TITLE: Coagulation Quality Control

PURPOSE

The Coagulation department requires a comprehensive Quality Control program to ensure accurate test results. Quality Control serves to verify the accuracy and precision of reported test values by checking instrument performance, reagent performance and Technical performance. Quality control results are reviewed for acceptability before reporting patient results. Appropriate action is required if results are unacceptable. Monthly QC data is submitted each month to Dade IAQP for evaluation.

PERSONNEL

Medical Technologists and Technicians

SPECIMEN

Manufacturer’s Reagent Controls

REAGENT PREPARATION & EQUIPMENT

1.	Sysmex CS-2500 and Sysmex CA-660 Coagulation analyzers and instrument supplies.

2.	Dade Citrol controls: Levels 1, 3, Fibrinogen Abnormal Control, D-Dimer QC Level 1 and 2 and Control N and Control P control for AT3.

3.	All reagents in Hematology and Coagulation are properly labeled, as applicable and

appropriate, with: the content and quantity, concentration or titer; storage requirements;

dated prepared or reconstituted/opened by the laboratory and the expiration date on the

container or the box housing the individual smaller bottles. All reagents are stored

according to manufactures instructions and used within their expiration dates. Reagents

with no stated manufactures expiration are used until visible or performance changes

occur, then discarded.

Citrol Levels 1 & 3, Abnormal Fibrinogen, D-Dimer Controls and Control N&P

4.	Preparation of Controls:

A.	Add 1 ml of bottled sterile water using the 1000 uL MLA

pipette. Restopper the vial and gently tilt the vial to mix.

B.	Allow to stand for 15 minutes until dissolved after reconstitution.

C.	Invert gently to mix. -- DO NOT SHAKE. Gently mix once more before use.

D.	Store at 2 to 8 oC when not in use. Reconstituted control is Stable for 24 hours on-board the CS-2500. Do not store open QC on-board the CA-660. See individual QC product for more detailed storage requirements.

E.	Date bottle or control sample cup with reconstitution date,

time and initials. Expiration dates/times need to be on all reagent bottles.

CALIBRATION

Calibration for Fibrinogen, D-Dimers and AT3 is performed with each new lot of reagent and every 6 months thereafter. Calibration may also be required if QC is not within the acceptable limits, after analyzer component replacement or major maintenance procedures.

STEPWISE PROCEDURE for QC

I	PT and PTT Quality control:

Level 1 and 3 (Citrol)

Run 2 levels of QC every 8 hours, with the change of any reagents or diluents, following maintenance procedures or if patient results are questionable.

Controls are good to 24 hours once reconstituted on-board the Sysmex CS-2500. Do not let QC sit on-board the Sysmex CA-660.

Reconstituted QC is stable for 16 hours when stored at 2-8 oC.

Quality Control results for CS-2500 and CA-660 will cross to the LIS. QC from the analyzers is reviewed and verified after each run. Monthly QC reports are printed and submitted to the Dade IQAP program for evaluation.

II.	Fibrinogen Quality Control:

A.	Citrol Level 1 and Abnormal Fibrinogen Control

1.	Run Citrol Level 1 as a normal control and Abnormal Fibrinogen as the low fibrinogen control. Run daily 2 levels of QC every 8 hours of patient testing, with the change of any reagents or diluents, following any maintenance procedures or if patient results are questionable

2. Controls are good to 24 hours once reconstituted on the Sysmex CS-2500. Do not let QC sit on-board the Sysmex CA-660.

3. Once reconstituted QC is stable for 16 hours when stored at 2-8 oC or

4 weeks at < 20 degrees.

4. Quality Control results for CS-2500 and CA-660 will cross to the LIS.

QC from the analyzers is reviewed and verified after each run. Monthly QC reports are printed and submitted to the Dade IQAP program for evaluation.

III.	D-Dimer Quality Control:

Run D-Dimer Level 1 and D-Dimer Level 2 with the reconstitution of new reagents and every eight hours of patient testing.

2.	Controls are stable on-board the Sysmex CS-2500 for 24 hours. Do not store QC on the Sysmex CA-660.

3.	Once reconstituted, D-Dimer controls are stable for 7 days when stored

at 2-8 oC.

IV.	AT3 Quality Control:

1.	Run Control N and Control P every eight hours when performing the Anti-Thrombin3 (AT3) assay.

2.	Controls are stable on-board the Sysmex CS-2500 analyzer for 24 hours. The Sysmex CA-660 has not been validated to run the AT3 assay.

3.	Once reconstituted Control N and Control P are stable for 4 weeks when stored at -20 oC.

V.	Quality Control Decisions:

PT, PTT, Fibrinogen, D-Dimer and AT3

A. All levels of quality controls should be within 2 SD. Patient samples will not auto-

Verify if QC is out 2SD.

B.	Rerun QC if it is not within 2SD. If it is still not within the acceptable range, prepare a new bottle of Quality Control material and rerun. Document your troubleshooting actions in the LIS. If QC is still unacceptable, prepare new reagents and rerun.

Any further problems - contact a Sr. Tech.

C. All QC problems must be documented in the LIS, this is a required action.

Patients results are not to be reported until QC results are acceptable.

D. New Lots: All new lots of reagents are verified before being put into use by

Running patient comparison studies, instrument comparisons or verifying calibrated test reagents with a known and verified reference material. Other reagents or kits are verified with the use of a negative and positve control prior to use for patient testing.

E.	New lot of Quality control material are verified by establishing ranges based on manufacturer’s recommended ranges, peer group evaluations and analyzer testing.

F.	When putting new lots of QC material in use, refer to procedure #4840-CO-0010 for detailed instructions.

G.	Performance Verification after service/maintenance: the FSI performs all function tests on the analyzer and runs all QC material to verify instrument function. QC is entered in the LIS. Service records are printed and saved in a binder.

PROCEDURAL NOTES

All QC results and QC outliers are reviewed on an ongoing basis in the LIS, and monthly by designated person in Heme/Coag or Sr. Tech.

REPORTING RESULTS

QC results are entered in TQC

REFERENCES

1. Quality Control: American Dade Publications by David Plant and Janis Silberman.

2. Dade Behring Ci-trol Coagulation Control Product inserts.