transport solutions for diagnostic specimens

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Transport Solutions for Diagnostic Specimens

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Preanalytical phase Analytical phase Postanalytical phase

Patient identification and acceptance

Preparation of specimen collection devices

Specimen collection

Preparation of transport containers

Transport

Delivery to laboratory

Acceptance of specimens

Channelling

Preanalytical treatment

Loading the analysers

TemperatureThe temperature conditions to which the specimens are exposed from collection to analysis.

ProceduresSpecimen packaging and placement criteria for and during transport.

TimeThe time elapsed between specimen collection and analysis.

Verification and DocumentationVerification and documentation of acceptance/rejection criteria.

PATI

ENT

DIA

GN

OST

IC S

PEC

IMEN


Patient identification and acceptance


Specimen collection


Transport


Acceptance of specimens

Channelling

Preanalytical treatment


TemperatureThe temperature conditions to which the specimens are exposed from collection to analysis.

ProceduresSpecimen packaging and placement criteria for and during transport.


Verification and DocumentationVerification and documentation of acceptance/rejection criteria.

What’s happening to the specimen during the preanalytical phase


Confirmation of patient identification


Specimen collection


Transport


Sample accession by laboratory

Sorting

Sample processing


PREA

NA

LYTI

CA

L TI

ME

TemperatureThe temperature to which the specimens are exposed, from collection to analysis.

Compliance and SafetySpecimen packaging for and during transport.


Verification and DocumentationVerification and documentation of sample acceptance/rejection criteria by laboratory.

EN ISO 15189:2007:Medical laboratories -particular requirements for quality and competence

Article 5.4 Pre-examination Procedures

Article 5.4.2 states that the specific instructions for the proper collection and handling of primary samples have to be documented and implemented by laboratory management.

The transport of biological specimens for laboratory testing (diagnostic specimens), is a critical variable with growing impact on the quality and safety of the preanalytical phase.

International standards and regulations (ISO 15189, ADR 2009) describe certain provisions which should be met.These provisions emphasise the importance of the four critical variables illustrated.

Article 5.4.6 refers to the responsibility of the laboratory to monitor the transport of samples to ensure that this activity is carried out:

According to laboratory sample handling protocols and within a time frame which is appropriate to the specific nature of each requested analysis

Within a specified temperature interval according to the primary sample collection manual

With the appropriate designated preservatives to ensure the integrity of the samples

Using an approach which ensures the safety of all those persons involved in the collection, preservation and transport of the biological samples for laboratory testing

In compliance with national and international regulations

Article 5.4.8 requires the laboratory to develop and document criteria for acceptance or rejection of primary samples . If the laboratory accepts compromised samples, then the final report has to indicate the nature of the problem and, if applicable, has to state that caution is required when interpreting the result.

BD Stands Available in various materials, sizes and shapes, these stands keep samples safe and upright to reduce haemolysis due to mechanical stress.Designed to be used in conjunction with secondary containers (H-BIN Biotransport®).

BD TransportSecondary containers (H-BIN Biotransport®) and strong outer box containers, are designed to transport diagnostic specimens safely and in compliance with European Regulations. Available in a wide range of shapes, sizes and configurations, these products meet various organisational requirements.

COLLECTION PREPARATION TRANSPORT LABORATORY ANALYSIS

BD Hemobox® 4BD Hemobox® 4 is the ideal solution for in-home sample collection

and safe transportation of specimens. BD Hemobox® 4 has also been designed to fulfill certain regulations of the European Union.

BD T&T® System

BD T&T® SoftwareBD T&T® software facilitates the complete and advanced managementof the BD T&T® system. Its many functions provide:• the possibility of customising the BD™ Mission Starter and BD™ System Manager configurations (shipment profiles, acceptability

ranges, sender identification, etc.); • graphic/table processing and archiving of mission

data; • the ability to extract specimen information

that falls outside specified parameters• the possibility of client/server installation

ACCEPTANCE SPECIMEN PREPARATION ANALYSIS REPORT

The BD T&T® system is designed to monitor critical variables (time and temperature) during the transportation of diagnostic specimens. In its basic configuration, the system consists of:• BD TempStick®: miniaturised datalogger capable of recording

times and temperatures at predetermined intervals.• BD™ Mission Starter: Intuitive and easy to use, the mission

starter provides flexible programming, ensuring a unique and tailor-made approach/solution.

• BD™ System Manager: mission decoding device. In addition to the activation function, it enables reading, capture and validation of BD TempStick® data acquired during the mission. Compatible with a personal computer, it is easy to use and is managed by the receiving laboratory personnel.

BD TempStick®

BD TempStick® is self-powered, does not require any maintenance, and has a battery life of 10 years for an average of 35 acquisitions/hour. BD TempStick® is calibrated to traceable standards by SIT (Italian Calibration Centre) and carries the appropriate certification.

Further informationIn order to transport specimens from one location to another, either by road, air or other means, it is

necessary to meet the provisions of one or more international regulations, collectively referred to as the

‘Carriage of Dangerous Goods Regulations’.

Each mode of transport has its own specific regulation which contains detailed, unique requirements.

The two regulations that most frequently apply to users of blood and urine collection systems are

concerned with the carriage of dangerous goods by air and by road.

• The International Agreement Concerning the Carriage of Dangerous Goods by Road, commonly

referred to as ADR 2009 that includes the packaging instruction P650 specifically designed for

UN3373 products.

• The International Air Transport Association Dangerous Goods Regulations, commonly referred to as

IATA DGR.

Each of these regulations defines infectious substances as substances which are known or are reasonably

expected to contain pathogens, and goes on to categorise infectious substances as either category A (if

known to contain one of a list of high risk pathogens) or category B, for all others.

Unless the carrier of a blood or urine specimen can reasonably judge there to be minimal likelihood

of the presence of a pathogen, then the specimen will usually fall into the category of “Category B

Infectious Substance”.

The regulations go on to specify multiple requirements applicable to the packaging and labelling of

such substances, including robustness & strength, size, ability to withstand pressure, ability to absorb

liquids, leak proofing and more. In addition to helping to ensure the safety of your personnel and your

carriers, and protecting your samples, the BD transport solutions will help you to meet these regulatory

challenges.

Further information can be found at the following United Nations Web address

http://www.unece.org/trans/danger/publi/adr/adr2009/09ContentsE.html

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BD DiagnosticsPreanalytical SystemsThe Danby BuildingEdmund Halley RoadOxford Science ParkOxford OX4 4DQwww.bd.com [email protected]

BD and BD Logo are trademarks of Becton, Dickinson and Company. © 2010 BD. Becton, Dickinson U.K. Limited. Registered in England: 00852702. Registered Office: The Danby Building, Edmund Halley Road, Oxford Science Park, Oxford, Oxfordshire OX4 4DQPAS Transport Brochure 2010, LC, 240310, 02

S E C O N D A R Y C O N T A I N E R S H - B I N B i o t r a n s p o r t ®

Code DescriptionDimension (mm)

(L x W x H)Weight (g) Capacity

Case Qty.

369641BIO 01P containerWith absorbent & document tray

242x169x155 72060 tubes ø 13 mm

2

369642BIO 02S containerWith absorbent & document tray

305x245x155 1080120 tubes ø 13 mm

2

369643BIO 03M containerWith absorbent & document tray

390x230x173 1470180 tubes ø 13 mm

1

369644BIO 04L containerWith absorbent & document tray

500x285x225 2610300 tubes ø 13 mm

1

T E R T I A R Y C O N T A I N E R S

Code DescriptionDimension (mm)

(L x W x H)Weight (g) Capacity

Case Qty.

369656BIO 701 containerWith insulation

560x340x340 27001 Ref. 369643

or1 Ref. 369644

1

369658BIO 301 containerWith insulation

510x280x260 17802 Ref. 369641

or1 Ref. 369643

1

369657 BIO 858 container 480x290x350 2620

2 Ref. 369641or

1 Ref. 369642or

1 Ref. 369643

1

368562ISOTHERMAL TERTIARY BLUE container.Includes 2 x 369722

485x300x415 35602 Ref. 369641

or2 Ref. 369642

1

369727New BIO ISOTHERM container.Includes 1 x 368720

390x375x365 36902 Ref. 369641

or1 Ref. 369642

1

368712Tertiary bag for BIO 01P with insulation

280x200x190 320 1 Ref. 369641 2

368713Tertiary bag for BIO 02S with insulation

330x260x190 510 1 Ref. 369642 2

368714Tertiary bag for BIO 03M with insulation

410x260x210 590 1 Ref. 369643 1

T I M E & T E M P E R A T U R E - B D T & T ®

Code Description Weight (g) Case Qty.

369719 System Manager includes BD T&T® Sofware 140 1

369712 Datalogger TempStick®with certificate of calibration 13 5

369720 Mission Starter 140 1

369723 Calibration Service 1

Transport Solutions

I N T E R N A L A C C E S S O R I E S

Code DescriptionWeight

(g)Dimensions (mm)

(L x W x H)Capacity

Case Qty.

369645 Tube rack in polyurethane 45 160x100x65 45 cavities Ø 13 mm

12

369646 Tube rack in polyurethane 55 160x100x103 28 cavities Ø 16 mm

12

369647Blood culture bottle and tube rack in polyurethane

65 305x165x8012 cavities Ø 13 mm + 12 blood culture

bottles5

369648 Urine cup tray in polypropylene 65 425x213x70 18 cavities Ø 60 mm 4

368563 Urine cup tray in polypropylene 55 213x140x706 cavitiesØ 60 mm

5

369659 Tube rack in polyethylene 95 244x100x68 90 cavities Ø 13 mm 8




369726Mini BIO ISOTHERM C container for transport of refrigerated specimens.Supplied with 1 x cooling device

118 195x95x612 critical care syringes

or 4 tubes 13x75 mm or 2 tubes 13x100 mm

20

H E M O B O X ® 4

Code DescriptionWeight

(g)Dimensions (mm)

(L x W x H)Capacity

Case Qty.

366903 Hemobox® 4 blue 175 150x100x708 tubes1 holder3 needles

24

366904 Hemobox® 4 green 175 150x100x708 tubes1 holder3 needles

24

366905 Hemobox® 4 red 175 150x100x708 tubes1 holder3 needles

24

A C C E S S O R I E S A N D C O N S U M A B L E S

Code DescriptionDimensions (mm)

(L x W x H)Weight (g)

Case Qty.

368717 Freeze board 200ml 160x110x14 200 10



369728 Freeze board 2000ml (for use with 369656 only) 375x215x29 1840 2

368720 Freeze Kit for 369727 400x270x200 2500 2

369703 CUS 01P absorbant 170x110 5 10

369707 CUS 02S absorbant 240x175 10 10

369708 CUS 03M absorbant 330x175 12 10

369709 CUS 04L absorbant 410x220 19 10

PAS Transport Product Insert Sheet 2010, LC, 310310, 03

transport solutions for diagnostic specimens

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