GEM 4000 Training Plan
GEM 4000 Training Plan
GEM 4000 Training Plan
: SOP-CB-POCT-D-24
GEM 4000
Critical Care Analyser
ACTIVE VERSION : 4
HARDCOPY AUTHORISED BY :
(SIGNATURE)
NUMBER OF COPIES : 8
REVISION HISTORY
INTRODUCTION..................................................................................................................................................... 4
STAFF RESPONSIBILITIES................................................................................................................................... 5
DATA COLLECTION............................................................................................................................................... 7
CLEANING .............................................................................................................................................................. 17
CHANGING PAPER............................................................................................................................................... 17
TROUBLESHOOTING.......................................................................................................................................... 17
Introduction
This booklet has been compiled by the Chemical Pathology laboratory at BHNFT
to help you, the healthcare professional, achieve consistently reliable and accurate
results.
The different sections of the booklet cover aspects of working with the GEM 4000
analyser including instructions on the routine use, maintenance, troubleshooting and
quality control of the analyser. On completing this training all users of the
instrument should be able to:
• Analyse all types of sample obtaining accurate results whilst minimising risk
to themselves and patients.
• Recognise and act on error messages.
• Look up patient results
Further information can be seen in the SOP available within Chemical Pathology.
However, if you have any queries please don’t hesitate to contact your Link Nurse
or the Chemical Pathology laboratory.
Staff Responsibilities
Clinical Laboratory Accreditation Ltd (CPA) requires all Clinical Biochemistry/Chemical
Pathology Laboratories to guarantee that all Point of Care Testing (POCT) within the Trust is
performed to the same standard as required in the laboratory and, in doing so, ensures the safety
of patients and staff.
The use of analysers by untrained staff, without adequate management supervision of the
equipment and without the use of quality control procedures, can lead to misleading results,
adversely affecting the treatment of patients1.
Recommendations
• All staff who perform sample analysis must be properly trained to use the equipment*.
• Quality control checks should form part of the maintenance routine, with the Clinical
Biochemistry laboratory directly involved.
• Quality control procedures should aim particularly at maintaining the competence of all
equipment users and ensuring the reliability of the results obtained.
The above recommendations are contained within the Department of Health Hazard Notice
pertaining to blood glucose measurement but apply equally to any Point of Care Testing.
*As such, it is extremely important that staff are properly trained in the use of the GEM 4000
analyser. The equipment will be password protected and staff will be issued with a password only
after they have undergone recognised training and obtained a certificate of competence. If in
doubt please contact your Link Nurse or Chemical Pathology before using the equipment.
1 Source: Blood glucose measurements: Reliability of results produced in extra-laboratory areas. Department of Health
2. Only staff who have received appropriate training may use the analyser.
3. Each member of staff takes responsibility for the quality of the results obtained by
him/herself using the following procedures:
• CVP (Calibration Validation Product) ampoules must be run on changing a reagent pack.
• If any parameter fails the Intelligent Quality Management procedures (iQM) patient results
for that parameter MUST NOT be acted upon.
• Full patient details must be entered into the analyser for every analysis performed (refer to
data collection procedure).
4. A nurse for each ward / department should be designated to ensure that equipment is
correctly maintained.
7. Results MUST be confirmed by sending a brown top gel tube to Chemical Pathology if they
meet the following criteria:
• Sodium <130 or >155 mmol/L
• Potassium <3.0 or >6.0 mmol/L
• Glucose <3.0 or >20.0 mmol/L
N.B. Sodium, Potassium and Glucose are performed on whole blood on the GEM4000 whereas
the laboratory analyse serum. Please note there may be a difference between the results
Data Collection
Accurate patient identification is essential to minimise clinical risk and to maintain pathology
electronic patient records. To ensure this the following procedure MUST be followed:
GEM 4000
After initiating sampling procedure:
• Input the Patient Unit number*, A/E number or, if this is not available, use the surname
and Date of Birth ‘ENTER’
• Select and Enter the Surname*
• Select and enter First Name*
• Select and enter date of birth*
* All these are mandatory data items and must be entered before analysis can be completed.
N.B. This information will be used to create a request on the pathology computer system. All
Blood Gas analysers are interfaced directly to the Pathology computer system; the results and
demographics received by the system from the analysers automatically register and record these
results prior to presenting them to the ward reporting system. The interface is set up to trap mis-
matched data and prevent this passing to the computer system, the more information entered the
more secure the system. A unit number or name alone is not acceptable. As there is only a
short lag period between the gas being performed and it appearing on the ward reporting system
please inform the laboratory immediately if you enter the details for a wrong patient.
Sample Type
Selection
Available Analytes
Sample Preparation
Prior to analysis, it is essential that the sample be thoroughly mixed. Hematocrit, total
hemoglobin, hemoglobin derivatives, and oxygen are particularly affected when samples are not
well mixed. A uniform distribution of red blood cells and plasma prior to sample aspiration is
mandatory for reliable results. The sample should be inverted at least 3 times and rolled between
outstretched palms at least 5 times if drawn within 5 minutes of sampling. The syringe should be
gently rotated for a minimum of 2 minutes immediately prior to analysis if more than 5 minutes
have elapsed from sample collection.
Capillary tube samples should be remixed if more than 5 minutes have elapsed since collection by
mixing the capillary tube between outstretched palms for at least 5 seconds.
• Select Normal or Micro sample by pressing the Normal/Micro toggle button on the left.
Micro sampling is available only with capillary tubes.
Sample volumes Full profile and CO-OX 150 µL
Full Profile 95µL
Micro Mode 65µL
• Select the sample type/container combination using the drop-down menu under 2.
Type, if it is not already selected.
• Alternatively select the required profile from the right hand side of the screen, this will
select the sample type automatically.
• Press GO! The sampler will emerge from its home position.
• Syringe or ampoule sampling – The sampler will extend from the luer and move
approximately 30 degrees from its home position. Push out a few drops of the sample
onto a tissue to ensure there is no clot in the syringe tip.
Present the syringe or ampoule by placing it over the end of the sampler. The sampler
should be inserted far enough into the container to allow sufficient sample to be
aspirated but not so far that the sampler touches the bottom of the device.
Revision : 4 Revision Date : 26/05/11 Page 10 of 18
Update Responsibility : S Dean
Approved by : SC Hall GEM 4000 TRAINING PLAN.DOC
QMS Ref. No.: SOP-CB-POCT-D-24
• Capillary tube – The luer will present just below the home area (the sampler will not
extend). If the blood is not flush with the end of the capillary tube that will be placed
into the sampler, gently tilt the tube down so that the blood is flush with the end of the
capillary tube prior to placing it into the sampler. Place the end of the capillary tube
with the blood flush with the end in the black portion of the sampler. Do not use
excessive force. Hold the exposed end of the tube, keeping the tube in line with the
sampler, and press OK to begin aspiration.
• The system will aspirate the sample and beep when aspiration is complete. Remove the
container promptly. Select OK to retract the probe (labour suite only). Dispose of the
remaining sample into a sharps bin.
• The system will perform analysis while you enter patient information on the Enter
Information tab using the alphanumeric keypad (the keypad becomes accessible when
you press a button requiring data entry) or barcode gun. Required fields are indicated
with an asterisk (*). Sample results cannot be viewed until all required fields have
entries made in them. If you ara analysing a sample for another person this can be
recorded using the ‘Comments’ button.
• Select View results to see patient results.
• There are ‘Normal Limits’ in the analyser for Arterial samples only, any results outside
these limits will have up/down arrows on them and be highlighted yellow on screen.
No flag may mean no normal range is entered e.g. Glucose. Any result highlighted red
is outside the technical limits for the analyser. Technical limits can be obtained from
the lab or from the IL User manual.
• When finished select Start new Sample to return to Main Menu.
sampler is immersed in the CVP solution, but the so that the end of the sampler does not
touch the bottom. Press OK to begin aspiration. The analyzer will issue an audio prompt
when it has aspirated enough of the CVP sampling solution (approximately 170 µL).
Remove the ampoule immediately upon hearing the audio prompt and select OK to
retract the probe. Dispose of the rest of the ampoule in a Sharps bin. See CVP Sample
Results on how to process results.
Analyte buttons will continue to be shown in red to indicate that CVP testing is not complete.
The analyzer will direct you to continue sampling the remaining ampoules. As you continue with
the CVP sampling process, more of the analyte selection buttons will turn green, indicating that
testing is proceeding correctly.
When you complete CVP sampling, you will see the Start New Sample tab, with all of the analyte
selection buttons shown green and the upper Status Bar indicating Ready. You are now ready to
begin patient sampling
Cleaning
The GEM 4000 analyser requires very little maintenance however it is essential that it be kept
clean at all times.
• Clean Analyser: Wipe with soapy water or 10% chlorine bleach solution.
• Clean touch screen. Carefully wipe the face of the touch screen free of fingerprints and
other smudges using a soft cloth moistened with water.
Changing Paper
To install the thermal printer paper in the paper area on top of the system:
• Press the tab at the top of the system to release the door.
• Open the door and extend paper guide if desired.
• Place the roll of paper in the compartment so the paper unfurls from the bottom.
• Press the door firmly closed.
NOTE: The thermal paper can only be printed on one side.
Troubleshooting
Faults on the GEM 4000 can be narrowed down to pack problems or hardware problems. This
makes troubleshooting straight forward. Change the pack or if this fails to resolve the problem
then call Chemical Pathology.
If there is a persistent error on one or more analytes or if the pack is blocked due to clots it may
be necessary to change the pack. Follow the procedure outlined earlier BUT inform Chemical
Pathology as soon as possible so that the pack data can be obtained and sent to I.L. for analysis.
If changing the pack does not alleviate the problems then it is likely to be faulty hardware. In this
instance inform Chemical Pathology as soon as possible so that a replacement GEM 4000 can be
supplied.
Details Of Process
An automated analyser for use with patient whole blood.
Other Hazards
Patient material:Infectious material
Mechanical: Moving sample probe.
Electrical: Electric shock.
CVP: None
Disposal Methods
• All biological materials and contaminated waste materials must be discarded into
appropriate bins for incineration
• Sharps to be disposed of into 'SHARPSAFE' bins.
ASSESSMENT: MINIMAL