that produce a curve, the system stores calibration
Data data for the active, previous active, and last run calibrations. You view stored data on
the Calibration Data screen.
Active The most recent calibration that passed, unless you switch it with
the previous active calibration.
Active calibrations are used to evaluate patient samples.
Previous The calibration that was previously the active calibration. You
Active can switch the previous active calibration with the active
calibration.
Last Run The results of the most recent calibration test request that either
passed or failed.
If the last run calibration passes, it also becomes the active
calibration.
NOTE
The format of the Calibration Data screen varies by whether the calibration
results are expressed with a cutoff (qualitative) or with a curve (quantitative).
Both formats and their screen descriptions are included below.
0768A.bmp
Figure 6-7 Calibration Data Screen (Cutoff)
You can change the stored calibration being reviewed by using Select Curve F1.
For more information about stored calibrations, see the Stored Calibration Data
topic in this chapter.
Status (Field) Displays the status of the calibration: Passed or Failed. The status of an
active calibration is always Passed. Only a last run calibration can have a Failed
status.
Reason (Field) Displays the failure code for a failed calibration. The field is blank if the
calibration passed.
For an explanation of the failure codes, see Table 6-11 in this chapter.
Cal Lot (Field) Displays the calibrator lot number used to generate the calibration data.
Units (Field) Displays the units of measure for the assay, which are defined for the
calibrator sample type in the APF.
Data table (Table) Displays a list of the calibration samples run and the results specific to each
test replicate. The table also contains mean result information.
Data includes:
• Stated concentration
The target concentration for the calibrator tested.
• RLU
The RLUs obtained for the calibration test or the calculated mean of the
replicates.
NOTE
If a result does not meet the acceptance criteria, it is not included in the
calculation of the mean.
• 1 SD
The standard deviation of the RLUs.
• %CV
The percent coefficient of variation for the calibrator replicates.
• Result
The interpretation of the test as reactive or non-reactive, based on the generated
cutoff.
NOTE
Confirmed or Not Confirmed is displayed for confirmatory assays (a
numeric result is not applied).
• Flags
The system displays up to 2 result flags if the calibration results were flagged.
Acceptance Limits (Table) Displays information about the upper and lower cutoff configured for this
(RLUs) assay, including:
• Level
The calibrator level.
• Replicate Low
The lowest acceptable RLU for a replicate test.
• Replicate High
The highest acceptable RLU for a replicate test.
• Mean Low
The lowest acceptable RLU for the mean of the calibrator level replicates.
• Mean High
The highest acceptable RLU for the mean of the calibrator level replicates.
Select Curve F1 (Button) Select to display a menu of these stored calibrations:
Active F1
Displays the active calibration for the assay.
Previous Active F2
Not available for assays with a cutoff.
Last Run F3
Displays the last run calibration.
For information about stored calibrations, see the Stored Calibration Data
information in this chapter.
NOTE
Select Curve F1 is available only if other calibrations exist.
Comment F3 (Button) Select to display the Comment window for the displayed calibration. You
can enter, view, or edit a comment for the calibration. Comments print on the
Calibration Data Report for a curve or the Calibration Data Report for cutoff.
Print F7 (Button) Select to print the Calibration Data Report (with a curve) or the
Calibration Data Report (with cutoff) for the displayed calibration.
0769B.bmp
Figure 6-9 Calibration Data Screen (Curve)
You can change the stored calibration by using Select Curve F1.
For more information about stored calibrations, see the Stored Calibration Data
topic in this chapter.
Status (Field) Displays the status of the calibration: Passed or Failed. The status of a
active or previous active calibration is always Passed. Only a last run calibration
can have a Failed status.
Reason (Field) Displays the failure code for a failed calibration. The field is blank if the
calibration passed.
For an explanation of failure codes, see the topic in this chapter.
Cal Lot (Field) Displays the calibrator lot number used to generate the calibration data.
Units (Field) Displays the units of measure that are configured for the calibrator sample
type. The calibrator sample type is defined in the APF and cannot be changed.
Data Table (Table) Displays a list of the calibration samples run and the results specific to each
test or replicate. The table also contains mean result information.
Data includes:
• Stated concentration
The target concentration for the calibrator.
• RLU
The RLUs obtained for the calibration test or the calculated mean of the
replicates.
• 1 SD
The standard deviation of the RLUs.
• %CV
The percent coefficient of variation for the calibrator replicates.
• Calculated Conc.
The actual concentration calculated for the calibrator tested and plotted on the
curve.
• Flags
The system displays up to 2 result flags if the calibration results were flagged.
Curve (Chart) Displays the curve generated for this calibration. You can use the left and
right arrow keys (under the chart) to scroll and view all of the data points.
• Point cursor
A blue, vertical line that highlights the point you have selected.
• RLUs (y-axis)
The y-axis displays the range of mean RLU readings for calibrator tested.
• Concentration (x-axis)
The x-axis displays the range of calculated analyte concentration means for each
calibrator tested.
• Points
The RLU and concentration means of each calibration test and its replicates are
plotted as points, which make up the calibration curve.
NOTE
Select Curve F1 is available only if other calibrations exist.
Switch Active Curve (Button) Select to switch the active calibration for the assay with the previous
F2 active calibration. The previous active calibration becomes the active calibration
and vice versa.
The system displays a confirmation message before the switch occurs.
Comment F3 (Button) Select to display the Comment window for the displayed calibration data.
You can enter, view, or edit a comment for the calibration. Comments print on the
Calibration Data Report for a curve or the Calibration Data Report for cutoff.
Print F7 (Button) Select to print the Calibration Data Report (with a curve) or the
Calibration Data Report (with cutoff) for the displayed calibration.
Calibration When a calibration fails, the system displays a failure code in the Status field on the
Failure Codes Calibration Data screens. The failure codes below are for either cutoffs or curves.
Bad Fit The curve does not meet the limits defined by the assay
protocol file (APF). This may be caused by poor precision or
a curve that was too flat or too steep.
CV Std 0 The %CV of the replicates for the S0 (zero) calibrator does
not meet the limits defined by the APF.
Insuff Data The system did not have enough data to perform calibration
calculations. This happens if two or more replicates are not
calculated, due to a short sample or an instrument error.
Limits The RLUs of either the individual replicates or the mean of
the replicates were outside the ranges specified in the APF.
Max Iter The system was unable to create a curve before performing
the maximum number of calculation iterations. The system
attempts to calculate the curve 400 times before generating
this error.
No Fit The system was unable to fit a curve to the data points.
Possible causes include math rule violations, such as division
by zero or calculating the log of a negative.
Resp Delta The difference between the total response of the curve was
too small.
Viewing Use this procedure to view the calibration curve or cutoff, along with detailed
Calibration calibration data.
Curves and
1 Go to the Calibration screen. To get to this screen from the Main Menu, select
Cutoffs
Calibration F5.
2 Select the button for the assay calibration and reagent lot you want to view.
G (Optional) To view the previous active calibration curve, select Select Curve
F1, then Previous Active F2.
G (Optional) To view the last run calibration curve or cutoff, select Select Curve
F1, then Last Run F3.
For more information about active, previous active, and last run calibrations, see the
Stored Calibration Data information in this chapter.
Switching the Use this procedure to switch the active calibration with the previous active
Active with calibration. This procedure is for quantitative assays only.
the Previous
Active NOTES
Calibration • You cannot switch active and previous active calibrations while the system
is in the Running or Paused mode.
• This procedure will not alter curve expiration dates or recalculate results for
patient samples that have already been run.
• If there is no previous active calibration, the Switch Active Curve F2 button
is unavailable.
1 Go to the Calibration screen. To get to this screen from the Main Menu, select
Calibration F5.
2 Select the button for the assay calibration you want to switch.
5 Select OK F1.
The active and previous active calibration curves are switched. The previous
active calibration curve is displayed.
6 Select OK F1.
The comment is applied to the calibration and is printed on the Calibration Data
Report.
6.3
Calibration Reports
You can print calibration data in a report format. If a comment is entered for a
calibration, the comment displays on the report. Printed calibration data reports
include:
Printing a Use this procedure to print the Calibration Report or a Calibration Data Report.
Calibration
1 Go to the Calibration Screen. To get to this screen from the Main Menu, select
Report
Calibration F5.
3 Select OK F1.
The system prints the report (see report examples in Figure 6-12, 6-13, and
6-14).
Laboratories, Inc.
Laboratory A
123 Lake Street
Calibration Report Townsville, ST 33333
Access 2 Immunoassay System 101-555-2323 ext. 109
S/N 502338 Jane Smith
Filter: All Calibrations - Ascending Sorted by Test Name and Reagent Lot
Page 1 of 1
Technologist_________________________________________ Printed 04/04/03 12:43 PM
0790C.bmp
Figure 6-13 Calibration Report
Laboratories, Inc.
Laboratory A
123 Lake Street
Calibration Data Report Townsville, ST 33333
Access 2 Immunoassay System 101-555-2323 ext. 109
S/N 500135 Jane Smith
Replicate Mean
Page 1 of 1
Technologist __________________________________________ Printed 10/10/01 11:05 AM
0907B.bmp
Figure 6-14 Calibration Data Report (Cutoff)
Laboratories, Inc.
Laboratory A
123 Lake Street
Calibration Data Report Townsville, ST 33333
Access 2 Immunoassay System 101-555-2323 ext. 109
S/N 500135 Jane Smith
____________________________________________________________________________________________________
Test Name: PSA-Hyb Curve: Active
Reagent Lot: 005711 Status: Passed
Calibrated: 01/22/01 12:34 PM Reason: (if Status is Failed, reason prints here)
Expiration: 02/19/01 12:34 PM Cal Lot: 006541
Comment:
Page 1 of 1
Technologist ______________________________________________ Printed 02-02-01 11:05 AM
0791C.bmp
Figure 6-15 Calibration Data Report (Curve)
6.4
Setting Up Calibrators
You calibrate an assay on an instrument before you run tests for that assay on the
instrument. However, before you calibrate, the solution used for calibrating the
individual assay must be set up on the Access 2 system. Whether you use a calibrator,
a calibration control, or a control to calibrate the assay, the Access 2 system and this
documentation generically refers to the reagent as a calibrator.
Most calibrators are multi-level. They contain more than one solution, with each
solution containing a different level of analyte. When you add a multi-level calibrator
to the system, you add all levels of the calibrator as one calibrator. When you select a
multi-level calibrator to be used for a calibration, all levels of the calibrator are
included in the selection.
When you set up a calibrator, you associate it with a calibrator lot. Calibrator lots that
are set up on the system can be used to run calibrations on any instrument in your
workgroup. In contrast, a calibration curve or cutoff is only valid on the instrument on
which it was run.
For more information about running calibrations, see Chapter 3: Sample Management
in this manual.
To get to this screen from the Main Menu, select Calibration F5 to display the
Calibration screen, then select Calibrator Setup F5.
0771A.bmp
Figure 6-16 Calibrator Setup Screen
Calibrator List (Fields) Displays all of the calibrators set up for your Access 2 system. The
following information about each calibrator is displayed:
• Test
Displays the test name.
• Calibrator Lot
Displays the calibrator lot number.
• Expiration
Displays the calibrator lot expiration date.
Add Calibrator F1 (Button) Select to setup a calibrator by entering information in the Add Calibrator
window.
Edit Calibrator F2 (Button) Select to edit an existing calibrator by editing the information in the Edit
Calibrator window.
Delete Calibrator F6 (Button) Select to delete a calibrator from the Access 2 system.
Main Menu
Calibration
F5
Calibration
Calibrator Setup
F5
Calibrator Setup
Add Calibrator
F1
Add Calibrator
Calibrator
information No
correct?
Yes
OK
F1
0528A.wmf
Figure 6-18 Adding a Calibrator Flowchart
0765A.bmp
Figure 6-19 Add Calibrator Window
Bar Code (Field) Using the bar code wand or keyboard, enter the bar code ID printed on the
calibrator card for the calibrator to be added to the system.
Calibrator Name (Field) Displays the name of the calibrator.
Lot Number (Field) Displays the lot number for the calibrator.
Expiration Date (Field) Displays the expiration date of the calibrator.
Test (Column) Displays the test name of the calibrator.
Level (Column) Displays the level of the calibrator.
NOTE
This column is only for quantitative assays.
3 Use the bar code wand to scan the bar code IDs listed on the calibrator card.
NOTES
• For some multi-level calibrators (usually quantitative assays), you must
enter the bar code for each level in the Bar Code field. The system then
displays the level information in the table.
• For other multi-level calibrators (usually qualitative assays), the system
populates the calibrator levels, stated concentrations, and units automatically
in the table.
• If you enter an expired calibrator, the system displays a warning message.
• If you cannot scan the bar code ID on the calibrator card, you can type the
characters printed underneath the bar code in the Bar Code field.
Editing a Use this procedure to edit the bar code ID of an existing calibrator.
Calibrator
1 Go to the Calibrator Setup screen. To get to this screen from the Main Menu,
select Calibration F5 to display the Calibration screen, then select Calibrator
Setup F5.
3 Use the bar code wand to enter the bar code ID.
NOTES
• If you cannot scan the bar code ID on the calibrator card, you can type the
characters printed underneath the bar code in the Bar Code field.
• You cannot change the Calibrator Name, Lot Number or Expiration Date.
• You cannot edit qualitative assays. The Bar Code field is unavailable for
these assays.
1 Be sure the system is in the Ready or Not Ready mode, then go to the
Calibrator Setup screen. To get to this screen from the Main Menu, select
Calibration F5 to display the Calibration screen, then select
Calibrator Setup F5.
NOTES
• Deleting a calibrator will also delete all calibration curves associated with
the calibrator lot.
• Within a workgroup, deleting a calibrator will delete it from all instruments
in the workgroup.
The system displays a confirmation window.
4 Select Yes F1 to delete the calibrator from all instruments in the workgroup.
Quality Controls
7.1 Quality Controls ............................................................................................. 7-3
7.1
Quality Controls
Quality controls are samples of known reactivity. You can run quality control samples
along with patient samples to monitor system performance.
The system performs quality control (QC) calculations by comparing the results to the
acceptable range of expected values you entered during QC Setup. QC calculations
include:
• The mean (average) test result value
• Standard deviation (SD) from the mean
• Percent coefficient of variation (%CV)
NOTE
These statistics are calculated on pooled data from all runs on a particular
instrument of that QC level.
The system stores the QC data in the database. You can view, print, copy, or delete
QC data. QC data can be viewed in a graphical format called a Levey-Jennings chart.
If the system is configured to apply Westgard rules to quality control test results, the
system alerts you when a quality control test result violates an applied Westgard rule.
When the system flags a result, the Quality Control status button turns red.
You can also enter comments for a specific patient result or quality control, and omit
points from the calculations. For example, you may want to enter a comment for a
known technical error. You may also want to enter a comment about why you are
excluding the result. The system displays omitted results on the screen and in reports,
but does not include them in calculations.
NOTE
Quality control samples should be run after any scheduled or unscheduled
preventive maintenance or repair to verify calibration.
For information about how to enter quality control test requests, see Chapter 3:
Sample Management.
For information about reviewing test results and result flags, see Chapter 5: Test
Results.
For help on how to interpret failed quality controls, see Appendix A: Troubleshooting
in the Reference Manual.
Review QC
0750B.wmf
Figure 7-1 Quality Controls Flowchart
To get to this screen from the Main Menu, select Quality Control F4. Or, select the
Quality Control button from any screen.
0713A..bmp
Figure 7-3 Quality Control Screen
NOTE
The system only displays quality controls that have been set up and run on
the instrument.
Applying a A quality control filter is a set of parameters you can change to reduce or expand the
QC Filter number of quality controls displayed on the Quality Control screen.
The screen is always filtered. The default filter is All Controls - sorted by Test Name,
then by Control Name.
NOTE
If you change the system ID for an instrument in your workgroup, the
instruments selected in the applied filter may also change. Test and update the
filter to make sure it operates as expected.
Use this procedure to select a filter for the quality control data.
1 Go to the Quality Control screen. To get to this screen from the Main Menu,
select Quality Control F4.
0758A.bmp
Figure 7-5 Filter (Quality Controls) Window
3 Select a filter from the list. The default sort orders for all filters are:
• 1st sort order: Test Name
• 2nd sort order: Control Name
Y (Optional) To use a different sort order, clear the default selections and select
the sort order you want to apply.
4 Select OK F1.
The system displays all quality controls that meet the selected parameters on the
Quality Control screen.
Deleting QC Use this procedure to delete a saved comparison. The comparison button is removed
Comparisons from the Quality Control screen.
1 Go to the Quality Control screen. To get to this screen from the Main Menu,
select Quality Control F4.
4 Select OK F1.
7.2
Reviewing Quality Control
Charts and Data
The system stores all quality control test results and QC calculations for each quality
control. You can review QC data, apply a filter to the quality controls displayed, and
compare Levey-Jennings charts for two or more quality controls.
QC data includes:
• Quality control name and lot number
• Date range (for all results)
• Number of results used in QC calculations (excluding omitted results)
• All test results (including all reagent pack lots used)
• Information set up in the system for the quality control
Each test result includes the measured response in RLUs, standard deviation intervals
(SDI), date and time of completion, applied QC rules, flags, and comments. Setup
information includes the quality control expiration date, expected mean, and expected
SD from the mean.
You can view a Levey-Jennings chart to determine if quality control test results, over
a period of time, are within range or out of range. QC results that are within an
acceptable range form a normal distribution pattern with equal numbers of points
above and below the mean. A normal distribution has approximately:
• 70% of the points within +1 SD
• 25% between +1 and 2 SD
• 5% between +2 and 3 SD
You can detect out of range QC data by looking for the flagged result. The Access 2
instrument flags results that are out of range, based on the values you input during the
quality controls setup.
To get to this screen from the Main Menu, select Quality Control F4 to display the
Quality Control screen, select the quality control you want to view, then select
Review Chart and Data F2.
0751B.bmp
Figure 7-7 QC Chart and Data Screen
Levey-Jennings Chart (Chart) Displays a graph of the plotted points from each control. Points for up to
31 days can be viewed at once. You can scroll left to right and back, to view all
of the data points, using the arrow buttons beneath the chart. Also see the Levey-
Jennings Charts topic in this section.
• Point cursor
The blue vertical line on the graph. You can move the line by using the left
and right arrow keys (found by each corner of the chart). This line marks the
point you have selected.
• Calibration Line
The dotted vertical line on the graph. This line marks a changed calibration
curve between the point the line runs through and the previous point.
• Y-axis Left Scale
Displays the 7 y-axis coordinates. These are the stated values for the mean
and 1, 2, and 3 SDs above and below the mean.
• Y-axis Right Scale
Displays the 7 y-axis coordinates. These mark the mean and 1, 2, and 3 SDs
above and below the mean.
• X-axis
Displays the dates for the chart.
• Points
Represent the numerical value of the result. A diagonal line through the point
indicates an omitted point. Points greater than 3 SD above the mean are
indicated as solid triangles on the +3 SD line, and points greater than 3 SD
below the mean are indicated as solid triangles on the -3 SD line. Points that
violate QC rules are colored red.
Arrow Buttons Select to move the point cursor on the chart left or right to the next data point,
and to select the corresponding row of the data table. The chart and table scroll as
necessary to display the new selection.
Data Grid (Table) Displays a list of QC results and information specific to each data point
within the current date range, and contains the following columns:
• Value
Displays the result and the unit of measure.
• SDI
Displays the number of SD intervals the result is above or below the expected
mean.
• Completion
Displays the date and time of the completed result.
• QC Rules
Displays the QC rules applied to the test in bold black type and displays the
violated rules in red type with an asterisk on both sides.
• Comment
Select to read or enter a comment for a quality control sample. The default
value is no comment (pen). After you enter a comment and select OK, the pen
symbol turns into a note pad.
• Omit
Select to omit the result from QC calculations (point remains on chart).
• Pipettor
Displays the value N/A. This field is reserved for future use.
When you select a row in the data grid, the corresponding point is displayed on
the Levey-Jennings chart.
Filter F1 (Button) Select to limit displayed data to certain reagent lots and date ranges. For
more information, see the Applying a QC Chart and Data Filter topic.
Delete Point F5 (Button) Select to delete the currently selected point and all of that point data
from the system. You must have a password to use this feature. For more
information regarding passwords, see Chapter 4: System Configuration in the
Reference Manual.
Copy to Disk F6 (Button) Select to copy QC data to a disk. For more information about how to
copy QC data to a disk, see the Copying QC Data to Disk procedure in this
section.
Print F7 (Button) Select to print the QC chart and data for the currently selected quality
control.
Viewing Use this procedure to view the quality control data for a selected test. If you want to
Quality view or compare more than one test, see the Comparing QC Charts procedure in this
Control section.
Charts and
1 Go to the Quality Control screen. To get to this screen from the Main Menu,
Data
select Quality Control F4.
(Optional) To display data for a certain date range, or for a certain reagent pack
lot number, apply a filter. For more information, see the Applying a QC Chart
and Data Filter procedure in this section.
(Optional) To add, edit, or view a comment for a selected result, select the
Comment button (pen or notepad) next to the appropriate result.
(Optional) To omit data from the QC calculations, select the Omit box next to
the appropriate result.
Applying a A QC chart and data filter controls the amount of data displayed on the QC Chart and
QC Chart and Data screen and printed in reports. The filter limits data according to the following
Data Filter parameters:
• By date range - You can display data for the last week, the last month, or
you can specify a starting and ending date.
• By reagent lot - You can display data from a single reagent lot or all reagent
lots.
Use the following procedure to apply a filter to the QC Chart and Data screen.
1 Go to the QC Chart and Data screen. To get to this screen from the Main Menu,
select Quality Control F4, select the quality control for which you intend to
view data, then select Review Chart and Data F2.
1026A.bmp
Figure 7-9 Filter (QC Chart and Data) Window
NOTE
When viewing charts for date ranges greater than 31 days, the last date
displayed on the chart will be the date of the most recent point in the date range.
4 Select a single reagent lot to view, or select All to view data for all lots of the
reagent for the selected test.
5 Select OK F1
The system applies the filter and displays the results on the QC Chart and Data
screen.
Entering Use this procedure to enter, edit, or delete comments for quality control samples on
Quality the QC Chart and Data screen.
Control
1 Go to the Quality Control screen. To get to this screen from the Main Menu,
Comments
select Quality Control F4.
4 Select the Pen or Notepad button next to the appropriate result to display the
QC Comment window.
Omitting a Use this procedure to omit a point from the mean, SD, and %CV calculations (QC
QC Data Point calculations). The point remains on the chart, marked as omitted by a diagonal line
through it.
1 Go to the Quality Control screen. To get to this screen from the Main Menu,
select Quality Control F4.
2 Select the quality control that contains the point you want to omit.
NOTE
If a data point is omitted by the system due to a fatal flag or other error
condition, the omission is permanent and the Omit box cannot be cleared.
Deleting a QC Use this procedure to delete a selected point from the screen, reports, and statistical
Point calculations. You must have the correct system password to use this option. An
information event is created in the Event Log.
1 Go to the Quality Control screen. To get to this screen from the Main Menu,
select Quality Control F4.
2 Select the quality control that contains the point you want to delete.
4 Select the point to delete. Touch the point or use the arrow keys in the bottom
corner of the chart to select the point.
Copying QC Use this procedure to copy QC data to a disk. Use a 3.5-inch high density, DOS-
Data to Disk formatted disk. The Access 2 system copies the QC data into a comma-separated field
format that you can import to a PC-based spreadsheet program. The QC data fields
are:
• Control lot headers
• Control lot data
• Data point headers
• Rows of data point values
NOTE
Copying QC data does not remove it from the database.
1 Be sure the system is in the Ready or Not Ready mode, then go to the Quality
Control screen. To get to this screen from the Main Menu, select Quality
Control F4.
3 Insert a 3.5-inch disk into the 3.5-inch disk drive of the PC.
NOTE
Be sure you insert the disk into the 3.5-inch disk drive of the PC, not the
Access 2 instrument.
4 Select Review Chart and Data F2 to display the QC Chart and Data screen,
then select Copy to Disk F6.
The Copy to Disk window is displayed.
5 Enter a name and file extension for the data file in the File Name field.
NOTES
• If you do not enter a file name or extension, the system supplies a default file
name based on the date and time and a .csv (comma delimited) extension.
• If the file name already exists, the system displays a message. To overwrite
the existing file, select Yes F1. To rename the new file, select Cancel F8.
G (Optional) To format the disk before the system copies the data, select the
Format Disk option.
6 Select OK F1.
A progress window is displayed. Select Cancel F8 to stop the copy process at
any time. When the copy process is complete, the system displays a message.
To get to this screen from the Main Menu, select Quality Control F4 to display the
Quality Control screen, select the quality controls you want to compare, then select
Compare Charts F3.
0752A.bmp
Figure 7-10 Compare Charts Screen
Chart name (Field) Displays the test name, quality control name, quality control lot number,
and instrument number for data on the screen.
Date range (Field) Displays the start and end dates for the chart and data.
Mean (Field) Displays the calculated mean of the points within the date range.
SD (Field) Displays the calculated standard deviation of the points within the date
range.
%CV (Field) Displays the calculated coefficient of variation of the points within the date
range.
Points (Field) Displays the number of points within the date range.
Levey-Jennings (Chart) Displays two or three graphs of the plotted points from each quality
Charts control. You can scroll left to right and back, to view all of the data points, using
the horizontal scroll bar.
• Point cursor
The blue vertical line on the graph. You can move the line by using the left and
right arrow keys (found by each corner of the chart). This line marks the point
you have selected.
• Y-axis Left Scale
Displays the 7 y-axis coordinates. These are the stated values for the mean and
the 1st, 2nd, and 3rd SDs above and below the mean.
• Y-axis Right Scale
Displays the 7 y-axis coordinates. These mark the mean and the 1st, 2nd, and
3rd SDs above and below the mean.
• X-axis
Displays the dates for the chart.
• Points
Represent the numerical value of the result. A diagonal line through the point
indicates an omitted point. Points greater than 3 SD above the mean are
indicated as solid triangles on the +3 SD line, and points greater than 3 SD
below the mean are indicated as solid triangles on the -3 SD line. Points that
violate QC rules are colored red.
Save Comparison (Button) Select to save the comparison. If you save the comparison, the system
F1 creates a comparison button. You can then select the comparison button from the
Quality Control screen to view it.
Review Chart and (Button) Select to display a menu of the following options:
Data F2
Top F1
Select to display the top chart only on the QC Chart and Data screen.
Middle F2
Select to display the middle chart only on the QC Chart and Data screen.
Bottom F3
Select to display the bottom chart only on the QC Chart and Data screen.
Edit Date Range F4 (Button) Select to change a date range of QC points to view.
Main Menu
Quality Control
F4
Quality Control
Compare Charts
F3
Is correct date
range displayed? No
Yes
Save the
No
comparison?
Yes
Save Comparison
F1
Save Comparison
0779C.wmf
Figure 7-12 Comparing QC Charts Flowchart
Comparing Use this procedure to view QC charts and data for two or three quality controls at the
QC Charts same time.
1 Go to the Quality Control screen. To get to this screen from the Main Menu,
select Quality Control F4.
(Optional) To change the date range of the displayed data, select Edit Date
Range F4 and then enter the date range you want to view.
(Optional) To save the comparison for viewing again, select Save Comparison
F1. For more information about how to save comparisons, see the Saving QC
Comparisons procedure in this section.
(Optional) To view one of the charts in more detail, select Review Chart and
Data F2, then select the button corresponding to that chart.
Saving QC Use this procedure to save the comparison from the Compare Charts screen.
Comparisons
1 Select Save Comparison F1 to save the selected quality controls as a
comparison button on the Quality Control screen.
The Save Comparison window is displayed.
2 Enter text for the comparison button (notes or information about the
comparison) in the Line 1 and Line 2 fields.
3 Select OK F1 to save the comparison and create a button on the Quality Control
screen.
NOTE
You can delete a saved comparison from the Quality Control screen using
Delete Comparison F4.
7.3
Quality Control Reports
You can print QC data and charts or a list of quality controls in a report format. For
QC data and charts, the system prints the displayed data. To print what is not
displayed, use the date range option.
QC Review Report This report contains all of the quality controls in the
current filter and includes the quality control lot, test
name, reagent lot, expiration, and instrument. The report
is available only from the Quality Control screen.
QC Data Report This report contains the data for a specific quality control
and date range. The report is available only from the QC
Chart and Data screen.
QC Chart Report This report contains a Levey-Jennings chart for a specific
quality control and date range. If the applied filter
exceeds 31 days, the data continues on additional pages.
The report is available only from the QC Chart and Data
screen.
Printing a QC Use this procedure to print a QC Review Report (see Figure 7-15).
Review Report
1 Go to the Quality Control screen. To get to this screen from the Main Menu,
select Quality Control F4.
Printing a QC Use this procedure to print a QC Chart Report, a QC Data Report, or a combination of
Chart or Data both reports.
Report
1 Go to the QC Chart and Data screen. To get to this screen from the Main Menu,
select Quality Control F4, select the quality control you want to print, then
select Review Chart and Data F2.
0759A.bmp
Figure 7-13 Print (QC Chart and Data) Window
Report Type (Boxes) Select either chart, data table, or both to print. For
an example of each report format, see Figure 7-16 and see
Figure 7-17.
Print Entire Date (Box) Select to print a report for the entire date range
Range selected on the QC Chart and Data screen.
• If you select this box, the report contains information for
the entire date range selected.
• If you clear this box, the report contains QC information
for only the date range displayed on the screen.
G (Optional) To print a wider range of data than you can view on the screen for a
QC Data or QC Chart report, select Print Entire Date Range.
4 Select OK F1.
The system sends the report to the printer.
Laboratories, Inc.
Laboratory A
123 Lake Street
Townsville, ST 33333
QC Review Report 101-555-2323 ext. 109
Access 2 Immunoassay System Jane Smith
Page 1 of 1
Technologist ____________________________________________ Printed 10/10/02 02:43 PM
0772C.bmp
Figure 7-15 QC Review Report
Laboratories, Inc.
Laboratory A
123 Lake Street
QC Data Report Townsville, ST 33333
Access 2 Immunoassay System 101 - 555 - 2323 ext. 109
S/N 501240 Jane Smith
Page 1 of 1
Technologist _____________________________________________ Printed 10/10/02 05:32 PM
0773D.bmp
Figure 7-16 QC Data Report
7-30
Laboratory A
123 Lake Street
QC Chart Report Townsville, ST 33333
Access 2 Immunoassay System 101-555-2323 ext. 109
S/N 501240 Jane Smith
________________________________________________________________________________________________________________________________
Test: cTnI Start Date: 10/01/02
Control: CardiacB End Date: 10/07/02
Control Lot: 1234567B Points: 7
7.3: Quality Control Reports
0.600 3
0.500 2
0.400 1
0.300 0
0.200 -1
0.100 -2
-0.000 -3
10/02 10/04 10/06
Page 1 of 1
Technologist ________________________________________________ Printed 10/10/02 05:32 PM
7.4
Setting Up Quality Controls
You can set up quality controls to make them available to run on your Access 2
system and to define quality control (QC) rules the system checks test results against.
You must set up each new lot of a quality control before you can select it during test
request entry. You must complete the following fields:
• Control
• Lot number
• Expiration date
• Sample type
• Test name
• Mean
• SD
• Units
• Westgard QC rules
You must establish the acceptable range of expected values (mean and standard
deviation) for quality controls specific to your Access 2 instrument. For each new lot,
use the manufacturer’s suggested ranges from the product insert as a guideline for the
expected mean and standard deviation (SD), until you have processed enough quality
control samples to determine a mean and SD specific to the instrument you use.
QC rules are a set of five interpretive rules devised to avoid excessive false rejection
rates, improve quality monitoring, and decrease subjectivity of data analysis. The
system checks quality control test results against applied QC rules and flags any
results that violate a rule. Your laboratory determines which rules you will apply and
the course of action you will take when a result violates a rule. Know how to use QC
rules before you set up quality control information in the system.
Main Menu
Quality Control
F4
Quality Control
QC Setup
F5
QC Setup
Add Control
F1
Add Control
OK
F1
All control
parameters No
entered?
Yes
Done
0780A.wmf
Figure 7-18 Setting Up Quality Controls Flowchart
QC Setup Screen
You use this screen to:
• View all of the quality controls for all of the instruments in the workgroup
• Add a quality control to be used on any instrument in the workgroup
• Edit an existing quality control
• Delete a quality control
To get to this screen from the Main Menu, select Quality Control F4 to display the
Quality Control screen, then select QC Setup F5.
0753B.bmp
Figure 7-19 QC Setup Screen
QC Setup List (List) Displays information for all quality controls defined in the workgroup.
The four columns of information are:
• Control
Displays the name of the quality control.
• Control lot
Displays the number of the quality control lot.
• Expiration
Displays the quality control lot expiration date.
• Sample
Displays the sample type.
Add Control F1 (Button) Select to add a quality control to the QC Setup list and enter the tests,
means, SDs, units, and QC rules to define it.
Edit Control F2 (Button) Select to edit an existing quality control.
Delete Control F6 (Button) Select to permanently remove a quality control from the system.
Adding a Use this procedure to define a new quality control and enter the tests, means, SDs, and
Quality QC rules for that quality control.
Control
1 Go to the QC Setup screen. To get to this screen from the Main Menu, select
Quality Control F4 to display the Quality Control screen, then select QC Setup
F5.
0762C.bmp
Figure 7-21 Add Control Window
Control (Field) Enter a unique name for the new quality control.
Lot Number (Field) Enter a unique lot number for the new quality control.
Expiration (Field) Enter the expiration date for the new quality control lot number.
Sample Type (List) Select a sample type from the list.
Test Name (List) Select a test name from the list of tests enabled on any instrument in the
workgroup.
Mean (Field) Enter the expected mean for the test.
SD (Field) Enter the expected SD for the test.
Units (Field) Displays the test units.
Westgard QC Rules (Boxes) Select the rules box(es) you want to enable for the new control.
Application of a Westgard QC rule consists of screening quality control test results
for the number of standard deviations (designated SD) above or below the mean,
and the number of consecutive occurrences. For example, 41S is shorthand for four
consecutive test results exceeding ±1 SD from the mean. You can select any of
these QC Rules:
• 12s (1-2s)
The system displays a flag if 1 point is more than 2 SD from the mean.
• 13s (1-3s)
The system displays a flag if 1 point is more than 3 SD from the mean.
Clear Row F3 (Button) Select to clear the information from a selected row.
Designate (Button) This button is reserved for future use.
Pipettor F4
3 Enter the quality control information and select the appropriate options to
define the new quality control.
NOTES
• Some multi-level quality controls have the same lot number for each level.
You can add the level (such as 1, 2, or 3) to the lot number to make it unique.
• The expiration date format follows the format you set up on the System
Setup screen. The system displays a message if the incorrect format is used.
For more information about setting the date format, see Chapter 4: System
Configuration in the Reference Manual.
• For a qualitative test, the standard deviation must be greater than 1. If you
enter an expected SD that is less than 1, the QC chart may not display the
data correctly.
(Optional) To delete the information in a row and start over with a blank row,
select Clear Row F3.
4 Select OK F1.
The system saves the new quality control and adds it to the QC Setup list.
NOTE
A warning message is displayed if you have missing or incomplete information.
(Optional) To delete the new quality control without saving it, select Cancel F8
and return to the QC Setup screen.
5 Record the quality control information on the QC worksheet. Do this for any
quality control you set up.
4 To edit the expected mean for a quality control test, enter the new value in the
Mean field.
5 To edit the expected standard deviation for a quality control test, enter the new
value in the SD field.
7 Select OK F1.
The system saves the quality control and updates the QC Setup screen.
NOTE
A warning message is displayed if you have missing or incomplete information.
1 Be sure the system is in the Ready or Not Ready mode, then go to the QC
Setup screen. To get to this screen from the Main Menu, select Quality Control
F4 to display the Quality Control screen, then select QC Setup F5.
2 Select the quality control you want to delete from the QC Setup list.
5 Select OK F1.
The system removes the quality control from the QC Setup screen and any
buttons associated with it from the Quality Control screen.
7.5
Establishing QC Ranges
This section provides a recommendation to establish quality control ranges for the
Access 2 Immunoassay System. This is only a recommendation and is not intended to
replace your existing laboratory procedure(s). Use this procedure, along with your
standard laboratory practices and manufacturer’s recommendations, for your quality
controls.
You can use the Quality Control worksheet to record the quality controls you set up
and all of the data associated with them.
NOTES
• Use fresh quality control materials for best results.
• Do no re-use quality controls by pooling into sample cups or storage
containers.
• For more information about requesting QC tests, see Section 3.4: Quality
Control Test Requests in this manual.
Collecting Use this procedure, along with your standard laboratory procedure, to establish
Data to quality control ranges.
Establish QC
Ranges Required Materials
• Access 2 system assay calibrators (2 lots, if available)
• Access 2 system reagent packs (2 lots, if available)
• Tri-level quality controls (prepare the quality controls according to the
manufacturer’s instructions)
Steps
1 Run 1 or 2 replicates of each quality control one time each day. Vary the
sequence in which the quality control samples are processed.
4 Calculate the mean, %CV, 1SD, 2SD, and 3SD values, and the 3SD range for
each quality control level/analyte combination.
6 Perform a second outlier evaluation. Remove any values outside of the 3SD
range, then recalculate the mean, %CV, 1SD, 2SD, and 3SD values.
7 Calculate the acceptable 1SD, 2SD, and 3SD quality control ranges.
NOTE
If the %CV< 6, you may consider widening the ranges by multiplying the stated
SD by 1.5, then recalculating the 1SD, 2SD, and 3SD ranges.
8 Periodically recalculate the values and ranges during the life of the control lot.
Assigning Use this procedure to assign temporary or provisional quality control ranges.
Temporary
1 Run 1 or 2 replicates of each quality control daily.
QC Ranges
2 Record the values, using the following guidelines:
• If 1 replicate is run, record only 1 value per quality control level.
• If 2 replicates are run, record both individual values.
• Do not exceed 2 recorded values a day.
5 Verify that the calculated mean is within the manufacturer assigned range
provided in the quality control product insert (if more than 1 range is listed, use
the 2SD range).
• If the mean is within the assigned range, calculate a temporary range for
each quality control level.
• If the mean is not within the assigned range, contact Technical Support.
• If no manufacturer assigned ranges are listed in the product insert, contact
Technical Support.
7.6
Quality Control Worksheet
After you set up the quality controls for the Access 2 instrument, you can record the
setup information on the Quality Control Worksheet. You can use the worksheet on
the following page as an original and make photocopies for use on each Access 2
instrument. Keep the worksheet, along with the any others, in one place that can be
referenced in the future.
0784a.bmp
Figure 7-23 Quality Control Worksheet
Routine Maintenance
8.1 Routine Maintenance ................................................................................... 8-3
8.1
Routine Maintenance
For optimal performance, the Access 2 system requires routine maintenance. Routine
maintenance includes: Daily Maintenance, Weekly Maintenance, and the Utility
Assay.
Daily maintenance includes inspection, cleaning, and priming procedures that you
perform once every 24 hours. Weekly maintenance includes more cleaning
procedures and the System Check routine. You perform the System Check routine as
part of weekly maintenance to verify system performance. You can also run the
System Check routine to troubleshoot the system.
The Utility Assay runs automatically every four hours when the system is not
processing samples, and after the instrument finishes running the samples in the last
on-board rack. You can also run the Utility Assay manually, when requested by
Technical Support.
You can use the Maintenance Log as a checklist for performing all routine
maintenance procedures. Keep the Maintenance Log in this chapter as an original and
make photocopies for use with each Access 2 system in your laboratory. Retain the
completed Maintenance Logs for reference.
For instructions on running the Utility Assay manually, see the Running the Utility
Assay procedure in this section.
The original version of the maintenance log is in this chapter, see Section 8.6:
Maintenance Log.
To get to this screen from the Main Menu, select Maintenance Review F6.
0775A.bmp
Figure 8-1 Maintenance Review Screen
Running the The Utility Assay runs automatically or manually to clean the interior of the aspirate
Utility Assay and dispense probes.
NOTE
If you will not be using the instrument to process samples for a long period of
time, be sure that you load enough RVs on the system so the Utility Assay can
continue to run. The Utility Assay runs every four hours, and uses three RVs
each time it runs. To calculate the number of RVs needed, use the following
formula:
For example:
50 (hours)
= 12 * 3 = 36
4 (hours)
Be sure 36 RVs are loaded on the instrument.
0922A.wmf
You can run the Utility Assay manually when additional cleaning is requested by
Technical Support or required for troubleshooting. Use this procedure to run the
Utility Assay manually.
NOTE
You can perform other tasks while the Utility Assay is running, including
loading racks and most supplies.
Enabling/ Use this procedure to disable the Utility Assay. Disabling the Utility Assay prevents it
Disabling the from running every four hours that the instrument is not processing samples.
Utility Assay
WARNING
Disable the Utility Assay while you are working on the instrument for
extended periods of time to prevent injury from the instrument
accidentally starting up.
1 Go to the Maintenance Review screen. To get to this screen from the Main
Menu, select Maintenance Review F6 (see Figure 8-1).
G To restart the timer for the Utility Assay, select Enable Utility Assay F6.
Requesting Use this procedure to request maintenance routines. You can request and load
Maintenance maintenance routines while the system is processing patient samples. The
Routines maintenance routines run after the system completes the on-board patient samples.
WARNING
You will come in contact with potentially infectious materials during this
procedure. Handle and dispose of biohazard materials according to proper
laboratory procedures. Proper hand, eye, and facial protection is required.
1 Go to the Sample Manager screen. To get to this screen from the Main Menu,
select Sample Manager F1.
2 Be sure that the Rack ID field is selected, then type the rack ID and press
[Enter].
NOTE
When you select Maintenance Requests F4, the Sample Manager screen is no
longer displayed.
NOTES
• If you select Daily Clean System or Special Clean and a System Check, the
system runs the Daily Clean System or Special Clean routine before the
System Check.
• When you run the System Check or Special Clean routine, the system
records it in the Event Log.
0667A.bmp
Figure 8-3 Request Maintenance Window
Daily Clean System (Option) Select to run the Daily Clean System maintenance routine. The Daily
Clean System routine cleans the interior of the primary, dispense, and aspirate
probes and primes the wash buffer lines (see the Running the Daily Clean System
Routine procedure in this section).
Special Clean (Option) Select to run the Special Clean maintenance routine. Perform the Special
Clean routine at the end of the day if the Access 2 system is processing the B12
assay.
For more information about running the Special Clean routine, see Section 8.5:
Special Clean.
No Clean (Option) Select to clear the Daily Clean System and the Special Clean options.
System Check (Box) Select to run the System Check maintenance routine. You run the System
Check routine as part of weekly maintenance or for troubleshooting (see the
Running the System Check Routine procedure in Section 8.4: System Check).
(List) Select a System Check maintenance routine from the list.
Values are: None, All, Washed, Unwashed, and Substrate.
You can run the individual system checks for troubleshooting purposes.
For more information on running individual system checks, see Chapter 5.11:
Individual System Checks in the Reference Manual.
5 Select OK F1.
The system displays the requested routine, sample types, completion time, and
status on the Maintenance Requests screen (see Figure 8-5).
NOTE
The completion time is updated when Run is selected in step 8.
6 Select Load Rack X F1. (The X represents the number of the rack that you
entered into the Rack ID field on the Sample Manager screen.)
The system displays the Load Rack window and the instrument moves the
sample carousel into position for loading.
NOTE
Load the rack after requesting the maintenance routine, If you load the rack
first, the system recognizes the rack as a patient sample rack, and will not accept
the maintenance request. If the rack is already loaded, take the rack off board,
clear it, and load it again after requesting the maintenance routine.
8 Select Run.
CAUTIONS
• Unless there is an emergency, let the maintenance routine run to
completion. Cancelling the routine may damage the instrument and
compromise the integrity of subsequent test results.
• If you stop the routine, do not initialize the system. Call Technical
Support for assistance.
9 When the maintenance routine is complete, unload the rack and select Done F1.
For more information on unloading a rack, see Section 3.1: Sample
Management.
To get to this screen from the Main Menu, select Sample Manager F1 to display the
Sample Manager screen, then
Select a rack (must have a rack ID between 1-57 or 400-456) that contains a
previously requested maintenance routine from the On Board or Off Board list, then
NOTE
To get to the Maintenance Requests screen by entering a new rack, see the
Requesting Maintenance Routines procedure in this section.
0668A.bmp
Figure 8-5 Maintenance Requests Screen
Rack Icon (Indicator) Displays the rack ID and position of each sample cup in the rack.
If any of the following errors occur after loading, the system turns the affected
sample cup red:
• The sample cup is missing
• There is not enough sample to complete one or more tests
Rack ID (Field) Displays the ID of the rack selected on the Sample Manager screen. If you
want to change the selected rack, you must go back to the Sample Manager screen,
select a different rack, then select Maintenance Requests F4.
Rack Location (Field) Displays the location of the rack.
Values are: On Board or Off Board.
Rack Status (Indicator) Displays the sample processing status for the rack as determined by the
least processed sample in the rack.
Values are: No Tests, Requested, Supply Wait, In Progress, Aspirated, Done,
and *Done*.
For more information about rack statuses, see Section 4.4: Monitoring Sample
Progress in this manual.
Position (Icon) Shows the samples in rows numbered 1-10. The rows correspond to the ten
positions in the selected rack, from left to right with the convex side of the rack
facing you.
The fields in each sample position row pertain to the sample in that position in the
rack.
Routine (Field) Displays the name(s) of the maintenance routine(s) being run.
Values are: Daily Clean System, Special Clean, and System Check.
If you select individual system checks, System Check appears in the Routine
field.
Sample (Field) Displays the contents and quantity of each sample cup needed in the rack,
according to the requested maintenance routines.
Completion (Field) Displays the estimated time the system will finish processing the tests
requested for the sample. The format of this field is defined when you configure
the system. For more information, see Chapter 4: System Configuration in the
Reference Manual.
For Special Clean and Daily Clean System, the completion time is for the entire
rack. For System Check, the completion time is shown for each part of the routine.
Status (Field) Displays the sample status, as determined by the least processed test
requested for the sample.
Values are: No Tests, Requested, Supply Wait, In Progress, Aspirated, Done,
*Done*, and QNS (sample quantity not sufficient).
If the system cancels a test, it records the test name and sample ID on the Event
Log screen and the Event Log button turns red.
Load/Get Rack X F1 (Button) X is the rack ID of the rack selected on the Sample Manager screen. If the
selected rack is off board, select Load Rack X to load it. If the selected rack is on
board, select Get Rack X to present the rack at the sample carousel door, where
you can add, remove, or rearrange samples, or you can unload the rack
Edit Request F2 (Button) Select to display the Request Maintenance window. Use this window to
change the selected maintenance routines.
Maintenance (Button) Select to display the Maintenance Review screen (see Figure 8-1).
Review F6
8.2
Daily Maintenance
In order to keep the Access 2 system running properly, perform daily maintenance
once every 24 hours. Daily maintenance is made up of the following procedures,
performed in sequence:
NOTE
If you use the Access 2 system to process the B12 assay, you should also run the
Special Clean routine at the end of every day or whenever the instrument will
not process samples for 8 hours or more, see Section 8.5: Special Clean.
Main Menu
Check the
Run the Daily
Zone Temperatures*
Clean System*
OK
F1
Check Diagnostics
System Check the Supplies F7 Maintenance Request
Status and Waste Prime Fluidics
Containers* F2
Prime Fluidics
Main Menu
Sample Manager
F1
Check the
Backup* Run
0787C.wmf
Figure 8-7 Daily Maintenance Flowchart
Daily You need to gather the following materials to perform daily maintenance. This is the
Maintenance complete list of materials for all of the procedures. For a list of part numbers and for
Required ordering information, see the Quick Reference Guide.
Materials • Fiber-free polyester swabs (or equivalent fiber-free applicators)
• Maintenance Log (see Section 8.6: Maintenance Log)
• 13 mm rack for 2 mL sample cups; the rack must have a rack ID between
1-57 or 400-456
• Wash buffer (or deionized water)
• Citranox* cleaning solution
• Contrad** 70 cleaning solution
• 2.0 mL sample cups (three cups)
NOTE
Use only the 2.0 mL sample cups when performing the maintenance routines.
Using any other sample containers may result in level sensing errors and
cancellation of the maintenance routine.
WARNINGS
• You will come in contact with potentially infectious materials during this
procedure. Handle and dispose of biohazard materials according to proper
laboratory procedures. Proper hand, eye, and facial protection is required.
• Citranox cleaning solution is acidic and may cause eye or skin irritation. See
the manufacturer’s label for details.
• Contrad 70 cleaning solution is alkaline and may cause severe eye irritation
or mild skin irritation. See the manufacturer’s label for details.
Main Menu
Maintenance Review
F6
Maintenance
Call
Temperatures No Technical Support
in range?
Yes*
Supplies
Supplies Correct Supply
sufficient?
No Condition
For information on adding supplies,
see Chapter 2: Supplies.
Yes*
Waste Supplies
Correct Supply For information on changing the
containers No Condition
OK? waste containers, see Chapter 2:
Supplies.
Yes*
Yes*
0592B.wmf
Figure 8-8 Daily Maintenance: Checking System Status Flowchart
Checking the Use this procedure to check the system status (see Figure 8-8).
System Status 1 Go to the Maintenance Review screen. To get to this screen from the Main
Menu, select Maintenance Review F6.
2 Verify that the temperatures in the Zone Temperature (Degrees Celsius) fields
are within their expected ranges displayed on the Maintenance Review screen.
Out-of-range temperatures are displayed in red. If a temperature is out of range,
call Technical Support for assistance.
G (Optional) Replenish the supplies and change the waste containers if the system
status buttons are red or yellow (see Chapter 2: Supplies).
For printer supplies, see the documentation that came with your printer.
3 Go to the PC Admin screen on the server system. To get to this screen from the
main menu, select Configure F8, then PC Admin F7.
4 Verify that the system backup was successful. For more information, see the
Scheduling System Backups procedure in Section 4.10: PC Administration
Setup of the Reference Manual.
NOTE
Depending on your laboratory’s schedule, the system backup may or may not
run daily.
5 Initial the appropriate sections of the Maintenance Log (see Section 8.6:
Maintenance Log).
Crystalline
Call
buildup Yes Technical Support
or corrosion?
No
Initial
Maintenance Log
0593B.wmf
Figure 8-9 Daily Maintenance: Inspecting the Fluidic Module Flowchart
Inspecting the Use this procedure to visually inspect the fluidic module (see Figure 8-9).
Fluidic
Module WARNING
You will come in contact with potentially infectious materials during this
procedure. Handle and dispose of biohazard materials according to proper
laboratory procedures. Proper hand, eye, and facial protection is required.
1 Be sure that the system is in the Ready, Paused, or Not Ready mode.
2 Open the front panel of the instrument. To open the front panel, gently pull the
bottom of the panel toward you, then lift upward.
3 Visually inspect all accessible tubing connections and valve and pump fittings
for crystalline buildup or corrosion.
If you find crystalline buildup or corrosion, call Technical Support for
assistance. Deposits indicate that a connection or fitting may be leaking.
Clean substrate
probe exterior with
deionized water
Clean dispense
probe exteriors with
deionized water
Clean aspirate
probe exteriors with
deionized water
Initial
Maintenance Log
0594A.wmf
Figure 8-10 Daily Maintenance: Cleaning the Wash Carousel Probe Exteriors Flowchart
Cleaning the Use this procedure to clean the exterior of the substrate, dispense, and aspirate probes.
Wash
Carousel WARNING
Probe You will come in contact with potentially infectious materials during this
Exteriors procedure. Handle and dispose of biohazard materials according to proper
laboratory procedures. Proper hand, eye, and facial protection is required.
CAUTIONS
• Be sure not to bend or damage the fragile probe tips.
• To avoid contamination, use a new swab on each type of probe.
• Do not wipe the tip of the probe. Fibers on or inside the probes can clog
the probes or valves in the fluidic module.
1 Be sure that the system is in the Ready, Paused, or Not Ready mode.
2 Open the front panel of the instrument. To open the front panel, gently pull the
bottom of the panel toward you, then lift upward.
3 Locate the substrate, dispense, and aspirate probes (see Figure 8-11).
7
6
1
5 4 3 2
1
6
3 2
5
4
0195H.eps
4 Gently wipe the exterior of the substrate probe with a new, fiber-free polyester
swab moistened with wash buffer (or deionized water).
5 Gently wipe the exterior of the dispense probes with a new, fiber-free polyester
swab moistened with wash buffer (or deionized water).
6 Gently wipe the exterior of the aspirate probes with a new, fiber-free polyester
swab moistened with wash buffer (or deionized water).
NOTE
You do not need to clean the exterior of the aspirate probes if you are
performing weekly maintenance, and you have already installed clean aspirate
probes.
Main Menu
Diagnostics
F7
Prime Fluidics
F2
Prime Fluidics
Select Substrate
Start Priming
F2
Cancel
F8
Initial
Maintenance Log
0595A.wmf
Figure 8-12 Daily Maintenance: Priming the Substrate Flowchart
Priming the Use this procedure to prime the substrate fluidic lines (see Figure 8-12). The priming
Substrate sequence takes about 8 minutes.
1 Go to the Prime Fluidics window. To get to this window from the Main Menu,
be sure the system is in the Ready mode, then
Select Diagnostics F7 to display the Diagnostics menu, then
Select Prime Fluidics F2 (for more information, see Section 5.3: Prime Fluidics
in the Reference Manual).
G (Optional) Select the Cycles field to change the number of times the system
primes the substrate.
NOTE
When the substrate is priming, Start Priming F2 changes to Stop Priming F2.
Sample Manager
Load Rack
F1
F1
Sample Manager
Load rack
Enter the Maintenance Rack
Number in the Rack ID field
Maintenance Request
F4 Run
Request Maintenance
The system cleans
probe interiors
Select Daily Clean (15 minutes)
System
OK
F1
Wait until the status bar
indicates the cleaning
is complete
Place 2.0 mL sample
cups in rack positions
1, 2, and 3
Unload rack
Pipette 2.0 mL
Contrad 70 into cup 1
Initial the
Maintenance Log
Pipette 2.0 mL
1/5 Citranox/deionized
water dilution into cup 2
Complete the remaining
Daily Maintenance
Pipette 2.0 mL routines
deionized water
or wash buffer
into cup 3
0596B.wmf
Figure 8-13 Daily Maintenance: Running the Daily Clean System Routine Flowchart
Running the Use this routine to clean the interior of the primary, dispense, and aspirate probes and
Daily Clean to prime the wash buffer lines (see Figure 8-13). In addition to running this routine
System during daily maintenance, you should also run this routine if you know that the
Routine instrument will not process samples for an extended time period. Once you prepare
and load the rack, the Daily Clean System routine takes about 15 minutes to run.
WARNING
You will come in contact with potentially infectious materials during this
procedure. Handle and dispose of biohazard materials according to proper
laboratory procedures. Proper hand, eye, and facial protection is required.
NOTES
• When you are performing the weekly maintenance routines, the Daily Clean
System routine is run with the System Check routine.
• Load the rack after requesting the maintenance routine. If you load the rack
first, the system recognizes the rack as a patient sample rack, and will not
accept the maintenance request. If the rack is already loaded, take the rack
off board, clear it, and load it again after requesting the maintenance routine.
1 Be sure that the system is in the Ready mode. Go to the Sample Manager
screen. To get to this screen from the Main Menu, select Sample Manager F1
(see Section 3.1: Sample Management).
2 Be sure that the Rack ID field is selected, then type the rack ID and press
[Enter].
The new rack is displayed in the Off Board list on the Sample Manager screen.
NOTE
When you select Maintenance Requests F4, the Sample Manager screen is no
longer displayed.
5 Select OK F1.
The system displays the requested routine, sample types, completion time, and
status on the Maintenance Requests screen.
NOTE
The completion time is updated when Run is selected in step 12.
6 Place the 2.0 mL sample cups in sample positions 1, 2, and 3 of an empty rack.
9 Pipette 2.0 mL of wash buffer (or deionized water) into the sample cup in
position 3.
10 Select Load Rack X F1. (The X represents the number of the rack that you
entered into the Rack ID field on the Sample Manager screen.)
The system displays a message and presents a rack position.
12 Select Run.
WARNING
Unless there is an emergency, let the maintenance routine run to completion.
Canceling the routine may damage the instrument and compromise the integrity
of subsequent test results.
CAUTION
If you stop the routine, do not initialize the system. Call Technical Support
for assistance.
NOTE
The Daily Clean System routine runs after the system completes the on-board
patient samples.
13 When the Daily Clean System routine is complete, unload the rack and select
Done F1.
8.3
Weekly Maintenance
In order to keep the Access 2 system running properly, perform weekly maintenance
once every seven days. Weekly maintenance is made up of the following procedures,
performed in sequence:
6 Run Daily Maintenance (for more information, see Section 8.2: Daily
Maintenance in this chapter)
7 Run System Check (for more information, see Section 8.4: System Check in
this chapter)
Clean the
Instrument Exterior*
Run Daily
Maintenance*
Run System
Check*
0808B.wmf
Figure 8-14 Weekly Maintenance Flowchart
Weekly You need to gather the following materials to perform weekly maintenance. This is
Maintenance the complete list of materials for all of the procedures. For a list of part numbers and
Required for ordering information, see the Quick Reference Guide.
Materials • Lint-free cloth
• Deionized or distilled water
• Maintenance Log (see Section 8.6: Maintenance Log)
• Alcohol or alcohol swabs or wipes (methanol can be substituted for cleaning
the exterior of the aspirate probes)
• Proper hand, eye, and facial protection for handling biohazardous materials
• Clean aspirate probes (three)
• Contrad 70 cleaning solution
• Beakers (two)
• Aspirate Probe Cleaning Kit (3.0 mL syringe, disposable aspirate probe
brush, aspirate probe syringe fitting assembly consisting of a fitting and
tubing)
• Disposable aspirate probe brushes (as needed)
• Absorbent paper
• Wash buffer
• Spare waste filter bottle (as needed)
WARNINGS
• You will come in contact with potentially infectious materials during this
procedure. Handle and dispose of biohazard materials according to proper
laboratory procedures. Proper hand, eye, and facial protection is required.
• Methanol is extremely flammable. Do not use near heat or flame. Do not
ingest. Avoid contact with eyes, skin, and clothing. Use with adequate
ventilation.
• Contrad 70 cleaning solution is alkaline and may cause severe eye irritation
or mild skin irritation. See the manufacturer’s label for details.
Cleaning the Use this procedure to clean the exterior of the system.
Instrument
1 Moisten a clean, lint-free cloth with deionized water (or distilled water).
Exterior
2 Wipe the exterior of the instrument with the moistened cloth.
Yes
Initial
Maintenance Log
0600A.wmf
Figure 8-15 Weekly Maintenance: Checking for Fluid in the Waste Filter
Bottle Flowchart
Checking for Use this procedure to check the waste filter bottle for fluid.
Fluid in the
Waste Filter WARNING
Bottle You will come in contact with potentially infectious materials during this
procedure. Handle and dispose of biohazard materials according to proper
laboratory procedures. Proper hand, eye, and facial protection is required.
1 Inspect the waste filter bottle for fluid collecting in the bottom.
(Optional) If fluid is visible, replace the waste filter bottle (see the Replacing
the Waste Filter Bottle procedure in Section 7.4: Fluids Tray and Instrument
Base Procedures of the Reference Manual).
Is the probe
undamaged?
No Replace primary probe
Yes
Inspect primary
probe for
crystalline buildup
Is there Initial
No
buildup? Maintenance Log
Yes
0599C.wmf
Figure 8-16 Weekly Maintenance: Inspecting and Cleaning the
Primary Probe Flowchart
Inspecting A bent, damaged, or dirty primary probe can lead to level sensing errors. During
and Cleaning weekly maintenance, visually inspect the primary probe for damage before cleaning
the Primary the probe exterior.
Probe
WARNING
You will come in contact with potentially infectious materials during this
procedure. Handle and dispose of biohazard materials according to proper
laboratory procedures. Proper hand, eye, and facial protection is required.
Use this procedure to inspect the primary probe and clean the probe exterior.
1 Be sure that the system is in the Ready, Paused, or Not Ready mode.
2 Open the front panel of the instrument. To open the front panel, gently pull the
bottom of the panel toward you, then lift upward.
3 Visually inspect the primary probe. If the probe is bent or damaged, replace the
primary probe. For more information about replacing the probe, see Section 7.6:
Main Pipettor Procedures in the Reference Manual.
4 Inspect the upper portion of the primary probe for crystalline buildup (see
Figure 8-17).
0161B.eps
(Optional) If you see crystalline buildup, carefully wipe the upper portion of
the primary probe with an alcohol swab or a lint-free cloth dampened with
alcohol.
CAUTION
Do not wipe the tip of the probe. Fibers on or inside the probes can clog the
probes or valves in the fluidic module.
Turn the
instrument off
Install a clean
aspirate probe
Turn the
instrument on
Yes
0776C.wmf
Figure 8-18 Weekly Maintenance: Replacing the Aspirate Probes Flowchart
2 3
1
6
5 4 3 2
6 5 4
0152Ic.eps
NOTE
There are seven probes on the wash arm: three wash buffer dispense probes,
three aspirate probes, and one substrate dispense probe. The probe positions are
numbered sequentially from RIGHT to LEFT. If you cannot identify the correct
probes, contact Technical Support.
4 Gently grasp a black aspirate probe retainer above the wash arm. Gently push
down on the retainer, then rotate it 1/4 turn counterclockwise.
CAUTION
Handle the aspirate probes with extreme care. The probes are fragile, and
will not function properly if bent.
5 While holding the probe by the black probe retainer, lift up to remove the probe
from the wash arm. Be careful not to bend the probe.
6 At the barbed fitting, grasp and pull the aspirate probe tubing until it separates
from the fitting. The tubing will stretch (see Figure 8-20).
2
4
3
0153dC.eps
7 Install a clean aspirate probe (see the Installing Clean Aspirate Probes
procedure in this section).
8 Repeat steps 4 through 7 to remove and install the other two aspirate probes.
(Optional) If you want to clean the removed probes now, perform the Cleaning
the Aspirate Probes procedure. Then perform the Installing Clean Aspirate
Probes procedure.
(Optional) If you do not plan to clean the removed probes within one hour,
place them in distilled water.
NOTE
You can either install clean aspirate probes from a supply of probes in the
CARE kit, or clean the removed probes and reinstall them on the instrument.
1 Push the aspirate probe tubing onto the barbed fitting of a clean aspirate probe,
being careful not to damage the barbed fitting or probe assembly. Be sure that
the tubing is pushed all the way to the barbed fitting collar.
If the tubing is not flush against the collar, the wash system may be adversely
affected.
0799B.eps
2 Route the tubing under both the clear, rigid pipettor tubing and the wiring
located to the left of the pipettor gantry.
3 From the top of the wash arm, carefully route the clean probe down through the
opening in the wash arm. Rotate the black probe retainer until the two tabs
engage the slots in the wash arm.
4 While holding the probe by the black probe retainer, gently push down on the
retainer and then turn it 1/4 turn clockwise.
5 Lift gently on the probe tubing to be sure the probe moves up and down.
(Optional) Reorder any CARE kit parts that you use. For ordering information,
see the Quick Reference Guide.
8 Turn the instrument on by pressing the upper part of the power switch to on
(| position). See Figure 7-8 in the Reference Manual.
CAUTION
The disposable aspirate probe brush handle bends easily.
NOTE
Always keep a spare set of new or previously cleaned aspirate probes in the
CARE kit. During weekly maintenance, remove the aspirate probes and replace
them with the spare set from the CARE kit. Clean the removed probes and store
them in the CARE kit for the next time you perform the weekly maintenance
procedures. For information about ordering replacement probes, see the Quick
Reference Guide.
0818a.wmf
Figure 8-22 Weekly Maintenance: Precleaning the Aspirate Probes Flowchart
3 Dip the aspirate probe brush in the undiluted Contrad 70 cleaning solution.
4 Carefully insert the aspirate probe brush into the bottom end of the aspirate
probe and push it in until the brush tip protrudes slightly from the other end of
the probe.
WARNING
Take the necessary precautions when removing and reinserting the probe
brush to avoid scattering droplets of biohazardous material into the air.
6 Repeat steps 3 through 5 several times on the same probe, or until no orange
residue is visible on the brush after removing it from the probe.
8 Clean the probes with Contrad 70 cleaning solution (see the Cleaning the
Aspirate Probes with Contrad 70 Cleaning Solution procedure in this section).
0819a.wmf
Figure 8-23 Weekly Maintenance: Cleaning the Aspirate Probes with Contrad 70 Cleaning
Solution Flowchart
2
0400d.eps
1 Syringe
2 Syringe Fitting Assembly
3 Push the aspirate probe’s plastic barbed fitting into the open end of the tubing
on the syringe fitting assembly.
4 Empty the syringe, forcing the Contrad 70 cleaning solution through the
aspirate probe and back into the beaker.
5 Flush the probe again by drawing the Contrad 70 cleaning solution into the
syringe through the aspirate probe and then emptying the syringe through the
probe into the beaker.
6 Remove the aspirate probe tubing from the syringe fitting assembly.
8 Clean the probes with distilled water (see the Cleaning the Aspirate Probes with
Distilled Water procedure in this section).
Initial the
Maintenance Log
0778a.wmf
Figure 8-25 Weekly Maintenance: Cleaning the Aspirate Probes with Distilled Water Flowchart
3 Empty the syringe, forcing the water through the aspirate probe tubing and into
a sink.
4 Rinse the probe three more times by drawing water from the same beaker into
the syringe through the aspirate probe, and then emptying the syringe through
the probe into a sink.
5 Remove the aspirate probe tubing from the syringe fitting assembly.
7 Position the probe upright on absorbent paper for about 10 minutes to allow
residual fluid to drain.
9 Store the clean set of probes in your CARE kit or reinstall them on the
instrument.
Running Daily As part of weekly maintenance, you should perform daily maintenance procedures.
Maintenance For information about how to do this, see Section 8.2: Daily Maintenance.
NOTE
Because installing clean aspirate probes is part of weekly maintenance, you do
not need to clean the exterior of the aspirate probes, as described in the daily
maintenance procedures.
Running As part of weekly maintenance, you should run the System Check routine. For
System information about how to do this, see Section 8.4: System Check.
Check
8.4
System Check
You perform the System Check routine as part of weekly maintenance to verify
system performance. During weekly maintenance, the three System Checks (washed,
unwashed, and substrate) are run together. You can also run the System Check routine
more often, or perform individual checks
For information on running individual system checks, see Section 5.11: Individual
System Checks in the Reference Manual.
To get to this screen from the Main Menu, select Maintenance Review F6 to display
the Maintenance Review screen, then select System Checks F2.
0782B.bmp
Figure 8-26 System Checks Screen
Out-of-Limit Data (Icons) Red triangles identify results that are above or below the expected range.
Points
Red diamonds identify results that are within the expected range, but the %CV is
out of range.
Date Run (Scrolling Region) The x-axis at the bottom of the screen shows the date that the
System Check routine was run. The system displays a maximum of 25 dates, and
only displays the dates when a System Check was run. If more than one System
Check was run on the same date, the date is repeated on the x-axis.
Point Cursor (Cursor) A blue vertical line indicates the System Check that is currently selected.
The point cursor can be moved left or right by selecting the left and right arrow
buttons, or by touching a data point.
Washed RLU (Chart) Displays the mean RLUs of the washed check within the range of expected
results, from 5,000 to 20,000 RLUs.
• Red triangles identify results that are above or below the range.
• Red diamonds identify results that are within the range, but the %CV is out of
range.
Substrate RLU (Chart) Displays the mean RLUs of the substrate check within the range of
expected results, from 5,000 to 9,000 RLUs.
• Red triangles identify results that are above or below the range.
• Red diamonds identify results that are within the range, but the %CV is out of
range.
Unwashed RLU (Chart) Displays the mean RLUs of the unwashed check within the range of
expected results (guideline only), from 4 to 10 million RLUs.
• Red triangles identify results that are above or below the range.
• Red diamonds identify results that are within the range, but the %CV is out of
range.
Wash Efficiency (Chart) Displays the results of the wash efficiency calculation within the range of
PPM expected results, from 0 to 5.00 ppm (parts per million). Red triangles identify
results that are above or below the range.
Substrate Ratio (Chart) Displays the results of the substrate ratio calculation within the range of
expected results, from 0 to 1.40.
Red triangles identify results that are above or below the range.
Substrate : Washed (Chart) Displays the substrate to washed ratio calculation within the range of
Ratio expected results (guideline only), from 0 to 1.00. Red triangles identify results that
are above or below the range.
System Check Data (Button) Select to display the System Check Data screen for the selected System
F2 Check (see Figure 8-28). You can use the screen to view the detail of the System
Checks and to print the System Check Report.
To get to this screen from the Main Menu, select Maintenance Review F6 to display
the Maintenance Review screen, then
Select System Checks F2 to display the System Checks screen, then
Select a System Check on the System Checks screen, then
Select System Check Data F2.
0783C.bmp
Figure 8-28 System Check Data Screen
Completion (Field) Displays the completion date and time of the System Check.
Wash Efficiency (Field) Displays the results of the wash efficiency calculation in parts per million.
Out-of-range results are displayed in red.
Substrate Ratio (Field) Displays the results of the substrate ratio calculation. Out-of-range results
are displayed in red.
Substrate : Washed (Field) Displays the results of the substrate to washed ratio calculation.
Ratio Out-of-range results (guideline only) are displayed in red.
Washed (Field) Displays the mean RLUs, SD, and %CV of the washed check. Out-of-range
results are displayed in red.
All three results (mean RLUs, SD, and %CV) will display in red if the system
encounters a fatal flag, such as QNS, while running a replicate.
Clean (Field) Displays the mean RLUs, SD, and %CV of the clean check. The results of
the clean check are used for troubleshooting purposes only. As a guideline, the
clean check mean should be less than the washed and substrate check means.
Substrate (Field) Displays the mean RLUs, SD, and %CV of the substrate check.
Out-of-range results are displayed in red.
All three results (mean RLUs, SD, and %CV) will display in red if the system
encounters a fatal flag, such as QNS, while running a replicate.
Unwashed (Field) Displays the mean RLUs, SD, and %CV of the unwashed check.
Out-of-range results (guideline only) are displayed in red.
All three results (mean RLUs, SD, and %CV) will display in red if the system
encounters a fatal flag, such as QNS, while running a replicate.
Sample ID (Data Column) Displays the name of the System Check that was run on the sample
(either washed, unwashed, clean, or substrate).
RLU (Data Column) Displays the RLUs for the selected sample.
Dark Count (Data Column) Displays the dark count for the selected sample.
Drift Corr (Data Column) Displays the drift correction factor for the selected sample.
Pipettor (Data Column) Displays the value N/A. This column is reserved for future use.
Flags (Data Column) Displays up to two result flags for the selected sample.
Previous Check F2 (Button) Select to display the data for the previous date that a System Check was
performed.
Next Check F3 (Button) Select to display the data for the next date that a System Check was
performed.
Print F7 (Button) Select to print the System Check Report for the selected System Check
(see Figure 8-30).
Viewing Use this procedure to view the detail for the System Check results.
System
1 Go to the Maintenance Review screen. To get to this screen from the Main
Check Result
Menu, select Maintenance Review F6.
Data
2 Select System Checks F2.
The System Checks screen is displayed.
3 Select the System Check result you want to view the data for.
Laboratories, Inc.
Laboratory A
System Check Report 123 Lake Street
Access 2 Immunoassay System Townsville, ST 33333
S/N 501240 101-555-2323 ext. 109 Jane Smith
Page 1 of 1
Technologist______________________________ Printed 10/10/01 07:41AM
0807C.bmp
Figure 8-30 System Check Report
Sample Manager
Load rack
Type Rack ID
Unload rack
OK
F1
Pipette 2.0 mL
undiluted System
Check Solution Results Repeat the
into cup 7 acceptable? No System Check
Enter values
Results
and initial Yes acceptable?
Maintenance Log, as
applicable
Leave cup 9 empty
No
Troubleshoot System
Pipette 1.0 mL Check results, or
1/501 System Check contact Technical
Solution into cup 10 Support
0601B.wmf
Figure 8-31 Running the System Check Routine Flowchart
System You need to gather the following materials to perform the System Check routine. This
Check is the complete list of materials for the procedure. For a list of part numbers and for
Required ordering information, see the Quick Reference Guide.
Materials • 13 mm rack for 2 mL sample cups; the rack must have a rack ID between
1-57 or 400-456
• 2.0 mL sample cups (four cups)
NOTE
Use only the 2.0 mL sample cups when performing the maintenance routines.
Using any other sample containers may result in level sensing errors and
cancellation of the maintenance routine.
WARNING
System Check Solution contains ProClin* 300 preservative, which is a potential
skin sensitizer. Avoid spilling or splashing this reagent on skin or clothing. In
case of contact with the solution, thoroughly flush with water.
Running the Use this procedure to run a System Check routine. After you prepare and load the
System rack, the System Check routine takes approximately 40 minutes to complete.
Check
Routine WARNING
You will come in contact with potentially infectious materials during this
procedure. Handle and dispose of biohazard materials according to proper
laboratory procedures. Proper hand, eye, and facial protection is required.
NOTE
If a fatal flag is applied to a system check result, the system will not use the
results in the calculation of the mean, SD, or %CV. For more information, see
Section A.2: System Check Troubleshooting in the Reference Manual.
1 Be sure that the system is in the Ready mode. Go to the Sample Manager
screen. To get to this screen from the Main Menu, select Sample Manager F1.
2 Be sure that the Rack ID field is selected, then type the rack ID and press
[Enter].
The new rack is displayed in the Off Board list on the Sample Manager screen.
NOTE
When you select Maintenance Requests F4, the Sample Manager screen is no
longer displayed.
4 Select the System Check box and select All from the list.
NOTE
If you are running weekly maintenance, select the Daily Clean System option
to run the Daily Clean System and System Check routines at the same time.
Also, follow the Running the Daily Clean System Routine to load the sample
cups.
5 Select OK F1.
The Maintenance Requests screen is displayed.
7 Place the empty 2.0 mL sample cups in sample positions 7-10 of a rack.
8 Pipette 2.0 mL of undiluted System Check Solution into the sample cup in
position 7. The sample cup should be full, but the solution level should not
be higher than the top of the cup.
9 Pipette at least 1.0 mL of wash buffer into the sample cup in position 8.
11 Pipette 1.0 mL of the 1/501 diluted System Check Solution into the sample cup
in position 10.
12 Select Load Rack X F1. (The X represents the number of the rack that you
entered into the Rack ID field.)
The system displays the Done window and presents a rack position.
NOTE
Load the rack after requesting the maintenance routine. If you load the rack
first, the system recognizes the rack as a patient sample rack, and will not accept
the maintenance request. If the rack is already loaded, take the rack off board,
clear it, and load it again after requesting the maintenance routine.
14 Select Run.
The system displays the testing results as the samples are processed. When
processing is complete, the system runs the Utility Assay.
CAUTIONS
• Unless there is an emergency, let the maintenance routine run to
completion. Cancelling the routine may damage the instrument and
compromise the integrity of subsequent test results.
• If you stop the routine, do not initialize the system. Call Technical
Support for assistance.
15 When the System Check is complete, unload the rack and select Done F1.
For more information on unloading a rack, see Section 3.1: Sample
Management.
16 Compare the obtained results with the expected results. The results are listed in
the report and Table 8-32.
• If the results are within the expected limits, and you are running weekly
maintenance, proceed to step 17.
• If the results are outside the expected limits, repeat the System Check
routine. If out-of-range results persist, see Appendix A: Troubleshooting in
the Reference Manual or call Technical Support.
17 Record the results of the System Check routine in the appropriate section of the
Maintenance Log.
Printing the Use this procedure to print the System Check Report for a selected System Check.
System
1 Be sure that the system is in the Ready mode. Go to the System Check Data
Check Report
screen. To get to this screen from the Main Menu, select Maintenance
Review F6 to display the Maintenance Review screen, then
System The following results from the System Check routine should display on the System
Check Checks and System Check Data screens. For troubleshooting information, see
Expected Appendix A: Troubleshooting in the Reference Manual:
Results
System Check Expected Results
8.5
Special Clean
The Special Clean routine prevents buildup of debris in the primary and aspirate
probes. You perform the Special Clean routine when additional cleaning is requested
by Technical Support or required for troubleshooting.
NOTE
If you run the B12 assay on your Access 2 system, perform the Special Clean
routine at the end of each day or whenever the instrument will not process
samples for 8 hours or more.
For an overview of how to perform the Special Clean routine, see Figure 8-33.
Sample Manager
Load rack
Enter the Maintenance Rack
Number in the Rack ID field
Maintenance Request
F4 Run
Request Maintenance
The system cleans
probe interiors
(30 minutes)
Select Special Clean
OK
F1
Wait until the status bar
indicates the cleaning
is complete
Place 2.0 mL sample
cups in rack positions
1, 2, 3, 4, 5, and 6
Unload rack
Pipette 2.0 mL
Contrad 70 into cup 1
Pipette 2.0 mL
1/5 Citranox/deionized
water dilution into cup 2
Pipette 2.0 mL
deionized water or
wash buffer into cup 3
Pipette 2.0 mL
70% methanol into cups
4, 5, and 6
0810B.wmf
Figure 8-33 Special Clean Routine Flowchart
Special Clean Gather the following materials to perform the Special Clean routine. For a list of part
Routine numbers and for ordering information, see the Quick Reference Guide.
Required • 13 mm rack for 2 mL sample cups; the rack must have a rack ID between
Materials 1-57 or 400-456
• 2.0 mL sample cups (six cups)
NOTE
Use only the 2.0 mL sample cups when performing the maintenance routines.
Using any other sample containers may result in level sensing errors and
cancellation of the maintenance routine.
WARNINGS
• You will come in contact with potentially infectious materials during this
procedure. Handle and dispose of biohazard materials according to proper
laboratory procedures. Proper hand, eye, and facial protection is required.
• Contrad 70 cleaning solution is alkaline and may cause severe eye irritation
or mild skin irritation. See the manufacturer’s label for details.
• Citranox cleaning solution is acidic and may cause eye or skin irritation. See
the manufacturer’s label for details.
Running the Use this procedure to run the Special Clean routine. After you prepare and load the
Special Clean rack, the Special Clean routine takes approximately 35 minutes to complete.
Routine
WARNING
You will come in contact with potentially infectious materials during this
procedure. Handle and dispose of biohazard materials according to proper
laboratory procedures. Proper hand, eye, and facial protection is required.
1 Be sure that the system is in the Ready mode. Go to the Sample Manager
screen. To get to this screen from the Main Menu, select Sample Manager F1.
2 Be sure that the Rack ID field is selected, then type the rack ID and press
[Enter].
The new rack is displayed in the Off Board list on the Sample Manager screen.
NOTE
When you select Maintenance Requests F4, the Sample Manager screen is no
longer displayed.
5 Select OK F1.
10 Pipette 2.0 mL of 70% methanol into each of the cups in sample positions 4, 5,
and 6.
Sample
1 2 3 4, 5, 6
Position:
The system displays the Done window and presents a rack position.
NOTE
Load the rack after requesting the maintenance routine. If you load the rack
first, the system recognizes the rack as a patient sample rack, and will not accept
the maintenance request. If the rack is already loaded, take the rack off board,
clear it, and load it again after requesting the maintenance routine.
13 Select Run.
CAUTIONS
• Unless there is an emergency, let the maintenance routine run to
completion. Cancelling the routine may damage the instrument and
compromise the integrity of subsequent test results.
• If you stop the routine, do not initialize the system. Call Technical
Support for assistance.
14 When the Special Clean is complete, unload the rack and select Done F1.
For more information on unloading a rack, see Section 3.1: Sample
Management.
8.6
Maintenance Log
You can use the Maintenance Log to verify that you perform all routine maintenance
procedures. Make photocopies of the log for use with each Access 2 system.
A paper copy of the log is provided in the Quick Reference Guide. You can also print
a copy of the log from the online version of this manual. Retain completed
Maintenance Logs for reference.
8-66
Check System Supplies
Check Liquid Waste Container
System Backup Successful?
Inspect Fluidic Module
8.6: Maintenance Log
Perform the tasks listed at the left and draw a check () in the accompanying box on the right. Initial the Tech Initials box.
WEEKLY MAINTENANCE Week 1 Week 2 Week 3 Week 4 Week 5
Zone Expected Results Temperature ºC
Today’s Date Incubator 36.13-36.73
Clean Instrument Exterior Wash Carousel 36.23-36.63
Check Waste Filter Bottle Substrate 36.23-36.63
Refrigerator 1-5
Inspect/Clean Primary Probe
Replace/Clean Aspirate Probes
Run Daily Maintenance
(Initial above) System Check Expected Results
Run System Check Washed Check
RLU mean 5,000–20,000
Tech Initials
% CV < 12.00
Enter the System Check Results in the boxes. Initial the Tech Initials box. Substrate Check
SYSTEM CHECK RESULTS Week 1 Week 2 Week 3 Week 4 Week 5 RLU mean 5,000–9,000
% CV < 5.00
Today’s Date Substrate ratio 0 - 1.40
Washed RLU/%CV Substrate : Washed Ratio 0 - 1.00*
Unwashed Check
Substrate RLU/%CV
RLU mean 4–10 million*
Unwashed RLU/%CV % CV < 2.00
Wash Efficiency PPM Wash Efficiency
PPM 0 - 5.00
Substrate Ratio * The Substrate : Washed Ratio and the Unwashed Check RLU
Substrate : Washed Ratio mean result are not system specifications. They are only reference
Access 2 Operator’s Guide
guidelines.
A.1
Racks
You load sample containers onto the Access 2 instrument in racks. Each rack holds up
to 10 samples in the rack sample positions. The instrument holds up to six racks.
To accommodate sample containers of different sizes, the instrument uses three types
of racks:
• 13 mm (for 12 mm and 13 mm sample tubes)
• 16 mm (for 16 x 75 mm sample tubes)
• 16 mm (for 16 x 100 mm sample tubes)
Racks are identified by a bar code label. You affix the label to the rack according to
the type of rack and the type of sample container you plan to use in the rack. Rack bar
code labels 100 to 1899 include an icon to identify the type of sample container in the
rack. Bar code labels 1 to 99 do not include an icon because you can use them for
several different types of sample containers.
When the instrument scans the rack bar code label, it identifies the type of sample
containers in the rack and determines the appropriate pipetting depth for aspirating
sample. You must be sure that the sample volume is sufficient for pipetting. For
example, a 13 x 75 mm separator gel tube, such as an SST* tube, has a corresponding
dead volume of 3.4 mL and is placed in a rack with an ID between 800 and 899. Table
A-1 summarizes which rack and rack ID you must use for the various sample
containers.
CAUTION
Only load sample containers on a rack with the appropriate ID.
1 - 99 or
Access 2.0 mL/13 mm Sample Cup 13 mm 400 - 499
1 - 99 or
13 x 75 mm Tube with Separator Gel 13 mm 800 - 899
1 - 99 or
13 x 100 mm Tube with Separator Gel 13 mm 100 - 199
Access 2.0 mL/16 mm Insert Cup in
16 x 100 mm Tube 16 x 100 mm 200 - 299
Access 3.0 mL Sample Container or Primary 13 mm or
Access Chlamydia Collection Kit Tube 16 x 100 mm 500 - 599
Access 1.0 mL/13 mm Insert Cup in
13 x 100 mm Tube 13 mm 600 - 699
Access 1.0 mL/13 mm Insert Cup in
13 x 75 mm Tube 13 mm 700 - 799
16 x 100 mm Tube with Separator Gel 16 x 100 mm 900 - 999
16 x 75 mm Elevated Tube 16 x 75 mm 1000 - 1099
Access Chlamydia Insert Cup in Chlamydia 13 mm or
(Round-Bottomed) Transport Tube 16 x 100 mm 1200 - 1299
12 x 75 mm Tube 13 mm 1300 - 1399
13 x 100 mm Tube 13 mm 1400 - 1499
16 x 100 mm Tube 16 x 100 mm 1500 - 1599
Auto Aliquot Tube, 13x100 mm
False Bottom 13 mm 1600 - 1699
Access 2 Pediatric Insert Cup in Pediatric
Tube Adapter for 13 mm Rack 13 mm 1800 - 1899
Table A-1 Sample Containers with Corresponding Rack and Rack IDs
For information about sample containers for the Access 2 system with corresponding
dead volumes and ranges for rack IDs, see Table A-5 in Section A.2: Sample
Containers.
Attaching To be sure that the internal bar code reader can accurately read the rack bar code label,
Rack Bar use this procedure to place the label on a rack.
Code Labels 1 Lay the rack on a table so the ends of the rack curve towards the table.
2 Locate the rack spine. The spine is located directly below the handle of the rack
and divides the 10 sample positions into two sets of 5.
3 Locate the indentation on the spine that indicates the correct location for the bar
code label.
4 With the bar code nearest the handle of the rack and the corresponding number
underneath it (see Figure A-2), align the bar code label with the indentation and
attach the label securely to the rack. To be sure the rack bar code is scanned
correctly, there should be only a 0-1 mm gap at the bottom of the label.
2
3
05
05
05 1
0126C.eps
R
1 0-1 mm
2 Handle
3 Spine
Cleaning Clean racks in a dishwasher or autoclave, or use a brush and a mild detergent.
Racks
A.2
Sample Containers
You place sample containers into the 10 sample positions in the racks. The Access 2
system identifies the types of sample containers by reading the rack bar code label. In
addition, some laboratories affix sample bar code labels to the sample containers. The
system identifies the sample by reading the bar code label on the sample container.
NOTES
• The 2.0 mL/13 mm sample cups in racks 1-99 or 400-499 must be used for
maintenance. You do not affix bar code labels to maintenance sample cups.
The system recognizes the sample cups by the rack ID, by the way you
request tests in the system, and by the way you load the racks onto the
instrument (see the Requesting Maintenance Routines procedure in Section
8.1: Routine Maintenance).
• You can intermix the allowable types of sample containers that are used in
racks 1-99 for patient samples and quality controls. For calibrators, each
sample in a calibrator set must be in the same type of sample container.
You place most sample containers directly in the rack. If you use insert cups,
however, place them into sample tubes or rack inserts before adding them to the rack.
CAUTION
Use only the recommended sample containers on the Access 2 instrument.
The system software contains specific parameters for each of the
recommended sample containers. Other containers can damage the system
and compromise the integrity of the test results.
For information about sample containers for the Access 2 system with corresponding
dead volumes and ranges for rack IDs, see Table A-5 in this section.
Calculating To be sure the sample volume is sufficient for the tests to be run, calculate the total
Sufficient volume of sample needed for the sample container by using this equation:
Sample
Volume Sample volume
Number of Total sample
required per x replicates + Dead volume = volume required
replicate
0616A.wmf
NOTES
• To find the sample volume required per replicate, see the product insert.
• Dead volume is the amount of sample in the bottom of a sample container
that is required to be sure that enough sample is available for the instrument
to complete an assay.
WARNING
If you use tubes with separator gel, be sure that the tube contains sufficient
sample volume. Insufficient sample volume may cause the instrument to attempt
to aspirate the separator gel, which can damage the instrument and compromise
the integrity of the test results.
For information about sample containers for the Access 2 system with corresponding
dead volumes and ranges for rack IDs see Table A-5 in Section A.2: Sample
Containers.
Attaching To be sure the internal bar code reader can correctly read the sample bar code label,
Sample Bar use this procedure to place a label on a sample container.
Code Labels
WARNING
You will come in contact with potentially infectious materials during this
procedure. Handle and dispose of biohazard materials according to proper
laboratory procedures. Proper hand, eye, and facial protection is required.
NOTE
The internal bar code reader automatically discriminates between symbologies,
so samples with bar code labels using different symbologies can be included on
the same rack. You may need to enable parameters for the bar code symbologies
you use (see Section 4.3: Bar Code Reader Setup in the Reference Manual).
1 Place the bar code label on the sample container so that the label is at least 0.25
inches from the top and bottom of the container (see Figure A-3). Be sure that it
is securely fastened.
2 When you add the sample container to the rack, be sure the sample bar code
label is centered in the opening slot of its rack position for accurate scanning.
ABC123456789
ABC123456789
2
0124D.eps
Using Insert An insert cup has a smaller sample volume requirement and a smaller dead volume
Cups in Bar than a sample tube. You may need to transfer sample from a sample tube to an insert
Coded cup to meet the total sample volume required for testing.
Sample
Use this procedure to add an insert cup to a bar-coded sample tube.
Containers
1 Transfer the required sample volume from the sample tube with a bar code label
into the insert cup.
NOTE
Carefully pipette small sample volumes into the insert cup to prevent air
bubbles from forming at the meniscus. Air bubbles can affect level sensing by
the instrument and compromise the integrity of the test results.
2 Place the cup back into the original sample tube, which has the bar code label
attached (see Figure A-4).
3 Add the tube to a rack appropriate for the insert cup and the sample tube. Be
sure the sample bar code is centered in the opening slot of its rack position for
accurate scanning.
ABC123456789
XXX
3
0127D.eps
1 Insert Cup
2 Sample Tube
3 Rack ID
Access 2 The following table lists all of the sample containers you can currently use on the
System Access 2 instrument, the corresponding rack ID range and the dead volume for each
Sample container.
Containers
WARNING
You must have a sufficient volume of sample to process the tests you requested.
To be sure you have enough sample, calculate the total volume needed for the
sample container using the Calculating Sufficient Sample Volume procedure in
this section. If you do not follow the provided procedure, sample processing
problems may occur without warning.
Sample Container Information Bar Code Sample Container Information Bar Code
Label Icon Label Icon
13x75 SST
• Rack IDs: 1 - 99 or 400 - 499 • Border: Yellow
(only 400 - 499 have the icon) • Rack IDs: 1 - 99 or 800 - 899
• Dead Volume: 150 µL (only 800 - 899 have the icon)
• Dead Volume: 3.4 mL
13 x 100 mm Tube with Separator Access 2.0 mL/16 mm Insert Cup
Gel in 16 x 100 mm Tube
13x100 SST
16 mm
• Rack IDs: 1 - 99 or 100 - 199 • Rack IDs: 200 - 299
(only 100 - 199 have the icon) • Dead Volume: 400 µL
• Dead Volume: 4.9 mL
Access 3.0 mL Sample Container Access 1.0 mL/13 mm Insert Cup
or Primary Access Chlamydia in 13 x 100 mm Tube
Collection Kit Tube • Border: Blue
13x100
Sample Container Information Bar Code Sample Container Information Bar Code
Label Icon Label Icon
16x75
• Rack IDs: 1000 - 1099
Chlamydia
• Border: Brown
• Dead Volume: 700 mL
• Rack IDs: 1200 - 1299
• Dead Volume: 175 mL
13x100
• Rack IDs: 1300 - 1399 • Rack IDs: 1400 - 1499
• Dead Volume: 500 mL • Dead Volume: 3.0 mL
Autoaliquot
• Border: Midnight blue False Bottom
16x100
• Border: Pink
• Rack IDs: 1800 - 1899
• Dead Volume: 100 mL
Table A-5 Sample Containers with Rack and Volume Requirements (continued)
Index
Curves E
Quantitative 6-2
Edit Filter (Test Results) Window 5-14, 5-20
Curves and Cutoffs
Electronics Module 1-4
Viewing Calibration 6-17
Elevated Tube A-3
Customize search capabilities 14
Evaporation 3-10
Cutoffs
Qualitative 6-2 Event Log Button 4-12, 4-16
Viewing Calibration Curves and 6-17 Example Button 10
Exclamation Point Label 1-5
D
Daily Clean System 8-7, 8-8, 8-15, 8-27 F
Flowchart 8-26 Failure Codes
Running the Routine 8-27 Calibration 6-17
Daily Maintenance 8-15 Filter (Quality Controls) Window 7-8
Checking System Status Flowchart 8-18 Filter (Reagent Inventory) Window 2-42
Checking system status flowchart 8-18 Filter (Test Results) Window 5-11
Cleaning the Wash Carousel Probe Exte-
Filter (Work Pending) Window 4-22
riors Flowchart 8-21
Cleaning the wash carousel probe exteri- Filters
ors flowchart 8-21 Applying 5-10
Daily clean system flowchart 8-26 Applying (Flowchart) 5-10
Flowchart 8-16 Applying a Calibration 6-6
Inspecting the Fluidic Module Flowchart Applying a QC 7-7
8-20 Defining a Test Result 5-18
Inspecting the fluidic module flowchart Defining a Test Result (Flowchart) 5-17
8-20 Deleting a Test Result 5-18
Priming the Substrate Flowchart 8-24 Editing a Test Result 5-14
Priming the substrate flowchart 8-24 Editing a Test Result (Flowchart) 5-13
Required Materials 8-17 Quality Control 7-7
Running 8-46 Work Pending 4-21, 4-23
Running the Daily Clean System Rou- Find 13
tine Flowchart 8-26
Find (Test Result) Window 5-22
Daily Maintenance Flowchart 8-16
Find Feature, Help 13
Daily Maintenance Required Materials 8-17
Flags 4-17
Dead Volume A-2, A-6, A-9
Float level sensor 2-8
Disks
Flowchart Button 10
Copying Multiple Files to One 5-37
Copying One File to Multiple 5-37 Flowcharts
Copying Test Results to a 5-35 Adding a Calibrator 6-28
Applying Filters 5-10
Dispense Cap Assembly 2-10
Calibration 6-3
Dispense, Aspirate, and Substrate Probes 8-22
Changing the Liquid Waste Bottle 2-12
Distilled Water, Cleaning the Aspirate Probes Changing the RV Waste Bag 2-25
with 8-46
Changing the Substrate Bottle 2-16
Changing the Wash Buffer Bottle 2-9
Checking for Fluid in the Waste Filter
O
M
On-Board Samples
Main Menu 1-11 Deleting Test Requests for 3-51, 3-52
Workflow 1-13 Editing Test Requests for 3-50
Main Menu Function Buttons 1-10 Editing Test Requests for (Flowchart)
Calibration Review 1-12 3-49
Configure 1-13 Working with 3-46
Diagnostics 1-13 One Sample Container
Maintenance Review 1-12 Rules for 4-9
Support, Technical 15 T
Syringe Fitting Assembly, Attaching 8-44
Technical Support 15
System Check Data Screen 8-51
Test Menus
System Check Report Calibration 3-40
Printing 8-59 Patient Samples 3-31
System Check Result Data QC 3-44
Viewing 8-53 Test Request Screen 3-19
System Check Routine Expected Results 8-59 Test Request, LIS
System Checks 8-3, 8-5, 8-7, 8-9, 8-47, 8-48, See LIS Test Requests
8-59
Test Requests
Acceptable results 8-59
Calibration 3-37
Data Screen 8-51
Deleting for On-Board Samples 3-51,
Expected Results 8-59 3-52
Report 8-54 Editing for On-Board Samples 3-50
Required Materials 8-55 Editing for On-Board Samples (Flow-
Routine Expected Results 8-59 chart) 3-49
Running 8-57 Entering Calibration 3-40
Running (Flowchart) 8-56 Entering for Patient Manually 3-30
Screen 8-48 Entering for Patient Manually (Flow-
Viewing Result Data 8-53 chart) 3-29
System Checks Screen 8-48 Entering Quality Control 3-44
System Command Buttons 1-16 Patient 3-18
Pause 1-16 Processing LIS Patient 3-27
Run 1-16 Quality Control 3-42
Stop 1-16 Test Result
System Modes 1-15 Finding a 5-21
Not Ready 1-16 Test Result Filter
Paused 1-16 Defining a 5-18
Ready 1-15 Defining a (Flowchart) 5-17
Running 1-16 Test Result Filters 5-8
System Navigation 1-22 Test Result Flags 5-26
Keyboard Equivalents 1-22 Test Result Status 5-15
Select and Enter 1-23 Test Results 5-1, 5-2
System Overview 1-3 Copying to a Disk 5-35
System Software 1-5 Deleting 5-39
System Status Buttons 7, 1-17, 2-2, 2-3 Deleting (Flowchart) 5-38
Event Log 1-19 Finding a (Flowchart) 5-21
Help 1-20 Flowchart 5-3
Liquid Waste 1-17 Managing 5-30
Quality Control 1-19 Printing Reports (Flowchart) 5-42
Reaction Vessels 1-18 Reports 5-40
RV Waste Bag 1-18 Reviewing 5-8
Supplies Required 1-19 Sending to the LIS 5-32
Wash Buffer 1-17 Test Results Screen 5-4
Work Pending 1-19 Test Status 4-29, 5-6, 5-43
Z
Zone Temperature 8-5, 8-19