GEM 4000 TRAINING PLAN - Barnsley Hospital NHS Foundation Trust
Contents
1. Blood Science POCT Filename GEM 4000 TRAINING PLAN DOC QMS No SOP CB POCT D 24 Internal Quality Control Scheme Intelligent Quality Management iQM is used as the quality control and assessment system for the GEM Premier 4000 analyzer Once the cartridge calibration is verified the internal iQM Process Control solutions internal checks and software pattern recognition monitor the status of the system during the cartridge use life If this process detects an error on a sensor it will deactivate that sensor showing the analyte on the screen as grey with fixing written underneath It is possible to use the analyser at this time but no result will be given for that analyte If the iQM process is unable to fix the sensor the analyte will be permanently disabled and will show as grey with QM disabled written in Red on the screen It is possible to continue to use the analyser at this time but no result will be given for that analyte A more in depth description of IQM can be found in the GEM 4000 Reference Guide Version 4 2 Page 14 of 22 Author L Wilson Approved by S Dean Active Date 04 09 2013 Review due 04 09 2015 Barnsley Rotherham Integrated Laboratories Department Blood Science POCT Filename GEM 4000 TRAINING PLAN DOC QMS No SOP CB POCT D 24 External Quality Control Scheme Every analyte assayed on the IL gas analyser must be entered in at least one Accredited External Q A scheme Blood gas par2. Sodium lt 130 or gt 155 mmol L Potassium lt 3 0 or gt 6 0 mmol L e Glucose lt 3 0 or gt 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 Version 4 2 Page 5 of 22 Author L Wilson Approved by S Dean Active Date 04 09 2013 Review due 04 09 2015 Barnsley Rotherham Integrated Laboratories Department Blood Science POCT Filename GEM 4000 TRAINING PLAN DOC QMS No SOP CB POCT D 24 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 e Input the Patient Unit number A E number or if this is not available use the surname and Date of Birth ENTER e Select and Enter the Surname e Select and enter First Name e 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 s
3. Moving test table Electrical Electric shock Control measures required Proper Training and supervision Installation and maintenance of equipment as defined by Health Authority policy All spillages must be dealt with as by ward policy Fire precautions must be observed as ward policy Disposal methods All biological materials and contaminated waste materials must be discarded into appropriate bins for incineration lt HS PA 003 Section 10 gt Sharps to be disposed of into SHARPSAFE bins Small amounts of chemical solutions associated with minimal risk may be disposed of down the sink and flushed away with copious amounts of water Assessment of staff exposure Consequence score 1 5 x Likelihood score 1 5 Assessment of staff exposure Consequence score 1 5 x Likelihood score 1 5 Consequence 3 x Likelihood 1 3 Low Risk Significant risk of infection from patient material sharps however adherence to the control measures above should be adequate in controlling the risk Version 4 2 Page 17 of 22 Author L Wilson Approved by S Dean Active Date 04 09 2013 Review due 04 09 2015 Barnsley Rotherham Integrated Laboratories Department Blood Science POCT Filename GEM 4000 TRAINING PLAN DOC QMS No SOP CB POCT D 24 Appendix 2 Competency Reassessment form GEM 4000 Competency Re assessment This form should be used by the link nurse or equivalent for re assessing competence when there have been no m
4. 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 Version 4 2 Page 8 of 22 Author L Wilson Approved by S Dean Active Date 04 09 2013 Review due 04 09 2015 Barnsley Rotherham Integrated Laboratories Department Blood Science POCT Filename GEM 4000 TRAINING PLAN DOC QMS No SOP CB POCT D 24 Assaying a Patient sample Sample types which can be used on the GEM 4000 are whole blood and fluids Remember when processing fluids to be aware that gelatinous samples or samples containing a lot of debris may block the probe and it may be better to sent them to laboratories for processing Before any sample is introduced always check that all the analytes on the Gem are highlighted green and showing no errors If this is not the case perform the necessary maintenance Any analytes not highlighted in green will not give a result Any results marked with question marks are unreliable green Fully operational or normal Area GP4000 07 01 2006 16 25 V A Menu OM 459 27 D N Ready k Tests Days 0 Conditional state awaiting specific action 998 27 CHER _ Days ES Stopped or non functional grey shaded Functionality unavailable or not selected e Select Normal or Micro sample by pressing the Normal Micro toggle button on the left Mi
5. ft Trained BY esenee ner eae e ns gas ea aO ds das Dad pasa Daley aeree neinet Method of Assessment Self assessment of competency in the use of medical device in relation to defined key elements and countersigned by appropriate member of staff Key Trainer Manager Educator Mentor etc Self assessment key statements elements Competent Date Y N 1 Routine operation e Demonstrate analyzing a sample e Describe a result print out e Demonstrate finding a previous result 2 iQM e Explain what iQM diasabled next to an analyte means e Describe when you would perform a 2 point calibration e Demonstrate performing a 2 point calibration 3 Maintenance e Describe when you would change a pack e Demonstrate changing a pack including running CVP e Demonstrate changing the paper e Describe how you would clean the Gem 4 Security e Explain the need for password security Having answered YES to the above key statements and taken into account my personal assessment of my competence in the use of the medical device declare that have been trained and am competent to use the device safely as per the Trusts guidelines Signat re men aa se hates ab Dr Rabo Print NAM assina E Date OR require further training in the use of this equipment in order to reach a competent level of practice and will discuss these needs with my Mentor Ward Manager Trainer Equipment Controller Signat e ceive
6. risk in using the Gem see appendix 1 as long as gloves and protective clothing are worn Departmental policy should be followed when dealing with a blood spillage 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 Version 4 2 Page 16 of 22 Author L Wilson Approved by S Dean Active Date 04 09 2013 Review due 04 09 2015 Barnsley Rotherham Integrated Laboratories Department Blood Science POCT Filename GEM 4000 TRAINING PLAN DOC QMS No SOP CB POCT D 24 Appendix 1 Risk Assessment Details of process This is an automated analyser for use with patient whole blood samples for measurement of blood gas analytes Chemicals to be used and hazards None Other hazards Patient material Infectious material Q C sera Human sera Infectious material Mechanical
7. throughout your working life NMC 2008 The Code Healthcare organisations keep patients staff and visitors safe by having systems to ensure that all risks associated with the acquisition and use of medical devices are minimised HCC C4b safe use of medical devices 2008 Version 4 2 Page 22 of 22 Author L Wilson Approved by S Dean Active Date 04 09 2013 Review due 04 09 2015
8. 00 TRAINING PLAN DOC QMS No SOP CB POCT D 24 CVP and iQM This process ensures the integrity of the new cartridge and the overall analysis system providing a clear baseline for operation It is only necessary to perform CVP when inserting a new cartridge Testing will require approximately 3 minutes per ampoule to complete The analyzer will inform you that CVP testing is due via the Status Bar along the top of the screen which will be highlighted in yellow with the words CVP Due prominently displayed You will be unable to report patient results for an analyte until CVP testing is successfully completed for that analyte 998 27 Tests Days a amp Start New Sample Enter Information View Last Results pH cl conb pco Cas Methb po Het HHb Press GO to begin sampling e Select an ampoule from the choices on the screen or scan the 2D bar code on the ampoule label using the bar code gun Press OK to begin CVP testing There is no specific order to do the CVP e Immediately prior to use hold the ampoule by the top above the break line and shake vigorously for approximately 10 seconds NB Hold the ampoule only above the break line Holding the ampoule in your hand will cause the aqueous solution to exceed the recommended testing temperature and can adversely affect CVP results Gently tap the ampoule so the liquid settles back to the bottom e Carefully snap open the ampoule e NOTE Aspirate samples imm
9. 2013 Review due 04 09 2015 Barnsley Rotherham Integrated Laboratories Department Blood Science POCT Filename GEM 4000 TRAINING PLAN DOC QMS No SOP CB POCT D 24 Protocol for the use of the GEM 4000 analyser This protocol relates to the responsibility of all staff designated to use the GEM 4000 analyser 1 Follow the manufacturer s guidelines and hospital policy on POCT 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 e CVP Calibration Validation Product ampoules must be run on changing a reagent pack e If any parameter fails the Intelligent Quality Management procedures IQM patient results for that parameter MUST NOT be acted upon e 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 5 The department must be enrolled in an external quality control scheme 6 Unexpected results MUST be confirmed by sending the appropriate sample to Chemical Pathology Blood gas confirmation requires an arterial blood gas sample Electrolyte confirmation requires a brown top gel tube 7 Results MUST be confirmed by sending a brown top gel tube to Chemical Pathology if they meet the following criteria
10. Barnsley Rotherham Integrated Laboratories Department Blood Science POCT Filename GEM 4000 TRAINING PLAN DOC QMS No SOP CB POCT D 24 Gem 4000 Critical Care Analyser Training plan for Ward Staff No of copies 8 Location of copies Accident and Emergency Intensive Care Unit Ward 18 Respiratory Acute Medical Unit AMU Labour Suite Special Care Baby Unit NNU SHDU POCT laboratory based SOP file Your Link Nurse Staff are Please keep this booklet with your Gem 4000 analsyer How to obtain further supplies Spare cartridge packs Contact Chemical Pathology CVP s Contact Chemical Pathology Paper Contact Chemical Pathology Useful Contacts amp Telephone Numbers Clinical Biochemistry 2733 or 2673 Lindsey Wilson 2733 or 2673 Senior Biomedical Scientist POCT Coordinator Version 4 2 Page 1 of 22 Author L Wilson Approved by S Dean Active Date 04 09 2013 Review due 04 09 2015 Barnsley Rotherham Integrated Laboratories Department Blood Science POCT Filename GEM 4000 TRAINING PLAN DOC QMS No SOP CB POCT D 24 Contents INTRODUCTION aicsssissscssccsccesttescsuscececsdsacessssdadscesiccescsssceuascadedssdssscassscoccesceseavascsdssdssccbasadsacdccsateessssschessedevasoandus 3 STAFF RESPONSIBILITIES vssssscsassccesscessssccaiieassctcaceassceecicssscsensssstacessacecbestsssesnssadadsassssuescecsesansseadstensbcssesaceaacens 4 PROTOCOL FOR THE USE OF THE GEM 4000 ANALYSER ccssscsssssscc
11. ajor changes to the procedure and both the trainer and trainee are satisfied they are competent in the use of the GEM 4000 If the above criteria are not met a full re assessment of competency is required Name Ward Department Existing Password This form is being used because a itis 1 year since last full assessment Yes e No e b The member of staff has been absent from work for a period greater than 6 months since the last competence assessment Yes e No e c Any other reason please state Having taken into account my personal assessment of my competence in the use of the GEM 4000 Blood Gas Analyser I declare that I have been trained and am competent to use the device safely Signed Trainee Date I certify that the above person is competent in the use of the GEM 4000 Blood Gas Analyser Signed Trainer Date Please keep this in your ward records and send a copy to Chemical Pathology so your password can be renewed Version 4 2 Page 18 of 22 Author L Wilson Approved by S Dean Active Date 04 09 2013 Review due 04 09 2015 Barnsley Rotherham Integrated Laboratories Department Blood Science POCT Filename GEM 4000 TRAINING PLAN DOC QMS No SOP CB POCT D 24 Appendix 3 Competency Assessment form Equipment Make amp Model IL GEM 4000 Risk Rating 1x2 2 Frequency of Update Annual Siafi Name Ps este ee seh Ye ee te Job Title cece eee eee ee eeeeeeeees Depam eE assa os aaah a a tue
12. ameters are entered in the WEQAS Blood Gas scheme e The Chemical Pathology Department will send out the external QC samples once a month There are no expected values for the external QC samples e The sample is prepared according to WEQAS instructions and is run as a proficiency sample e The results must be recorded on the sheet of paper accompanying the sample This sheet must be returned to Chemical Pathology who will forward it to WEQAS Analysing External Quality Control Samples Select Proficiency sample type and press GO to start sampling Select the Blood Gas Profile Select an ampoule and hold by the top above the break line Shake vigorously for approximately 10 seconds Gently tap the ampoule so the liquid settles back to the bottom Carefully snap open the ampoule NOTE Aspirate samples immediately after opening Any delay in measuring may cause room air contamination and result in lower pCO and higher pO values than stated in the insert Present the opened ampoule to the sampler which will emerge from the grey sampling area at the front of the analyzer Hold the ampoule so the sampler is immersed in the QC 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 solution Remove the ampoule immediately upon hearing the audio prompt Labour Suite should select OK to retract the probe Dis
13. ceedsascseutesicecesseiveonscedecssssedstsaseuduccedes 16 TROUBLESHOOTING osiinsa enteo Sa eS o SE EEE SE E oS Edie E oS E E esoo Sissi 16 APPENDIX 1 RISK ASSESSMEN Teecscssscscsscscscccscannscescconssescscssccsscssceseccsscesecsssnecacscdeccossceessscscansscesescessesecsasoessess 17 APPENDIX 2 COMPETENCY REASSESSMENT FORM cccsssssssssssccssssccssssscccsssescsssscesssssssesssssecsssssceees 18 APPENDIX 3 COMPETENCY ASSESSMENT FORM ccsssscsssssccsssssscsssseccssssseccsscssscscsscessssssccsssssesscssssees 19 APPENDIX 4 MEDICS COMPETENCY ASSESSMENT FORM 1 cscccssssscssssscccssssscssssccccsssssccssssecsssssseses 21 Version 4 2 Page 2 of 22 Author L Wilson Approved by S Dean Active Date 04 09 2013 Review due 04 09 2015 Barnsley Rotherham Integrated Laboratories Department Blood Science POCT Filename GEM 4000 TRAINING PLAN DOC QMS No SOP CB POCT D 24 Introduction Designed to help you 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 e Analyse all types of sample obtaining accurate results whilst minimising risk to
14. cro sampling is available only with capillary tubes Sample volumes Full profile and CO OX 150 uL Full Profile 95uL Micro Mode 65uL e Select the sample type container combination using the drop down menu under 2 Type if it is not already selected e Alternatively select the required profile from the right hand side of the screen this will select the sample type automatically e Press GO The sampler will emerge from its home position e 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 e 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 Version 4 2 Page 9 of 22 Author L Wilson Approved by S Dean Active Date 04 09 2013 Review
15. d the upper Status Bar indicating Ready You are now ready to begin patient sampling CVP Sample Results All results within range will be indicated in green text with a white background out of range in white text on a red background If all results are within range press Accept In the event of an out of range result e Exclude the sample e Runa full calibration by selecting Menu gt Diagnostics gt Run IQM Process e Repeat the analysis with a new vial Do not sample with the original ampoule e If analytes that failed the acceptable range the first time fail again do not use the cartridge e Ifthe original analytes that failed pass but analytes that passed the first time fail on the second vial run a third new vial You will once again be prompted to run a full calibration before repeating the process e If any analytes fail following the third attempt and that analyte is crucial do not use the cartridge Insert a new cartridge and start again If any analytes fail following the second third attempt and that analyte is not crucial e g Glucose you can Accept the CVP and run the pack without the analyte You can retry the CVP at a later time The decision as to if this is a possible solution as opposed to trying a new pack is down to individual wards Version 4 2 Page 13 of 22 Author L Wilson Approved by S Dean Active Date 04 09 2013 Review due 04 09 2015 Barnsley Rotherham Integrated Laboratories Department
16. due 04 09 2015 Barnsley Rotherham Integrated Laboratories Department Blood Science POCT Filename GEM 4000 TRAINING PLAN DOC QMS No SOP CB POCT D 24 excessive force Hold the exposed end of the tube keeping the tube in line with the sampler and press OK to begin aspiration e 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 e 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 are analysing a sample for another person this can be recorded using the Comments button e Select View results to see patient results e 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 e When finished select Start new Sample to return to Main Menu Finding Rep
17. ediately after opening Any delay in measuring may cause room ait contamination and result in lower pCO and higher pO values than stated in the insert e Present the opened CVP ampoule to the sampler which will emerge from the grey sampling area at the front of the analyzer Hold the ampoule so the 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 uL Remove the ampoule immediately upon hearing the audio prompt and select OK to retract the probe Version 4 2 Page 12 of 22 Author L Wilson Approved by S Dean Active Date 04 09 2013 Review due 04 09 2015 Barnsley Rotherham Integrated Laboratories Department Blood Science POCT Filename GEM 4000 TRAINING PLAN DOC QMS No SOP CB POCT D 24 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 an
18. es ee ee ARTEA Et Print Name eaaa aaa oa Date Version 4 2 Page 19 of 22 Author L Wilson Approved by S Dean Active Date 04 09 2013 Review due 04 09 2015 Barnsley Rotherham Integrated Laboratories Department Blood Science POCT Filename GEM 4000 TRAINING PLAN DOC QMS No SOP CB POCT D 24 You must keep your knowledge and skills up to date throughout your working life NMC 2008 The Code Healthcare organisations keep patients staff and visitors safe by having systems to ensure that all risks associated with the acquisition and use of medical devices are minimised HCC C4b safe use of medical devices 2008 Version 4 2 Page 20 of 22 Author L Wilson Approved by S Dean Active Date 04 09 2013 Review due 04 09 2015 Barnsley Rotherham Integrated Laboratories Filename GEM 4000 TRAINING PLAN DOC Department Blood Science POCT QMS No SOP CB POCT D 24 Appendix 4 Medics Competency Assessment form Stal Name 2a sair s Gala e sa a a bows Equipment Make amp Model GEM 4000 Medic User Risk Rating Minimal 1x2 2 Frequency of Update Annual Department ise anke ee E Aer a da O UR DS ee LLECUN By us e sa a O Do Reet Pere eee ney ern Aran Renn Job Title sesta sense Dale usas Asa Method of Assessment Self assessment of competency in the use of medical device in relation to defined key elements and countersigned by appropriate member of staff Key Trainer Manager Educator Mentor
19. et 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 Version 4 2 Page 6 of 22 Author L Wilson Approved by S Dean Active Date 04 09 2013 Review due 04 09 2015 Barnsley Rotherham Integrated Laboratories Department Blood Science POCT Filename GEM 4000 TRAINING PLAN DOC QMS No SOP CB POCT D 24 The GEM 4000 Analyser 1 Color touch screen 2 DVD CD RW drive 3 PCMCIA slot 4 Sampling area 5 Cartridge door 6 Bar code gun a Meni Ready Coon AM ao rests vom E Start New Sample Enter Information Viow Last Results Sample Type Selection Available Analytes Version 4 2 Page 7 of 22 Author L Wilson Approved by S Dean Active Date 04 09 2013 Review due 04 09 2015 Barnsley Rotherham Integrated Laboratories Department Blood Science POCT Filename GEM 4000 TRAINING PLAN DOC QMS No SOP CB POCT D 24 Start New Sample Tab Home Page The Status Bar along the top of the screen provides quick access to critical information and capabilities e Menu Touching the blue Menu button in the upper left triggers a drop down menu that provides fast access to other functiona
20. etc Self assessment key statements elements Competent Y N Date 1 3 Routine operation e Demonstrate analyzing an arterial sample Demonstrate analyzing a capillary sample Describe when you would send a sample to Clinical Biochemistry Describe a result print out Demonstrate finding a previous result e Explain what iQM diasabled next to an analyte means and what would happen if you ran a sample in this situation e Describe when you would perform a 2 point calibration e Demonstrate performing a 2 point calibration Security e Explain the need for password security Print Name Having answered YES to the above key statements and taken into account my personal assessment of my competence in the use of the medical device declare that have been trained and am competent to use the device safely as per the Trusts guidelines Signat re rescues ae Ae e a i ies eas Date usuario tah Do ES ai OR Signature a Ss Daio ea spi clk OO ad T Print Name require further training in the use of this equipment in order to reach a competent level of practice and will discuss these needs with my Mentor Ward Manager Trainer Equipment Controller Barnsley Rotherham Integrated Laboratories Department Blood Science POCT Filename GEM 4000 TRAINING PLAN DOC QMS No SOP CB POCT D 24 You must keep your knowledge and skills up to date
21. gement or therapeutic decision based on an unreliable result could be fatal e Getting it right first time is important Recommendations e All staff who perform sample analysis must be properly trained to use the equipment e Untrained or insufficiently trained staff should not use the equipment e Quality control checks should form part of the maintenance routine with the Clinical Biochemistry laboratory directly involved e 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 Remember an incorrect result could lead to serious consequences for the patient in your cate 1 Source Blood glucose measurements Reliability of results produced in extra laboratory areas Department of Health HN hazard 87 13 Version 4 2 Page 4 of 22 Author L Wilson Approved by S Dean Active Date 04 09
22. lity beyond patient sampling e Analyzer Status indicates overall readiness of analyzer for patient sampling it will turn yellow if a specific action e g CVP testing is needed e Date Time system clock runs on 24 hour time e iQM On Button iQM is Instrumentation Laboratory s patented Intelligent Quality Management software which ensures the integrity of the overall analysis system Quality testing runs automatically in the background e Tests days Button these figures indicate how many days tests remain before you must change the cartridge Selecting this button will display the exact day time the cartridge will expire When either 2 days or 20 tests are reached the button background color will turn yellow e Mail Button alerts you to incoming e mail messages if the system is attached to a network and system error messages Sample Preparation Prior to analysis it is essential that the sample be thoroughly mixed Hematocrit total haemoglobin haemoglobin 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
23. ou whether you want to continue Press No to stop the process and return to the Main Sampling screen Press Yes to continue e Once you press Yes the door will click open slightly Move the door to the left grasp the cartridge and pull it gently toward you Dispose of cartridge in an appropriate biohazard container The system will now be inactive until you reinsert a new cartridge NOTE Cartridges cannot be reused once they have been removed e Unpack the cartridge from its protective wrapper Remove the plastic cover from the pump winding area Discard the protective wrapper and plastic cover e Position the cartridge with the grey sampling area facing forward Push the cartridge in until you feel resistance Please note that approximately one inch of the cartridge will extend beyond the front of the analyzer e Guide the analyzer door to the right to close it and move the cartridge into its final position e In approximately 20 seconds the analyzer will inform you that the cartridge is warming up The clock will count down for the next 40 minutes as the cartridge warms up During this time the sensors will hydrate and the analyzer will perform internal checks and calibration Assay both levels of CVP once warm up is complete Version 4 2 Page 11 of 22 Author L Wilson Approved by S Dean Active Date 04 09 2013 Review due 04 09 2015 Barnsley Rotherham Integrated Laboratories Department Blood Science POCT Filename GEM 40
24. pose of the rest of the ampoule in a Sharps bin The system will perform analysis while you enter the information on the Material Information tab Enter the distribution number sample number can be found on the results sheet e g 159 1 Select View results to see results When finished select Start new Sample to return to Main Menu Remember to write the results on the return sheet and send to the laboratory Version 4 2 Page 15 of 22 Author L Wilson Approved by S Dean Active Date 04 09 2013 Review due 04 09 2015 Barnsley Rotherham Integrated Laboratories Department Blood Science POCT Filename GEM 4000 TRAINING PLAN DOC QMS No SOP CB POCT D 24 Maintenance Cleaning The GEM 4000 analyser requires very little maintenance however it is essential that it be kept clean at all times e Clean Analyser Wipe with soapy water or 10 chlorine bleach solution e 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 e Press the tab at the top of the system to release the door e Open the door and extend paper guide if desired e Place the roll of paper in the compartment so the paper unfurls from the bottom e Press the door firmly closed NOTE The thermal paper can only be printed on one side Health and Safety There is a minimal
25. rinting Previous Results Each GEM 4000 keeps a record of all samples performed on that analyser if you wish to look up and or reprint a previous result e Press the blue Menu button in the upper left corner e Select Search Results from the pull down menu e Select the search criteria in the Search Criteria screen e These buttons are data entry fields or drop down menus e Date and time frame criteria lower right hand corner of screen are required for all seatches Version 4 2 Page 10 of 22 Author L Wilson Approved by S Dean Active Date 04 09 2013 Review due 04 09 2015 Barnsley Rotherham Integrated Laboratories Department Blood Science POCT Filename GEM 4000 TRAINING PLAN DOC QMS No SOP CB POCT D 24 Changing Reagent Packs As changing the cartridge will result in the analyser being out of operation for approx 60 minutes it is better to change it during a quiet period and not wait until the pack is totally empty or expired The GEM Cartridge should also be replaced if there is a problem with IQM on any of the channels If the pack is empty the cartridge door will automatically open and display a message to the operator to remove the cartridge To remove a cartridge prior to its maximum onboard use life or test capacity follow the instructions provided below e Press the blue Menu button in the upper left corner of the screen Select Remove Cartridge e Enter your password As a precaution the system will ask y
26. sscscccssscccsssescccsssecssssssessssssseesess 5 DATA COLLECTION scssssccsssscissicnssocecesssssvssestacecssesseieasssoctessssses sacssedssssevtedsedece cdsessasessccuascesstesssiaenssaddesesssevasesiods 6 THE GEM 4000 ANALYSER cccsscssssssccsssscscssseccsssscsccsssesssssssessossessccssnssssssessssossessccssnssssssasascsssessscssnessssseseceoss 7 START NEW SAMPLE TAB HOME PAGE ssccsssssssssessscsssensssscesssssescnsssonsessssssensssnesenssssssseessoessesscossonseens 8 SAMPLE PREPARATION osissccccssiscssssseccessccsesccscsectsesscasassceccsssssesscceeantsesecooasssusesdsessasessestossdsesscdsossescasentesdseccdsoestes 8 ASSAYING A PATIENT SAMPLE scccsssssssssssscssssssccssssscsssssessssssscccssscssssesescssecsccsssssssssesascsssesscsssssssssseseccoss 9 FINDING REPRINTING PREVIOUS RESULTS ccssssscssssssssccsssccssscsssscsssscesssessnsssssesssesssssssssscssnssees 10 CHANGING REAGENT PACKS ssssssscssssssccssssscssssssccsssscccsssssssssssessssseccccsssessssssssssssessccsssesssssssssssssessccoes 11 EVPANDAQM iss sssrstess cocos di SE TTO TEE EE TEATE 12 INTERNAL QUALITY CONTROL SCHEME j ccsscccssssrcssssscccssssccscssscscsssssscscsssecsssssscscsssecsscsssesssssssesseses 14 EXTERNAL QUALITY CONTROL SCHEME cssssssssssscssssscccssssccssssscccssssccscsscescsssssssssssessscsssessssssseseess 15 MAINTENANCE visiscsssscscccsstcscsssctecesssesctssiseteccssccvcntasentecssssctssessectsecedsntcdecdicde
27. themselves and patients e Recognise and act on error messages e Look up patient results Nursing staff should also be able to e Change reagent packs and run CVP samples e Be aware of Quality Control procedures e Change the instruments paper e Clean the instrument 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 ot the Chemical Pathology laboratory The purpose of this booklet is to provide you with the information you need to achieve accurate results Thus providing the best quality care for your patients Version 4 2 Page 3 of 22 Author L Wilson Approved by S Dean Active Date 04 09 2013 Review due 04 09 2015 Barnsley Rotherham Integrated Laboratories Department Blood Science POCT Filename GEM 4000 TRAINING PLAN DOC QMS No SOP CB POCT D 24 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 patients e A mana
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