GEM OPL

Oxygenation Portable Laboratory

READ POLICY PRIOR

TO STARTING TUTORIAL
 Qualified Personnel
Testing personnel are required to take the Initial Orientation
and Training, 6 Methods of Competency Exam, and a second
Competency Exam within the first year of certification for this
POCT.

Competency exams are then required annually thereafter.

Clia 88 requires staff to have a high school diploma or a

college degree in one of these listed sciences to perform this
moderately complex test. Please submit a copy of your HS
Diploma or College Degree in Chemical Science,
Biological Science, Physical Science (or Nursing) to
POCT Services.
 Before Testing a Patient
Orient yourself to your working area:
Locate the analyzer.
Locate testing supplies:
Single-use cuvettes
Optical QC filters (yellow and orange)
Mutli-4 Co-Oximeter Control (Multi-pack)
Temperature probe
Operator Manual
 GEM OPL
Using the GEM OPL is considered Moderate in complexity by
the FDA.
Purpose: The GEM OPL is intended for rapid whole blood
oximetry testing in the cardiac catheterization laboratory at
SFGH.
 Quality Control
Optical QC Filters (Yellow and Orange)
Run one of each filter daily prior to patient
testing
Run if analyzer is brought from hot to a cold
temp or vice versa.
Run whenever the performance of the analyzer
requires verification.
 Quality Control
Optical QC Procedure
Confirm that the filters have the same serial number
as the GEM OPL.
Wait until the READY message appears on the
display.
Remove any debris from the surface of the optical
filters by wiping them with dry gauze prior to
inserting them into the GEM OPL.
 Quality Control
Optical QC Procedure
Insert the filter into the cuvette slot and enter the
sample information at the prompt.
Verify that each of the results is within the
established range for the filter. Proceed with the
other filter if each value is within range.
Document all Optical QC results on the daily Optical
QC Log.
 Quality Control
Optical QC Procedure
Ranges:
Analyte Range for Yellow Range for Orange
Filter Filter
tHb (g/dL) 7.8 to 8.2 16.7 to 17.3

%O2Hb (O2 Sat) 93.7 to 96.l3 37.8 to 40.2

 Quality Control
IL Multi-4 CO-Oximeter Controls: Level 1, 2 and 3
(Liquid QC)
Store at 2-8C.
Follow manufacturers insert for expiration date(s) that are
stamped on the box and ampule label.
Controls should be reddish in color when received and
remain so until the expiration date. Change of color to
brown and/or inability to achieve listed values is an
indication of deterioration.
 Quality Control
Liquid QC
The purpose of liquid controls is to serve as another
means to verify that the GEM OPL system is
functioning properly.
Control materials compatible with the GEM OPL are
the IL Multi-4 CO-Oximeter Controls levels 1, 2, and
3. Other controls may give erroneous results.
Run weekly to verify proper storage of cuvettes.
 Quality Control
Liquid QC
Run every time there is a new lot or new shipment of
cuvettes prior to patient testing.
QC results should fall within the manufactures
reference range found listed on each lots package
insert.
 Quality Control
Liquid QC Procedure
Prior to analyzing liquid controls, QC lot information
must be defined:
Press the Computer key, then Data Management
#1, press Enter/On.
Press QC Lot #4, press Enter/On.
Select Level: 1, 2, or 3
 Quality Control
Liquid QC Procedure
Prior to analyzing liquid controls, QC lot information must be
defined:
Select Lot Select the Lot number to be changed or
deleted.
Option 1. Cancel or OK to accept the Lot Number
displayed.
Option 2. Enter a new Lot Number from one to seven
numeric digits in length or press Enter/On to delete the
previous Lot Number.
Entry of a new Lot Number requires confirmation.
Deletion of a Lot Number automatically shifts the remaining Lot
Numbers up one selection on the Select Lot screen.
When specifying Lot Numbers, ignore leading letters.
 Quality Control
Liquid QC Procedure
Ensure that the temperature probe is firmly plugged into the
instrument.
If the instrument is not powered up, press the Enter/On key
and wait for the Ready screen.

Temperature Probe
Enter/On Key
 Quality Control
Liquid QC Procedure
Verify GEM Code, fill cuvette with the control, and
insert the cuvette into the instrument.
Press the Main Menu key, then Calibration #1,
press Enter/On.
Press Cuvette GEM Code #1, press Enter/On.
The currently defined GEM Code is displayed on
the Ready screen for visual verification each time
a sample is analyzed.
 Quality Control
Liquid QC Procedure
Selecting the GEM Code option from the
Calibration Menu displays the GEM Code
currently defined. Press Cancel or OK to leave the
GEM Code as currently displayed, or change the
current value.
After entering a four digit numeric GEM Code, the
operator must confirm the entry in a subsequent
display.
GEM OPL presents an error message if the GEM
Code entered does not match one of those
defined by the manufacturer.
 Quality Control
Liquid QC Procedure
Hold the ampule by the top above the break line and
shake the ampule with gentle tapping. Restore all
liquid to the bottom of the ampule with gentle tapping.
Use appropriate commercially available ampule
openers to protect fingers while opening.
Carefully snap open the ampule.
 Quality Control
Liquid QC Procedure
Sample contents immediately after opening.
Verify that QC results are within manufacturers
package insert ranges.
If values are not within range, repeat QC.
If still not passing range, contact POCT Services.
Do not use instrument for patient testing if QC fails.
Document all QC results on the Liquid QC Log.
Document all corrective actions taken.
Specimen Collection and Stability
Verify patient identification with two identifiers (patients
name and date of birth) before drawing the blood
sample.
Observe universal precautions; wear gloves and other
personal protective equipment as appropriate.
If there is the potential for specimen mix-up, the
specimen must be labeled with patients full name and
medical record number.
Specimen Collection and Stability

Collect blood samples in a sodium or lithium

heparinized plastic syringe. Collect and handle the
specimens according to medically-accepted sterile
techniques.
When drawing blood samples with a syringe from a
saline filled catheter, withdraw the saline first and
make sure that only whole blood is sampled.
Specimen Collection and Stability
Roll the tightly sealed syringe between your palms to
keep the red blood cells and plasma well mixed.
When handling cuvettes, hold them only by their black
caps.
To avoid warming the cuvette, do not pick it up until
you are ready to fill it and analyze the sample.

Hold here
Specimen Collection and Stability

Always fill cuvette prior to inserting it

into the instrument.
When filling a cuvette, do not use
excessive pressure or cause the vent
patch to bulge outward. If the vent patch
protrudes, discard the cuvette.
If the sample in the cuvette is poorly
mixed or contains clots, then discard the
cuvette to prevent erroneous results.
Specimen Collection and Stability

Always store cuvettes in the sealed bag with a

desiccant pouch or erroneous results may occur.
Prior to use, verify desiccant color indicator is blue.
If the color indicator has changed, do not use cuvettes
until a new desiccant pouch can be added to the bag.
Patient Sample Analysis Procedure

Confirm that the temperature probe is plugged firmly

into its socket on the rear panel of the instrument.
Press the Enter/On key to turn on the GEM OPL, enter
your operator ID (your RN License Number), and
confirm that the self-test was successful.
The instrument is ready to analyze samples when the
display reads:

--- READY ---

Insert Cuvette
GEM Code = 3138
Patient Sample Analysis Procedure

Verify that the GEM Code is correct for the cuvette bag
in use. If not, you must change/update the GEM Code
through the Calibration Menu (Refer to GEM OPL
Operators Manual on how to change GEM Code on the
GEM OPL instrument).
Collect and prepare the heparinized blood sample as
described.
 Patient Sample Analysis Procedure

Expel one drop of sample from syringe Bubbles ok here

and connect sample-filled, plastic
syringe to a new disposable cuvette.
Hold cuvette downward at 45o angle
and inject sample into cuvette until
sample reaches the vent patch at the
opposite end. Leave the syringe
attached to the cuvette.
Confirm that the light path at the widest
portion of the sample chamber is free of
debris or air bubbles. Ignore bubbles
outside of the light path.
Light Path
Hold at black caps

Discard if bulging
Patient Sample Analysis Procedure

Remove any sample (blood) on cuvettes exterior

surfaces before inserting cuvette into the GEM OPL.
Do not overpressure the cuvette or cause the vent
patch to bulge outward.
Insert cuvette within 10 seconds of filling it.
Patient Sample Analysis Procedure

Wait for Analyzing Sample to complete.

Select sample type. For patient select #1. Press
Enter.
Press #1 to enter patient ID. Press Enter.
Enter the patients MRN. Press Enter.
Verify that youve entered the correct MRN. If ok, press
#1. If not correct, press #2 to renter the MRN. Press
Enter.
Patient Sample Analysis Procedure

After the information is entered, the result will be

displayed as follows:

Sample #1
tHb O2Hb COHb MetHb
17.0 39.7 56.6 1.1
g/dL % % %
Patient Sample Analysis Procedure

After the results appear, the data will stay on the

display until the Enter/On key is pressed.
A second screen displaying SO2, O2Ct and O2Cap
results is accessible by pressing the Enter/On key.
Pressing the Enter/On key a second time will return to
the Ready screen.
To analyze the next sample, obtain a fresh cuvette
from the bag next to the instrument, and repeat the
previous steps.
 Reporting Results
Report results in the patients medical record.
 CAP Survey
Proficiency Testing (PT)
All staff performing co-oximetry participates in regular PT surveys
offered by an approved provider, i.e., the College of American
Pathologists (CAP).
The survey material and instructions are distributed by a
Hematology Laboratory Specialist / Designee.
PT must be performed under the same conditions like any patient
sample.
PT cannot be sent to the central laboratory for testing.
PT results are returned to the Hematology Laboratory Specialist /
Designee for reporting to CAP.
Survey results are reviewed by a Hematology Supervisor, Division
Chief and Laboratory Director. If necessary, remedial action plans
are prepared, implemented and corrective actions monitored.
 Maintenance
TEMPERATURE PROBE
Prior to running QC, check instrument temperature
and log result on daily Optical QC Log.
Press Computer Key, then press Time, Date,
Temp #3, press Enter/On.
Press Temp & Battery #3, press Enter/On.
Temperature will be displayed document on daily
Optical QC Log.
 Maintenance
BATTERY CHARGE
The following tips will help the user maximize the number of samples that
can be analyzed from a single battery charge:
Turning the display backlight off will conserve battery energy.
If the backlight is needed, the LOW backlight setting is the next
best choice.
Press the Computer key, select Device Settings, and select LCD
to set the level of backlighting.
Setting the Standby Delay to the shortest time (10 minutes) will
conserve battery energy by putting the GEM OPL into Standby
Mode if it is not used for 10 minutes.
Press the Computer key, select Device Settings, and select
Standby Delay to change the setting.
Ni-Cad batteries suffer from a memory effect if they are charged
before being completely discharged. To prevent memory effect,
let batteries discharge completely before recharging. Batteries
are almost completely discharged when the battery critical
status screen is displayed.
 Maintenance
BATTERY STATUS
Battery status can be checked by pressing the
Computer key, selecting Time, Date, Temp, and
selecting Temp & Battery. The battery charge status
will fall into one of four categories: High, OK, Low,
or Critical.
When the GEM OPL is in the Sample Analysis
Mode, the status of the battery will be displayed on
the LCD display when it becomes critical. When the
battery status becomes critical, the GEM OPL will
immediately go into Standby Mode and will prompt
the user to plug in the battery charger.
 Maintenance
ANALYZER CLEANING
Clean the analyzer surface and
screen with a soft cloth dampened
with isopropyl alcohol, distilled
water, or 10% bleach solution.
Immediately wipe off any excess
alcohol or accidental liquid spill.
A cotton swab may also be used to
clean the outside of the cuvette slot
as needed (do not insert cotton
swab into the analyzer).
NOTE: Do not use excessive force,
strong detergent, concentrated bleach,
or abrasive cleaning solution because
they can scratch or damage the
surface.
 Maintenance
OPTICAL FILTER CLEANING
Clean the surface of the optical filters with dry
gauze to prevent scratching
 Limitations
Substances that can potentially interfere with
sample analysis include:
Citrate is known to change the pH of the blood and
cause errors in spectrophotometric measurements.
Similarly, fluoride, oxalate, and EDTA should be
avoided.
Excessive volumes of anticoagulant or saline may
oxygenate the sample or cause dilution errors.
Other interferences with sample analysis may
include:
Cuvettes stored improperly (not in a sealed bag with a
desiccant pouch) may cause erroneous results.
Poorly mixed samples or those containing clots.
 For Further Question or
Information Contact POCT
Services

SFGH-POCT.org