ROCHE COBAS-INTEGRA 400 PLUS CHEMISTRY OPERARTION SOP

Non-SMILE created resources

Author: N/A
Document Origin: MU-JHU Research
Collaboration Laboratory (Uganda)
Review by

Heidi Hanes

Document Number:

Equ24-02

Effective (or Post) Date:

17 July 2008

Company:

MU-JHU

SMILE Approved by:

Jo Shim

Review date

9-Feb-12

SMILE Comments: This document is provided as an example only. It must be revised to accurately reflect your labs
specific processes and/or specific protocol requirements. Users are directed to countercheck facts when considering
their use in other applications. If you have any questions contact SMILE.

MU-JHU RESEARCH COLLABORATION LABORATORY (Uganda)

Roche Cobas-Integra 400Plus Chemistry Operations SOP

ROCHE COBAS-INTEGRA 400 PLUS CHEMISTRY OPERARTION SOP

Effective Date:
Jan 15, 2005

Revision #1

Supersedes Rev# 0

Revised/Prepared By

Date

Ali Elbireer / Gad Bihabow

Jan 01, 2006

Approved By

Signature

Date

Signature

Date

Laboratory Medical Director

Laboratory Administrative Dir

Annual Review By
(Lab Supervisor/Lab Management)

Jan 2006

Rev# 1

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Roche Cobas-Integra 400Plus Chemistry Operations SOP
1. PRINCIPLE
The Roche Cobas Integra 400 plus chemistry analyzer is used for diagnostic clinical chemistry
testing. Classic chemistry, electrolytes, specific proteins, therapeutic drug monitoring, drugs of
abuse, and thyroid hormone testing are consolidated into one system with one reagent cassette
design. The instrument carries out all test orders automatically and is equipped with measuring
modules:
FP photometer
Fluorescence polarimetry
Absorbance photometer
Absorbance photometry
ISE (Ion-Selective Electrode)
module Ion selective potentiometry
Samples are automatically transferred from a sample tube or cup to the module where the
measurements are made. All optical measurements use the same transparent plastic containers,
called cuvettes.
The graphical user interface - running under Windows NT - provides quick and easy access to
sample, control, and calibration data, while continuously monitoring all system functions. Colorcoded icons alert you to changes in the system status. Connection to a host system allows for
automatic transfer of results to and from the COBAS INTEGRA 400 plus.
2. SCOPE
This Roche Chemistry analyzer will be used for chemistry and electrolyte testing in the MU-JHU
laboratory. All operators of the machine must be trained in this SOP which will describe procedures
and general operations of the instrument.
3. GENERAL SAFETY NOTES:
3.1. Never attempt to access any parts of the instrument other than those specifically described in
the user documentation. In particular, never open or manipulate any components on the
rear of the instrument.
3.2. Before removing the main cover, disconnect mains plug from socket. Hazardous Voltage is
present on ISE power supply even if main switch is off. Danger of electric shock when
touching power supply components.
3.3. Samples analyzed with this instrument may contain potentially infectious material.
3.4. Samples derived from humans, animals, tissue culture, or in vitro cultures should be handled
and processed with appropriate safety precautions.
3.5. Spills should be immediately disinfected with an approved disinfectant solution to avoid
contamination of laboratory personnel and equipment.
3.6. The laser transmitter warning designates the presence of a laser transmitter. Do not stare into
the laser transmitter of the barcode scanners.
3.7. Danger of explosion through sparks. Keep all potentially flammable of explosive materials (for
example anesthetic gas) away from the instrument.
3.8. Spraying liquid on the power supply can cause a short circuit and results in a fire. Keep the
cover closed while the instrument is connected to the main power supply and do not use
sprays in the vicinity of the Cobas Integra 400 plus.
3.9. Danger of injury to hands by moving parts. Keep the instrument cover closed while initialization
or measuring is in progress.
3.10. Danger of eye damage from the bright light of the absorbance photometer lamp.
3.11. Samples containing solids can produce false results and block probes. Ensure that samples
are free from insoluble particles.
3.12. Danger of cauterization and skin poisoning through contact with reagents. Pay attention to
the notes in the Cobas Integra Method Manual and the warnings on the cassettes.
3.13. Incorrect cleaning and maintenance can cause damage to personnel and equipment.
Perform cleaning and maintenance.
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Roche Cobas-Integra 400Plus Chemistry Operations SOP
3.14.
3.15.
3.16.

Incorrect cleaning materials can damage the Integra. Organic solutions damage cuvettes,
tubing, and other plastic materials. Use only 70% propanol solution to clean the equipment.
Never remove a rack from the rack area if the rack status indicators are red.
Never place any objects on top of the instrument

4. DAILY START UP PROCEDURE:

4.1. Starting the instrument
4.1.1. If the power is off, press the main switch on the analyzer to start a full instrument
initialization. Turn on the computer after switching on the analyzer.
4.1.2. If the instrument is sleeping (blue background), press F11 on the keyboard, or click
the Start on the navigation bar to start a partial instrument initialization.
4.1.3. If the instrument is in standby (gray background), no action is needed and you are
ready to log on.
4.2. Logging into the system
4.2.1. Press Shift + F3
4.2.2. MU-JHU lab users must log into the system with the
User name: mu-jhu
password: mu-jhu
4.3. Beginning of the day report (BOD):
4.3.1. The system performs pre-selected service actions and other automatic actions at the
assigned Begin of Day (BOD) time (08:00 am). No user action is required.
4.3.2. The Begin of Day report summarizes all information about the last performed BOD. Use
the report to plan your next steps, such as preparing calibrators and controls, loading
cassettes, or performing service actions that are due.
4.3.3. To check the Begin of Day report:
a. Choose File > Print Report > Begin of Day.
b. Click OK. - The Begin of Day report will print.
4.3.4. Check the Begin of Day report for the following items and plan your next steps
accordingly.
4.4. Note: Cleaning the instrument externally This task will not be listed on the BOD but must
be performed daily (at the end of day) and documented on the COBAS INTEGRA 400 plus
Maintenance Log
a.
External cleaning can be performed with a cloth and solution of 70% propanol.
b.
Clean the instrument only while it is on Stand-by.
I.
Do not use organic cleaning solvents, such as petroleum, benzene, petrol, or
other solvents, because they can damage cuvettes, tubing, and other plastic
materials.
II.
Do not use an alcohol solution with a concentration greater than 70% alcohol,
because this may damage transparent viewing modules.
III.
Do not use sodium hypochlorite solution (i.e., Bleach) because it causes
corrosion on metal parts.
4.5. Activator: Activating ISE Electrode:
This is an automatic service action that does not require manual intervention. The electrode
surfaces must be activated with fresh serum so that the correct potentials are measured. This
service step is particularly important because the electrodes may be damaged if they are
deprived of regular contact with serum.
4.5.1. Acceptable activator material
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Roche Cobas-Integra 400Plus Chemistry Operations SOP
a.
b.

Filtered -0.22 um- normal human serum is used for ISE activator.
Filtered -0.22um- fetal bovine serum pooled human serum or reconstituted Roche
controls (ie. Preicpath or Precinorm) may also be used as activator if normal human
serum is not available.
4.5.2. Activator container should be cleaned out using DI water and replaced at the end of
each workday with 5 ml of serum (see 4.5.1 above).
4.5.3. Once per week, clean activator bottle out with 10% bleach and then rinse with plenty of
DI water.
4.5.4. Activator is placed in plastic bottles, such as those previously used for ISE Etcher or ISE
Solutions.
4.6. Loading cleaners, diluents, and ISE solutions
4.6.1. Check for any expired or low level reagents.
4.6.2. Load the necessary cleaners and diluents on their correct rack positions according to the
Begin of Day report (BOD)
4.6.3. Insert the racks
Note: After loading or replacing ISE solutions on the ISE rack, the ISE rack replaced
dialog box is displayed. On the dialog box select the ISE solutions that you have
replaced and leave the other boxes blank.
4.7. Loading and Mixing Cassettes
4.7.1. Check for any expired or low level cassettes
4.7.2. Click on the Cassettes tab in the status work area to check what cassettes you need to
load for the daily routine.
4.7.3. Unwrap the cassettes (pierce the aluminum foil on the bottles-as needed), using the tip
of the unlock rack tool.
4.7.4. Place the required cassettes on a cassette rack, and insert the rack into a free slot in the
cassette area.
4.7.5. To mix cassettes: Click the New Messages tab in the Messages work area to check for
messages of the format Cassette <name> on rack <number>, Position <position>
requires mixing.
4.7.6. Click the Cassettes tab in the Status work area and check for cassettes with the Req.
Mixing status.
4.7.7. Wait until the rack status light is green and remove the racks containing the cassettes to
be mixed.
4.7.8. Place the reconstituted cassettes on the external mixer (use the Plate-form shaker) for
10 minutes.
4.7.9. Place the cassettes needing periodical mixing on an external
mixer for one minute.
4.7.10. Re-insert the rack into the cassette area.
4.7.11. After the required mixing time is elapsed, remove the rack again
and put the reconstituted cassettes on the rack, and re-insert the
rack into the cassette area.
4.8. CHECKING RESOURCES:
4.8.1. If you need to take some action to keep the system running
efficiently, the background color and the picture on the Status
button change: for example, if cuvettes are running low, you see
the cuvette icon with a yellow background.
4.8.2. The background color of the Status button tells you whether you
need to take action or not:
I. Red (running man)
Immediate action Required
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Roche Cobas-Integra 400Plus Chemistry Operations SOP
II. Yellow-soon
III. Green or gray

Soon (earliest convenient)

No action needed

4.8.3. The various status buttons will change color as above when action is needed.
4.8.4. Replacing the Cleaner
a. When the cleaner is nearly finished, the system warns you by displaying the cleaner icon
with a yellow background.
b. The system automatically detects that cleaner has been replaced and resets the icons to
their normal states.
c. If the system completely runs out of cleaner, or if the cleaner temperature exceeds
37.5C, the icon turns red and the system stops.
d. To replace the cleaner bottle
I. Lift the main cover
II. Remove the cap (B) from the existing cleaner bottle and
place the level detection sensor and tubing carefully to
one side.
III. Discard the used cleaner bottle
IV. Remove the cap from the new cleaner bottle and place
the bottle in the slot provided (C).
V. Reinsert the sensor and the tubing. The cap should fit
loosely on the top of the bottle.
VI. Close the main cover.
4.8.5. Refilling the Cuvette reservoir
a. When the cuvette icon turns yallow you must refill the cuvette reservoir before the
system runs out of cuvettes. The number of cuvettes that are still available for use is
displayed in the Analyzer tab in the Status work area.
b. You can perform this task at any time while the system is running.
c. The cuvette reservoir can hold a maximum of 1400 cuvettes. Each pack contains
approximately 1000 cuvettes.
d. Make sure that you do not touch the surface of any cuvettes. Result accuracy may be
affected.
e. To refill the cuvette reservoir
I. Open the cuvette reservoir access panel (A)
II. Remove the cuvette reservoir together with the covering slide.
DO not remove the slide from the reservoir.
III. Turn the reservoir upside down.
IV. Cut open the cuvette pack and, taking care not to touch the
cuvettes, pour the cuvettes into the reservoir.
V. Reinsert the reservoir and the slide back into position.
VI. Remove the slide, taking care not to spill any cuvettes
VII. Replace the slide at the top of the reservoir.
VIII. The system automatically detects that the cuvette reservoir has been refilled.
4.8.6. Refilling the external Water reservoir
a. When the water supply icon turns yellow, you must refill the external water reservoir.
When the icon is red, the system stops.
b. To refill the reservoir
I. Remove the tubing adapter from the reservoir and put it temporarily into a clean
empty plastic bucket.
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Roche Cobas-Integra 400Plus Chemistry Operations SOP
II. Refill the reservoir with reagent grade, type I Deionized (DI) Water
III. Insert the tubing adapter into the reservoir.
4.8.7. Emptying the external waste reservoir
a. If the waste drain icon turns yellow or red, you must empty the external reservoir.
b. To empty:
I. Ensure that the system is in standby, sleep, or turned off
II. Remove the tubing adapter from the reservoir and place it temporarily in a clean
empty plastic bucket.
III. Dispose of the waste down the designated biohazards waste drain.
IV. Rinse the waste reservoir with water
V. Add 100% bleach (JIK) to the bottom of the reservoir (empty one Bottle -750 ml- of
Jek)
VI. Replace the rubbing adapter.
4.8.8. Replacing the cuvette waste box
a. The cuvette waste box stored fluid waste from the ISE module, and up to 1000 used
cuvettes.
b. When the yellow cuvette waste box icon appears, you must replace the cuvette waste
box as soon as possible. When the icon is red, the system stops.
c. Replace the waste box while the system is in standby
d. To replace:
I. Wait until system is in standby
II. Construct new waste box according to the instructions inside the cuvette waste access
panel B. The cuvette box is supplied with a yellow biohazard sticker already in place.
III. Open the cuvette waste access panel
IV. Remove the full waste box, taking care not to spill any of the contents
V. Put a rectangular sticker over the holes in the top of the waste box.
VI. Insert the new assembled waste box, taking care to ensure that the lip around the
middle of the box fits into the guide rails.
VII. Close the cuvette waste access panel.
VIII. The system asks whether the cuvette box is empty, click yes if it is empty.
IX. Dispose of the old box in biohazards waste container.
4.8.9.
a.
b.
c.
d.

Documentation of Daily start up

Complete the COBAS INTEGRA 400 plus Maintenance Log, initial and date
Fill in each block when each action has been performed.
Charts are to be reviewed and initials by the lab supervisor at least monthly.
Any problems should be noted in the Corrective Action (C/A) space provided and the box
on the daily chart checked.

5. CALIBRATION:
5.1. Calibrations are performed at regular intervals, as defined for each analyte/lot#, each reagent
cassette has the calibration intervals information pre-programmed by the manufacturer into its
bar code, and interrupted automatically by the instrument.
5.2. Additional calibrations also have to be performed when certain physical events occur. These
include:
I. A change in cassette
II. A change in cassette reagent lot
III. A change in the defined interval.
IV. Failure of quality control to meet required specifications
V. Major service of equipment
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Roche Cobas-Integra 400Plus Chemistry Operations SOP
VI. As deemed necessary by lab Chemistry tech or Roche representative.
5.3. The exact composition of calibrators and reagents vary between lots. Therefore, it is important
to check the lot numbers each time you replace a cassette or a calibrator and make sure that
the configurations are appropriated.
5.4. Tests for most enzymes and substrates have linear calibration curves, which require only a twopoint calibration.
I. One calibrator has a known amount of the analyte
II. The other is DI water, which is the zero calibrator.
III. The calibrators are placed next to each other on a sample rack. The calibrator with the
highest concentration must be placed first.
IV. All Calibrators are programmed to be placed in Slot I Rack #20
5.5. Prepare Cfas calibrator as follow:
I. Cfas Reconstituted in 3.0 ml DI water using the Eppendorf 5ml adjustable pipette.
II. Swirl gently and let sit in the instruments cabinet; keep in the dark as much as
possible.
III. Swirl occasionally (every 5-10 minutes)
IV. After 30 minutes and Calibrator is completely reconstituted aliquots are made.
V. 500ul aliquots should be made in cryovials, using the Eppendorf 1ml pipette.
VI. Cryovials should be labeled with calibrator name Lot # reconstitution date expiration
date and preparers initials.
VII. Expiration of 2 weeks should be assigned for Cfas calibrator, and stored at -20C
Freezer
VIII. Calibrators should be thawed as required
IX. Calibrators should be thawed by placing at room temperature and keeping in the dark
(in the instruments cabinet) for at least 30 minutes swirling occasionally.
X. To Run: Transfer to Cobas-cup and place on pre-defined position on rack. Tube
directly after should have 500ul of DI water Type 1(i.e., Cfas-2).
5.6. The CO2 calibrator comes in a squeeze bottle that is stored at 4C. The second tube is water,
as in the CFAS calibrator.
5.7. Requesting calibrations
5.7.1. Most calibrations are scheduled to run automatically, but you may need to request a
calibration if
A new calibrator lot is started
The test definition is changed
More than one cassette for a test is on board
Control measurements are outside the specified range.
5.8. Any related controls (QC) must ALWAYS be run after a calibration.
5.9. Click Orders on the navigation bar, click calibration tab, click on the tests that you want to
calibrate, save.
5.10. Setting up calibrators
a.
Information about a calibrator for a test is stored in the test and calibrator definitions,
which you can access through the Configurations area.
b.
When you change calibrator lots you have to specify the lot number and expiration
date, and the assigned values of the new lot.
c.
To manually update a calibrator lot number
I. Click configuration
II. Double click on calibrators in the definitions groups.
III. Select the required calibrator from the calibrators list.
IV. Click the Lot tab, click new lot
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Roche Cobas-Integra 400Plus Chemistry Operations SOP
V.
VI.

Enter new lot number and expiration, click save.

Select a test from the test list and type in the new values for each test from the
package insert. Clicks save

6. QUALITY CONTROL (QC):

6.1. Three modes of controls are recognized: accuracy, precision, and limit.
6.2. The test definition defines (refer to Core Lab Chemistry Bench Reference list) which controls
are used for a test.
6.3. Controls are always run
At the beginning of each day for each test to be run
After calibration of cassettes
6.4. Controls are run automatically according to the control interval defined in Configuration.
6.5. Reconstitution/thawing of controls
6.5.1. Reconstitution
a. Precinorm and Precipath - Carefully open one bottle, avoiding the loss of
lyophilizate, and pipette in exactly 5.0 ml of distilled/deionized water, using the
Eppendof 5ml pipette
b. Carefully close the bottle and dissolve the contents completely by occasional gentle
swirling within 30 minutes. Avoid the formation of foam.
c. Swirl occasionally (every 5-10 minutes)
After 1 hour and control is completely reconstituted aliquots are made.
d. 500ul aliquots should be made in cryovials using the Eppendof 1ml Adjustable
pipette.
e. Cryovials should be labeled with control name Lot # reconstitution date expiration
date and preparers initials.
f. Expiration date of 1 week from reconstitution should be assigned for precinorm and
precipath
I. Controls are stored at -30C freezer
6.5.2. Thawing of controls
a. A new aliquot of control should be thawed daily.
b. Controls should be thawed by placing at room temperature and keeping in the dark
for at least 30 minutes swirling occasionally.
6.6. Loading controls on board
6.6.1. Load in rack 20 - and position from the Status/Samples tab (each QC position is
predefined)
6.6.2. Remove the rack from its slot
6.6.3. Place 500ul of controls into Cobas Cups in appropriate positions. using the Eppendorf 1
ml Adjustable pipette.
6.6.4. Load the rack into slot I.
6.6.5. Requesting controls manually
a. Click Orders Quality Control tab.
b. In the Tests ad Profiles group, click test for which you want to request a control. Click
save.
6.7. Updating lot number of controls
6.7.1. Click configuration, double click controls in the definitions groups, select the required
control from the controls list.
6.7.2. Click the lot tab. Click new lot. Type the new values for the lot number and expiration
date. Click save.
6.7.3. For each test, select the control mode and type the values for this mode according to the
product insert. Click save.
6.8. Reviewing control results
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Roche Cobas-Integra 400Plus Chemistry Operations SOP
6.8.1. Click Results on the navigation bar, click the quality control tab.
6.8.2. Controls must meet the predefined West-guard rules programmed in the instrument for
each QC
6.8.3. If controls do not meet above specifications they must be re-run.
6.8.4. When control results fail to pass the following actions should be taken
a. Check to make sure that control aliquot is within one week of reconstitution
b. Check that calibration has been performed within required time
c. Re-run same aliquot of control up to 2 times
d. Thaw new aliquot of control
e. Re-constitute new control and run
f. Re-calibrate
6.8.5. Use the from button on the toolbar to specify a period to reduce the number of results
displayed.
6.9. Control results printing/documentation
6.9.1. Check and Print control results for all analytes that are run on that day.
6.9.2. Document observation (if any) in the Lab Daily QC sheet, initial and date.
6.9.3. Results are signed by the lab technician and then filed in the appropriate notebook.
6.9.4. At the end of each month results should be printed for the month, for the lab supervisor
to review and initial.
7. DAILY ROUTINE PROCEDURE:
7.1. Creating orders
7.1.1. Before creating new orders, completed orders from the previous day should be purged if
the machine has not already done so.
7.1.2. An order is created in as follow:
I.
Add Samples Accession# on the Sample tab of the orders work area
II.
Add Samples Accession# (in the Order ID Space)
III.
Select tests and click save
IV.
Choose rack number and position for samples
7.1.3. Select tests and save the order, as follows:
a. Click the buttons for the required profiles or tests.
b. Click STAT for a high priority order (only for STAT tests)
c. Click save
7.1.4. Confirm rack positions, as follows:
a. Check the automatically assigned rack number and position for each sample. Modify
the position as needed.
b. Select the Cup on tube check box if the sample is placed on a secondary cup on a
primary tube. Click ok.
Note: when a sample type is used for the first time on a day, you must assign it manually.
7.1.5. Loading samples on board
a. Once orders are entered into the system, print the load list by clicking on
FilePrint Load list
b. Set appropriate racks with adapters for samples in Cryovial ( need at least 300-500
ul sample vol) according to the loadlist.
c. If using Roche Cups must aliquot 300-500 ul using transfer pipette - Tap cups
lightly on surface of hood to make sure no air bubbles on bottom of cup
NOTE: Position Number 1 is at the end farthest from the rack handle. The
position number is indicated on the right side of the rack.
d. Once all samples loaded, load the sample rack into one of the slots in the sample
area.
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Roche Cobas-Integra 400Plus Chemistry Operations SOP
7.1.6. Make sure correct controls and calibrators are loaded on board in their pre-defined slots
(Slot I Rack # 20)
7.2. Start analyzing
7.2.1. If the system is in standby, press start
7.2.2. If the system is sleeping, press start. Once the system is in standby, press start to begin
the processing or press F11.
7.2.3. Check the work list as the processing begins, as follows:
a. Click Orders on the navigation bar and click the work list tab.
b. Check the work list for orders that are blocked or have no samples on board. Double
click blocked order to see the reason for the blockage.
c. Take the appropriate actions to resolve the problem.
7.3. Results Validation
7.3.1. Software has been configured to automatically flag any Critical results - These tests are
automatically repeated by the machine. Must report as stated in critical value
documented in the critical values SOP
7.3.2. These test results must be individually reviewed and accepted by the technician.
7.3.3. Click on the Validate tab of the Results work area. check all results located in the to
validate folder
7.4. To rerun or repeat a test
7.4.1. Click on the validate tab in the results work area
7.4.2. Select a sample, calibration, or control order
7.4.3. Select the results in question
7.4.4. Select rerun
7.5. To accept a result
7.5.1. Click on the results in the result window
7.5.2. Click accept
7.6. Printing of the final report
7.6.1. Once all of the results are accepted or validated, a final report will automatically be
printed out.
7.6.2. Final reports are printed
8. END OF THE DAY PROCEDURE:
8.1. Logging off the system
8.1.1. Logging off leaves the system ready for the next used.
8.1.2. To log off, double click on the user ID in the status bar and click log off.
8.1.3. Clean the Instrument and Replace the Activator (refer to point 4.4 )
8.2. Shutting down the system
Note: Instrument is designed to run continuously, so there is no need to switch it off,
unless directed to do so by the lab supervisor/Lab Team Lead or Roche Service
representative.
8.2.1.
8.2.2.
8.2.3.
8.2.4.
Note:
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Choose File>shut down

When shut down is complete, switch off the computer
Switch off the instrument at the main switch
Switch off the printer
Once you initiate a shutdown, I will take system about 15 minutes to complete shutdown.
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Roche Cobas-Integra 400Plus Chemistry Operations SOP
8.2.5. After shutdown, certain maintenance procedures will be run automatically from a
separate standby power supply
9. DOCUMENTATION:
9.1. Quality Control (QC) results should by reviewed daily and documented in the instrument Daily
QC sheet (if any QC didnt pass must document as No and comments in the comments
section)
9.2. Quality Control results for each test should be printed daily and saved in the Integra QC file (to
be reviewed weekly by the lab Team Lead/ Lab Supervisor.
9.3. QC results for each month should be printed at the end of each month and submitted to the lab
Supervisor for review.
9.4. All test results should be printed, reviewed by the bench tech and verified by a Sr. Tech.
9.5. All results are kept electronically on the computer.
10. WEEKLY DATA ARCHIVAL:
10.1.
On computer
10.1.1. At the end of each week data should be archived by selecting: File; Archive Results.
10.1.2. Be sure that Calibration, Quality Control, Samples, and Patient results are checked and
click on Archive
10.1.3. Enter dates to be archived. Last data archived should already be entered. Use the last
date from the last archive as the beginning date and todays date as the end date.
10.1.4. Select folder; My documents
10.1.5. File name should appear already with dates you have previously entered. Clicks save.
10.1.6. This will save all quality control calibration and test results
11. REFERENCES:
11.1. Roche Diagnostics, Reference Ranges for Adults and Children, Pre-Analytical Considerations,
2004.
11.2. Roche Cobas Integra Method Manual, Version 2
11.3. Roche Cobas Integra User Manual, Version 2.1
11.4. RV156 Protocol
12. APPENDICES
12.1. COBAS INTEGRA 400 plus Maintenance Log
12.2. Core Lab Chemistry Bench Reference list
12.3. Core Lab Chemistry Processing Reference list

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