Central Laboratory - EBF

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Central Laboratory -From Specimen Reception to Reporting- Bärbel Wilke LKF

Transcript of Central Laboratory - EBF

Page 1: Central Laboratory - EBF

Central Laboratory

-From Specimen Reception to Reporting-

Bärbel Wilke LKF

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Central Laboratory Procedure

Define the requirements on trial basis Define optimal supply Specimen collection and preparation Define shipment conditions Specimen accessioning and storage Reporting and data transfer

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How to identify the individual needs?

-Protocol review

-Mono center or multi center trial?

-Timelines for inclusion of patients

-Distribution of countries and sites

-Special requirements for PK/BM?

-Pro-active communication with involved PK/BM labs

-Collection of stability data, decision of transport temperature and frequency

-Declaration of shipped material, packaging guidelines

-Reporting/data transfer requirements

-Central storage

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History of Laboratory Medicine

(15th Century)

Well trained Phase I Units Standardized processes are established

SOPs are available High acceptance to implement new and

complicate procedures Cooling centrifuges are no problem

Freezers up to -80°C available Temperature control no problem

Mono center trial

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Multi center trials

More difficult to implement complicated procedures, equipment could be an issue. To follow guidelines which differs from routine

might create error situation.

So many countries, sites and patients! Different levels of understanding!

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Lab Material Lab Supply

Individual Lab Manual -including details about pre-analytical requirements

Visit specific lab kits Shipment material Pre-labeled storage boxes Study specific labels Study specific storage lists PK/BM lab specific lists Centrifuge? Freezer?

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Composition of kits by central lab

Additive

No

Heparin

EDTA

Citrate

Fluoride/ Oxalate

Effect

No

Thrombin Inhibition

Ca-Binding

Ca-Binding

Ca-Binding/ Enolase-Inhibition

red

green

lavender

blue

grey

Analyses

Biochemistry, Serology

PK, Biochemistry

Hematology

Coagulation

Glucose, Alcohol, Lactate

Color Vacutainer Monovette

white

orange

red

green

yellow

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Recommendations for blood collection

Supine or sitting position for 10 min. Tourniquet not longer than 1 min. No fist clenching No handgrip exercise Open tourniquet before aspiration

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The posture affects the intravasal blood volume

Cells

Total Volume 4.0 l

Upright Supine

+ 14,3% - 14,3 %

+10 % - 10 %

Total Volume 4.4 l Cells

Plasma

„Water“

Plasma concentration

Cell concentration

Plasma Plasma

Extravasal space

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Effect of blood sampling conditions

Position: Supine (15‘) 189 mg/dL Tourniquet: no (4,86 mmol/L) Position: Upright 242 mg/dL Tourniquet: 5 min. (6,23 mmol/L)

Example: Cholesterol

Difference: +22%

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Pre-Analysis: Buffy Coat

Buffy coat

Plasma

Erythrocytes

(Leukocytes and platelets)

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Hemolyses

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centrifugation within 30 minutes transfer of

0.5 ml supernatant Into 6 tubes

store 3 tubes in box A store 3 tubes in box B

Instruction with pictures and color-codes

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-70 C or below

Standardization

Centrifugation speed and time Identical volumes per aliquot!

Same color codes! Two separate storage boxes!

Two identifiers only (eg: Screening number)

PK Box B

How to reduce queries and mix-up

Store until pick up

PK Box A

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Choose the right courier!

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Biological specimens are not dangerous goods

Biological specimens are categorized as

Risk group 2-3 (WHO)

Declaration UN 3373 Biological Substance Cat. B

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Country distribution – more or less problematic

1 2 3 4 5 6 7 8 9 10

Germany Skandinavia

Poland The Netherlands

Belgium France

UK Lithuania

Spain Italy

Romania Bulgaria

USA Canarian Islands

Argentinia Peru

Ukraine Russia Brazil

Mexico Taiwan Georgia

Turky India Egypt

China Belarus Georgia

Easy

Costs increase accordingly Difficult

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Temperature – more or less problematic

1 2 3 4 5 6 7 8 9 10

Ambient Not controlled! 5°C – 30°C

Cooled

2 bis 8°C Frozen

-20°C bis -70°C

Liquid Nitrogen

≤ -190°C

Easy Difficult

Costs increase accordingly

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Cheap solutions to check temperature

Electronic data logger or Temperature indicator (Chill Checker) What to do with deviations? Temperature control without defined ranges is not recommended!

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Establish an active tracking system

Trial

Example 1

Example 2

Example 3

Example 1

Example 2

Example 3

Example 1

Site

0512

0122

7304

0072

0071

0401

0401

Name

Example 1

Example 2

Example 3

Example 4

Example 5

Example 6

Example 6

Sampling

19.03.13

21.03.13

21.03.13

21.03.13

21.03.13

20.03.13

21.03.13

Schedule

-1

1

1

1

1

1

2

Country

B

SK

PL

PL

PL

MAC

MAC

Courier

DHL

DHL

DHL

DHL

DHL

DHL

DHL

AWB

9949597453

9934158235

9748583262

9388574628

9948875235

9938476543

9718374654

Patient

0000051203

0000012206

0000730408

0000072011

0000071004

0000040114

0000040113

Delay

Contact the site/courier

In time

No action

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Scan of each individual sample aliquot

unique 2 dimensional

Barcode

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Aliquot

Storage box

Drawer Device

Location

Specimen tracking database

Specimen Management

Database

Transportbox (reorganization)

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Central laboratory assistance Organize shipments by

knowing stability of each parameter

Lab Manual with ALL information Contact for BM/PK labs

Active tracking

Communication with courier service

Contact for the sites

Sponsor contact

Accession of all samples

Shipment to PK/BM labs

Global data base/data

transfer/reporting Central

Laboratory

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Vielen Dank

Thank you