use of point of care testing device: coaguchek xs plus for all trust staff
Contents
1. e Within your Warranty period 5 years if itis a meter fault then it will be replaced free of charge if it is deemed to be a user fault for example contamination then this warranty will not apply To ensure patient safety and correct management of patients on anticoagulation therapy Designated user Maintenance of the machine As there are no moving parts no annual maintenance is required apart from regular Quality Control testing To ensure patient safety and correct management of patients on Designated user Ratification Date March 2015 Page 7 of 10 Use of Point of care testing device CoaguChek XS Plus for All Trust staff Wirral Community NHS NHS Trust anticoagulation therapy EQUALITY ASSESSMENT During the development of this procedure the Trust has considered the clinical needs of each protected characteristic age disability gender gender reassignment pregnancy and maternity race religion or belief sexual orientation There is no clinical evidence of exclusion of these named groups If staff become aware of any clinical exclusions that impact on the delivery of care this should be reported using the Trust s incident reporting system and an appropriate action plan put in place TRAINING SPECIALIST Refer to the Trust s Training Matrix COMPETENCIES OR All Clinicians providing warfarin management must complete QUALIFICATIONS BMJ e le2. day as test undertaken and refer to Wirral anticoagulation regarding warfarin dose Anticoagulant Oral Therapy Prescribing Guidelines therapy The clinician managing the patient should ensure that all relevant information has been sought from the patient on assessment e g e General status of patient Has the patient e Had any recent bruising or bleeding To ensure patient safety and correct management of patients on anticoagulation therapy Designated user performing sample taking and or clinician providing clinical input regarding warfarin dose Ratification Date March 2015 Page 6 of 10 Use of Point of care testing device CoaguChek XS Plus for All Trust staff Wirral Community NHS NHS Trust e Had a recent fall or any other impact injury e Any change in medication or diet e Commenced any over the counter OTC medications e Been compliant with warfarin dosing schedule e Understood the information given to them at last appointment See appendix 1 for more information relating to this Failure of machine to produce results Meter will not register an INR of above 8 A venous blood sample will be required for laboratory INR Following discussions with the identified service anticoagulation lead ensure collection of a venous blood sample and further dosing as per Lab results To ensure patient safety and correct management of patients on anticoagulation therapy Designated user pe
3. result will be displayed and saved to memory Repeat the test if the result is unexplained e g below 1 5 or greater than 5 To enable user of the meter to interpret result document in patient notes and computer decision support software Designated user performing sample taking On completion of procedure remove e the test strip from the measurement chamber e personal protective equipment PPE To prevent cross infection and environmental contamination Designated user performing sample taking Ratification Date March 2015 Page 5 of 10 Use of Point of care testing device CoaguChek XS Plus for All Trust staff Wirral Community NHS NHS Trust and dispose of appropriately Decontaminate hands To remove any accumulated transient skin flora that may have built up under the gloves or acquired during the procedure Designated user performing sample taking Turn the meter off and clean as per manufacturer s guidance To prevent cross infection or contamination of further tests Designated user performing sample taking 3 Documentation Document all actions observations and INR result including consent in the patient s record and in the Oral Anticoagulation Therapy OAT book yellow book Ensure compliance with NMC GMC and local record keeping guidelines Designated user performing sample taking and or clinician providing clinical input regardin
4. Care testing must have registered with National External Quality Assurance Scheme NEQAS Perform EQC as per manufacturer s instructions when instructed via NEQAS Participating centres in the INR programmes will be sent four surveys per year each comprising two samples for INR determination Participants will be provided with instructions on reconstitution and testing of the samples Results will be analysed and individual reports sent to participants approximately one week after the closing date of a survey To ensure external monitoring of device and comparison with other centres using the same device Designated user 2 Performing capillary blood sample INR At the initial appointment on outlining the Point Of Care Testing POCT service explain procedure to patient and obtain informed consent document in the patient s record N B POCT INRs have been shown to be unreliable in patients with antiphospholipid antibodies and their use is not recommended in this group of patients To allow the patient to make an informed decision and gain co operation Designated user performing sample taking Check that quality control test has been performed within recommended time limits To ensure meter is functioning correctly Designated user performing sample taking Advise patient to wash their hands prior to procedure assist if necessary Alcohol gel may be used but ensure gel is dry before compl
5. Wirral Community NHS NHS Trust STANDARD OPERATING PROCEDURE USE OF POINT OF CARE TESTING DEVICE COAGUCHEK XS PLUS FOR ALL TRUST STAFF Issue Issue Purpose of Issue Description of Change Planned History Version Review Date To ensure safe point of care testing using the CoaguChek XS Plus machine resulting in an One accurate INR Named Responsible Officer Approved by Medicines Governance Pharmacist Quality Patient Experience and March 2015 Risk Group Target Audience Section Medicines Management All trust staff who use the CoaguChek XS Plus machine as part of their job MMSOP45 role UNLESS THIS VERSION HAS BEEN TAKEN DIRECTLY FROM TRUST WEB SITE THERE IS NO ASSURANCE THIS IS THE CORRECT VERSION Ratification Date March 2015 Page 1 of 10 Use of Point of care testing device CoaguChek XS Plus for All Trust staff Wirral Community NHS NHS Trust CONTROL RECORD Title Standard Operating Procedure for the use of point of care testing device CoaguChek XS Plus Purpose To ensure safe point of care testing using the CoaguChek XS Plus machine resulting in an accurate INR Author Quality and Governance Service QGS J Edwards Impact Assessment Incorporated into procedure Yes No Subject Experts Trust Pharmacist Document Librarian QGS Groups consulted with N A Infection Control Approved March 2015 Date formally approved by March 2015 Quality Patient E
6. arning modules initiating and maintaining anticoagulant therapy available on line at www learning bmj com The anticoagulation lead or designated person must ensure the competence of all staff involved in the use of CoaguChek XS Plus machine and INRstar dosing decision software where appropriate and be able to provide evidence of competency CONTINUING EDUCATION amp TRAINING 1 Staff must comply with the Trust s Training Matrix which specifies mandatory training requirements 2 In addition staff must comply with their service level training matrix for training and competencies as required for role e Completion of training for use of CoaguChek meter and annual updates competencies e Annual updates in warfarin management and dose decision making e Evidence of training updates to be retained in professional portfolio 3 All staff to have an annual appraisal IF APPLICABLE RISK ASSESSMENTS The service has a responsibility to ensure correct storage and maintenance of the consumables and the CoaguChek XS Plus machine as per manufacturer s instructions ORGANISATION Wirral Community NHS Trust DEPARTMENT Primary and Unplanned Care Ratification Date March 2015 Page 8 of 10 Use of Point of care testing device CoaguChek XS Plus for All Trust staff Wirral Community NHS NHS Trust Individual Authorisation Staff involved in the management of patients on anticoagulation therapy named below bas
7. ed Bl vs iuweincuduecbteuscitdunnsseancancuataadxsancus Service or GP Practice have read and understood this Standard Operating Procedure and agree to handle the equipment in accordance with this procedure Name of Employee Signature Practice Anti Date coagulation lead General Practitioner Ratification Date March 2015 Page 9 of 10 Use of Point of care testing device CoaguChek XS Plus for All Trust staff Wirral Community NHS NHS Trust Appendix 1 Anti Coaqulation Monitoring Form Answers to these questions will provide information to aid the interpretation of the INR result and guide the clinician when arranging the next appointment Have any of your details changed Phone no GP etc Have you had any unexplained bruising bleeding or unusual headaches ince your last visit Do you or have you ever suffered with any stomach problems Have you varied from the warfarin dose shown in your book or missed any ablets Have you been unwell off your food or are you on a special diet Have you had any special celebrations or been away on holiday Have you had any medication changes any additions deletions or dose alterations Do you take any herbal or over the counter medicines Have you been admitted to hospital since your last clinic visit Do you have an admission date for the future Are you likely to be unavailable during the next 3 months Ratification Date Marc
8. eting test To prevent sample contamination and warm patients hands to improve blood circulation Designated user performing sample taking The designated user must prepare the single use disposable lancet device as per manufacturer s instructions To ensure correct use of equipment Designated user performing sample taking Switch the meter on press patient test button input patient ID number or add if a new patient To ensure the correct patient identified before proceeding with test Designated user performing sample taking Ratification Date March 2015 Page 4 of 10 Use of Point of care testing device CoaguChek XS Plus for All Trust staff Wirral Community NHS NHS Trust Check meter and test strip code match remove new test strip from vial replace lid tightly To ensure meter is calibrated to test strip and to prevent deterioration of remaining strips Designated user performing sample taking Slide test strip into test strip guide with lettering facing upwards a beep tone will indicate the meter has detected the strip A blood drop icon will flash to indicate the meter is ready to accept the blood sample To ensure the test strip is inserted correctly Designated user performing sample taking Decontaminate hands To remove any accumulated transient skin flora that may have built up under the gloves or acquired during the procedure Designated
9. g warfarin dose If available input INR result into Clinical Decision Support Software CDSS e g INR Star To enable Clinician to provide warfarin dose information to be discussed with patient Designated user performing sample taking and or clinician providing clinical input regarding warfarin dose Explain results to patient and any necessary action needed Document all discussions actions in clinical systems and OAT book yellow book Ensure the next appointment is given to the patient If CDSS is used Ensure that the patient is given the printed diary from INR Star detailing their result and dosage schedule for each day prior to their next appointment as well as details of their next appointment Keep a printed file copy of the patient s dosing diary as a backup in case of IT systems failure Patient to be fully informed of actions and potential changes to treatment in order to give informed consent Designated user performing sample taking and or clinician providing clinical input regarding warfarin dose 4 Special considerations If any clinical concerns arise regarding the management of the patient or if INR levels are outside of target range discuss with General Practitioner or To ensure patient safety and correct management of Designated user performing sample taking and or clinician authorised prescriber responsible for the patient on the patients on providing clinical input same
10. h 2015 Page 10 of 10 Use of Point of care testing device CoaguChek XS Plus for All Trust staff
11. l trust staff who have undertaken appropriate training and assessment to Staff authorised to follow this SOP competently use the CoaguChek XS Plus machine EVIDENCE TO NPSA alert 18 2006 SUPPORT Wirral Anticoagulant Oral Therapy Prescribing Guidelines 2012 PROCEDURE CoaguChek XS Plus Operator s Manual RELATED POLICIES Please refer to relevant Trust policies and procedures Wirral CCG Anticoagulation Enhanced Service Agreement if appropriate IT IS THE RESPONSIBITITY OF ALL STAFF TO COMPLY WITH RELEVANT TRUST POLICIES PROCEDURES AND PROTOCOLS IN CONJUNCTION WITH THIS PROCEDURE Ratification Date March 2015 Page 3 of 10 Use of Point of care testing device CoaguChek XS Plus for All Trust staff Wirral Community NHS NHS Trust Procedure Activity Rationale Responsibility 1 Quality Control Internal Quality Control IQC Perform IQC weekly as per manufacturer s instructions see operator s manual and also consider if INR appears out of range for a specific patient Manufacturers recommendations on storage must be adhered to Document the results in the quality control recording log To ensure accuracy and performance of meter and provide an audit trail for the future Designated user General Practitioner Practice Nurse Health Care Assistant Advanced Nurse Practitioner Nurse Practitioner External Quality Control EQC All practices providing Point of
12. rforming sample taking and or clinician providing clinical input regarding warfarin dose All services participating in INR monitoring are required to maintain a stock of Konakion MM Paediatric 2mg 0 2mL ampoules for administration to patients with an INR gt 8 who do not have major bleeding The decision to administer Konakion should be made by a clinician doctor or nurse with the appropriate knowledge amp training following the High INR pathway or for the DVT Service departmental guidance To ensure patient safety and correct management of patients on anticoagulation therapy Designated user performing sample taking and or clinician providing clinical input regarding warfarin dose 5 IT system or machine failure If the INRstar dosing programme is not available due to IT system failure Discuss the INR result with anticoagulation lead clinician referring to printed copies of the dosing diary or summary sheet and yellow book To ensure patient safety and correct management of patients on anticoagulation therapy Designated user performing sample taking and or clinician providing clinical input regarding warfarin dose Failure of the machine to operate e Contact Roche Diagnostics Technical Support Line on 0808 100 19 20 they will try to resolve this over the phone e If the meter is required to be sent in for examination then they will provide you with a loan meter to cover this period
13. user performing sample taking Apply single use disposable non sterile gloves To protect hands from contamination with organic matter and transfer of micro organisms Designated user performing sample taking Using the disposable lancet obtain a blood sample from the side of the finger massage the lanced finger until a drop of blood is formed Do not press or squeeze the finger Side of finger is a less painful site to use To ensure an accurate result Designated user performing sample taking Apply one drop of blood directly to the semicircular transparent area of the test strip OR you can touch the blood drop against the side of the sample area making sure to hold the blood drop to the strip until the flashing blood drop icon has disappeared The test strip draws up the blood by capillary action Designated user performing sample taking Apply the blood drop to the test strip within 15 seconds of lancing the fingertip To prevent false results due to the coagulation process already beginning Designated user performing sample taking Dispose of used lancet into sharps container To reduce the risk of innoculation injury Designated user performing sample taking The meter will perform an automatic quality control test on test strip before it displays test result QC will appear in the display To ensure accuracy of test Designated user performing sample taking The INR
14. xperience and Risk Group Method of distribution Email Intranet Archived Date Location S Drive QGS Access Via QGS VERSION CONTROL RECORD Author Status Changes Comments J Edwards N Status New Revised Trust Change Ratification Date March 2015 Page 2 of 10 Use of Point of care testing device CoaguChek XS Plus for All Trust staff Wirral Community NHS NHS Trust NAME OF DISCIPLINE PRIMARY CARE OBJECTIVES To ensure safe point of care testing using the CoaguChek XS Plus machine resulting in an accurate INR SCOPE The purpose of this document is to e Cover all aspects of point of care testing inclusive of internal and external quality control testing e Ensure accurate documentation inclusive of patients record and OAT Oral Anticoagulation Therapy book e Ensure safe storage of machine and consumables as per manufacturer s recommendations e Ensure strips and quality control medium are in date and the code chip number of test strip is recorded in meter for each patient test To be read in conjunction with the CoaguChek XS Plus Operator s Manual This document does not provide guidance on the e Use of computer decision dosing software please refer to the manufacturers user manual e Management of high INRs for information refer to the Wirral High INR Pathway for GP practices or departmental guidance for the DVT Service only TARGET GROUP Al
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