POCT and Coagulation · GEHT Subcommittee CBP and POCT • Created in 1998 by B. Jude (Lille) and D. Lasne (Paris) • Ann Fr Anesth Reanim 2004 23(6): 589-596 : ... catheterization

POCT and Coagulation

Antwerp, 23 Otober 2014

Dominique LASNELaboratoire d’hématologie, Hôpital Necker-Enfants-Malade, Paris

Particularities of Haemostasis

� Specific pre-analytical and analytical complexity

� Some of POCT does not have a counterpart in thelaboratory

� Some of them make possible the assessment ofsteps of haemostasis unexplored by the usualtechniques (fibrinolysis, clot firmness, quality ofplatelets)

I-Stat

I-Stat

Medical Biology – Legal framework in France

• 2010 : reform of medical biology

By 2020, 100% of the analysis will be certified by theCOFRAC (French committee of accreditation) according to thestandard NF EN ISO 15189.

• Code of public health (CSP)• Code of public health (CSP)

The examination procedures of a medical biology analysiscan not be performed outside of a medical laboratory exceptif it is necessary due to an urgent treatment decision. In thiscase, examination procedures have to be performed :

• In a health establishment

• Or in locations determined by order of state board

This document provides specific requirementsapplicable to POCT and is intended to be used inconjunction with EN 15189 standard

EN ISO 22870 standard : 2006

• Close to standard of EN ISO 15189 with

specificities

• Definition of Point of Care Testing : analysis made

Medical Biology – Legal framework in France

• Definition of Point of Care Testing : analysis made

near the patient or where he is, whose the result

can lead to a possible change in patient care

• Multidisciplinary group in health establishment to

evaluate the need of POCT in different contexts

Medical Biology – Legal framework in France

Nurses

Midwives

Physicians

Pharmacist

Gives practical advice for every

POCT

Gives practical advice for every

steps of the fulfillment of

examinations and for the

management of quality in the

medical laboratories according to

the current standards

Contents

� SGA4-01 Description of the processes involved in the control pf point-of-care testing. M. Vaubourdolle, V. Annaix, J. Goudable, P. Pernet

� SG4-02 Guidelines for the formation of a multidisciplinary group for point-of-care

testing supervision according to EN ISO 2287. P. Pernet M. J. Goudable V. Annaix, Vaubourdolle, A.

Szymanowicz

� SG4-03 Guidelines for selection and implementation of a point-of-care testing device

according to the EN ISO 22870 anf French regulation. P. Pernet, MC Guimont, I. Vuillome, S.

Penet, A. Szymanowicz, C. houlbert, V. Annaix, M. Vaubourdolle. Penet, A. Szymanowicz, C. houlbert, V. Annaix, M. Vaubourdolle.

� SG4-04 Guidelines for point-of-care testing quality management according to ISO

22870. P. Pernet, A. Szymanowicz, C. Oddoze, A. Vassault, V. Annaix, A . Gruson, M. Boisson

� SG4-05 Guidelines for documentation management mastery according to the EN ISO

22870 P. Pernet, A. Szymanowicz, J. Goudable, MC. Guimont

� SG4-06 Guidelines for the management of point-of-care testing pre-examination,

examination, and post-examination phases according to the EN ISO 22870 standard A.

Vassault, V. Annaix, C. Houlbert, Z. Berkane, M. Vaubourdolle, J. Goudable, MC Guimont, P. Pernet.

� SG4-07 Guidelines for the management of point-of-care testing non conformities

according to the EN ISO 22870 C. Houlbert V. Annaix, A. Szymanowicz, A. Vassault, MC Guimont, P.

Pernet

� SG4-08 Guidelines for te point-of-care testing post-examination phase management S.

Penet, I. Vuillaume, T. Nicolas, A. Szymanowicz, C. Houlbert, P. Pernet.

GEHT Subcommittee CBP and POCT

• Created in 1998 by B. Jude (Lille) and D.Lasne (Paris)

• Ann Fr Anesth Reanim 2004 23(6): 589-596 :

• In 2008, reimbursement of INR self testing forchildren

• Since 2013 : Guidelines for certification ofPOCT in Haemostasis :

GEHT Subcommittee CBP and POCT

POCT in Haemostasis :

– ACT : accepted in ABC (Annales de biologie

clinique)

– POCT INR : in process

– ....

ACT :

• Absolutely essential for CPB

• No equivalent in the laboratory

• Used for a long time by anesthetists

Guidelines for certification of ACT

• Used for a long time by anesthetists

METHODOLOGY

• Review of the literature

– medical justification

– performance of the method

Guidelines for certification of ACT

– performance of the method

• Survey : assessment of the current organization

• Assays in 4 laboratories

– Precision of the method

– Control the risks

• Limit : only university hospital

• 26 responses. 22 usable questionnaire (2 from Belgium)

Survey on ACT in France (2013)

6

4

Context of use

Cardiac catheterization

30%

Survey 2013

4

3 3

2

1 1 1

Other35%CBP

35%

Devices usedSurvey 2013

Hemochron (Gamida, ITC) ACT Plus (Medtronic)64% 36%

EBMD/Normes 22870

Multidisciplinary group on POCT

No response

8%

Instrument connexion

22 22

20

25

Survey 2013

Yes50%

No42%

2 2

0

5

10

15

Hospital data mangement system

Laboratory's data management system

Yes No

Role of the laboratory

• Choice of the devices in consultation with thelaboratory in 25% in CPB, and 43% in othercontext

• Biological validation (delayed) in 17%

Survey 2013

• Biological validation (delayed) in 17%

• Maintenance program in 12.5%

• Empowering staff :

– Done in 27%

– By the lab in 33%

Role of the laboratory

• Method comparison

– Between ACT : 25%

– With Anti-Xa : 33%

– With aPTT : 1 response

Survey 2013

– With aPTT : 1 response

unknown21%

5

6

7

8

Electronic controls

Quality program Survey 2013

21%

No8%

Yes71%

0

1

2

3

4

Whole blood control

unknown17%

Yes44% 4

5

6

7

8

Quality program Survey 2013

No39%

0

1

2

3

Each new batch

Each new delivery

Weekly Monthly Monthly or each new

batch

No External Quality Control

Reference values

• CPB (High range cartridges)

– Basal value : 100-140 sec

– Threshold for CPB : > 400 sec for more than 50%

of participantsof participants

• Catheterization (Low range cartridges)

– Basal value : near to 160 sec

– > 250 sec for 78% of participants

• Inter-assay variability

Analytical assays

CPB Catheterization

Lyon

Marseille

Toulouse

Lille

Paris-Necker

Paris-Necker Limoges

Toulouse

HR-ACT (Hemochron Elite)

HR-ACT (ACTPlus, Medtronic)

LR-ACT (Hemochron)

Normal

level CV = 5,7 à 9,5 % CV = 14,2

Abnormal

level CV = 2,2 à 7,8 % CV = 11,6 % CV = 13,2

Comparison ACT Hemochron

Time

Signature plus

Operating room 2

Elite laboratory

Signature Plus

Operating room 1

Mean SD CV Informations

T0 119 120 121 120 1,0 0,8 Before Heparin

T1 396 385 382 388 7,4 1,9 After Heparin

T2 516 537 610 554 49,3 8,9 per CEC 20°C

T3 475 438 463 459 18,9 4,1 33°CT3 475 438 463 459 18,9 4,1 33°C

T4 133 123 132 129 5,5 4,3 After protamine

T0

T1 386 379 382,5 4,9 1,3

T2 434 425 445 435 10,0 2,3

T0 154 33°C

T1 654 >1000 30°C

T2 >1000 829 29°C

T3 >1000 >1000 >1000 30°C

T4 540 423 481,5 82,7 17,2 35°C

T5 137 126 131,5 7,8 5,9 36°C

Comparison ACT Hemochron/Medtronic

Time

ACT Plus (Medtronic)Mean of Hemochron (3 different devices)

Informations

Canal 1 Canal 2

T0 144 136 120 Avant

T1 443 36 388 Apres héparine

T2 808 0 554 per CEC 20°C

T3 435 560 459 33°C

T4 182 200 (qi) 129 Post protamine

T0

T1 338 331 382,5

T2 435

T0 33°C

T1 999 999 30°C

T2 29°C

T3 >1000 30°C

T4 481,5 35°C

T5 131,5 36°C

HR-ACT vs plasmatic Anti-Xa

y = 68,417x + 135,05

R2 = 0,7667

500

600

700

800

900

AC

T (

se

c)

N=27

R2 = 0.81 without ACT > 600 sec

0

100

200

300

400

0 1 2 3 4 5 6 7

AC

T (

se

c)

Plasmatic anti Xa (UI/mL)

LR-ACT vs plasmatic Anti-Xa

Guidelines for ACT certification from the

GEHT

• Pre analytical procedure

• Analytical procedure– CV intra-assay : not possible

– CV inter-assay

– Quality control

• EC : at least once a day of use

• Liquid control : at least for each new batch, and when a new shipment is received, and monthly.

– Method comparison

• Recommended with antiXa

– Performing the test

– Reference values

• Verification by each laboratory

Guidelines from the GEHT

• Post analytical procedure

– Results used immediately

– A posteriori validation is mandatory

– Editing– Editing

– Archiving

• Managing stock reagent

• Management of non-conformities

Guidelines from the GEHT

• Table with different risks and how to control these risks

• Operator training and empowerment

– Proposition of quizz and enabling grids– Proposition of quizz and enabling grids

CONCLUSION

• POCT in coagulation essential in somecontexts

• Taken into account some particularities ofhaemostasis for certificationhaemostasis for certification

• Because ACT is used for a long time byclinical team : difficulty to cope with the newstandards.

• Importance of training and intermittent re-evaluation

CONCLUSION

• Lack of EEQ for ACT

• Feasible in the best conditions only ifcomputer connections exist

• In process by the GEHT POCT group :• In process by the GEHT POCT group :Guidelines for INR POCT

Aknowledgment

• Anne Bauters (Lille), Agnes Le Querrec (Caen), Sophie Voisin (Toulouse)

• All the members of the GEHT working group on POCT on POCT