F Examination Process
F2 Examination procedures
Printed on : 15/02/2016
Pathology Directorate
Page 1 of 4
Blood Sciences
Section : Point of Care
Analysis of samples on the Siemens 348 analyser.
Site/Area of application
Point of Care
Index code
BSF2POC030 v1
Superseded documents
BIMEBGC1 v 4
Implementation date of this version
30th July 2010
Approver of content of SOP
Uche Okeahialam
Reason for change
New SOP template.
Keywords for search on EQMS
Poct, Sample, analysis, 348.
Author: Rob Coleman
This document is controlled using the Pathology EQMS software.
Controlled printed copies can be identified by the authorisation signature present in the space below. Upon request further authorised
copies can be obtained through the department’s quality system.
Uncontrolled copies may be printed for an individuals use but should not be used after 1 week from the date of printing.
Signature
1.
CLINICAL RELEVANCE/PURPOSE OF PROCEDURE
The analyser is designed to measure pH and blood gases as well as sodium, potassium, ionised calcium.
2.
PRINCIPLE OF PROCEDURE
The Siemens 348 analyser measures pH, pC02, p02, Na+, K+, ionised Ca++, chloride, using glass
electrodes, selective membrane systems . The 348 also calculates the following parameters: a)
b)
c)
d)
e)
f)
actual bicarbonate (HCO3- act)
standard bicarbonate (HCO3- std)
oxygen content (O2 CT)
base excess in vivo (BE VV)base excess in vitro (BE VT)
total carbon dioxide (t CO2)
haematocrit (HCT)
3.
PERSONNEL / TRAINING REQUIREMENTS
BSW, MTO, BMS staff after completion of training and ward staff trained by Point of Care staff.
4.
SPECIMEN REQUIREMENTS
Blood gas analysis
Sample type :- Whole blood (arterial or venous) collected into a syringe containing balanced heparin.
Minimum volume :- Syringe 200 L. Capillary 140 L
Stored at :- N/A
Means of identification :- Hospital number or Surname.
Samples are known to be stable for :- 10-15 minutes at room temperature, or one hour if chilled with an
ice slurry.
INDEX CODE: BSF2POC030 version 1
TITLE: Analysis of samples on the Siemens 348 analyser
Page
Copies without an Authorised stamp or document manager signature are no longer valid after 7 days of this date 15/02/2016
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Electrolyte analysis
Sample type :-Serum/plasma. Used to check abnormal/ unusual results obtained from main Biochemistry
analysers.
Pleural fluid pH (ref:British Thoracic Society( BTS) guidelines 2003, Annals of Clinical Biochemistry:
2006:43: 17-22)
Sample type :- Pleural fluid. Collect anaerobically into a heparinised blood gas syringe. Sample must be
analysed within 60 minutes.
Minimum volume :- Syringe 200 L.
Notes:
Pleural fluid pH should be assessed in all non-purulent, possibly infected effusions.
Sample must be collected anaerobically in a heparinised syringe. Do not spin the sample down.
It is acceptable to process a bloodstained sample.
Measure within 60 minutes of sample being taken.
pH < 7.2 indicates that the patient requires chest tube drainage.
It is not necessary to put frank pus through a gas analyser, as this already indicates a need for chest tube
drainage of the effusion.
Pleural fluid pH must not be measured on a POCT blood gas machine due to risk of blockage. Pleural
fluid pH must not be measured using litmus paper, or a pH meter due to unreliability of results.
5.
EQUIPMENT
Siemens 348 analyser.
Pump tubing kit 4814094
Probe and tubing kit 107275
Probe and housing kit 673253
Gas cartridge pack 374192
6.
HEALTH AND SAFETY/RISK ASSESSMENT
See the COSHH assessment BICOSHH153
7.
REAGENTS
Supplier’s catalogue number :- Buffer pack 1410308
Wash and CD pack 2490356
Hct slope ampoules 105670
Hct Level A 4116087
Hct Level B 6081547
All the above reagents are supplied by Siemens.
Storage conditions and location :- Stored at room temperature in Point of care laboratory.
8.
CALIBRATION
The equipment is calibrated automatically at intervals set by the manufacturer.
9.
QUALITY CONTROL
Catalogue number :- CC525 Multi level QC from Protech medical.
Storage of IQC material :- Long term storage - refrigerated. Use at room temperature.
Lot/batch number records are stored in “Rapidlink”. One level of QC is analysed each day on a rotational
basis.
Criteria against which process is judged and accepted or rejected :- QC must be within the limits set in the
analyser.
External Quality Assessment participation :- In – house EQA system.
10.
COMPUTER / TELEPATH CODES
N/A
11.
PROCEDURE OR METHODOLOGY
1) Lift sample entry port to 90o position.
2) Present syringe sample and gently push until sample aspirates. When prompted remove the sample
device and return the probe to the lowest position’.
3) The system performs a wash at the end of analysis and then returns to the Ready
INDEX CODE: BSF2POC030 version 1
TITLE: Analysis of samples on the Siemens 348 analyser
Page
Copies without an Authorised stamp or document manager signature are no longer valid after 7 days of this date 15/02/2016
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screen.
4) If you are in any doubt as to the veracity of the results obtained contact the Laboratory
5) It is the operators responsibility to clean up after themselves. Samples that have been
analysed should be disposed of in the adjacent "sharps" bin.
Calculation of results :- N/A
Recording results :- Results should be recorded in the patient’s notes.
Technical authorisation of results :- N/A
Clinical authorisation of results :- N/A
Reporting results :- N/A
Monitoring reports :- N/A
Disinfection procedures for equipment :- See SOP BIPEEXA1
Disposal of waste :- Sluice.
High risk samples – All samples must be treated as potentially high risk.
12.
UNCERTAINTY OF MEASUREMENT
a) Blood continues to metabolise after being drawn, consuming O2 and producing CO2 with consequent
changes in PH, glucose, lactate and bicarbonate. It is essential to analyse the sample immediately for
maximum accuracy and clinical usefulness
b) The sample should be well mixed, clot and bubble free.
c) If the machine is used in a Point of Care setting, any error codes must be reported immediately to the
Chemical Pathology Dept. ( see phone numbers in the front of this manual). Under no circumstance
should this equipment be used until corrective action has been taken.
d) The instrument aspirates samples automatically, do NOT inject.
e) If the system determines that there is insufficient sample a message appears informing the operator.
f)
To interrupt sample analysis at any time press Cancel. The system stops analysis and performs a
wash. The Ready screen appears when the wash finishes.
g) All patient samples are potential biohazards.
PH
6.50 - 8.00
0.67 - 33.33
kPa
0.00 - 106.66 kPa
PO2
Na+
70 – 200
mmol/L
K+
0.5 - 20.0
mmol/L
Cl40 – 160
mmol/L
Ca++
0.10 - 5.70
mmol/L
Calculated
Actual bicarbonate 0 - 60.0 mmol/L CO2 content (C0ct) 0 - 60 mmol/L
Standard bicarbonate 0 - 60.0 mmol/L Base excess -29.9 - +29.9 mmol/L
PCO2
13.
REFERENCE RANGE / ACTION LIMITS
pH
pC02
p02
Na+
K+
Arterial Blood gas Reference range :7.35 - 7.45
4.8 - 5.9
kPa
11.3 - 13.3
kPa < 40 years
8.7 - 13.3
kPa > 40 years
135 – 145
mmol/L
3.5 - 5.0
mmol/L
INDEX CODE: BSF2POC030 version 1
TITLE: Analysis of samples on the Siemens 348 analyser
Page
Copies without an Authorised stamp or document manager signature are no longer valid after 7 days of this date 15/02/2016
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Ca++
Cl Glucose
Lactate
tHb
OxyHb
HHb
MetHb
COHb
1.13 - 1.32
98 – 107
3.7 - 5.2
0.50 - 2.00
12.0 - 18.0
94.0 - 97.0
0.0 - 5.0
0.0 - 1.5
0.0 - 1.5
mmol/L (N.B. this is ionised NOT total Ca++)
mmol/L
mmol/L (Fasting)
mmol/L
g/dL
%
%
%
% (up to 5.0 in smokers)
Calculated values
Actual bicarbonate 22 - 26 mmol/L
STD bicarbonate 21 - 25 mmol/L
T CO2
22 - 26 mmol/L
Base excess
-2 - +2 mmol/L
14.
REFERENCES
Methodology references :- Manufacturers handbook.
The quality records for this procedure :- are stored in “Rapidlink”.
15.
APPENDICES
N/A
INDEX CODE: BSF2POC030 version 1
TITLE: Analysis of samples on the Siemens 348 analyser
Page
Copies without an Authorised stamp or document manager signature are no longer valid after 7 days of this date 15/02/2016
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