Ernst---What You MUST Know About the
New CLSI Venipuncture Standard
What You MUST Know
About the New
CLSI Venipuncture Standard
Dennis J. Ernst MT(ASCP), NCPT(NCCT)
Center for Phlebotomy Education, Inc.
www.phlebotomy.com
Format restructuring
•Path of workflow
7/11/2016
Design and Designation
•Cover redesigned
•More graphic elements
inside
•Renamed as
“Collection of Diagnostic Venous
Blood Specimens”
Format restructuring
•Path of workflow
•Quality Management System (QMS)
•Focus on venipuncture as a
“________________________”
References gutted
•Over _______ articles and studies
reviewed
•_____ References removed
•_____ New references added
Copyright 2016 Center for Phlebotomy
Education, Inc. All rights reserved.
www.phlebotomy.com
Substantive changes: imperatives
• “Must”
•“Shall”
•“Should”
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Ernst---What You MUST Know About the
New CLSI Venipuncture Standard
Substantive changes:
Phlebotomy trays
Disinfection
Placement on
patient surfaces
X
Substantive changes:
BP cuff as a tourniquet
Old: 40 mm Hg
New: below __________________
Substantive changes:
Collection manual
•Must be available
to all who draw for
the lab
Copyright 2016 Center for Phlebotomy
Education, Inc. All rights reserved.
www.phlebotomy.com
7/11/2016
Substantive changes:
Needles, syringes, holders
____ preassembling
Sterile, single use
Safety features where
regulated
Substantive changes:
Safety transfer devices
•Must be used when
transferring from a
syringe
X
Substantive changes:
NCE management
• Deviations from approved phlebotomy procedures
• Sample mislabelling
• Improper sample collection, transport, handling,
and/or processing practices
2
Ernst---What You MUST Know About the
New CLSI Venipuncture Standard
Substantive changes:
NCE management
•Customer service incidents
•Safety infractions
•Breaches of confidentiality
Substantive changes:
Personnel
•Initial orientation to the organization
•Initial, ongoing, and remedial training
Substantive changes: patient ID
• Old:
• Patient must verbalize, not affirm name,
address, unique identifier and/or DOB.
Patient must spell last name.
• Inpatients: compare with ID band,
label/orders.
• Outpatient: Compare with labels/orders
Copyright 2016 Center for Phlebotomy
Education, Inc. All rights reserved.
www.phlebotomy.com
7/11/2016
Substantive changes:
Quality indicators
A program must be in place to identify
________________ _______________.
Substantive changes:
Personnel
•Initial and periodic competence
assessment and performance
evaluation
•Continuing education and
professional development
Substantive changes: patient ID
New
Patient must verbalize full name and birth date,
must _____________
first and last name.
Banded: Compare with ID band, label/orders
Unbanded: proof of ID, compare with
labels/orders
3
Ernst---What You MUST Know About the
New CLSI Venipuncture Standard
Substantive changes: Consent
The collector must
_____________ _______________
in accordance with
facility protocol.
Substantive changes:
fainting history
Patients with a history of
fainting must be
_____________________
during the procedure.
Substantive changes:
Unacceptable sites
•___________ _____________
•Infected sites
Copyright 2016 Center for Phlebotomy
Education, Inc. All rights reserved.
www.phlebotomy.com
7/11/2016
Substantive changes: Inquiries
•“Problems” with prior
draws
•Latex allergy (if latex is in
use)
Substantive changes:
Patient positioning
•Must not be seated upright:
•on an exam table
•side of a bed
•any surface without
arm rests or other
barrier
Substantive changes:
Sites to avoid
•Extensive scarring, healed burns
•Hematoma
•Above and below infusing fluids or from
a VAD
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Ernst---What You MUST Know About the
New CLSI Venipuncture Standard
Substantive changes:
Sites to avoid
•Inflamed sites
(including inflamed tattoos)
•Edematous sites
•Extremity affected by stroke
and injury
Substantive changes:
Vein selection
•Old: avoid basilic
•New: avoid the basilic and the
______________ _______________
of the median cubital, and median
basilic
Substantive changes: Cleansing
•________________
cleansing
no longer necessary
Copyright 2016 Center for Phlebotomy
Education, Inc. All rights reserved.
www.phlebotomy.com
7/11/2016
Substantive changes:
Mastectomy patients
•Section enhanced
•No changes in how/when to draw
Substantive changes: Supplies
•_____-___________ _______required
•New gloves
•Must remain intact throughout
Substantive changes: Winged-collection sets
•Must be
secured
throughout
procedure
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Ernst---What You MUST Know About the
New CLSI Venipuncture Standard
Substantive changes:
Filling tubes
•Must be filled to
their stated volume
•Tube contents
cannot be
combined
X
Substantive changes:
Needle relocation
7/11/2016
Substantive changes:
Trace element tubes
X
Consult the tube manufacturer’s
recommendations.
Substantive changes:
One stick per needle
•Greater detail
•Describes a “calculated relocation”
Additional punctures to access a vein
must be conducted with a new needle
and started from the beginning of the
procedure.
Substantive changes:
tube labeling
Substantive changes:
tube labeling
•Sample ID
verification
changed from
“where possible”
to
•Labeling tubes only after the
draw contested.
“___________.”
Copyright 2016 Center for Phlebotomy
Education, Inc. All rights reserved.
www.phlebotomy.com
6
Ernst---What You MUST Know About the
New CLSI Venipuncture Standard
7/11/2016
Substantive changes:
Post-venipuncture care
Substantive changes:
Post-venipuncture care
• Must observe the
site for at least
__________
seconds.
•Return items to original location/position
Substantive changes: Complications
Substantive changes: Complications
•Accidental arterial puncture
•Nerve injury
•Hematoma
•Hemolysis
Substantive changes: Complications
•First aid
•Dizziness, syncope, etc.
•Nausea
•Vomiting
•Seizure
Copyright 2016 Center for Phlebotomy
Education, Inc. All rights reserved.
www.phlebotomy.com
•Monitoring blood volume
The volume of blood drawn from patients
susceptible to iatrogenic anemia
must be _____________ and ______________.
Substantive changes: Complications
All complications and incidents occurring
during the draw must be reported.
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Ernst---What You MUST Know About the
New CLSI Venipuncture Standard
Substantive changes:
Special situations
•Blood Cultures
•Line draws
•TDMs
•Patients in isolation
Substantive changes:
Appendices
•Appendix B
provides guidance for
establishing maximum
volumes to prevent
iatrogenic anemia
Substantive changes:
Appendices
•Appendix D
provides guidance for
preventing syncope
Copyright 2016 Center for Phlebotomy
Education, Inc. All rights reserved.
www.phlebotomy.com
7/11/2016
Substantive changes:
Appendices
•Appendix A provides guidance
and remedies for:
• Children
• Elderly
• Obese
• Oncology
• Needle-Phobic patients
• Cognitively impaired/combative
Substantive changes:
Appendices
•Appendix C
provides guidance
when drawing proximal
to an IV infusion
GP48: Essential Elements of a Phlebotomy
Training Program
GP48
Essential Devices of a Phlebotomy
Training Program;
Approved Guideline
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Ernst---What You MUST Know About the
New CLSI Venipuncture Standard
7/11/2016
GP48
•Target audience:
•Laboratory educators
•School administrators
and educators
Copyright 2016 Center for Phlebotomy
Education, Inc. All rights reserved.
www.phlebotomy.com
9