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Beckman Coulter DxC General Overview

Clinical Laboratories


Duke University Health Systems

DxC General Overview


Page
1

of
53

Prepared

February 2008

Susan Neblett , Marilou Bell,




Donna Kirsch




DIRECTOR'S APPROVAL

SIGNATURE

Bruce Lobaugh

DATE

3/31/2008

Bruce Lobaugh, PhD

Director of Rapid Response Laboratory, DUHS


SECONDARY REVISIONS

PAGE #

ITEM REVISED

DATE OF
REVISION

SUPERVISOR'S APPROVAL





SIGNATURE

DATE























































ANNUAL REVIEW

REVIEWED BY

DATE
























Beckman Coulter DxC 800/600 Operation Overview

Clinical Laboratories


Duke University Health Systems

DxC General Overview


Page
2

of
53


DxC Operator Overview



Table of Contents




General

Overview


1.
Intended Use …………..
……………………………………………
.
………
.

.
.

3

2. Components Overview


...
…………………………………………….…
..
…..


3

3. Operation
al

Resources ……………

……….…………………….
…….…
..…..


5

4. Specimen Requirements …………… …
….……………………………

..…..


6

5. Reagent Information ……………

……….…………………………….…
..
..…..


7

6. Calibration
Overview …

……….………………
…………..
…………….…
..…..


10

7. Quality Control

……………

……….……………
………
……………….…
..…..


12

8. Pre
-
Analytical Processing

………
.…………………………….…
..…………….


14

9. Analytical Processing

……………

……….…………………………….…
.
.…
.
..


16

10. Post
-
Analytical Processing …………… ……….………………….
….…
..…..


1
9

11. Daily Start Up …………… ……….……………………..………….
….…
..…..


19

12. Scheduled Maintenance …………… …………………..………….
….…
..…..


20

13. Analyzer Troubleshooting …………… …………………..………….
….…
..…..


22



Protocols


1. Daily Start
-
Up ……………………………………………………………………… 23

2. Performing Calibration...………………………………...………………………… 25

3. Troubleshooting Calibration Failures Flowchart……...………………………… 27

4. Running Quality Control ………………………...……...…………………………

29

5. Sample Processing ……………………………..
.……...………………………… 30

6. Shutdown Procedure ………
.…………………...……...………………………… 32

7. Specimen Dilution ………….…………………...……...………………………… 3
3



Quality Control
/ Calibrator / Reagent
Information


1. Biorad
MultiQ
ual
QC .
……………………
………………………………
..…….



3
8

2. Biorad
ImmunoAssay QC ......
……………………
……………………


..



3
9

3. Biorad Urine Toxicology QC

......………………………………………………..


40

4
. Biorad
Urine Chemistry QC …...
…………………………………………
…….
.


41

5
. Biorad
Ethanol/ Ammonia QC

..
…………

…………………………………
.
.



42

6
. Biorad Spinal Fluid QC …………………………………….…………………




43

7
. Biorad Pediatric QC ..……………………………...……….…………………




44

8. Beckman Synchron QC


serum chem……………...……….……………………


45

9. Beckman Synchron QC


urine DAT low…………...…
…….……………………


46

10.

Beckman Calibrator Info Cha
rt ……..……………...……….……………………


4
7

11
. Beckman Reagent Info Char
t ..…….………………...…….……………………


4
8

12
. 5% HSA ...............................................................................
......................... 50

13. DILUENT 1 …………………………………………………………………………. 53

Beckman Coulter DxC 800/600 Operation Overview

Clinical Laboratories


Duke University Health Systems

DxC General Overview


Page
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of
53




BECKMAN COULTER

DXC

800
/600

(CLINICAL CHEMISTRY ANALYZER OPERATION)




INTENDED USE


The UniCel
®

DxC Synchron
®

Clinical Systems are fully automated, computer
-
controlled
clinical chemistry analyzers designed for the in vitro determination of a variety of general
chemistries, therapeutic drugs, and other chemistries. Analysis can be performed on
serum, plasma, u
rin
e, and cerebrospinal fluid (C
SF
), (sample is chemistry dependent).



SYSTEM COMPONENT OVE
RVIEW


A UniCel DxC System (600 or 800) can be divided into the following components:


1.

Sample Handling System



used to deliver samples to the Modular Chemistry and
Cartridge Chemistry systems. The handling system is used to: load samples onto
the system, identify sample programming by bar code ID or manual programming,
position the samples for pipetting and ana
lysis, and remove the samples when they
are no longer needed by the system. Analyzers with the CTS option (Closed Tube
Sampling) are capable of piercing validated sample container caps.




2.

Modular Chemistry (MC) System



The Modular Chemistry (MC) System
performs rapid analysis of the more commonly ordered, high volume analytes.

a)

I
on Selective Electrode (ISE) Module



consists
of an Electrolyte I
njection
Cup (EIC), flow cell, and electrodes specific for each analyte.

DXC 600 and 800
: Na+ (sodium), K+ (pota
ssium), CL
-

(chloride), CO
²

(carbon dioxide), CA+ (calcium)
.

b)

Cup Modules



are individual
modules
for each analyte and have individual
precision pumps to deliver reagent to the reaction cup. The MC sample
probe and syringe deliver samples to the cup wher
e it is mixed with reagent
by a stir bar. The detection system is chemistry dependent but will detect
either light transmitted or electrical charges.


DXC 600
: Glucose (only)


DXC 800
: Glucose, BUN, Creatinine, Phosphorus, Albumin,
Total Protein






Beckman Coulter DxC 800/600 Operation Overview

Clinical Laboratories


Duke University Health Systems

DxC General Overview


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53





3.

Cartridge Chemistry (CC) System



The Cartridge
Chemistry System provides
random access analysis of analytes. Reagent cartridges are stored in a refrigerated
compartment that houses up to 59 cartridges. The reactions occur in permanen
t
glass cuvettes
that are housed

in a reaction carousel. Reagents are delivered to the
reaction carousel by reagent probes using a reagent syringe. Sample is added by a
CC sample probe using the CC sample syringe. Mixers are responsible for mixing
the reagent and the sa
mple. Reactions are read by a photometer assembly. A
cuvette wash station cleans the cuvettes for reuse.





4.

Hydropneumatic System



The hydropneumatic system is responsible for
providing vacuum, compressed air, diluted wash solution, and deionized water

for
use on the instrument. Wash concentrate. No Foam an
d Auto Gloss reagents are
stored

in this compartment.




5.

Operation and Control Components



Basic operating functions are controlled
and reviewed by utilizing the DxC monitor, mouse, touch screen, k
eyboard and
push
-
button controls. These provide the interface b
etween the operator and the
DxC analyzer.




















Beckman Coulter DxC 800/600 Operation Overview

Clinical Laboratories


Duke University Health Systems

DxC General Overview


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53


RE
SOURCES FOR OPERATION OF THE
Dx
C
800
/600




This procedure is a general guideline for the operation of the
DxC 800
/600 analyzers.



The following references provided from Beckman Coulter contain
detailed information
about the DxC
600/800 components

and analyzer operation and should be utilized in
conjunction with the laboratory
-
specific procedures.


o

UniCel DxC Synchron Clinical Sys
tems Instructions For Use Manual


This manual covers BASIC operating instructions and maintenance guidelines for
the analyzers. This manual is available through the on
-
board analyzer software for
quick and easy reference.



o

UniCel DxC Synchron Clinical S
ystems Reference Manual

This manual c
ontains
DETAILED

system description, comprehensive operating
instru
ctions
, theory of operation, system calibration, and programming
procedures, and quality control information
.



o

Synchron Clinical Syst
ems Chemistry
Information

CD


This manual
contains specific chemistry information for the full range of analytes

available on the

UniCel DxC and Synchron LX Systems.

The Duke laboratory
-

specific

analyte procedures should be the first source of reference followed by this

document if additional information is needed.



o

UniCel DxC
600/800 Synchron

Operator Tips

Notebook

Selected laminated information sheets
provide additional information about the

s
ystem, including

reagent, sample and basic troubleshooting information.








Beckman Coulter DxC 800/600 Operation Overview

Clinical Laboratories


Duke University Health Systems

DxC General Overview


Page
6

of
53




SPECIMEN REQUIREMENTS



Detailed specimen require
ments and handling are

described for each analyte in the

analyte
-
specific procedures.


Quick references available for
specimen requirements:


(Also found in Operator Tips Notebook).


o

Sample Volume requirements:

Synchron LX
®
/UniCel DxC Clinical Systems Sample Template(967178
-
AH
):

This template defines sample volumes for primary tube sampling as well as minimum
sample
volumes

utilizing a 0.5 mL sample cup.


o

Anticoagulants Compatible with Analyte Testing
:

Beckman Coulter Operator Tips (A20901
-
AC
):

This laminated chart lists

analytes and indicates compatible a
nd incompatible
anticoagulants.


o

Urine Chemistry Sp
ecimen Analy
sis

Protocol

Chart
:

This chart lists the urine chemistries and summarizes any
special specimen
preparation, i.e. acidification, pre
-
dilution,
as well as
dilution require
ments for out
-
of
-
range results.


o

Analyte Stability

Guideline Chart



This chart l
ists s
tability
time
for the various analytes
, to be used for referencing add
on requests. (Note: chart is reference for plasma samples only). Additional analyte
storage and stability can be found

in
the analyte
-
specific procedures.
















Beckman Coulter DxC 800/600 Operation Overview

Clinical Laboratories


Duke University Health Systems

DxC General Overview


Page
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53




REAGENT INFORMATION



Each analyte
-
specific procedure contains detailed information regarding reagent

constituents, product packaging, storage, preparation, stability, and required volume for

testing.


Cartridge Chemistry Reagents

o

are

stored in wedge
-
shaped cartridges containing 3 separate compartments.

o

include a majority of chemistries (excluding the electrolytes).

o

include user
-
defined reagents (i.e.

non
-
Beckman Coulter tests/reagents)


Modular Chemistry Reagents

o

Modular reagents are
stored inside the lower left compartment in either 500 mL, 1L,
or 2L bottles.

o

Other solutions associated with modular reagents include:

-

No Foam

(used to eliminate bubble formation in the analyzer waste line
)

-

CTS Auto
-
Gloss (used to lubricate the CT
S blade for cap
-
piercing)


-

Wash Concentrate II
(u
sed in wash cycles for cuve
ttes
)


-

Alkaline Buffer
(used in CO
2
analysis)




No Foam, CTS Auto
-
Gloss, and Wash Concentrate II are stored in bottles in the


center hydropneumatics compartment. The Alkaline Buffer is stored in a bottle


within the ISE module.



Reagent Status


The

Rgts/Cal


icon provides immediate
reagent status at
-
a
-
glance.
If the icon is yellow


o
r

red, it should be viewed to determine what action(s) need to be taken before patient


sample analysis is initiated.



Once accessed, the Reagent/Calibration Status screen lists the following:

o

Volume (%) Tests Left

o

Days Left (open expiration)

o

Lot #

o

Reagent

Status (Load Requested/Reag OK/Reag Exp/Days Exceeded/etc)

o

Serial Number of Reagent

o

Mfr’s Expiration

o

Calibration Time Left (Days/Hours/Minutes)

o

Calibration Status



RED
” highlighted chemistries will not run.


YELLOW
” highlighted chemistries will run, but
the reagent volume should be


considered before patient testing to determine if the volume is sufficient to complete the


patient run.

Beckman Coulter DxC 800/600 Operation Overview

Clinical Laboratories


Duke University Health Systems

DxC General Overview


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Reagents are never to be used beyond their
manufacturer

s expiration date, or on
-
board
stability claim.



Loading/Unloading Reagents

Reagent sets (cartridge chemistries or modular chemistries with multiple components) are

never to be interchanged or mixed with like reagent/components.


The specific detailed instructions for loading both MC and CC reagents can be found in
the “Daily Start Up Routine
” protocol contained in this manual
,
on p
age
23
.



Cartridge Chemistry Reagents

The DxC analyzer uses the cartridge bar code to identify and r
ecord data regarding


reagent name, lot number, expiration date, and serial number of the cartridge.

(Exception: “User
-
Defined” chemistries must have this information manually entered


each time a reagent cartridge is loaded.)



The

system retains calibrat
ion status of loaded and unloaded cartridges.

o

Cartridge reagents can be loaded while the system is “Running” or in “Standby”.

o

The reagent box or reagent prep card should be used for reagent preparation
instructions.

o

Caps must be removed from the cartridg
e before loading.

o

The cartridge must be checked for bubbles in the reagent compartments before
loading. Use an applicator stick to remove bubbles.



Modular Chemistry Reagents

The DxC system loads and unloads the modular chemistries using the bar code syst
em.
Reagent information is encoded on the label and is read by the bar code reader when the
reagent is loaded or unloaded from the system. This information makes each container
unique and allows the DxC to maintain an accurate inventory of reagents.


Reagent volumes are automatically tracked by the system after the initial volume is set.
When a new reagent bottle is replaced the system assumes the bottle is 100% full. If the
new bottle is not 100% full, the volume may be adjusted.



Important General N
otes Regarding Reagent Loading

Whenever reagents are being loaded, always check the monitor to verify that the reagent
data shows

up correctly
.


If the bar code is damaged or cannot be scanned, manual entry
of the information can be utilized.



Beckman Coulter DxC 800/600 Operation Overview

Clinical Laboratories


Duke University Health Systems

DxC General Overview


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CAREFULLY

assess reagent needs at the beginning
of
each

shift to

assure that adequate
reagents will be available to an
alyze samples.
Loading reagents to maximize the
efficiency of daily calibrations and quality contro
l analysis will maintain uninterrupted
workflow

throughout the shifts.




Reagent Verification

Quality control must be

run on all reagents immediately after being loaded onto the
analyzer,
and results within acceptable limits,
prior to
resuming
patient testing.



Reagent Lots Currently in Use


Reagents

of the

same lot are verified using the daily

routine QC products, i.e. Bio
-
Rad.

New shipments of a lot number
in use
,

may also be verified

with
same daily qc

material
.




New Reagent Lots


New lots of reagents are also verified using the daily routine QC products. From time to
time,
QC

shifts can be seen with new re
agent lots (especially
calibrator lots). If QC shifts
are noticed
,

Beckman
Specialty Controls (i.e.
Synchron
) should be utilize
d.
These

manufacturer’s QC product
s have

method
-
specific
target values

that

are designed to
validate reagent
and analyzer
performance following lot changes.



Reagent
Lot Tracking



Analyzer printouts of the reagent inventory provide reagent lot
information. These are to
be printed daily and filed for referencing. For MC reagents, the lot number also print out
on the QC sheets.










Beckman Coulter DxC 800/600 Operation Overview

Clinical Laboratories


Duke University Health Systems

DxC General Overview


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53




CALIBRATION

OVERVIEW



Reagent
calibration is used to standardize the analysis of samples to existing
conditions.

Refer to the analyte
-
specific procedures for detailed information regarding such

conditions.


In general, reagent

calibration is required when:


o

A new Cartridge Chemistry (CC) reagent cartridge is used (except when within
-
lot
calibration
applies; an explanation of this follows in this section.)

o

A new Modular Chemistry (MC) reagent is loaded.

o

At recommended calibration frequency intervals (as defined in the analyte
-
specific
procedures).

o

Indicated by quality control results.

o

Electronic or mo
dule adjustment is performed.

o

A calibration setpoint is modified.

o

Specific maintenance procedures as defined in Chapter 9


Instructions For Use

Manual

are performed.


Calibrator Diskettes

Serum based calibrators
require a calibrator diskette

be loaded on
t
o

the system. The
calibrator diskette is loaded only one time per lot number.


To check what lot number is currently loaded on the system
, select the “
Rgts/Cal
” icon
from the menu bar, then select Options F6. Use the pull
-
down menu to select “Calibrator
A
cceptance Limits”. To find the calibrator, use either the “Prev” and “Next” button or
use the pull
-
down menu and select the calibrator name.



Calibration Intervals

Every 12

hours: ISE chemistries (Na
+
,
K
+

,
CL
-
, CO
2
, Ca
+

)



All

other analytes are calibra
ted
at manufacturer’s recommended interval
s. These
intervals are

defined in the analyte
-
specific procedures.


Within Lot Calibration


The Within
-
Lot Calibration option provides multiple reagent load of cartridges of

the

same lot number without having to calibrate each cartridge. The calibration

factor established f
rom a fresh cartridge (<

8 hours on board the

instrument) is stored

and applied to subsequently loaded cartridges of the same

lot.


The analyzer software keep
s track of the calibrations for

each lot and the remaining
calibration stability time
. When calibration is needed, it

will be indicated on the


Beckman Coulter DxC 800/600 Operation Overview

Clinical Laboratories


Duke University Health Systems

DxC General Overview


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53





Rgts/Cal


screen by th
e appropriate reagent cartridge,
i.e. the user only has to review

this

screen for eval
uating calibration requirements.


When a fresh cartridge is loaded onto the analyzer
, the software checks the lot

number:

o

If the lot number matches a calibra
ted lot for that chemistry,

it
then
accepts and labels
the cartridge as “Calibrated”. No additional

calibration is required.

o

If no

within
-
lot calibration
is
in memory (i.e. a new lot), the cartridge will show a
“Calibration Required” status.

Using

this “Cal Required” status:

-

If the calibration is less than

8 hours
of loading
(“
wf
” designation
-
“fresh”), the
analyzer
will store that calibration for future
use on
cartridges of the same lot.

-

If the calibration is more

than 8 hours after loading (“
w
” designation
-
“within lot”),

the

calibration is
then
good only for that cartridge,

not for the lot. This cartridge’s

status changes to “
ws
” designation (“stand alone”).


Calibration Procedure

Specific calibration racks for each calibrator set are programmed within the analyzer
software, thereby, eliminating the need for manual calibrati
on programming by the
operator. The racks are labeled with the calibrator name to facilitate easy recognition.


Refer to the

Performing Calibration


protocol
,
page 25
,

for
detailed in
struction on
programming

analyte calibrations and
verifying calibrator l
ot information.


Refer to the “DxC Calibrator Information” Chart
in the Operator Tips Notebook
for a
quick reference of calibrator
handling and
storage
requirements
.




Calibrator Lot Tracking

Any calibrator that is loaded into the system via calibrator di
skette, will print the
corresponding lot # on the calibration report.


Because Aqua
-
Cals & other non
-
serum based calibrators are manufactured to have
constant set points

(thereby not requiring disk updates for different lots), the analyzer wil
l
not print
these calibrator lot

numbers on the calibration reports. Calibrator lots are
to be
documented using a tracking
system of each
lot shipment
,

when received and when
placed in use.


Calibration Report Handling

All calibration printouts are to be filed for
long
-
term retention.

Printouts should be
initialed by the operator and placed
in the corresponding analyzers Calibration Notebook
.


Beckman Coulter DxC 800/600 Operation Overview

Clinical Laboratories


Duke University Health Systems

DxC General Overview


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53





QUALITY CONTROL



Interval


Quality control is routinely performed for each analyte a minimum of
two levels
once/d
ay

or each shift, depending on each lab’s requirements
.

Specific QC intervals for
each analyte are defined in the analyte
-
specific procedures.



In addition to the routine QC t
esting, Quality C
ontrol is always performed:


o

with each new reagent container.

o

after each analyte calibration.

o

after certain scheduled maintenance procedures (refer to the on
-
board maintenance.
log to determine the necessary QC to be performed after maintenance procedures.)

o

after extensive trouble
-
shooting procedures (as defined in t
he on
-
board IFU).





QC Materials


The following
QC products are utilized in DUHS Clinical laboratories
:
Refer to each

analytes’ specific procedure for its designated control (s).


o

General chemistries


BioRad Multiqual Unassayed Controls (3 levels)

o

Urin
e chemistries


BioRad Liquic
he
k Urine Controls (2 levels)

o

TDM assays


BioRad Liquic
he
k Immunoassay Plus Controls (3 levels)

o

Urine DATs


BioRad Liquichek
Urine
Toxicology Control (2 levels)

o

Elevated
Total/Direct Bilirubin testin
g


BioRad Liquiche
k P
ediatric Control (1 level)

o

Etoh/Ammonia


BioRad Liquichek Ethanol/Ammonia Control (3 levels)

o

CSF


BioRad Liquichek Spinal Fluid Control (2 levels)

o

Beckman Specialty Controls


per laboratory need.





QC Material Storage and
Handling


Specific instructio
ns for t
he storage and handling of QC products are included in this

manual
beginning on
page 38
.






Beckman Coulter DxC 800/600 Operation Overview

Clinical Laboratories


Duke University Health Systems

DxC General Overview


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53




Programming QC Analysis on the DxC



For QC analysis of all analytes in a particular QC product


Pre
-
programmed QC testing (“Autogen”)
allows the technologist to utilize specific


reserved sample racks for loading/analyzing QC for
all analytes

of a

particular QC

product.

Each QC sample has a designated Cerner accession number and barcoded cup

adapter for use with Autogen anal
ysis.


For QC analysis of individual analytes


(i.e. to repeat unacceptable analytes; to
initiate
QC
on
a new

reagent container)

T
he “Autogen” feature must be manipulated to prevent running QC on

all analytes

unnecessarily.

To program individual analyt
e QC runs,
refer to the protocol page


entitled “
Running
Q
uality Control
”,


section
B,
page 29.






Quality Control Review
/Follow Up



Quality Control review




Refer to the laboratory’s
General
QC Pro
tocol

for documentation and validation of


daily qc
, located in the
laboratory’s
Q
uality Assurance (QA)

manual
.



For any unacceptable
values, trouble
-
shooting must occur and acceptable values


obtained before patient

sample testing is resumed
.




Suggested initial trouble
-
shooting
, if repeat analysis
alone does not come in
:


o

Consider the integrity of the QC product, i.e. was it poured into the aliquot cup a
significantly long time before it was placed on the analyzer; was the vial almost
empty; is the vial beyond or near its open expiration?



If
indicated, repeat testing with fresh/new QC product.

o

Evaluate the age of the reagent, the last calibration date, etc.

If indicated, recalibrate and/or replace the reagent and recalibrate.



Seek assistance from the MTIII (SMT), PIC, or Analytical Speciali
st if the problem is



not resolved.


Extensive

trouble
-
shooting/corrective actions must be appropriately documented
in
the

analyzer’s corresponding Problem Log book.









Beckman Coulter DxC 800/600 Operation Overview

Clinical Laboratories


Duke University Health Systems

DxC General Overview


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53




PRE
-
ANALYTICAL

PR
OCESSING



Sample preparation and acceptability is

defined in each analyte
-
specific procedure
.


After required sample preparation, the appropriate rack size with the appropriate

“reserved/non
-
res
erved” status must be utilized.


o

Failure to use the correct racks may lead to sample l
evel sense errors or rac
k jams.

o

Sample containers must be completely seated in the rack to prevent “jamming” at the
load station.


Primary Container S
ampling

This function may be
utilized for all samples judged to have adequate volume.
Appropriate volume can

be determined by
visu
ally comparing to the BCI sample volume

template (“Synchron Sample Template
-
967178
-
AH

).


Primary containers with adequate volume


o

P
rimary containers which are capped

must use “Non
-
Reserved Racks”
.

o

Remove visible blood from the top of capped tubes using a
cotton tipped swab
moistened with CLRW (Clinical Laboratory Reagent Water/

RGII H
2
O).

o

The appropriate sample rack for the container must be used, i.e. 13 x 75 mm, 13 x 100
mm, etc.


P
rimary containers without adequate volume


D
irect sampling
can be
achieved by using
nesting or
“insert” pour off cups
.

The plasma

/serum from the primary container is pipetted into the insert cup which is then “nested” in
the primary container.

o

Any sample with a nesting cup must use “Reserved Racks”

to prevent damage to

the sample probes.

o

The use of insert cups on the DxC ana
lyzers should be limited to ONLY the
Beckman
-
validated product for this usage (Product #81916

DxC inserts or #81915
DxI inserts
). Other insert cups have the potential to damage the sample probes.



A
liquot Sampling

Samples with significantly low volume (
<

500 uL) can be analyzed utilizing a 0.5 mL
sample cup.


Aliquot
Labeling

o

L
abel the aliquot container appropriately, i.e. Pathnet aliquot labels if available.


If no Pathnet label is available,
cup should be labeled with a minimum of the last


5

digits of the accession number and any ot
her appropriate identifier

(i.e. “x
2”


for a dilution aliquot).

Beckman Coulter DxC 800/600 Operation Overview

Clinical Laboratories


Duke University Health Systems

DxC General Overview


Page
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53


o

When actually pouring the sample into the aliquot cup, ALWAYS
check the sample
identification (accession #) with the labeled aliquot cup to assure that the correct
sample is poured.

o

Remove any trapped bubbles to prevent sampling errors.

o

Be aware of potential sample evaporation if analysis is delayed! If analysis dela
yed,
the cups should be capped until immediately prior to analysis.



Aliquot Sample Volume Requirements



Dead
-
volume
” requirement
s (the minimum amount of sample that must be present to
prevent level sensing and probe m
otion errors)

must be considered
when assessing
appropriate sa
mple volume for aliquot testing:


o

0.5 mL sample cup


40 uL “dead
-
volume”

o

0.5 mL sample cup nested in red metal insert


20 uL “dead
-
volume”


Other considerations:


o

Sample indices (which are automatically performed on all sampl
es) require 14 uL.

o

The volume needed for the requested analyte testing. (This can be determined by
referring to the analyte
-
specific procedures.)


Example
: BMP order


“Dead volume”


40 uL

(cup alone) or 20 uL (cup with red metal insert)


Serum indices



14 uL


Electrolytes (any/all)


4
0 uL


BUN (modular)


1
0 uL


Creatinine (modular)


16.
5 uL


Glucose (modular)


1
0 uL



Using a 0.5 mL sample cup
: Minimum volume = 130.5

uL



Using a 0.5

mL sample cup WITH red me
tal insert: Minimum

volume = 110.5

uL



Aliquot Rack Requirements


“Reserved” racks
must be

utilized for all aliquot sampling.





Beckman Coulter DxC 800/600 Operation Overview

Clinical Laboratories


Duke University Health Systems

DxC General Overview


Page
16

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53




ANALYTICAL

PROCESSING


Detailed instructions can be obtained:


o

Chapter 6,
Instructions for Use Manual

(on
-
board analyzer/paper copy/CD)


The
following information contains general instruction on programming and processing
samples received in the laboratory.



Processing Bar Coded

S
amples


Patient

demographics and test orders are contained on sample b
ar

code labels which are


generated when te
st orders are placed. At sample collection, these labels are applied to

the samples.

When
the
bar

coded
samples
reach the laboratory and
are logged as

“received”

in

the laboratory

information system, the

patient

information
and test requests

are

downloaded to the analyzer via

the DL2000. The ability to employ bar

codes

minimizes the need for manual sample

programming.



Processing Samples Manually



Typically this should only
be necessary for situations

such as computer “downtimes”
,

samples wit
hout bar codes, i.e. interlaboratory samples, off
-
line dilutions, etc.

Note: When manually programming samples other than serum/plasma, (ie. CSF,

Urine), you must select the proper sample type, prior to analysis.



Initiating Sample A
nalysis


Refer to Sa
mple Processing Protocol,
page 30.





Serum Indices Testing



Serum indices testing (quantitation of hemolysis, icterus, and lipemia) is performed on

each sample. This analysis takes place on the cartridge chemistry side of the analyzer.

The Serum Indices

Chart defining the level of interference that effects each analyte and

the

reporting criteria is located at the beginning of the Analyte Specific Procedure book.


Various levels
of these interferents

are

categorized as “NSI” (No Significant


Interference)
,
“Interferent Present”(Result is to be interpreted with caution), or

“Significant

Interference”(Result is not reported).

The DL2000 is set up to apply these

rules to the interferent results and to handle the result appropriately, i.e. no comment

need
ed; comment is needed; result is suppressed.

Beckman Coulter DxC 800/600 Operation Overview

Clinical Laboratories


Duke University Health Systems

DxC General Overview


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Repeat Sample Analysis for Result Confirmation



Confirmation of “Alert” Values

utilizing Analyzer “Critical Results Rerun”


T
he analy
zer will automatically rerun those Stat analytes
on the MC side of the an
alyzer,

which have been pre
-
defined
with the “alert repeat” ranges. For alerts on the CC side, the

DL2000 will prompt the user to repeat the alert run with a “pop up” screen message. The

operator must find the sample and place it back on the autoloader

for repeat analysis.

Both results will be sent to the DL2000 and the operator will
select one (usually the first

alert)

result to

be reported
back
to the patient’s medical record.


The
DUHS “Alert” value

for each specific analyte can

be found on the CRR chart located


at the beginning of the Analyte Specific Procedure book.


Notification of “Alert Values”

are to

be handled as defined in the:

DUHS Clinical Laboratories Administrative Policy

“Alert Values”

protocol
.



Repeat Sample
Analysis

for Analytes
Requiring Dilution

Auto ORDAC


When a result exceeds the analyzer range and Auto ORDAC (Over

R
ange Detection and
Correction) function is enabled, the sample will automatically rerun with either:

o

a smaller sample size

o

an on
-
line diluti
on (chemistry dependent)


No operator intervention is needed
.


The following

chemistries have

“ORDAC”

capability
:
ALT, ALP, AMY, AST, CAFF,

CK, GGT,
GLUC, HCG
, LD, LIP,
LITH, NAPA, PROCAIN,
UREA,

URIC, VAN
CO.




Manual Dilution
s


Each analyte
-
specific pr
ocedure contains the analytical measuring range and the


recommended

diluent for preparing dilutions.


The
CRR (Clinically Reportable Ranges)

document
located in the Analyte Specific

Manual,
defines the clinically reportable ran
ge for each analyte, which is the cutoff value
an analyte is needs to be diluted out,
when the
result is greater than analyzer linearity.



For a quick reference list of recommend diluents, refer to the “Recommended Chemistry

Dilution Material” sheet loca
ted in the Operator Tips Notebook.
Prepare the appropriate

manual dilution using the “Chemistry Specimen Dilution Protocol”
located
page 33.



Manually program the sample ID (use the last 5 digits of the accession # with the dilution

factor behind it, i.
e. 32153
x2). Enter the dilution factor using Options F3 in the sample

programming screen.

Beckman Coulter DxC 800/600 Operation Overview

Clinical Laboratories


Duke University Health Systems

DxC General Overview


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Repeat Sample Analysis to Confirm Results (Non
-
alert)


For repeat analysis to confirm
suspect
results
, refer to

Add Tests or Rerun a Sample



section
of the Samp
le Processing Protocol,
page 30.





Offloading specimens from the analyzer


After analysis is complete and results are screened for potential follow
-
up actions, the

samples should be removed from the analyzer as soon as possible

and

re
-
capped, to

prevent any evaporation.


*
NOTE
: Aliquot samples in the 0.5 mL cups are very susceptible to evaporation. These



should be given priority in being capped and stored
,

to preserve sample integri
ty.


Beckman Coulter DxC 800/600 Operation Overview

Clinical Laboratories


Duke University Health Systems

DxC General Overview


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19

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53





POST ANALYTICAL PROCESSING




(REPORTING)



Autoverifi
cation of results occurs if a sample “passes” the rules set up for analytical

measuring ranges, “alert” values, delta checks, serum indices limits, and any other
pre
-


defined “review” criteria.


Result review and reporting is handled through the DL2000.

Please refer
to
the DL2000

Procedure

Manual for further information on
result
reporting.











DAILY START UP


D
etailed instructions

for performing the necessary daily start up functions are

contained
in

the “DxC Daily Start Up Routine” protocol
located
on
page 23
.


This protocol covers:

o

Clearing manual rack assignments.

o

Checking reagent status and loading reagents.

o

Checking calibration status and calibrating chemistries.

o

Programming

and processing Quality Control.

o

Programming

and processing patie
nt samples.




The

“start
-
up” protocol is
to be
performed
every 12 hours
.


Beckman Coulter DxC 800/600 Operation Overview

Clinical Laboratories


Duke University Health Systems

DxC General Overview


Page
20

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53



SCHEDULED MAINTENANCE


Detailed instructions for the
weekly and
various maintenance intervals and tasks are
covered in the “Instructions for Use”
(IFU)
manual provided
within

the on
-
board
software, using the Alt
-
F1 keys to access.

(Hard copy and CD copies are also available.)





Although Beckman does not require any daily maintenance to be performed, good
laboratory practice should include the following:


Daily

Maintenance

o

Reload Printer Paper

o

Print and File Daily Reagent Log (first shift only)

o

Clear Manual Rack Assignments

o

Check Reagent Inventory/ Reload as Needed

o

Calibrate Needed Analytes

o

Run QC

o

Disinfect Work Area



►Beckman “required” maintenance

includes the following
:


Twice
-
Weekly Maintenance

o

Perform the “Twice
-
weekly
ISE maintenance” procedure
.


Weekly Maintenance

o

Perform the “Flush Sample & Reagent Probe” procedure.

o

Perform the “Replace Cuvette Wiper” procedure.

o

Perform the “Clean ALBm and TPm

Cup Modules” procedure.
(800 only)

o

Perform the “Clean Probes (Exterior) procedure.

o

Visually inspect sample syringes, replace as needed
.

o

Perform the “Check Chloride Span” procedure.



Twice
-
Monthly Maintenance

o

Perform “Clean All Cup Modules” maintenance.

o

Perform the “Calibrate Lamps and Sensors” procedure.



Monthly Maintenance

o

Perform BUNm/UREAm Electrode maintenance.

o

Replace Alkaline Buffer Reagent and In
-
Line Filter.

o

Perform the “Clean Mixers” maintenance.

o

Perform
the “Clean Chloride Electrode Tip & Fl
ow Cell Port” procedure. (See
addendum
.
)

Beckman Coulter DxC 800/600 Operation Overview

Clinical Laboratories


Duke University Health Systems

DxC General Overview


Page
21

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Additional Scheduled Maintenance P
rotocols


2
-
month, 3
-
month, 4
-
month, and 6
-
month protocols are defined on the on
-
board
maintenance log screen. The on
-
board “Instructions For

Use” can be utilized for detailed
instructions.




Scheduled Maintenance D
ocumentation


The analyzer software tracks the maintenance schedule and notifies the operator by a
“yellow” menu icon that maintenance is due.

As each maintenance task is complete
d, the
operator “initials” and dates the task within the software.

These on
-
board records are
to
be
printed monthly

and reviewed
by

the Analytical Specialist.




As Needed M
aintenance


Additional
miscellaneous
/as needed

maintenance
or other maintenance activities
performed by
the operator(s)
should be documented
in the “Action Log” of the analyzer.

Preventive maintenance procedures are performed by BCI Field Service representatives
on a scheduled basis.

Service
reports generated by
the Field Service Engineers
are

filed
with the Analytical Specialist for retention

and a copy placed in the analyzer’s Problem
Log Notebook for tech referencing
.



Unscheduled Maintenance


When situations arise where unscheduled maintenance is performed to

rectify
a

problem,
the work performed should be noted in the analyzer’s Problem Log Notebook.

If BCI service is called in, their service reports are also placed in the Problem Log and a
copy retained with the Analytical Specialist.


Beckman Coulter DxC 800/600 Operation Overview

Clinical Laboratories


Duke University Health Systems

DxC General Overview


Page
22

of
53




ANALYZER
TROUBLE
-
SHOOTING



Analyzer
software “
Online Help


is available for trouble
-
shooting common error messages.


On the DxC console, error messages contain links to the Online manuals. Select the Help icon
next to the event number to display specific informat
ion about the error.




For error messages that do not have a Help icon next to the event number, refer to the “
DxC
Synchron Clinical Systems Reference Manual


for trouble
-
shooting information.



The “
Instructions for Use
” manual, Chapter 12,
also
contains

guidelines for follow up of:

o

Calibration errors
-

p. 12
-
1

o

Result Errors and Codes


p. 12
-
15

o

Error Code


Definitions


p. 12
-
18



For
Hot Line Assistance




Call
1
-
800
-
854
-

3633






Have
System ID#

available




Note:

“Standard Business” hours for
service are Mon


Fri, 8


5.
If necessary

service is
required “off hrs”,
when calling Hotline you must then provide them this PO# so that service can
be properly billed:


P.O. # 4520655323


Beckman Coulter DxC 800/600 Operation Overview

Clinical Laboratories


Duke University Health Systems

DxC General Overview


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23

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*
*** *** ***
Protocols

*
** *** ****


DxC Daily Start Up Routine


A.

Prime As Necessary




Priming before calibration may be necessary after the instrument remains i
dle for a long

period of time between shifts, or post extended maintenance down times:


1.

Select
UTILITIES

from the menu bar

2.

Select #1
PRIME

3.

Select all Modular Chemistry tests

4.

At the Repeat Box, enter 10 for the number of primes

5.

Press START PRIME



B.

Clear Manual Rack
/QC

Assignments


1.

Select
Samples

(tube icon) from
the menu bar.

2.

Select
Clear F7
.

Highlight the
Racks

field.

Type 1
-
999 to clear all racks.

3.

Select
Enter
.

Select
OK
, then s
elect
OK

again to confirm.

4.

To clear any sample that may have been programmed in using an alpha prefix,

Select
Clear F7
. Highlight the Sample ID
“FROM”

field. Ty
pe AA
,

and enter.
S
elect

TO


field and type
ZZ

and enter
. Select
OK,

then
OK
, then
OK

agai
n.

5.


To clear numeric samples, s
elect
Clear F
7

then h
ighlight
the
Sample ID
“FROM”
field.

Type
in (but do not enter the dashes
, this is to represent that qc

accession
numbers are similar to pt accession numbers
)
38
-
000
-
00000

“TO”

39
-
000
-
00000

to clear
any outstanding
QC s
amples
.



Notes about clearing racks:




Clearing racks does not cl
ear programming for Sample IDs,
it only clears the


assignmen
t to
a rack/position.




You may get a message informing you that some racks are reserved for


Calibration, Requested, Removed, or are In
-
Progress. This feature protects you


f
rom inadvertentl
y clearing a rack that is designated for

these conditio
ns.




C.

Check Reagent Status



1.

Select
Rgts/Cal

from the menu bar (reagent cartridge icon).

2.


Select
Print F10
.

3.


Review the printed document for available reagent volume and expiration dates



and file in maintenance book
.

Replenish and/or replace as necessary.

Beckman Coulter DxC 800/600 Operation Overview

Clinical Laboratories


Duke University Health Systems

DxC General Overview


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53



D.

Load Modular Chemistry (MC) Reagents





1.

Prepare reagent(s) if required.

2.


Select
Rgts/Cal

from the menu bar.

3.


Select
MC Rgts
.

4.


Select
Load F1
.

5.


Open the MC reagent compartment door.

6.


Remove the cap and in
let tubing from the existing reagent and place it in the new


reagent. Place the new bottle into the reagent storage area. Discard the old bottle


according to laboratory procedures. Note: take care not to contaminate the inlet


tubing.

7.


Use the hand h
eld bar code reader to scar the bar code label on the new reagent or


manually enter Lot #, Serial # and Expiration date. Select the tab key on the


keyboard to save the entries.

8.


Verify that the new reagent information is displayed on the monitor.

9.


Sele
ct
Done F10
.

Close the MC reagent compartment door.





E.

Load CC Reagents


1.


Prepare reagents if required

2.


Remove caps, remove any liquid adhering to the chimneys of the cartridge and

remove any bubbles on the surface of the reagent.

3.


Select
Rgts
/Cal

from the menu bar (reagent cartridge icon).

4.


Page down to locate the positions on the CC carousel where reagents will be

placed.

5.


Select all positions to load reagent cartridges.

6.

Select
Load F1
.

When prompted, open the Reagent Carousel door
.

7.


Place the cartridge in the load position in front of the blinking bar code reader



beam OR manually enter the Reagent name, Lot Number, Serial Number, and


Expiration Date. Use the tab key on the keyboard to save the entrie
s

8.


Verify that the new reagent information is displayed on the monitor.

9.


Select
Done F10
.

Close the CC reagent compartment door.



F.

Manual Loading of MC or CC Reagents


1.

Choose reagents as you normally would
, then select
Load (F1)
.

2.

For MC reagents:

a.

Highlight the reagent
, p
ress
Clear (F1)
. Enter data from the reagent bottle


4.

For CC reagents:



a. Enter data from the cartridge into the open spaces of the instrument monitor
.



b
.

If offloading a manually loaded cartridge, press
Clear (F1)

after
selecting




the position and press
Load
.

Beckman Coulter DxC 800/600 Operation Overview

Clinical Laboratories


Duke University Health Systems

DxC General Overview


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25

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53



PERFORMING CALIBRATION



A.

CHECK CALIBRATION STATUS

1.

Select
Rgts/Cal

from the menu bar.

2.

Select
Print F10
.

3.

Review the printed document for reagents needing calibration. Review
Cal Time

Left

column as well as
C
al Status

column.



B.

CALIBRATING


1.

Select
Rgts/Cal

from the menu bar.

2.

Select each chemistry
needing

calibration.

3.

Select
Cal F4
.

4.

Select
List F5
.

5.

Review the calibrator load list which indicates the calibrators needed for the
requested calibrations.

IMP
ORTAN
T NOTE
:

-

Verify
that
the calibrator lot #

in use matches the load list for the


calibrators listed below:



o

Multi Calibrator



Magnesium, Uric Acid, Lactate

o

Bilirubin Calibrator



Total Bilirubin, Direct Bilirubin

o

Enzyme Validator



Lipase

o

Microprotein
Calibrator



Micro
-
TP (urine and CSF protein)

o

Protein Calibrator


ALBm, TPm


-

If the lot number of the calibrator does NOT match the lot number on the


load list,
then that lot’s
calibrator diskette must be loaded.


-

To load a new lot calibrator

disk
,

locate the calibrator diskette in


the calibrator box.



The analyzer must be in “Standby”.



Select “Rgts/Cal” from the menu bar; then “Options F6”.



Select “Load calibrator diskette”; verify that the lot number on the diskette
matches the lot number on the
calibrator bottle.



Insert the diskette into the disk drive; select “OK”.



Verify that the lot number on the screen is the same as the lot number on
the calibrator bottle.



Remove the diskette from the disk drive.



If
no other diskettes

are to be loaded, select “Cancel”.

Proceed with
pouring/preparing the calibration run.



Beckman Coulter DxC 800/600 Operation Overview

Clinical Laboratories


Duke University Health Systems

DxC General Overview


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If
additional calibrator diskettes

need to be loaded, select “OK” and
proceed.



If
the incorrect diskette

was placed in the disk drive, select “OK”, obtain
the corr
ect diskette, and proceed.



6.

Locate the racks to be used for calibration.

Pour the calibrator(s) into sample cups:


a.
For Aqua Cals 1,2, and 3,
-

pour 1 mL of calibrator into a
2

mL

cup.


b.
All other calibrators
only require

3 drops of calibrator in a
0.5 mL cup.

Place the sample cups in the assigned calibrator rack in the assigned bar

code labeled tube(s).

Load the racks on the autoloader with the bar codes facing to the right.

7.

Press the
<RUN>

button.

8.

When calibration is complete, view calibration sta
tus on
Rgts/Cal

screen.

9.

If calibration is successful, calibration procedure is complete.
Initial and file all
calibration printouts in the corresponding Cal notebook.

10.

If
calibration is
not successful, consult Beckman’s

“Troubleshooting Calibration
Failures” flowchart

on the following page,

for troubleshooting assistance.























Beckman Coulter DxC 800/600 Operation Overview

Clinical Laboratories


Duke University Health Systems

DxC General Overview


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27

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53



Troubleshooting

C
alibration

F
ailures

When a calibration attempt is unsuccessful, use the following process to troubleshoot.



1. INVENTORY


What just happened to your instrument?


(Assess the status of your instrument.)



Continue with the
INTEGRITY

Check on
the next page.

YES

Verify procedure
correctly
performed, prime and
recalibrate.

YES

NO

NO

Did just one
chemistry fail to
calibrate for a single
calibrator

set?

If more than 1
chemistry failed, are
there any common
factors that can be
identified as the
cause? (For
chemistries using the
same calibrator.)

Ensure correct calibrators and
calibrator placement.

Pour
correct/fresh calibrators and
recalibrate.

Reagent
?

Ensure correct reagent preparation.

Verify
adequate/correct reagent, prime, and
re
-
calibrate.

Sample?

Ensure instrument integrity
.

Repair the
failure, prime, and recalibrate.

In
s
trument

Components?

Were any
maintenance or
part(s) replacement
procedures
performed?

Beckman Coulter DxC 800/600 Operation Overview

Clinical Laboratories


Duke University Health Systems

DxC General Overview


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53



2. INTEGRITY

How bad is the damage?


(Assess the magnitude of the unsuccessful attempt.)


Calibration Error Code Is

Check to see if

If so, then do this


Range

(a measurement of accuracy,
quality. Is the instrument
detecting the concentration
that it should?)




Calibrators have been switched



Reagents are:




prepared incorrectly?




switched or expired?



Hardware is malfunctioning:
lamps, electrodes, stirrers,
syringes aspirate, and dispense



Pour correct calibrators



Replace reagent, perform
reagent load/prime reagent




Repair
malfunction, adjust,
replace or repair


B
ack to Back

(
a measurement of precision,
reproducibility. Is the
instrument replicating itself
using the same sample?)



Bubbles are present: in calibrator,
reagent lines



Droplets of fluid are on probe tips



Stir bars

are stuck



Syringe tips are worn



Probes or mixers are scratched or
damaged



Remove bubbles from
calibrator, prime reagent
lines



Repair leakage



Restore proper operation



Replace syringe plunger rods



Replace damaged hardware


Span

(
a

measurement of sensitivity.
Is the instrument capable of
differentiating sample
concentrations?)



Reagents have deteriorated



Calibrator lot set points are
incorrect



Calibrators have deteriorated



Hardware has malfunctioned:
lamps, electrodes



Replace
reagents



Load correct calibration
parameters



Pour fresh calibrators



Repair malfunction


R
ange

and

Back to Back





Instrument has malfunctioned,
stirbars, solenoids, lamps





Repair malfunction and prime


R
ange

and

Span





Calibrators have been switched



Calibrator lot set points are
incorrect



Hardware has malfunctioned:
lamps, electrodes, stirrers,
probes, solenoids




Pour correct calibrator



Load correct calibration
parameters



Repair malfunction and prime

S
pan

and

Back to Back




Reagents have deteriorated
or
contain bubbles



Calibrators are outdated or
contain bubbles




Replace reagent, perform
reagent load/prime reagent



Pour fresh calibrators

Range,

Back to Back

and

Span





Instrument performance has
deteriorated





Repair malfunction and prime


3.
RECALIBRATE

Try it again. (Assess corrective steps have been performed and
reattempt calibration.)


4. HELP!

Don’t know what else to do? Call the Clinical Support Center (HOTLINE).

1
-
800
-
854
-
3633

Beckman Coulter DxC 800/600 Operation Overview

Clinical Laboratories


Duke University Health Systems

DxC General Overview


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29

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53



RUNNING QUALITY CONTROL




A.
USING
AUTO
-
GENERATION OF CONTROL


(Used during initial QC run)


1.

Locate the reserved rack containing the bar code labeled tube(s) for the control
sample(s).

2.

Pour the
required
control material into a sample cup. Nest the sample cup in the
corresponding
appropriate bar code labeled tube.

3.

Place the rack on the Autoloader with rack bar code facing to the right.

4.

Press the
>RUN>

button.

5.

When Quality Control is complete, review for acceptability.

Do not run any patient
samples until quality control is deemed
acceptable.





B.
MANUAL PROGRAMMING AND RUNNING OF CONTROL


(Used when repeating individual QC)


1.

Select
Samples

from the menu bar (tube icon).

2.

Select
Clear F7
.

3.

Enter the QC ID to be cleared in the Sample ID field. (Multiple QC IDs may be
cleared

by typing in each control ID separated by a comma.)

4.

Select
Enter
.

5.

Select
<OK>
.

6.

Select
<OK>

again to confirm.

7.

Type the Control ID in the Sample ID field.

8.

Enter the rack/position number in the rack/position fields if no bar code is available.

9.

Select the che
mistries to be run, then select
Next F10
.

10.

Place the appropriate QC material into a cup and place the cup in the assigned rack
and position or bar code labeled tube.

11.

Place the rack in the autoloader with the rack bar code facing to the right.

12.

Press the
<RUN
>

button.

13.

When Quality Control is complete review for acceptability.

Do not run any patient
samples until quality control is deemed acceptable.




Beckman Coulter DxC 800/600 Operation Overview

Clinical Laboratories


Duke University Health Systems

DxC General Overview


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30

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53




SAMPLE PROCESSING



A.

Running Samples with Power Processing LINE

On


For labs using Total Automation, t
he Power Processing Line will automatically
load and

unload samples to and
from the DxC.



B.

Running STAT samples with Power Processing LINE On




1.
If the
DxC

is running and there are other racks on the autoloader:

a.
Press “PRIORITY”.

The rack pusher moves
all the way to the left of the


autoloader

so that the STAT rack can be placed in front of the other racks.

b.
Press “RUN”.


2.
If the
DxC

is in
MANUAL mode,

place the STAT sample on the autoloader first and



press “RUN”.



C.

Running Samples with LINE Off

(DxC in MANUAL Mode)

1.

Determine if there is adequate sample volume by comparing to Primary Tube
Sample template.

2.

If there is a readable bar code, place sample in the appropriate rack. Verify the
tube is seated properly

and the bar code is visible through the rack slot.

3.

Load the rack on the autoloader with the rack bar code facing to the right.

4.

Press the
<RUN>

button.



D
.

Low Volume Processing

1.

Place the sample in a 0.5ml sample cup.

2.

Nest the 0.5ml sample cup in a red m
etal adapter to reduce the dead volume to
20ul.

3.

Place the nested red metal adapter in a reserved rack.

4.

Bar code label can be attached to red metal adapter or sample can be manually
programmed.

5.

Load prepared rack(s) on autoloader with rack bar code facing t
o the right.



D.

Manually Programming Samples

1.

Select
Samples

from the menu bar.

2.

Identify the samples:


a.

If the sample has a readable bar code:




-

Type the sample ID




-

If previous programming appears, it may be necessary to clear it
.




-

If no
previo
us program appears, go to Step 3.

Beckman Coulter DxC 800/600 Operation Overview

Clinical Laboratories


Duke University Health Systems

DxC General Overview


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53






b.

If the sample has no bar code or bar code cannot be read:




-

Type the sample ID




-

Type the numbers in the Rack and
Pos

fields


3.

If the sample is stat, select the
STAT

check box.


4.

Select
Sample Type

f
rom the pull
-
down menu.


5.

Select
Sample Comment

from the pull
-
down menu.


6.

To enter Demographics, select
Demog F2
. Type the information provided




and select
Next F10

to return to the
Program Sample

screen.


7.

Select each chemistry

and/or select a panel. To access additional



chemistries, use the up and down arrows to move to other pages.


8.

Select
Next F10
.


9.

To program additional samples, repeat Steps 2


10.


10.

Place the samples into assigned rack positions.


11.

If runnin
g routine or STAT sample



For STAT samples
:




If the system is running and there are other racks on the autoloader,




press
PRIORITY
. The rack pusher moves back one space so the




STAT rack can be placed in front of the other racks.




For a Routine sample or if system is in
Manual Mode
:




Priority samples should be placed on the autoloader first. Place the




rack on the autoloader and press
RUN
.



E.

Add Tests or Rerun a Sample


1.

Select

Samples

from the menu bar.


2.

Select
Rerun F6
.


3.

Type the sample ID, rack, or rack and pos
ition for rerun. One or more
samples

can be programmed to rerun.



4.

Select on the following buttons:



-

To add or rerun specific tests press
Select
. All previous
programming is

highlighted. Deselect ch
emi
stries that are not to be

run.
Save F10

to
accept programming and exit screen.



-

To rerun all completed tests press
ALL


5.

For a Routine sample or if system is in
Manual Mode
:



-

Priority samples should be placed on the autoloader first.



-

Place the
rack in the autoloader with the

rack bar code label to the
right



-

Press
RUN



For a STAT sample:

-

If the system is running and there are other racks on the autoloader,


press
PRIORITY
. The rack pusher moves back one space so that


the STAT rack can be
run first

-

Press
RUN
.




Beckman Coulter DxC 800/600 Operation Overview

Clinical Laboratories


Duke University Health Systems

DxC General Overview


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of
53




SHUTDOWN PROCEDURE




POWER
ING

DOWN
:


1.

Verify that the system is in Standby or Stopped mode.


2.

Select the
Instr Cmd

icon from the menu bar.


3.

Select <4>
Shutdown
.


4.

Select <
OK
>.


DO NOT TURN POWER O
FF at this point.


5.

Select <
Shutdown
>


6.

When
System Halted
is displayed, turn OFF power switch at the instrument. Power

switch is located inside the right side door above the Power Supply.


8.

Turn Off power switch at the computer console.



Beckman Coulter DxC 800/600 Operation Overview

Clinical Laboratories


Duke University Health Systems

DxC General Overview


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C
HEMISTRY SPECIMEN DILUTION

PROTOCOL


PURPOSE


The intent of this protocol is to give definitive guidelines for the dilution of patient specimens,
which upon initial analysis, result in chemistry values which exceed established reportable range
and/or analyzer dynamic (linear) range, and, therefore, re
quire dilution.


CHEMISTRY VALUES WHICH REQUIRE DILUTION:


Refer to the “
Clinically Reportable Ranges

(CRR) Chart
for definition of each analyte’s
validated measuring range AND to determine the clinically reportable range limits to determine
the upper m
ost value beyond which further dilution for each analyte is no longer considered to be
clinically useful. For those dilutions that do not yield results within those guidelines, report as
“greater than” the upper limit of the defined clinically reportable r
ange.


Refer to the “Operator Tips


Recommended Chemistry Dilution Material” for a quick reference
defining the required diluents for each analyte.


Further specific dilution protocols are found in each analyte
-
specific procedure.


IMPORTANT
:
For all
analytes producing values above

the analyzer measuring
range which
cannot be diluted
(i.e., insufficient sample volume)
or for
valu
es below the
analyzer measuring
range,
report

the result as greater than the upper limit of the
analyte measuring range or a
s
less
than the lower
limit of the measuring range.


GENERAL SAMPLE GUIDELINES FOR PREPARING DILUTIONS


1.

NEVER

prepare dilutions from other dilutions unless specified in a procedure or


otherwise approved by a supervisor.




2. Use the smal
lest dilution factor that will arrive at a diluted value within the linear


range of the analyzer. (For example, do not prepare a 3
-
fold dilution when a 2
-
fold


dilution is all that is needed to achieve a value within the reportable range of t
he


analyzer.)


3
.
Pediatric

or Low Volume Samples
:
Conserve specimen
. Do not use more


specimen than is required to achieve a final “total” sample volume (specimen +


diluent) that will produce an accurate analysis of the specimen.


In the event that the dilution does not yield a valid result the first time, ample


specimen may then be available for additional dilutions.




Utilize the following chart in the preparation of dilutions for low
-
volume samples.



Consult with the
MT

III

or PIC if difficulty in preparing acceptable dilutions


is experienced.

Beckman Coulter DxC 800/600 Operation Overview

Clinical Laboratories


Duke University Health Systems

DxC General Overview


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53



Specimen volumes
:

50 uL is preferred for lower dilutions, if available.

<10 uL should not be used for dilution preparation!


No dilution with a
total

volume of <50 uL should be prepared/performed.





Note
:


The final sample volume of each dilution must be slightly more than the aspiration


volume to avoid “short sampling”. The sample cup dead volume must be taken into


consideration.


Refer to the
SPECIMEN REQUIREMENTS

section of

the appropriate analyte
-


specific procedure for detailed information.


DILUTION TYPE

SPECIMEN
VOLUME

DILUENT
VOLUME

MULTIPLY
BY

2
-
FOLD

1:2

50 uL

50 uL

2


1:2

25 uL

25 uL

2

3
-
FOLD

1:3

50 uL

100 uL

3


1:3

25 uL

50 uL

3

4
-
FOLD


1:4

50uL

150 uL

4

5
-
FOLD

1:5

50 uL

200 uL

5


1:5

25 uL

100 uL

5


1:5

10 uL

40 uL

5

10
-
FOLD

1:10

25 uL

225 uL

10


1:10

10 uL

90 uL

10

20
-
FOLD

1:20

10 uL

190 uL

20

50
-
FOLD

1:50

10 uL

490 uL

50

100
-
FOLD

1:100

10 uL

990 uL

100



GENERAL DILUTION PROCEDURE

Dilutions should never be reported prior to analyzing the specimen undiluted, i.e if a patient has
historically required dilution of specimen for a particular analyte, a dilution may be analyzed

in
conjunction with the undiluted sample to expedite the report time but may not be run in lieu of an
undiluted one.


1.
Preparation of diluent aliquot
:
Aliquot a working amount of diluent from its original


container to an appropriately labeled a
liquot container. Label with diluent


identification.


Use this aliquot for dilution preparation and discard after dilution preparation is


completed.


2.
Labeling sample dilution aliquot cups
: Always label the test cup in which the
dilution


is prepared with the last five digits of the original specimen’s number “X2” or “X3”,


etc., as appropriate for the dilution factor.


Beckman Coulter DxC 800/600 Operation Overview

Clinical Laboratories


Duke University Health Systems

DxC General Overview


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3



3.
Preparing a dilution
using Micopipettors
:


Refer to the

RRL

Micropipettes


Operation, Ma
intenance,
and Trouble
-
Shooting



p
rocedure
detailed instructions on using micropipettors for dilution preparation.




4.
Programming/Resulting an off
-
line manual dilution
:


a)

“Out
-
of
-
Instrument
-
High” Dilutions:




Prepare the sample dilution as outli
ned in this procedure.



Program the dilution analysis on the DxC:



Select the “Sample” icon.



Program the sample ID as the last 5 digits of the accession # along with
the dilution factor as “X 2”, “X 3”, etc.

Example
: Accession # = 08
-
084
-
23456.


Progra
m dilution ID as “23456 X 2” for a two
-
fold


dilution.



Assign a rack and position.



DO NOT USE THE SAMPLE BAR CODE



Select the test requiring a dilution.



Select [F3] Options.



Highlight the offline dilution factor box and type in the dilution factor.
The

analyzer will automatically multiply the result.



De
-
select

the serum index box. (This conserves sample AND shortens