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Dianne Kitchen TEG rotem qc

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Thrombelastography (<strong>TEG</strong>) and<br />

Rotational Thromboelastometry (ROTEM):<br />

UK NEQAS for Blood Coagulation pilot scheme<br />

<strong>Dianne</strong> <strong>Kitchen</strong><br />

Specialist scientific lead for POC programmes<br />

UK NEQAS ( Blood Coagulation), Sheffield, UK


N ational<br />

E xternal<br />

Q uality<br />

A ssessment<br />

S cheme<br />

Not for profit organisation<br />

Part of NHS<br />

Role is to improve quality of testing and<br />

ultimately patient care


quality control<br />

the process of looking at goods when they are<br />

being produced to make certain that all the<br />

goods are of the intended standard<br />

In a medical situation<br />

To ensure all results are valid and accurate (and<br />

to be able to prove that the correct procedures<br />

were in place)


Internal QC<br />

Purchased from manufacturer<br />

Compares your result to a pre<br />

determined range<br />

On-going process<br />

Are my results the same<br />

today as they were yesterday<br />

Precision/ Reproducibility<br />

External QA<br />

A service from an external<br />

organisation<br />

Compares your result with<br />

other users<br />

Spot check<br />

Are my results the same as<br />

other centres doing the same<br />

test<br />

Accuracy


If the True result is<br />

the bull's-eye, this<br />

group of tests is<br />

inaccurate and<br />

imprecise


If the True result is<br />

the bull's-eye, this<br />

group of tests is<br />

inaccurate but<br />

precise


If the True is the<br />

bull's-eye, this group<br />

of tests is both<br />

accurate and precise


Tests of global haemostasis<br />

Often used in a POC setting such as theatres<br />

Allow reduction in turnaround time of tests<br />

Often used by non laboratory staff<br />

Quality control not always performed


®<br />

Cup rotates pin is<br />

stationary<br />

Cup are either Plain cup<br />

or Heparinase cup


®<br />

Pin rotates Cup is stationary<br />

Many reagents available,<br />

INTEM, EXTEM and<br />

HEPTEM


Time for clotting to<br />

begin<br />

Time until clot is 20 mm<br />

Rate of clot growth<br />

Clot firmness - trace<br />

width<br />

ROTEM<br />

CT (sec)<br />

CFT (sec)<br />

Angle( degrees)<br />

MCF (mm)<br />

<strong>TEG</strong><br />

R (min)<br />

K (min)<br />

Angle (degrees)<br />

MA (mm)


ROTEM / <strong>TEG</strong> analysis<br />

Angle<br />

time<br />

60 mm<br />

20 mm<br />

maximum clot<br />

firmness<br />

(MCF / MA) [mm]<br />

clotting time (CT / R)<br />

clot formation time (CFT / K)


Introduced in April 2006 as a pilot study<br />

Performed 8 surveys with 2 sample per survey<br />

Samples are lyophilised plasma, provided with<br />

diluent and pipette to reconstitute<br />

Parameters to test are<br />

For <strong>TEG</strong><br />

R, K, Angle and MA at 30 minutes<br />

For Rotem- CT, CFT, Angle, A10, A20 and MCF at<br />

30 minutes


Plain cup n=40<br />

Heparinase cup n=40<br />

Median<br />

CV%<br />

Range<br />

Median<br />

CV%<br />

Range<br />

R (mins)<br />

6.3<br />

26.7<br />

5.2-14.1<br />

6.7<br />

25.7<br />

5.3-13.0<br />

Angle<br />

76.2<br />

8.8<br />

54.8-79.8<br />

74.8<br />

10.0<br />

43.2-80.7<br />

K (mins)<br />

0.9<br />

51.9<br />

0.8-3.8<br />

1.0<br />

47.1<br />

0.8-3.6<br />

MA<br />

(mm at 30<br />

mins)<br />

44.6<br />

10.6<br />

39.6-69.0<br />

43.7<br />

6.8<br />

37.6-49.6<br />

This was a normal pooled sample<br />

Interpretations of R time for this sample were 25/33 normal for<br />

Plain cup and 22/31 were normal for heparinase cup


INTEM n=16<br />

EXTEM n=16<br />

Median<br />

CV%<br />

Range<br />

Median<br />

CV%<br />

Range<br />

CT (secs)<br />

149<br />

12.6%<br />

135-196<br />

43.5<br />

131.4%<br />

35-417<br />

Angle<br />

84.5<br />

1.2%<br />

81-85<br />

85<br />

7.0%<br />

62-87<br />

CFT (secs)<br />

28<br />

16.4%<br />

24-43<br />

26<br />

91.4%<br />

19-147<br />

A10 (mm)<br />

35.5<br />

8.0%<br />

30-41<br />

37<br />

7.2%<br />

34-43<br />

A20 (mm)<br />

MCF (mm at<br />

30 mins)<br />

38.3<br />

38.5<br />

6.9%<br />

9.4%<br />

34-43<br />

30-46<br />

This was a normal pooled sample<br />

39.5<br />

41<br />

7.5%<br />

8.2%<br />

Interpretations of CT for this sample were 12/14 normal for<br />

INTEM and 10/11 for EXTEM normal<br />

37-47<br />

38-50


INTEM n=16<br />

EXTEM n=16<br />

Result<br />

Median<br />

Result<br />

Median<br />

CT (secs)<br />

182<br />

149<br />

417<br />

43.5<br />

Angle<br />

81<br />

84.5<br />

62<br />

85<br />

CFT (secs)<br />

43<br />

28<br />

147<br />

26<br />

A10 (mm)<br />

30<br />

35.5<br />

34<br />

37<br />

A20 (mm)<br />

38<br />

38.3<br />

37<br />

39.5<br />

MCF (mm at 30<br />

mins)<br />

30<br />

38.5<br />

38<br />

41<br />

EXTEM results showed some major deviations from to median value<br />

Upon contact reagents for this test were found to be out of date


Plain cup n=35<br />

Heparinase cup n=35<br />

Median<br />

CV%<br />

Range<br />

Median<br />

CV%<br />

Range<br />

R (mins)<br />

18.0<br />

22.8<br />

12.7-25.2<br />

MA (mm at<br />

30 mins)<br />

No clotting achieved<br />

40.8<br />

51.3<br />

3.7-56.5<br />

This was a sample with added heparin to mimic a heparinised patient<br />

Interpretations of R time for this sample were 31/31 abnormal for Plain<br />

cup and 24/24 were abnormal for heparinase cup


INTEM n=15<br />

HEPTEM n=13<br />

Median<br />

CV%<br />

Range<br />

Median<br />

CV%<br />

Range<br />

CT (secs)<br />

MCF (mm at<br />

30 mins)<br />

No clotting achieved<br />

354<br />

60<br />

19.0<br />

3.8<br />

281-<br />

516<br />

56-64<br />

This was a sample with added heparin to mimic a heparinised patient<br />

Interpretations of CT for this sample were 15/15 abnormal for INTEM and<br />

6/7 were abnormal for HEPTEM


Quality control is essential for any test whether<br />

laboratory based or POC.<br />

Participation in an EQA programme can help to<br />

ensure reliable results<br />

EQA performance will give reassurance that the<br />

tests are giving similar results to other users


www.ukneqasbc.org<br />

dianne.kitchen@coageqa.org.uk

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