HOW WESUPPORT YOU
VACUETTE®
Blood Collection System
Verification and Implementation Planfor Hospitals and Laboratories

The easy way to optimal
blood sample quality and toa safe blood collection
technique is the introductionof the VACUETTE® bloodcollection system.

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PHASES OF IMPLEMENTATION
Greiner Bio-One has a wealth of experiencein implementing conversions and demonstrates how planning and implementation can take place concurrently utilising

members of the Greiner Bio-One training team.
Greiner Bio-One will be providing a suitable
implementation timeline that includes thefollowing 5 basic phases and steps:

01.

PREPARATION PHASE

02.

ESTABLISH IMPLEMENTATION PLAN

Identification of Customer Needs and Compatibility Check
Laboratory Checks
Tube Guides
Stock Levels, Changeover Timelines and Ordering Details
Communication - Informing End Users

Planning Implementation Days
Planning Post Implementation Days

03.

TRAINING

04.

IMPLEMENTATION

05.

FOLLOW UP

Planning Training SessionsTraining Material and Support

Post Implementation Days
Post Implementation Training and Support

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01.

PREPARATIONPHASE

IDENTIFICATION OF CUSTOMERNEEDS AND COMPATIBILITY CHECK
The target of this section is to:
Check components of theVACUETTE® Blood Collection
System (e.g. safety holder/needle, safety blood collection
set, holder and tube).
Check laboratory equipment:
e.g. analysers, centrifuges.

Check instrumentation compatibility for the VACUETTE®
Blood Collection System. If
there is no information aboutcompatibility of the analyser
available on site, pleasecontact the Technical Services
in Austria (faq.pa@gbo.com)
for support.

LABORATORY CHECKS
Once the laboratory has decided
exactly which VACUETTE® BloodCollection Tubes they wish touse, a check would be doneto ensure full compatibility of
the chosen tubes. This check
would assess analyser adaptations or modifications, racking
systems, centrifuges, transport containers and any otherequipment used during theanalytical process.

If required, the laboratory shouldhave discussions with the manufacturers of analysers to ensure
full compatibility. This would
determine whether a “Day One”
start or “Roll-out” conversion
would be most suitable. In either
case, the following process
would be initiated but for a “DayOne” conversion, all stock will bedelivered to all end users prior tothe conversion day.

STOCK LEVELS, CHANGEOVER
TIMELINES AND ORDERING DETAILSStock levels will be reviewed inconjunction with Procurement
and/or Materials Management
Teams and the customer’s
selected distribution partner
on an on-going basis from theaward of the contract, with aview to the potential implementation date. It is recommended to roll out the VACUETTE®
Blood Collection System asexisting stocks (of the currentsupplier) run out. If necessary,the currently used blood collection system and the newly
introduced VACUETTE® BloodCollection System can be usedin parallel. This decision shouldbe based on individual conditions at each laboratory.
Once the date has been decided
for the start of the implementation, order route and details will
be discussed and defined withlead time expectations agreed
upon to ensure a seamless
supply when transferring fromone supplier to another. A
Product Matrix can be provided
listing all current products withthe corresponding new codesand packaging sizes.

COMMUNICATION –INFORMING END USERS
During the weeks leading up to
the conversion, Greiner Bio-One/the local distributor/laboratory
will communicate to all end users,
informing them of the changeto VACUETTE® Blood Collection

System. This could be in formof a letter, email or internal
newsletter. End users will be
asked to reduce their stocks to aminimum to reduce any wastage
at the time of changeover.

COMMUNICATIONTUBE GUIDES
Tube Guide charts in theOrder of Draw can be provided
when necessary, to ensurethat samples are being drawn

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in the correct order. Specifictraining and information literature are also available ifrequired.

For assistance, pleasecontact the Technical
Service in Austria(faq.pa@gbo.com).

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The Greiner Bio-One Training
Team is available for support
and additional training on-siteor online upon request.

02.

ESTABLISH
IMPLEMENTATION PLAN
PLANNING IMPLEMENTATION DAYS
During the implementation
days, the Greiner Bio-One
Training Team will be available for support and additional training on-site oronline, as requested. Thisis particularly importantduring conversions due tothe need for rapid reactions
and, where appropriate, thedeployment of additional resources or personnel.
Our core philosophy is tohave everything in place
to ensure the best level ofservice for customers in theuse of the VACUETTE® BloodCollection System. Prior toconversion, each facility will
be visited to identify key per-sonnel who may offer support
in introducing the VACUETTE®
Blood Collection System.
These could include e.g.:/ Laboratory
Personnel/ Phlebotomy Manager/ Infection Control/ IV Team/ Procurement/ Supply Chain Management

These are just someexamples of the personnel who have helped in
the successful implementation of the VACUETTE®
Blood Collection Systemin previous conversions.
The structure of each individual site will help decide
the final conversion plan.
Thus, allowing a partnership between the converted facility and Greiner
Bio-One ensuring the conversion is carried out in a
professional manner andto the satisfaction of all.

/ Occupational Health/ Head of Nursing

BEST LEVELOF SERVICEfor customers
when using theVACUETTE® bloodcollection system.

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PLANNING POST
IMPLEMENTATION DAYSIn the following days andweeks, Greiner Bio-One will
stay in contact with Phlebotomy/Nursing and Laboratory
staff, to ensure the changeover is progressing smoothly(and when possible, by circulating around all wards and departments ensuring everyone

is using the system correctly).
If any old tubes arrive in theLaboratory, staff is re-trained
where necessary and stockchanged to the VACUETTE®
Blood Collection System. Allwards and departments can bere-visited; ensuring everyone
is competent using the system.

03.

TRAINING

PLANNING TRAINING SESSIONS
Training can be offered, on-site, via the Greiner
Bio-One training platform, as well as online.
Hospital Wards and Departments:
Typically working with the main contact at thefacility, the local Greiner Bio-One company
walks the team through recommendations regarding tube verification, emphasizing that it
is up to the facility (and their medical director)
to determine the path forward for verification.
Training sessions could be arranged at avenue within the hospital, such as a designated room by the hospital over a set periodof days during the agreed upon time-periodleading up to implementation, if required.
Recent conversions have been based upon
Hospital “Walk Rounds” where ward/department-based training is provided. With all
conversions, the level and number of training
sessions are discussed with each site to meettheir individual needs. Night shift sessions,
Emergency, ITU/ICU and all high dependency
areas are contacted to discuss department
specific training sessions.
Physicians´ offices off-site user:
Based on the agreed plan between Greiner
Bio-One and the hospital/laboratory in view of
the time-period prior to conversion, the local
Greiner Bio-One company (sales representative), local distributor or hospital/laboratory will send out a further communication on
training details to users.
During the training planning, a person responsible for training at the customer side
will be defined. The responsibilities of thisindividual are to evaluate and authorize
training protocols and support the Greiner
Bio-One team in organizing training sessions.

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training.gbo.com

This would ensure that training sessions forusers who have specific training requirements, are arranged directly with Greiner
Bio-One to meet their needs and time restraints, e.g.: remote workers, shift workers
etc., where off-site and night sessions will bearranged. Off-site users who are employeesof the lab should be involved in the training
schedule. An option is a Train-the-Trainer
principle, where the trainers are also the keyusers and the internal contact persons.
Once these sessions have been arranged, theGreiner Bio-One (Sales) Team stays in contact
with the main facility contact. Usually, thetraining requirements differ from product toproduct (e.g. tubes or safety products). Therefore, the local Greiner Bio-One Team agrees
with internal project leader at the facility orhead of department (laboratory/blood collection) on the details of training sessions needed.
Product Demonstrations:
Greiner Bio-One would plan product demonstrations to identified healthcare staff. As theywill be the main users of the new system, it isimportant that they know what is happening andwhen. It gives the staff an opportunity to see andlearn about the VACUETTE® Blood Collection
System and ask questions about their specificrequirements. These demonstrations would beplanned during the agreed upon time-periodleading up to the product changeover.
If possible, Greiner Bio-One would suggest
training the Phlebotomists and Nurses sothat they use the system in the agreed upontime-period prior to implementation. This gives
them time to adjust to the system whilst underno pressure. It also makes other staff aware ofthe changes that are about to take place.

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TRAINING MATERIALS AND SUPPORT VACUETTE® TRAINING RESOURCE TOOLBOX
Throughout the duration of thecontract, a representative maincontact will keep in periodic
touch with Phlebotomy/Nursing
and Laboratory personnel
to provide further materials
and support for training andservice, where deemed necessary. Greiner Bio-One
takes the issue of training
very seriously, offering afully comprehensive training
program. The VACUETTE®
Training Resource Toolbox
has been developed as anongoing educational toolfor all healthcare workers
involved in the preanalyticalto analytical phase.
EXAMPLES OF WHAT
COULD BE INCLUDEDIN THE VACUETTE®
TRAINING RESOURCE/ Application training slides/ Presentations/ Handling Videos/ User guide booklets

A selection of training materials which will be updated on aregular basis are also available to provide answers to FAQs
(see following pages) such asa g-force to rpm graph, orderof draw, fill volume levels andother preanalytical variables:

completed and all users areready to use the VACUETTE®
Blood Collection System, oldstock can be removed or left
to be used, dependent on thepost award discussions.

/ VACUETTE® Blood
Collection Techniques
Booklet/ Customer Service/ Clinical and TechnicalSpecialists/ Samples Distribution/ Logistics/ Marketing Team/ Research and Development/ VACUETTE® Preanalytics
Manual
Product handling videos areavailable online which demonstrate, for example, how eachsafety device is activated.
E-learning courses are available on the Greiner Bio-One
online training platform. There
are no associated costs for thetraining and support given byGreiner Bio-One throughout
the duration of the contract.
Once the training sessions arecan be used for bothgroup and individual
learning sessions.

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Implementation Support is primarily carried out by the local
Greiner Bio-One Representatives or distributor, who have a
medical or clinical background
who can also be deployed onsite. Additional resources anddata (e.g. technical specifications, clinical data) can beprovided from our Headquarters as needed from:/ VACUETTE®Instructions
For UseTHE VACUETTE®
TRAININGRESOURCETOOLBOX

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IMPLEMENTATION

Support by local Greiner
Bio-One representatives ordistributors who have amedical or clinical background.
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We empower
people, whowork in health.

05.

FOLLOW-UP
POST IMPLEMENTATION

Upon completion of the agreed implementation plan, a review meeting can be scheduledwith the customer. This meeting could cover:/ Current status/ Feedback and adoption

POST IMPLEMENTATION TRAINING
AND SUPPORT
Once the full conversion to the VACUETTE®
Blood Collection System has taken place,ongoing training will be provided, utilising theVACUETTE® Training Resource Toolbox (asavailable and defined). This can be useful inthe following areas, for example:/ Tasks or issues arising or outstanding/ Points to be addressed/ Creation of forward action plan

Follow-up training on the VACUETTE® BloodCollection System/ New staff

Greiner Bio-One staff will be available asneeded, as mutually defined between Greiner
Bio-One and the customer during the agreed
upon time-period following conversion tofollow up on adoption with end users and key
stake holders and address any immediateneeds. Staff will have access to the Greiner
Bio-One account managers contact details
for prompt responses.

12 /www.gbo.com/ New VACUETTE® products
All VACUETTE® training and support complies
with CLSI (Clinical Laboratory Standards Institute). Greiner Bio-One value training andsupport as an integral part of any productrelated contract offering a fully comprehensive
training program, which has been implemented
successfully during and post conversion for
VACUETTE® users. Members of the Greiner
Bio-One (training) team would be available andsupport where required, dependent on thelocation to facilitate any conversion.

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MOST FREQUENTLY ASKEDCONVERSION QUESTIONSWhen converting from another manufacturer’s tubes, what steps are necessary
to verify the performance of Greiner Bio-One VACUETTE® Blood Collection Tubes
and to satisfy regulatory requirements?

What resources can Greiner Bio-One process?

QUESTIONS ANDANSWERSThe local Greiner Bio-One Application Specialists can assist
you in making the change to Greiner Bio-One VACUETTE®
Blood Collection System successful. We also offer educational material and literature that can be used for yourpurposes that is beneficial during the implementation
process as well as ongoing training.

CLSI has published a guidance document (GP34-A; Validation and Verification of Tubes for Venous
and Capillary Blood Specimen Collection) on tube verification to assist end users with this process.
Verification testing should include method comparison with representative analytes between
your current tube and the Greiner Bio-One sample collection system. If desired, within-tube precision can be determined by performing duplicate analyses during the method comparison. The
number of samples tested should be sufficient to be statistically valid. A minimum of 20 samples
is typically required, though most laboratories prefer 30 to 40 samples.

CHECKLIST
The following checklist can be used to follow each step

How much will it cost to perform an evaluation (testing appropriate for verification
purposes) in my laboratory?
Cost of evaluation testing is derived from the cost of the tube, the cost per test (or cost of reagent per test),
the average hourly pay rate of the technologists in your laboratory and the estimated time to run each test.

Instrument Compatibility for VACUETTE®
Blood Collection
System checked

Laboratory inspection
done (if needed bya vendor
representative)

Instrumentationand centrifugation
settings applicableto VACUETTE® BloodCollection System

Stock levels
reviewed

Ordering details
discussed

First orderplacedAll end users
informedTraining session
plannedInformation material
provided (supportiveliterature, examples)

Close contact with
Phlebotomy, Nursing
and Laboratory Staff toensure everyone is using
the system correctly

What is required if tubes are centrifuged at a different time or g-force than what
the Instructions for Use (IFU) recommend?
Many labs are limited by centrifuges unable to achieve the recommended g-force or have turnaround-time constraints that do not allow for the recommended time. Centrifugation of tubes
outside the manufacturer’s recommendation is considered as off-label use and requires testing
to validate that deviations from the manufacturer’s recommendations do not affect analyticaloutcome. This testing should include a method comparison with representative analytes and aminimum of 20 samples. Frequently, there are already studies available to support the adaption ofcentrifugation conditions.

Are the tubes of Greiner Bio-One VACUETTE® Blood Collection System validated
on the instrument platforms in my laboratory?
Greiner Bio-One works very closely with instrument manufacturers to ensure that tubes of Greiner
Bio-One VACUETTE® Blood Collection System are compatible with the instrument platforms
utilised in the clinical laboratory. In some cases, Greiner Bio-One can provide documentation fromthe instrument manufacturer indicating that specific tubes are approved for use. However, somemanufacturers simply publish physical specifications of tubes appropriate for their instrumentation in the instrument manual or literature.

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SUPPORTING DOCUMENTATION:
1.

GP34-A Vol.30 No. 25 Validation and Verification of Tubes for Venous and Capillary Blood Specimen Collection, Approved Guideline (2010), Clinical andLaboratory Standards Institute2.

Lippi et al, EFLM WG-Preanalytical phase opinion paper: local validation of blood collection tubes in clinical laboratories, Clin Chem Lab Med 20163.

EP28-A3c Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline – Third Edition (2010), Clinical andLaboratory Standards Institute4.

EP09c Measurement Procedure Comparison and Bias Estimation Using Patient Samples - Third Edition (2018), Clinical and Laboratory Standards Institutewww.gbo.com

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GREINER BIO-ONE GMBHKREMSMÜNSTER, AUSTRIAPHONEFAX
E-MAIL+43 7583 6791-0+43 7583 6318
office@at.gbo.com

This product information is addressed exclusively to healthcare professionals.
Devices of Greiner Bio-One are to be used by properly trained healthcare professionals
only in accordance with the relevant Instructions for Use (IFU). For a listing of indications,contraindications, precautions and warnings, please refer to the Instructions for Use
which accompanies each product. For more information contact your local
Greiner Bio-One sales representative or visit our website.
All information is provided without guarantee despite careful processing. Any liability, warranty
or guarantee of Greiner Bio-One GmbH is excluded. All rights, errors and changes are reserved.
If not stated otherwise, Greiner Bio-One GmbH has all copyrights and/or other (user-)rights inthis documents, in particular to signs such as the mentioned (word-picture-) brands and logos.
Any use, duplication or any other use of the rights of Greiner Bio-One GmbH is expressly prohibited.
Media owner: Greiner Bio-One GmbH / Manufacturer: [Samson Druck GmbH / 5581 St. Margarethen]981232 en [rev.00 10.2023]

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