Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien

INSTAND e.V.

JCTLM Member activities

Prof. Dr. Michael Spannagl Dr. Patricia Kaiser

2

EQAS organizer worldwide

infectious disease

transplant immunology transfusion coagulation haematology … POCT

3

0

2000

4000

6000

8000

10000

12000

1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015

Number of participants from 1993-2015

german participants foreign participants

4

RiliBÄK - Guideline of the German Medical Association on Quality Assurance in Medical Laboratory Testing

Section B1

5

Section A

RiliBÄK - Guideline of the German Medical Association on Quality Assurance in Medical Laboratory Testing

Section B1

6

Section A

RiliBÄK - Guideline of the German Medical Association on Quality Assurance in Medical Laboratory Testing

Sections B1 B2 B3 B4 B5

7

New Guideline for Quality Assurance of the German Medical Association (RiliBÄK)

-> mandatory for all medical laboratories in Germany

Section A Fundamental requirements for quality assurance

Effective since 1 April 2008 Update 2011

Specific Section B 1 Quantitative analyses in laboratory medicine - internal QA - external QA

Effective since 1 April 2008

Specific Section B 2 Qualitative analyses in laboratory medicine - internal QA - external QA

Effective since 1 July 2011

Specific Section B 3 Direct detection and characterization of pathogens - internal QA - external QA

Effective: 1 June 2015

Specific Section B 4 Analyses of ejaculate - internal QA - external QA

Effective since 1 July 2011

Specific Section B 5 Molecular- and cytogenetic analyses - internal QA - external QA

Effective since 1 October 2011

reimbursement

8

New Guideline for Quality Assurance of the German Medical Association (RiliBÄK)

-> mandatory for all medical laboratories in Germany (extract from annex B1)

9

Reference laboratory

Accredited as calibration laboratory according to ISO 17025 and ISO 15195

2006 Cholesterol 2009 Chloride, Potassium, Sodium, ALT, AST, GGT, CK, LDH Creatinine, Urea, Cortisol, Total Protein, HbA1c, Theophyline 2012 Calcium, Lithium, Magnesium, Uric Acid, Total Gycerides, Testosterone, Thyroxine 2015 Glucose, 17-ß-Estradiol, Progesterone, Digoxin, Digitoxin

RMP

at IN

STAN

D e.

V.

RiliBÄK requirements

pH, Phosphate Total hemoglobin, cell counting

10

Interlaboratory CV Glucose

EQAS results 2002 - 2015

0

1

2

3

4

5

6

7

8

coef

ficie

nt o

f var

iatio

n [%

] all manufacturers

target values set by RMP

devi

atio

n fr

om ta

rget

val

ue [%

]

187 112

209 197

Deviation from target value EQAS for HbA1c with lyophilized and fresh

whole blood samples

EQAS run

Jan 2014 Juli 2014 Okt 2014 May 2015

lyophilized samples

fresh samples

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HbA1c EQAS results

January 2009 lyophilized samples

May 2015 fresh blood samples

Sam

ple

2 Hb

A1c

[mm

ol/m

ol]

Sam

ple

2 Hb

A1c

[mm

ol/m

ol]

Sample 1 HbA1c [mmol/mol] Sample 1 HbA1c [mmol/mol] acceptability range ± 18 % from target value

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Participation in intercomparison studies

RELA – IFCC ring trials

IFCC HbA1c Network Laboratories

campaigns

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Further activities

Commutability

IFCC Working Groups

WG on HbA2 standardisation

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Further activities

Reference method for

cell counting

Reference method for

Total Hemoglobine

EMRP project „metalloproteins“

EMPIR call 2015

Coagulation factor VIII Replacement therapy 1950 - 2015

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USA/Canada

OS Assay WHO 7. IS

Xyntha 1000 IU 131 μg

Europe

CS Assay WHO 7. IS

ReFacto AF 1000 IU 95 μg

Xyntha/ReFacto AF

Worldwide

CS Assay WHO 6. IS

ReFacto 1000 IU 83 μg

previous ReFacto

ReFacto AF vs. Xyntha

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LC-MS/MS chromatogram of recomb. FVIII after triptic digestion

Perspectives

• High quality reference materials • Commutability • To convince the „real world“ of the traceability

concept

Thank you for your attention