HUSMHEMA-UPT STM C2

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HAEMATOLOGY DEPARTMENT, HOSPITAL UNIVERSITI SAINS MALAYSIA

TITLE:DETERMINATION OF FIBRINOGEN

BY CLAUSS METHODVERSION NO. 1

PROCEDURE NO. HUSM/HEMA-UPT/STM-C2 VERSION DATE. 01.11.2009

Page 1 of 14 STANDARD TEST MANUAL

APPROVED BY:

………………………………….………..ASSOC PROF DR ROSLINE HASSAN

HEAD OF HAEMATOLOGY DEPARTMENT

CONTROLLED COPY NO : 4

REGISTERED HOLDER

HAEMATOLOGY LABORATORY

RECORD OF REVIEW/AMMENDMENT

DATEVERSION

NO.DETAIL OF AMMENDMENT BY

1.8.2011Add test procedure for a new machine

STA-R Evolution (5.1b)

Wan Soriany bt

Wan Md Zain








PREPARED BY : WAN SORIANY WAN MD ZAIN

DESIGNATION : QUALITY OFFICER / SCIENTIFIC OFFICER

CHECKED BY : ASSOC PROF DR WAN ZAIDAH WAN ABDULLAH

DESIGNATION : DEPUTY QUALITY MANAGER / HAEMATOLOGIST

AUTHORISED BY : ASSOC PROF DR ROSLINE HASSANDESIGNATION : HAEMATOLOGIST/LAB DIRECTOR

1. OBJECTIVEQuantitative Determination of Fibrinogen in human citrated plasma.

2. METHOD

Detection of Clot formation by Clauss method

3. PRINCIPLE

Fibrinogen assay is a quantitative determination of fibrinogen level in plasma bythe 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 STA Compact or STA-R Evolution4.1.2 Centrifuge4.1.3 Micropipettes (500 µl, 1000 µl)

4.1.4 Pipette tips

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.

4.2.2 STA –Owren Koller (Cat. No: 00360)1. Ready for use.2. On board (15-19° C) stability: 4 days.

4.3 CONTROL

STA- Coag Control N + P (Cat.No: 00679)1. Reconstitute with 1 ml distilled water. Wait for 5 minutes2. 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 -20°C or below for better stability.








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 citrateanticoagulant (1 volume)

Centrifugation: 15 min at 2500 g

Plasma stability: 8 hours at 20 +/- 5° C

5. 1a PROCEDURE BY STA COMPACT

NO ACTIVITY RESPONSIBILITY

5.1 Run calibration when reagent lot number changed @ QC result not good

“Esc” Main Calib/ “Enter” Calibration “Enter”Menu Control

If calibration out, rerun the calibration

MLT/SO

5.2 Perform Quality Control

“Esc” Main Calib/ “Enter” Quality “Enter”Menu Control Control

If QC out of range, rerun the QC

MLT/SO

5.3 Loading Reagent@Control In Product Drawer

5.3.1 Open product drawer ( Press F2)5.3.2 Scan barcode label of STA-Fib 2 bottle

5.3.3 Press ”Enter” (the cursor will move to Pos)5.3.4 Put the bottle in the drawer ( ensure a beep sound is heard)

If the lot number of reagent change is detected, the following window isdisplayed:

i. Type “YES” and press “ENTER”

ii. Scan the barcode sheetiii. Press “ESC” when end of data processing

5.3.5 Continue loading STA-Coag Control N+P

MLT/SO

LOT NUMBER CHANGED

All concerned calibrations will bedefinitely invalid

Accept (YES/NO)








5.3.6 Close the Product Drawer when end of loading

5.3.7 Open Sample drawer (press F1)5.3.8 Scan barcode label of STA-Owren Koller bottle

5.3.9 Choose ‘F1’ for Diluent5.3.10 Press “ENTER” (the cursor will move to Pos)

5.3.11 Put the bottle in position 8 (ensure the beep sound is heard)5.3.12 Close the Sample Drawer when end of loading5.3.13 If QC results OK, proceed with patient testing

5.4 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 pediatricsample 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 validate5.4.7 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 ProcessingScreen appear – move cursor to green box.

5.4.10 Key in Patient’s name, RN and MLT. Move cursor to test selected,press F10 to save.

MLT/SO

5.5 Result Entry

1. The result is entered on the appropriate Request Form

2. Record the result in Laboratory Information System (LIS)

MLT/SO

5.6 Result Print-Out1. Press

“Esc” Main “Files ” “Enter” Confirmation/printout “ Enter”Menu

2. CONFIRMATION/PRINTOUT screen displayed,

Press the ESC key , the window displayed:

With cursor positioned on Quit

MLT/SO

Change File SelectionTransmitPrint

Quit








3. Move the cursor to Print by pressing the key, then confirm with the key.

The PRINTOUT window is displayed , see description below

Depending on the required patient files:

Move the cursor to all files or Unprinted Files, thenconfirm with the key. The file printout starts.

5. 1b PROCEDURE BY STA-R EVOLUTION

NO ACTIVITY RESPONSIBILITY

5.1 5.1 Loading Reagent @ Control in Product Drawer

5.1.1 To Open Product Drawer

1. From Functional Panel menu, click on icon

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 thedown 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

MLT/SO

PRINTOUTUnprinted FilesAll Files

Printer SetupQuit








5. Load reagent or control into appropriate position

6. If different lot number of reagent/control/calibrator is detected, followingQuestion 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 theProduct 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 in Lot column** 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



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

** 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 thedown 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, followingQuestion displayed “Do you wish to read the calibration parameters usingthe 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 closethe

Product drawer. Please proceed to step 7 to step 12.



9. In the “Product Screen” menu, click on in Lot column

** 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



CALIBRATIONCalibration 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 parametersusing the barcodes?”

MLT/SO








2. Click on “ OK” tab

3. Scan reagent or Control bar code sheet

4. Click on “ Confirm” tab

5. Click on “ Close and Calibrate” tab

6. Click on “Validate” tab

7. Enter Password and User Identification

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, rerun the calibration

5.2 Perform Quality Control

5.2.1 Multiple Test Controls Request

1. From Function Panel menu, click on icon

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



3. Click Control level 1 or Control level 2 tabs

4. Click on icon

5. Enter Password and User Identification6. The following message displayed:

MLT/SO








“PT Level: 1. Run the control?”


5.2.3 To View Quality Control Result

To View Daily Quality Control Result in Tabular Mode

1. From Function Panel menu, Click on icon

2. Click on 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

1. From Function Panel menu, Click on icon


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


2. Click on “Test Panel” tab

3. Make sure either icon or icon are presented in the Test Panel

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








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 ID’s in the rack. Please re-enter the ID’s”


10. Manual Input of Patient ID’s 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



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


MLT/SO









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


5.3.2c: Sample with Automatic Profile


2. Click on (Un) Loading tab3. √ 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


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

MLT/SO








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. Click on icon.

4. Select Search By tab and choosing the search method by clicking on

Identity or Date tab.

5. Click on Identity tab, click on Search tab for the entire day result. OR

6. 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


2. Tag the patient file to be printed.

3. Click on icon

4. The following message displayed: “Print All Tagged Files?”

5. Click to confirm.

MLT/SO








b. Printing Archived Patient Result


1. Click on icon.

2. Tag the patient file to be printed.

3. Click on icon or

4. Click the T column heading, select Printed All Tagged Files

5. 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 1IU/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








9. INTERPRETATION

Several congenital abnormalities of fibrinogen result in impaired conversion of fibrinogen to fibrin during blood coagulation. Fibrinogen is also a useful marker inevaluation 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. Diagnostica Stago Haemostasis brochure2. STA Compact User Operation & Training

Manual

3. STA Compact Operator’s Manual4. NCCLS Document H21-A3 /A4

5. Fibrinogen 2 Insert6. STA Compact Protocols- Tests Settings

MHT/DL/109

MHT/DL/110

Insert revision March 2007

MHT/DL/106

7. National Committee for Clinical Laboratory Standards. Preparation and Testing

of Reagent Water in the Clinical Laboratory, Third Edition, NCCLS DocumentC3-A3: Vol. 17 No.18

8. Lewis, S.M., Bain, B.J., Bates, I. (2006). Dacie and Lewis Practical

Haematology, Tenth Edition. Churchill Livingstone.9. Guideline: Quality Assurance Of Coagulation Laboratory10. HUSM/HEMA-UPT/QP-0411. Guidelines On Fibrinogen Assays (BJH 2003); Vol 21(3):396-404

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