POC Testing:
Analyzer Developments & Targeted
Survey Standards
Michaela Cvitkovic, BS., MT(ASCP)
Laboratory Compliance Manager
SpecialtyCare, Inc.
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ANALYZER COMPARISONS &
DEVELOPMENTS
Blood Gases:
epoc & iSTAT1
Bleeding Management:
ROTEM delta & TEG 5000
New Developments
Quality Control
POC analyzer
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CVOR POC
Lab Deficiencies




Competency
Credentialing
Q.C. Failures
Temperature Controlled Spaces
3
Top Deficiencies Cited by
JCAHO and CAP
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COMPETENCY & the
NEW employee

Must complete an Initial Training,
before patient testing


Must complete semi-annually
competency during the first year of
duties, by 6 months
Continue with current staff on an
annual basis
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COMPETENCY
New Equipment – “non-waived” testing
Retain Original Training Documents!!


Implementation of new methodologies must have documentation
of Initial Training (i.e. iSTAT1 to Gem3500).
Even if the analyzer is an upgrade must retain original training
material (i.e. iSTAT 200 to iSTAT1 – Signature Plus to Elite).

Save this documentation as long as the analyzer is available
for patient testing.
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CREDENTIALS
Testing Personnel Limitations

Perfusion Certification is not a “CLIA
defined eligibility route” –
may be asked to produce H.S. Diploma

Know who is permitted to be classified as
Testing Personnel.
For example, in CA – Perfusionists are exempt from the lab licensing
for patient testing, but staff like Perfusion Assistants or Anesthesia
Technicians, are not.
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QUALITY CONTROL
Failures



If have a ‘wet’ failure on an analyzer that uses EQC, carefully
determine C.A. before proceeding.
Do not continue to repeat ‘wets’ until get one in-range!
Two consecutive ‘wet’ failures in a row will trigger a repeat of the
10 or 30 day EQC study – depending on the analyzer.
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TEMERATURES
Refrigerator & Room



If supplies (cartridges, QC) are being stored in a small local
(O.R.) Refrigerator, there must be indication of
temperature monitoring.
CAP requires daily.
If Refrigerator is not hard wired to Engineering or
continuously monitored in some manner, must be
manual documentation.
If have supplies kept at Room Temp, such as cartridges,
should have a monitoring system also.
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TEMERATURE
Documentation
•
•
acceptable range
- C or F must be consistent
- tightest range in use, (iSTAT 18-30 RT while Gem Cart 15-25)
daily temp in addition to Min/Max
–
Daily is specified in CAP Checklist standards!
•
area for corrective action
•
explanation of date w/out temp recorded
•
monthly review w/ date & initials
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ANALYZER COMPARISON –
POC Blood Gas
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Epocal epoc® System
distributed by Alere
Reader
Host
Test Card
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Epocal epoc System
®
Common features vs. comparable
POC analyzer:
–
–
–
Single-use, self-calibrating, 95 mL
WB sample
Blood gases, electrolytes, metabolites
and hematocrit on a single cartridge
Data management
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epoc system
Unique features vs. comparable
POC analyzer:


up to 6-month Room Temp shelf-life
from date of manufacture
bar coded cards read on insertion
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epoc vs.
iSTAT1
Room Temp
storage only
1pt cal before sample
added, 165 sec ( 2.75 min )
Room Temp cart
storage for 2 wks
1 pt cal w/ sample
upon cart. insertion
35 secs
130-200 secs
sample only
Cal & sample processing
Separate ABG, Lytes,
Metabolite & Hct QC
vials
Available Eurotrol QC ABG,
Lytes, Metabolites & Hct one
vial
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epoc vs. iSTAT1
Notification of update via e-m
and installation from EDM via
WiFi
epoc analyzer = Reader & Host
- Multiple Readers w/ 1 Host
Updates mailed 2x/yr
self-installed
Analyzer all inclusive
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epoc vs. iSTAT1
Cart read upon
insertion; each
individually bar
coded
BGEM:
pH, pCO2, pO2, Na, K,
iCa, Glucose, Lactate, Hct
Only cartridge is
BGEM
Reader = Lithium Ion
rechargeable battery only
Each cartridge pouch
manually scanned
CG8+
(No Lactate)
Multitude of cartridge
configurations
Rechargeable or
Disposable batteries
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epoc vs.
iSTAT1
Automated Internal QC
( iQC ) - No External Sim.
Host display
“Windows”-like
Internal QC & also
External Simulator
Basic text display
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epoc
Future Developments as
related to CVOR:


Coag: ACT, PT, aPTT
Creation of single-vial QC
to contain ABG, Lytes, Metabolites & Hct
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New development in QC
Eurotrol QC
“one ampule all analytes”
ABG, Lytes, Metabolites &
Hct in one vial
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Eurotrol QC
Hyperbaric
X-High 710 mmHg
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Eurotrol QC
Hypoxic
X-Low 15 mmHg
Generic for all blood gas
analyzers –
one range fits all
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Eurotrol Hyper & Hypoxic
HYPER –
–
published ranges for iSTAT
use on any ABG analyzer, but
must establish In House ranges
HYPO –
one published range for all analyzers
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ANALYZER COMPARISON –
Bleeding Management
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ROTEM®delta
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ROTEM®delta System Thromboelastometry

1600 units in clinical
use in 50 countries

more than 500
publications
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ROTEMdelta System
Common feature vs. comparable
analyzer is the analysis platform:
Clot formation, strength &
stability, and subsequent lysis.
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ROTEM® vs. TEG 5000®
GENERAL INFO
– Incorporated in July 2008
– Primarily targeted
researchers at the start
– 2-test approval 3/23/10,
in-tem & hep-tem
– Additional 3 tests approved
8/12/11
– April 2000 Haemoscope
received the 510K
– Purchased by
Haemonetics 11/21/07
– 5 tests with different
activators
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ROTEM vs. TEG 5000
PRINCIPLE
Rotational
Thromboelastometry
trademarked by Rotem
Principle: pin oscillates as
the cup remains
stationary & as clot forms
rotation becomes
restricted & clot firmness
detected optically
Classical or ‘Original’ method:
Thromboelastography – originally
described by H. Hartert in 1948 &
trademarked by Haemoscope.
Principle: cuvette is rotated and as
clot forms it links the pin & cup
together; movement of the pin is
converted to electrical signals
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ROTEM delta & TEG 5000
PRINCIPLE via graphics
Rotating axis
(+/ - 4.75°)
Spring
Light source
Detector
Ball bearing
Plastic pin
Cuvette with blood
Fibrin strands and
platelet aggregates
between surfaces
Heated cuvetteholder
Cup takes 10 seconds per rotation
Electrical detection
Pin makes 13 oscillations per minute
Optical detection
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ROTEM vs. TEG 5000
COMPONENTS
Control unit integrated
4 channel instrument
Control unit on separate PC
2 channel instrument
Up to 8 channels can run on one PC
Scan can be viewed remotely
using Secure Viewer software
No leveling required
(constant monitoring system)
Scan can be viewed remotely
Some leveling required
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ROTEM vs. TEG 5000
COMPONENTS
Automated pipette
Touch screen monitor
Temp can be adjusted
for Hypothermia
Manual pipetting
N/A
(unless computer is set up as such)
Temp can be adjusted
for Hypothermia
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ROTEM vs. TEG 5000
QUALITY CONTROL
ROTROL N and ROTROL P
EQC Option 2 –
Aqueous QC’s once/week
Continuously monitors:
Phase Shift, Variance,
Center, Amplitude,
Temperature
Level I and II QC
Aqueous QC’s every 8 hours
of patient testing
No continuous monitoring, however
eTest verifies and/or maintains the
electronic functioning of the analyzer
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ROTEM vs. TEG 5000
REGULATORY
Both have available Proficiency Testing
with CAP & API
TEG5000 also has PlateletMapping
Proficiency Testing with CAP
CMS reimbursement
available
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ROTEM vs. TEG 5000
SAMPLE PREP
Once draw into Citrated
tube, sample can be run
immediately,
or up to 4 hrs later.
Citrated samples – must sit for
at least 15 min, but run within
2 hours
Non-Citrated samples – must be
run within 4-6 minutes
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ROTEM vs. TEG 5000
TEST MENU
in-tem®
hep-tem®
NATEM®
intrinsic pathway in citrated
whole blood specimens
the intrinsic pathway in the
presence of unfractionated
heparin, in citrated whole blood
specimens (open heart)
research and less
clinical practicality
- Kaolin activator, Citrated sample
- Kaolin activated, non-Citrated
- Kaolin activator, Citrated sample,
in Blue Heparinase cup
- Kaolin activated, non-Citrated s.
in Blue Heparinase cup
- Non-activated, Citrated sample
- Non-activated, non-Citrated s.
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ROTEM vs. TEG 5000
TEST MENU
Rotem tests approved 8/12/11
ex-tem®
hemostasis via the
extrinsic pathway
fib-tem®
measuring fibrinogen
contribution to the clot
ap-tem®
detects hyperfibrinolysis
RapidTEG, (TEG-ACT)
non-citrated or citrated
Research protocols using
Tissue Factor alone
Functional Fibrinogen
non-citrated or citrated
LY30 and lysis parameters
in all TEG assays
37
ROTEM vs. TEG 5000
TEST MENU
N/A
Platelet function
PlateletMapping® Assay
- Activator F
- ADP (tests for GPIIb/IIIa
receptors) clopidogrel, etc
- Arachidonic Acid (test for
aspirin and other NSAIDs)
N/A
No anticoagulant or
activator
(liver transplants)
Native, non-activated
non-anticoagulated or citrated
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ROTEM vs. TEG 5000
DECISION TREE
ROTEM
- Does offer on-line
FUZE Training.
Data Interpretation
using PowerPoint
Presentation.
- Discuss
temogram
interpretations.
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TEG 5000 - Scan
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ROTEM® - Screenshot
Lysis ML
(%)
A20 = Clot Firmness (mm)
20 minutes after CT

Clot Quality
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ROTEM
vs.
TEG
5000
SCAN PARAMETERS
CT - Clot Time, (seconds)
CFT – Clot Formation Time
(seconds)
α Angle – Alpha Angle, (°)
A (x) – Amplitude at a time
point (minutes)
10/15/20/25/30 mm
MCF – Maximum Clot
Firmness, (mm)
R = Reaction time, (minutes)
Time to initial fibrin formation
K = Coagulation time, (minutes)
Speed of fibrin build up
a = alpha angle, (°)
Speed of clot strengthening
No equivalent parameter
MA = maximum amplitude, (mm)
Strength of clot
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ANALYZER WITH
PENDING FDA SUBMISSION
& APPROVAL
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HELENA ABRAZO
Must stress For
Investigational
Use Only at this
time
FDA Submission
in Sept 2011
Tests to be
submitted for
FDA Approval:
aPTT, PT &
Celite ACT
Watch for further
developments
Specific contents of this slide approved by Helena
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~ THANK YOU ~
Michaela.Cvitkovic@specialtycare.net
Abbott / iSTAT 800-827-7828 www.abbottpointofcare.com
Epocal Inc 888-893-6225 www.epocal.com
Eurotrol, Inc. 866-234-5754 www.eurotrol.com
Helena 888-893-6225 www.helenapoc.com
Rotem 919-941-7777
www.rotem.de
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