Una Health Reflotron Plus Training Manual Download Page 54

Page: 54 / 54

Una Health Ltd

Document Control

Author: E. C. Hamer

UH-POC-TM-2 Revision 1

Date of Issue 26.04.10

Photocopied versions & handwritten amendments of this document are not controlled

Page 54 of 54

Printed 27 April 2010

References

MHRA Device Bulletin: Management & use of IVD Point of Care Test Devices;

DB2010 (02) Feb 2010.

UK Health Depts., Guidance for Clinical Healthcare Workers: Protection against

infection with Blood Bourne Viruses, Dept. Of Health (DOH) 1998

Summary of Contents for Reflotron Plus

Page 1: ...ment Control Author E C Hamer UH POC TM 2 Revision 1 Date of Issue 26 04 10 Photocopied versions handwritten amendments of this document are not controlled Page 1 of 54 Printed 27 April 2010 Reflotron Plus Training Manual ...

Page 2: ...ent Control Author E C Hamer UH POC TM 2 Revision 1 Date of Issue 26 04 10 Photocopied versions handwritten amendments of this document are not controlled Page 2 of 54 Printed 27 April 2010 This page is deliberately blank ...

Page 3: ... Author E C Hamer UH POC TM 2 Revision 1 Date of Issue 26 04 10 Photocopied versions handwritten amendments of this document are not controlled Page 3 of 54 Printed 27 April 2010 CONTACTS Una Health Ltd Customer Support 01782 575180 ...

Page 4: ...ent Control Author E C Hamer UH POC TM 2 Revision 1 Date of Issue 26 04 10 Photocopied versions handwritten amendments of this document are not controlled Page 4 of 54 Printed 27 April 2010 This page is deliberately blank ...

Page 5: ...LECTION PROCEDURES 20 SPECIMEN REQUIREMENTS 21 EQUIPMENT REAGENTS The Instrument Operational details The Reagents Operational procedure 22 METHOD Stage 1 Preparation of the Test System Stage 2 Performing the test Stage 3 Reviewing the Results 26 INTERNAL QUALITY CONTROL IQC Running a Quality Control QC 36 Training Competency Assessment 40 Training Knowledge Assessment 42 Appendix 1 Basic troublesh...

Page 6: ...ent Control Author E C Hamer UH POC TM 2 Revision 1 Date of Issue 26 04 10 Photocopied versions handwritten amendments of this document are not controlled Page 6 of 54 Printed 27 April 2010 This page is deliberately blank ...

Page 7: ...ide a good basic understanding of the system During the training session you will be given the opportunity to practice taking blood run samples and QC and ask any questions you may have The training guide covers the following topics Introduction Clinical Background Principals of Method Collection Procedures Specimen Requirements Equipment Reagents Operational procedure Reporting Reviewing Results ...

Page 8: ...ent Control Author E C Hamer UH POC TM 2 Revision 1 Date of Issue 26 04 10 Photocopied versions handwritten amendments of this document are not controlled Page 8 of 54 Printed 27 April 2010 This page is deliberately blank ...

Page 9: ...onditions serum amylase consists of about 40 pancreatic amylase and 60 salivary amylase Elevated serum α Amylase levels are most often seen in pancreatitis so a α Amylase determination is primarily carried out for diagnosis and therapeutic monitoring of acute as well as of chronic pancreatitis Pancreatic Amylase The real diagnostic value of the pancreatic amylase in contrast to total amylase is it...

Page 10: ...causes of death or early invalidity In myocardial damage such as in acute myocardial infarction CK is released from destroyed myocardial cells An increase of CK activity in the blood can be detected as early as 4 hours after the infarction CK activity reaches its peak after 12 24 hours and returns to the reference range after 4 5 days Haemoglobin Haemoglobin Hb is the red blood pigment of the eryt...

Page 11: ...ovascular diseases is of high importance GGT γ Gamma Glutamyltransferase GGT is a highly sensitive parameter for numerous disorders with involvement of the liver but it can also be found in pancreatic renal disorders and myocardial infarction Usually it is regarded as one of the enzymes that indicate cholestasis As GGT values rise before liver damage becomes evident this enzyme is especially impor...

Page 12: ...d nerves including the heart Potassium is also influenced by acid base disturbances e g treatment of very high blood glucose concentrations with insulin which can cause hypokalaemia Potassium is mainly excreted by the kidneys 90 and to a minor degree in the faeces 10 Disorders of the water and electrolyte balance occur mainly as a consequence of other diseases They may characteristically alter the...

Page 13: ...an enzyme defect resulting in an increase of purine degradation and overproduction of uric acid Determination of the uric acid concentration in the blood allows you to evaluate the patient s risk to diagnose and to monitor the therapy of gout or kidney stones PRINCIPLES OF METHOD The Reflotron Plus is an in vitro diagnostic device designed for the quantitative determination of clinical chemistry p...

Page 14: ...e of Issue 26 04 10 Photocopied versions handwritten amendments of this document are not controlled Page 14 of 54 Printed 27 April 2010 Measuring Range 8 5 205µmol L Measuring Range 2 59 12 9 mmol L Measuring Range 370 C 24 4 1400 IU L 300 C 15 4 900 IU L 25 0 C 10 0 600 IU L ...

Page 15: ...ate of Issue 26 04 10 Photocopied versions handwritten amendments of this document are not controlled Page 15 of 54 Printed 27 April 2010 Measuring Range 44 5 884 µmol L Measuring Range 370 C 5 0 3500U L 300 C 3 85 2700U L 25 0 C 2 80 2000U L Measuring Range 0 56 33 3mmol L ...

Page 16: ... 10 Photocopied versions handwritten amendments of this document are not controlled Page 16 of 54 Printed 27 April 2010 Measuring Range 370 C 5 0 500U L 300 C 3 25 325U L 25 0 C 2 25 225U L Measuring Range 370 C 5 0 2000U L 300 C 3 8 1520U L 25 0 C 2 66 1060U L Measuring Range 0 26 2 59mmol L ...

Page 17: ... UH POC TM 2 Revision 1 Date of Issue 26 04 10 Photocopied versions handwritten amendments of this document are not controlled Page 17 of 54 Printed 27 April 2010 Measuring Range 5 0 20 0g dl Measuring Range 14 850U L Measuring Range 0 80 6 86mmol L ...

Page 18: ...is document are not controlled Page 18 of 54 Printed 27 April 2010 Measuring Range 3 33 50 0mmol L Measuring Range 120 1190µmol L Measuring Range 2 0 12 0mmol L LDL cholesterol may be calculated using Cholesterol Triglycerides HDL results and the Friedewald formula in the inbuilt software HAZARD WARNINGS See COSHH Risk Assessments Appendix 4 5 ...

Page 19: ...eaning and disinfecting rota should be in place to ensure that cleanliness standards are achieved It has 2 chairs small table or suitable workbench Access to a supply of warm water The paperwork support material equipment are available Relevant health advice leaflets information are on display Health Safety Any accidental blood contamination of equipment or surfaces must be cleaned immediately wit...

Page 20: ...t to rub hands together to induce better circulation Offer a plaster at the end of the procedure The following procedure should be adopted if the client feels unwell at any time during the test Stop the test Allow the client to remain seated until they feel well again Offer the client a drink of water After recovery ask the client if they wish to proceed with the test Arrange an alternative appoin...

Page 21: ...mediately No storage required Specimen must be disposed of as clinical waste Using the Reflotron Potassium K test samples can be heparinised venous plasma or serum Capillary or haemolytic sample material is unsuitable to determine potassium Other anticoagulants especially anticoagulants containing potassium may not to be used Using Reflotron Uric Acid only heparins should be used as an anticoagula...

Page 22: ...eflotron Plus Analyser Power cable Keyboard Workstation Single use lancets Reflotron test strips Clean Check strips 32µl pipette tips Blood collection tubes EDTA Heparin Plastic coated capillary tubes applicator Workstation Clinical waste disposal service Equipment Material NOT Supplied Information booklets leaflets Hand washing sanitizing facilities Yellow clinical waste containers Protective glo...

Page 23: ...tron Plus analyser Specifications Analyser Weight approx 5 3 kg Size 300 x 350 x 210mm Display alpha numeric 2 lines each with 24 characters LCD Connections 1 RS 232 Keyboard 5 pin DIN Data Memory Capacity 60 results Power Supply Mains 115 230 v AC Operating Conditions Temperature 15o C to 34o C Humidity 95 max Storage Transport Temperature 20o C to 55o C Humidity 5 95 Integral printer LCD display...

Page 24: ... the test the result is displayed on the screen All parameter specific data are encoded in the magnetic strip on the reverse side of the test strip Results are stored in the Analyzer memory Up to 60 patient control results can be stored on the analyser The analyser is calibrated by the manufacturer and there are no user serviceable parts Daily maintenance required comprised of cleaning the instrum...

Page 25: ...esiccants contained in the lids to keep the strips dry The lid must be replaced after every opening Once the strip has been removed it must be used within the hour Once the blood sample has been added the test strip must be tested immediately Shelf life 6 12 months see expiry date on strip container Must be disposed of as clinical waste Calibration No calibration required all calibration informati...

Page 26: ...s heaters or instruments that radiate heat Room temperature should be between 150 C and 340 C Plug the power cable into the back of the Reflotron and then into a normal 240v wall socket Switch power on at the wall Switch Reflotron to ON by pressing the power switch on the front of the instrument The Reflotron will then warm up and conduct some self checks before displaying the message READY NB Nev...

Page 27: ... Open the lid of the measuring chamber and insert the check strip Close the measuring chamber lid The Reflotron will now read the magnetic strip on the underside of the Check Strip and will automatically begin the test The Check takes approximately 1 minute At the end of the check time three values will be displayed These values must be as close as possible to the middle row of numbers on the labe...

Page 28: ... are not controlled Page 28 of 54 Printed 27 April 2010 What to do if check strips are out of range Check strip FAIL Readings out of range Clean lens and upper and lower heater blocks with alcohol Wait 30 minutes Repeat the measurement with an unused dust free check strip Are the readings now within range YES OK to resume testing Call Customer Support NO ...

Page 29: ...rded provided that the grey test area is well protected and free from scratches NB The lid must be kept on the check strip container at all times as the strips are light sensitive and must be kept dry b Cleaning Procedure preferably at the end of the day session Clean the heating blocks and apertures using an alcohol wipe DO NOT USE THE REFLOTRON FOR AT LEAST 30 MINUTES AFTER CLEANING H S Guidelin...

Page 30: ... with the standard operating procedure and training provided How to undertake a fingerstick blood test step by step Pictures for the fingerstick procedures courtesy of E C Hamer BSc Hons MSc FIBMS Use a single use safety lancet to prick the patient s finger to get a good sized drop of blood about the same width as the blood collector Select a lancet device Hold and twist off the sterility cap by t...

Page 31: ...cotton wool pad as clinical waste and offer a plaster Place the capillary directly over the pad of the test strip and gently push the plunger down ejecting the blood sample onto the middle of the sample pad Do not allow the capillary to touch the pad A further downward push on the plunger releases the capillary into the sharps bin b For multiple tests Collect a sample of the correct volume using a...

Page 32: ...the dedicated 32µl pipette and a clean dry tip press the plunger down to the first stop then lower the tip into the blood sample Once the tip is below the surface gently release the plunger fully Check there are no bubbles in the tip Hold the pipette and tip vertically over the sample pad on the test strip Press the plunger down slowly releasing the blood onto the sample pad Dispose of the tip int...

Page 33: ...ip Countdown of test will appear on the screen At the end of the countdown the result will be displayed on the screen and printed Step 5 Open the Reflotron measuring chamber lid and remove the test strip Discard the test strip into a clinical waste container All soft waste e g gloves swabs etc should be disposed of as clinical waste in a yellow bag Any accidental blood contamination of equipment s...

Page 34: ...is event the whole blood sample collected as described in Step 3 b Page 31 will need to be centrifuged as follows Step 6 Place the blood collection tube containing the remainder of the sample into a mini centrifuge Balance with another blood collection tube containing approximately the same amount of water Close the lid and switch on for approximately 2 minutes Step 7 Pipette 32µl of plasma from t...

Page 35: ...client of the next appropriate steps NICE Guidelines May 2008 Communicating the results and referring The healthcare provider is responsible for communicating the test results and providing advice to the client Confidentiality Healthcare providers should ensure that the requirements of the Data Protection Act 1998 for data collection and use are complied with Information obtained in the course of ...

Page 36: ...e of transmitting infection Appropriate procedures should be used for their disposal The Reflotron Quality Control QC Kit The Reflotron Quality Control should be used with the Reflotron test strips to ensure that the strips are working correctly and giving accurate and reliable results Precinorm Hb QC kit should be used with the Hb test strips 4 x 2ml bottles for reconstitution with 2mls deionised...

Page 37: ...can be kept till the expiry date on the box Once reconstituted Precinorm U HDL is stable at room temperature for 8 hours or 14 days when refrigerated at 2 8o C Alternatively it can be stored for one month frozen at 20o C Once reconstituted Precinorm Hb is stable at room temperature for 8 hours or 14 days refrigerated at 2 8o C This control is unsuitable for freezing Preparing the Controls For the ...

Page 38: ...e control Using the dedicated 32µl pipette and a clean dry tip dispense 32µl of reconstituted control onto the appropriate test strip Check there are no bubbles in the tip Hold the pipette and tip vertically over the sample pad on the test strip Follow the steps as for patient sample Page 32 to 33 Steps 4 5 Reviewing the Results Check the result against the values provided in the appropriate pack ...

Page 39: ... Reflotron QC results are unacceptable QC FAIL Readings out of range YES OK to resume testing Call Customer Support NO Check expiry dates of QC material test strips Are they in date Perform cleaning procedure Page26 Repeat the QC Readings in range YES NO Discard expired components replace Repeat the QC Readings in range YES NO OK to resume testing Reconstitute a new bottle of QC material Repeat th...

Page 40: ...ration of the test system Fingerstick procedure Carried out correct preparation of self patient Demonstrates good use of lancet device Carried out successful fingerstick Patient test on Reflotron analyser Successful use of blood collector Correct application of sample to test strip Correct placement of test strip in analyser Successful test Read the results Reviewed the results IQC on Reflotron an...

Page 41: ...e Position Test site Signature Date Training representative to complete and confirm practical training assessment has been passed and the above person is confident and competent to undertake a blood screening test Name Signature Position Date IQC on Reflotron analyser cont Correct placement of test strip in analyser Successful test Read the results Reviewed the results Understands The Reflotron An...

Page 42: ... Reflotron test strips 2 What is the purpose of QC 3 How often should you run a QC 4 How should QC material be stored 5 What should you do if the QC is out of range 6 How is the analyser calibrated 7 What are the main Health Safety risks identified in running a test 8 What control measures are in place to reduce the risks of occupational exposure to BBVs 9 What Health Safety procedures should be m...

Page 43: ...ntrol Author E C Hamer UH POC TM 2 Revision 1 Date of Issue 26 04 10 Photocopied versions handwritten amendments of this document are not controlled Page 43 of 54 Printed 27 April 2010 Training Knowledge Assessment cont Answers ...

Page 44: ...ntrol Author E C Hamer UH POC TM 2 Revision 1 Date of Issue 26 04 10 Photocopied versions handwritten amendments of this document are not controlled Page 44 of 54 Printed 27 April 2010 Training Knowledge Assessment cont Answers ...

Page 45: ...ot controlled Page 45 of 54 Printed 27 April 2010 Training Knowledge Assessment cont Complete your details below Name Position Test site Signature Date Training representative to complete and confirm the training knowledge assessment has been passed and the above person is confident and competent to undertake a blood screening test Name Signature Position Date ...

Page 46: ... QC Precinorm Fail Readings out of range Check expiry dates Perform cleaning procedure Page 26 repeat If problem persists contact customer support Check strips fail Readings too low Readings too high Check storage conditions perform cleaning procedure Page 26 and repeat If problem persists contact customer support Recalibration of instrument may be required contact customer support Test readings c...

Page 47: ...flotron Glucose Diabetes lipid disorders acute parameter 2 C to 30 C B Reflotron GOT AST Liver disorders acute parameter myocardial infarction 2 C to 30 C A Reflotron GPT ALT Liver disorders myocardial infarction 2 C to 30 C A Reflotron HDL Cholesterol Diabetes lipid disorders 2 C to 30 C D Reflotron Haemoglobin Anaemia kidney diseases acute parameter 2 C to 30 C C Reflotron K Potassium Kidney dis...

Page 48: ... The keyboard functions Any key PSI in the 1st line Key F2 CHD risk calculator Key F3 LDL calculation according to Friedewald Key F4 CHOL HDL cholesterol ratio calculation Key F5 EDITEXT additional test information Key F6 Creatinine Clearance calculation Key F7 Marking of a control measurement Key F8 Profile transmission II to EDP Key F9 Profile transmission to EDP Key F10 Profile printing PRINT S...

Page 49: ...e safety lancing device Nurses must cover any pre existing open wounds with water proof plasters Plasters will be offered to clients after the finger prick blood test to cover their puncture wound protective gloves should be available at all times during the procedure All blood contaminated material should be disposed of as clinical waste Standard control measures such as hand washing and cleaning...

Page 50: ...ignificant risk assessment is required should any medium high risks be identified Any staff members unable to sign to accept the policy cannot undertake patient sample testing and should not Risk Assessment Acceptance be trained to do so The Healthcare worker providing the service must sign below to confirm they have read and understood the risk assessment Name Date Signature Assessed by Signature...

Page 51: ...of Care testing for 17 different chemistry analytes 2 Specific activity assessed Use of Reflotron Plus Analyser Reagent strips 3 Who carries out the task Name Job Title Healthcare provider 4 On observation does the actual working practice deviate from that intended No 5 Is the substance being used hazardous to health Trade Name Reflotron plus test strip Dry chemistry no hazards identified 6 Do you...

Page 52: ...tact NA 8 Evaluate the risk without controls in place Circle as appropriate Severity Likelihood 1 Minor 1 Rare 2 Serious Medical treatment 2 Unlikely 3 Major Excessive injuries 3 Moderately likely 4 Single fatality 4 Likely 5 Catastrophic 5 Certain Score I x L Risk Rating 1 3 Low 4 7 Moderate 8 12 Significant 15 25 High 9 List control measures required None No maintenance required 10 Re evaluate t...

Page 53: ...tice Disposal reagent strip to be disposed of in a clinical waste container 12 Spillage procedure NA 13 First Aid NA 14 Has any monitoring health surveillance been carried out Specify No 15 Summary conclusions Is exposure adequately controlled yes no 16 Action to be taken by Manager Person in Charge if not adequately controlled NA Assessed by Signature Elizabeth C Hamer BSc Hons MSc FIBMS Job Titl...

Page 54: ...4 of 54 Printed 27 April 2010 References MHRA Device Bulletin Management use of IVD Point of Care Test Devices DB2010 02 Feb 2010 UK Health Depts Guidance for Clinical Healthcare Workers Protection against infection with Blood Bourne Viruses Dept Of Health DOH 1998 www labtestsonline org uk www nice org uk www doh gov uk www mhra gov uk www roche diagnostics co uk www diavant com ...

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