Husmhema-Upt STM C2

HAEMATOLOGY DEPARTMENT, HOSPITAL UNIVERSITI SAINS MALAYSIA TITLE: PROCEDURE NO.
DETERMINATION OF FIBRINOGEN BY CLAUSS METHOD HUSM/HEMA-UPT/STM-C2 VERSION NO. VERSION DATE. 1 01.11.2009
APPROVED BY:
... ASSOC PROF DR ROSLINE HASSAN HEAD OF HAEMATOLOGY DEPARTMENT
CONTROLLED COPY NO : 4 REGISTERED HOLDER HAEMATOLOGY LABORATORY
RECORD OF REVIEW/AMMENDMENT
DATE 1.8.2011
VERSION NO.
DETAIL OF AMMENDMENT Add test procedure for a new machine STA-R Evolution (5.1b)
BY Wan Soriany bt Wan Md Zain
Page 1 of 14
STANDARD TEST MANUAL

PREPARED BY DESIGNATION CHECKED BY DESIGNATION AUTHORISED BY DESIGNATION 1. 2. 3.
DETERMINATION OF FIBRINOGEN BY CLAUSS METHOD HUSM/HEMA-UPT/STM-C2
VERSION NO. VERSION DATE.
1 01.11.2009
: WAN SORIANY WAN MD ZAIN : QUALITY OFFICER / SCIENTIFIC OFFICER : ASSOC PROF DR WAN ZAIDAH WAN ABDULLAH : DEPUTY QUALITY MANAGER / HAEMATOLOGIST : ASSOC PROF DR ROSLINE HASSAN : HAEMATOLOGIST/LAB DIRECTOR
OBJECTIVE Quantitative Determination of Fibrinogen in human citrated plasma. METHOD Detection of Clot formation by Clauss method PRINCIPLE Fibrinogen assay is a quantitative determination of fibrinogen level in plasma by the clotting method of Clauss. In the presence of an excess of thrombin, the clotting time of diluted plasma has a direct bearing on the level of plasma fibrinogen.
4.
REQUIREMENTS 4.1 EQUIPMENT 4.1.1 4.1.2 4.1.3 4.1.4 4.2 REAGENT 4.2.1 STA Fib 2 (Cat. No: 00238) 1. Reconstitute with 2ml distilled water. Wait for 5 minutes. 2. Mix manually : turn upside down several times 3. Leave at room temperature for 30 minutes. 4. Homogenize before loading. 5. On board (15-19 C) stability: 4 days. STA Owren Koller (Cat. No: 00360) 1. Ready for use. 2. On board (15-19 C) stability: 4 days. STA Compact or STA-R Evolution Centrifuge Micropipettes (500 l, 1000 l) Pipette tips
4.2.2
4.3 CONTROL STA- Coag Control N + P (Cat.No: 00679) 1. Reconstitute with 1 ml distilled water. Wait for 5 minutes 2. Swirl gently. Do not turn upside down. 3. Leave at room temperature for 30 minutes. 4. Homogenize before loading. 5. On board (15-19 C) stability: 8 hours. Can freeze at -20C or below for better stability.
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HAEMATOLOGY DEPARTMENT, HOSPITAL UNIVERSITI SAINS MALAYSIA TITLE: PROCEDURE NO. DETERMINATION OF FIBRINOGEN BY CLAUSS METHOD HUSM/HEMA-UPT/STM-C2 VERSION NO. VERSION DATE. 1 01.11.2009
Note: Action for out of limit controls: Refer to Guideline Quality Assurance of Coagulation Lab and HUSM/HEMA-UPT/QP-04 4.4 SPECIMEN COLLECTION AND TREATMENT Blood (9 volume) is collected in 0.109 M (i.e 3.2%) trisodium citrate anticoagulant (1 volume) Centrifugation: 15 min at 2500 g Plasma stability: 8 hours at 20 +/- 5 C 5. 1a NO 5.1 PROCEDURE BY STA COMPACT ACTIVITY Run calibration when reagent lot number changed @ QC result not good Esc Main Menu Calib/ Control Enter Calibration Enter RESPONSIBILITY MLT/SO
If calibration out, rerun the calibration 5.2 Perform Quality Control Esc Main Menu Calib/ Control Enter Quality Control Enter MLT/SO
If QC out of range, rerun the QC 5.3 Loading Reagent@Control In Product Drawer 5.3.1 5.3.2 5.3.3 5.3.4 Open product drawer ( Press F2) Scan barcode label of STA-Fib 2 bottle Press Enter (the cursor will move to Pos) Put the bottle in the drawer ( ensure a beep sound is heard) If the lot number of reagent change is detected, the following window is displayed:
LOT NUMBER CHANGED All concerned calibrations will be definitely invalid Accept (YES/NO)
MLT/SO
i. ii. iii. 5.3.5
Type YES and press ENTER Scan the barcode sheet Press ESC when end of data processing
Continue loading STA-Coag Control N+P

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5.3.6 5.3.7 5.3.8 5.3.9 5.3.10 5.3.11 5.3.12 5.3.13 5.4
1 01.11.2009
Close the Product Drawer when end of loading Open Sample drawer (press F1) Scan barcode label of STA-Owren Koller bottle Choose F1 for Diluent Press ENTER (the cursor will move to Pos) Put the bottle in position 8 (ensure the beep sound is heard) Close the Sample Drawer when end of loading If QC results OK, proceed with patient testing MLT/SO
Loading sample In sample Drawer 5.4.1 Open Sample Drawer 5.4.2 #Press F12 if the patient sample is STAT sample #Press F8 to change Normal Tube to Micro Tube if the pediatric sample tube has been transferred to adaptor 5.4.3 Enter Patient ID or Scan barcode label on tube. 5.4.4 Put the sample tube in the drawer (#ensure a beep sound is heard) 5.4.5 Select the test (Fibrinogen) 5.4.6 Press F10 to validate 5.4.7 Continue loading other patient samples. If not, close the Sample Drawer 5.4.8 Press ESC 2 times, test panel screen will appear. 5.4.9 Select barcode number, press ENTER, Test Panel - File Processing Screen appear move cursor to green box. 5.4.10 Key in Patients name, RN and MLT. Move cursor to test selected, press F10 to save.
5.5
Result Entry 1. 2. The result is entered on the appropriate Request Form Record the result in Laboratory Information System (LIS)
MLT/SO
5.6
Result Print-Out 1. Press Esc Main Menu Files Enter Confirmation/printout Enter
MLT/SO
2. CONFIRMATION/PRINTOUT screen displayed, Press the ESC key , the window displayed:
Change File Selection Transmit Print Quit
With cursor positioned on Quit

Page 4 of 14 STANDARD TEST MANUAL
3. Move the cursor to Print by pressing the key, then confirm with the The PRINTOUT window is displayed , see description below
PRINTOUT Unprinted Files All Files Printer Setup Quit
key.
Depending on the required patient files: Move the cursor to all files or Unprinted Files, then confirm with the key. The file printout starts.
Quit
5. 1b NO 5.1 5.1 5.1.1
PROCEDURE BY STA-R EVOLUTION ACTIVITY Loading Reagent @ Control in Product Drawer To Open Product Drawer icon RESPONSIBILITY MLT/SO
1. From Functional Panel menu, click on 2. Click on OPEN tab
5.1.2 Loading a reagent or control with bar code identification For STA bar coded reagent only 1. Open Product Drawer 2. Scan bar code label of reagent or control vial through build-in barcode reader 3. Check the box or press F8 key for microvolume sample ** Reagent or control must transfer into microcups ** Change the reagent or control volume if necessary 4. Check reagent appropriate position availability by clicking the down arrow ** R0 only reserved for calibrator, control, diluent and Desorb U ** R1 only reserved for intermediate reagent and Desorb U ** R2 only reserved for Start reagent and Desorb U
5. Load reagent or control into appropriate position 6. If different lot number of reagent/control/calibrator is detected, following Question displayed Do you wish to read the calibration parameters using the barcodes? Click on OK tab to read the reagent or control bar coded sheet immediately. Please proceed to step 10 to step 14. OR Click on Abort tab to read the reagent or control bar coded sheet after close the Product drawer. Please proceed to step 7 to step 12. 7. Continue loading of next reagent or control 8. Click on Close Drawer tab to close product drawer. 9. In the Product Screen menu, click on ** 583 represented last 3 digits of new reagent lot. 10. Scan reagent or control bar coded sheet 11. Click on Confirm tab 12. Click on Close and Calibrate to start the calibration 13. Continue loading of next reagent or control 14. Click on Close Drawer tab to close product drawer. 5.1.3 Loading a reagent or control using manual identification For non STA bar coded reagent 1. Open Product Drawer 2. Type the product identification as defined in the Test setup menu, then click on to confirm Example: ID for STA PTT Automate 5 is 12203 3. Check the box or press F8 key for microvolume sample in Lot column
** Reagent or control must transfer into microcups ** Change the reagent or control volume if necessary 4. Type the reagent or control lot number, then click on to confirm
5. Check reagent appropriate position availability by clicking the down arrow ** R0 only reserved for calibrator, control, diluent and Desorb U
** R1 only reserved for intermediate reagent and Desorb U ** R2 only reserved for Start reagent and Desorb U 6. Load reagent or control into appropriate position 7. If different lot number of reagent/control/calibrator is detected, following Question displayed Do you wish to read the calibration parameters using the barcodes? Click on OK tab to read the reagent or control bar coded sheet immediately. Please proceed to step 10 to step 14. OR Click on Abort tab to read the reagent or control bar coded sheet after close the Product drawer. Please proceed to step 7 to step 12. 7. Continue loading of next reagent or control 8. Click on Close Drawer tab to close product drawer. 9. In the Product Screen menu, click on ** 583 represented last 3 digits of new reagent lot. 10. Scan reagent or control bar coded sheet 11. Click on Validate tab 12. Click on Close and Calibrate to start the calibration 13. Continue loading of next reagent or control 14. Click on Close Drawer tab to close product drawer. CALIBRATION Calibration should be performed when reagent lot change. Pre-calibrated test Only 2 active calibrations per test (2 different lots) allowed. The oldest calibration curve will automatically delete when third reagent lot introduced to system 1. From the message box Do you wish to read the calibration parameters using the barcodes?
in Lot column
MLT/SO

2. 3. 4. 5. 6. 7. Click on OK tab Scan reagent or Control bar code sheet Click on Confirm tab Click on Close and Calibrate tab Click on Validate tab Enter Password and User Identification
1 01.11.2009
Notes : Review calibration. Shall perform and review a calibration* whenever reagent lot number changed or QC result not satisfactory. * If calibration invalid r 0.985, 5.2 Perform Quality Control 5.2.1 Multiple Test Controls Request icon rerun the calibration MLT/SO
1. From Function Panel menu, click on 2. Highlight the test, e.g. PT.
3. Continues selection of other tests, e.g. APTT, FIB and D-Dimer by using Shift key or Ctrl key for random selection 4. Click on icon
5. Enter Password and User Identification 6. Click on OK tab 5.2.2 Single Level Control Test Request icon
1. From Function Panel menu, click on 2. Highlight the test, e.g. PT.
3. Click Control level 1 or Control level 2 tabs 4. Click on icon
5. Enter Password and User Identification 6. The following message displayed:

PT Level: 1. Run the control? 7. Click on OK tab 5.2.3 To View Quality Control Result
To View Daily Quality Control Result in Tabular Mode 1. From Function Panel menu, Click on 2. Click on icon icon
3. Daily Control Screen open and daily quality control results displayed. 4. Re-sort the daily control displayed sequence by test, control level, result, etc by clicking on the heading of the column you would like to use. 5. If control is out or to be validate, double click or right click on the control in the Status column. Click on Validate, Delete or Rerun to validate, delete or rerun the control. 5.2.4 To view Daily Quality Control in Graphic Mode icon
1. From Function Panel menu, Click on 2. Highlight the test, e.g. PT.
3. Click Control level 1 or Control level 2 tabs to view QC graph Notes: Review quality control data.If QC out of range, rerun the QC. (Refer to Westgard et al for identification and resolution of out of-control situations). 5.3.1 Loading Sample Tubes 1. From Function Panel menu, click on 2. Click on Test Panel tab 3. Make sure either screen. 4. Load sample tubes into the sample rack 5. Load sample racks onto sample rack tray. 6. Load sample rack tray onto the Rack Tray Loading Zone (left side of STA-R) 7. The sample tubes automatically loaded and sample tube bar code label
MLT/SO icon
icon or
icon are presented in the Test Panel
automatically scan and identify. 8. If the sample tube bar code label unable to read, the sample rack will unload and following message appear: There are unread IDs in the rack. Please re-enter the IDs 9. Click on OK tab 10. Manual Input of Patient IDs screen appear for sample tube re-identification
1. Check the unread sample tube position. Click on unread sample tube to be enter by clicking the number of tube position on 2. Enter the sample tube bar code manually on STAT for urgent sample on Pediatric for microvolume sample.
3. Click on
to confirm.
5.3.2
Request Test 5.3.2a: Request Test by Profile 1. From Function Panel menu, click on 2. Click on Test Panel tab 3. Tag sample to be add test or Click on T column heading to Tag All sample 4. Click on Apply Profile to Tagged Identities 5. Choose and click on the profile from the list 5.3.2b: Request Single Test 1. From Function Panel menu, click on
Page 10 of 14
MLT/SO
icon
icon

2. Click on Test Panel tab 3. Tag sample to be add test or Click on T column to Tag All sample 4. Click on Test Abbreviation header, e.g. PT, Click on Add tab 5. Add Test for all Tagged Identities? Test: PT? message appear 6. Click on OK tab 5.3.2c: Sample with Automatic Profile 1. From Function Panel menu, click on 2. Click on (Un) Loading tab 3. on Add Automatic Profile 4. Loading sample rack 5. The tests will automatically add and perform 5.3.2d Loading STAT Sample 1. From Function Panel, click on 2. Please make sure there is no rack in loading position before ending of Initialization message appear 3. Click on OK tab 4. Initialization of rack loading system. Wait until The message Load a new rack inside the instrument is displayed. 5. Push rack into the STA-R Evolution analyzer with rack barcode face inside 6. Rack load into sample area 7. Tag STAT sample 8. Click on Test Abbreviation header, e.g. PT, Click on Add tab to add single Test OR Click on T column heading, Click on Apply Profile to Tagged Identities and Choose and click on the profile from the list 5.4 View Patient Result a.View Non-Archived Patient Result ** Sample test request completely processed and tube remain in the analyzer. 1. From Function Panel menu, click on icon. MLT/SO icon
1 01.11.2009
2. Click on Test Panel tab, ten patient files are displayed.

3. Use the horizontal scroll bar to view other patient results. 4. Click on icon, select Search By tab and choosing the search method by
Clicking on Identity, Name or First Name tab 5. Click on Search tab. 6. Click or enter key to confirm.
b.View Archived Result ** Sample test request completely processed and tube removed from the analyzer. 1. From Function Panel menu, click on icon.
2.
Click on
icon.
3. 4.
Click on
icon.
Select Search By tab and choosing the search method by clicking on Identity or Date tab.
5. 6.
Click on Identity tab, click on Search tab for the entire day result. OR Click on Date tab, change the date for the period of the result to be view. Click on Search tab.
5.5
Printing Patient Result a. Printing Non-Archived Patient Result
MLT/SO
1. 2. 3. 4. 5.
From Function Panel menu, click on Tag the patient file to be printed. Click on icon
icon.
The following message displayed: Print All Tagged Files? Click to confirm.
Page 12 of 14
b. Printing Archived Patient Result
1.
From Function Panel menu, click on
icon.
1. 2. 3. 4. 5. Click
Click on
icon.
Tag the patient file to be printed. Click on icon or
Click the T column heading, select Printed All Tagged Files The following message displayed: Print All Tagged Files? to confirm.
6.
LIMITATION The STA-Fib 2 procedure is insensitive to following substances: fibrin degradation products (up to 130 g/ml), hirudin (up to 3 g/ml), unfractionated heparin (up to 1 IU/ml), low molecular weight heparin (up to 2 anti-Xa IU/ml).
7.
REFERENCE RANGE The normal plasma fibrinogen level in the adult population is usually in the range of 2-4 g/l.
8.
RESULT Results may be reported in the following units: g/L
Page 13 of 14
9.
INTERPRETATION Several congenital abnormalities of fibrinogen result in impaired conversion of fibrinogen to fibrin during blood coagulation. Fibrinogen is also a useful marker in evaluation of several disease states including Disseminated Intravascular Coagulation, liver disease, inflammatory diseases and malignancies. High levels of fibrinogen are associated with an increased risk for cardiovascular disease. Increased levels are also found during pregnancy and oral contraceptive use, while reduced levels are found during thrombolytic therapy.
10.
REFERENCES 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. Diagnostica Stago Haemostasis brochure STA Compact User Operation & Training Manual STA Compact Operators Manual NCCLS Document H21-A3 /A4 Fibrinogen 2 Insert STA Compact Protocols- Tests Settings MHT/DL/109 MHT/DL/110 Insert revision March 2007 MHT/DL/106
National Committee for Clinical Laboratory Standards. Preparation and Testing of Reagent Water in the Clinical Laboratory, Third Edition, NCCLS Document C3-A3: Vol. 17 No.18 Lewis, S.M., Bain, B.J., Bates, I. (2006). Dacie and Lewis Practical Haematology, Tenth Edition. Churchill Livingstone. Guideline: Quality Assurance Of Coagulation Laboratory HUSM/HEMA-UPT/QP-04 Guidelines On Fibrinogen Assays (BJH 2003); Vol 21(3):396-404
END OF DOCUMENT
Page 14 of 14

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HAEMATOLOGY DEPARTMENT, HOSPITAL UNIVERSITI SAINS MALAYSIA TITLE: PROCEDURE NO.

... ASSOC PROF DR ROSLINE HASSAN HEAD OF HAEMATOLOGY DEPARTMENT

CONTROLLED COPY NO : 4 REGISTERED HOLDER HAEMATOLOGY LABORATORY

BY Wan Soriany bt Wan Md Zain

STANDARD TEST MANUAL

HAEMATOLOGY DEPARTMENT, HOSPITAL UNIVERSITI SAINS MALAYSIA TITLE: PROCEDURE NO.

DETERMINATION OF FIBRINOGEN BY CLAUSS METHOD HUSM/HEMA-UPT/STM-C2

VERSION NO. VERSION DATE.

STANDARD TEST MANUAL

i. ii. iii. 5.3.5

Continue loading STA-Coag Control N+P

HAEMATOLOGY DEPARTMENT, HOSPITAL UNIVERSITI SAINS MALAYSIA TITLE: PROCEDURE NO.

DETERMINATION OF FIBRINOGEN BY CLAUSS METHOD HUSM/HEMA-UPT/STM-C2

VERSION NO. VERSION DATE.

With cursor positioned on Quit

5. 1b NO 5.1 5.1 5.1.1

1. From Functional Panel menu, click on 2. Click on OPEN tab

HAEMATOLOGY DEPARTMENT, HOSPITAL UNIVERSITI SAINS MALAYSIA TITLE: PROCEDURE NO.

DETERMINATION OF FIBRINOGEN BY CLAUSS METHOD HUSM/HEMA-UPT/STM-C2

VERSION NO. VERSION DATE.

3. Click Control level 1 or Control level 2 tabs 4. Click on icon

5. Enter Password and User Identification 6. The following message displayed:

icon are presented in the Test Panel

HAEMATOLOGY DEPARTMENT, HOSPITAL UNIVERSITI SAINS MALAYSIA TITLE: PROCEDURE NO.

DETERMINATION OF FIBRINOGEN BY CLAUSS METHOD HUSM/HEMA-UPT/STM-C2

VERSION NO. VERSION DATE.

2. Click on Test Panel tab, ten patient files are displayed.

Printing Patient Result a. Printing Non-Archived Patient Result

STANDARD TEST MANUAL

b. Printing Archived Patient Result

From Function Panel menu, click on

Tag the patient file to be printed. Click on icon or

RESULT Results may be reported in the following units: g/L

STANDARD TEST MANUAL

STANDARD TEST MANUAL

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