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 Site/Area of application Point of Care Index code BSF2POC030 v1 Superseded documents BIMEBGC1 v 4 Implementation date of this version 30th July 2010 Approver of content of SOP Uche Okeahialam Reason for change New SOP template.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of samples on the Siemens 348 analyser Page Copies without an Authorised stamp or document manager signature are no longer valid after 7 days of this date 15/02/2016 1 of 4 Electrolyte analysis Sample type :-Serum/plasma.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 2 of 4 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 3 of 4 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 4 of 4