GEM OPL Oxygenation Portable Laboratory - SFGH-POCT · 2015. 4. 27. · conserve battery energy by putting the GEM OPL into Standby Mode if it is not used for 10 minutes. •Press

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


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


Ranges:

Analyte Range for Yellow

Filter

Range for Orange

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 2-8°C.

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 manufacture’s

reference range found listed on each lot’s 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 manufacturer’s

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 (patient’s

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 patient’s full name and

medical record number.


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.


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


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.


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


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

Operator’s Manual on how to change GEM Code on the

GEM OPL instrument).

Collect and prepare the heparinized blood sample as

described.


Expel one drop of sample from syringe 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

Bubbles ok here

Hold at black caps

Discard if bulging


Remove any sample (blood) on cuvette’s 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.


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 patient’s MRN. Press Enter.

Verify that you’ve entered the correct MRN. If ok, press

#1. If not correct, press #2 to renter the MRN. Press

Enter.


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 % % %


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 patient’s 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

Documents

GEM OPL Oxygenation Portable Laboratory - SFGH-POCT · 2015. 4. 27. · conserve battery energy by putting the GEM OPL into Standby Mode if it is not used for 10 minutes. •Press