PD-UserHbk-01. Pages printed from this document are uncontrolled - For latest versions please refer to electronic laboratory handbook

Departments PD-UserHbk-01 Pages printed from this document are uncontrolled - For latest versions please refer to electronic laboratory handbook

i General Information Trust POCT Policy Abbott Glucose Meter Standard Operating Procedure Instruction Manual MDA GEM Blood Gas Analyser Standard Operating Procedure Hemocue Standard Operating Procedure Instruction Manual Pages printed from this document are uncontrolled - For latest versions please refer to electronic laboratory handbook

REF: CORP/RISK 8 v.2 POINT OF CARE GOVERNANCE POLICY POLICY AND GUIDELINES FOR POINT OF CARE TESTING Summary of changes: Inserted 3.7 -Role of POCT Coordinator Written By: Dr J Wardell - Clinical Director, Pathology Dr R Stott - Clinical Governance Lead, Pathology Date: December 2004 Approved By: Clinical Review Group Date: 01 April 2005 Accepted By: Operational Board Reviewed : March 2007 Implementation Date: March 2007 Next Review Date: March 2009 WARNING: Always ensure that you are using the most up to date policy or procedure document. If you are unsure, you can check that it is the most up to date version by looking on the Trust Website: www.dbh.nhs.uk under the headings Freedom of Information Information Classes Policies and Procedures 1 Pages printed from this document are uncontrolled - For latest versions please refer to electronic laboratory handbook

REF: CORP/RISK 8 v.2 POINT OF CARE GOVERNANCE POLICY POLICY AND GUIDELINES FOR POINT OF CARE TESTING CONTENTS Section 1 - Introduction Section 2 - Pathology Services in the Trust Section 3 - Management Section 4 - Equipment and Consumable Procurement Section 5 - Standing Operation Procedures Section 6 - Training and Certification of Staff Section 7 - Quality Control and Quality Assurance Section 8 - Health and Safety 2 Pages printed from this document are uncontrolled - For latest versions please refer to electronic laboratory handbook

REF: CORP/RISK 8 v.2 SECTION 1 INTRODUCTION 1.1 Background Analysis of constituents in blood and other body fluids is a vital part of the decision making process associated with the diagnosis and management of disease. Typically specimens are sent to a laboratory for analysis with the results being returned by telephone or electronically and/or with a hard copy report. In some cases, delays caused by sending the specimen to the laboratory are unacceptable to the clinical and/or operational situation; in these circumstances testing at the bedside or in the clinic or GP surgery is preferred. This type of testing is termed point of care testing (POCT). Situations in which point of care testing may be appropriate include: (a) where clinical management in an acute or life threatening situation may be aided by the result of a diagnostic test (b) where availability of the result in the clinic may enable more effective counselling of the patient and/or change in therapeutic management (c) where the total attendance time for the patient can be reduced (d) where the clinician can assess the patient and initiate or change subsequent management in a single visit 1.2 Definition Point of care testing (POCT) refers to any form of diagnostic testing undertaken outside of an accredited laboratory environment. 1.3 Accreditation of services POCT has developed in a somewhat ad hoc way in recent years with evidence of poor training of staff, poor quality control and poor maintenance of equipment - all of which conspire to put the patient at risk. This is reflected in the fact that there have been several hazard notices published by the Department of Health following incidents of poor practice leading to the production of erroneous results. In one such notice, it was stated that all testing outside of the laboratory environment should only be undertaken in collaboration with, and support from, laboratory professionals. It is now implicit in the Clinical Pathology Accreditation (CPA) of laboratory services that there is appropriate accreditation of all POCT, with the appropriate involvement of 3 Pages printed from this document are uncontrolled - For latest versions please refer to electronic laboratory handbook

REF: CORP/RISK 8 v.2 laboratory professionals. It is also expected in the accreditation of hospital wide services that POCT will be subject to guidelines that ensure the maintenance of the highest quality of services. Guidelines on the organisation of POCT have been produced by a number of organisations and endorsed by accreditation bodies. These guidelines have been used in the development of this Trust policy. 1.4 Audit of services There are a wide range of different tests performed outside this laboratory with a very low degree of adherence to good practice in relation to training and certification of staff, as well as quality control. Furthermore, in some cases there is a wide range of equipment being used to perform the same analyses e.g. different manufacturers equipment used to measure blood gases. This has several implications for the Trust, including duplication of maintenance expertise, the risk of erroneous results being produced when staff trained on one system use another in the event of a system failure and the obvious economic disadvantages of using equipment and consumables from more than one manufacturer. 4 Pages printed from this document are uncontrolled - For latest versions please refer to electronic laboratory handbook

REF: CORP/RISK 8 v.2 SECTION 2 PATHOLOGY SERVICES IN THE TRUST 2.1 The pathology service The pathology service provided to this Trust conforms to the definition enshrined in the Strategic Review of Pathology Services. Thus the service provides full support to the testing and interpretation services which form the core of activities. This support includes training in use of the service, audit, research and development and continuing education, as well as some specialised services. 2.2 Location The majority of tests are performed in centralised laboratory facilities, and the service is accredited by Clinical Pathology Accreditation UK Ltd (CPA). The laboratories are physically located on two sites, although activity is managed as an integrated service. 2.3 Logistics The centralised laboratory facilities are supported by a transport system for delivery of specimens to the laboratories, with the opportunity for urgent referral when required. There is a laboratory information system that acquires test request information on specimens sent to the laboratory and returns completed reports of results and appropriate interpretative reports to the requesting source. In addition, it provides an archive facility enabling retrieval of data and gathering of workload statistics. The system does not currently collect data on any analyses undertaken outside the laboratory. 2.4 Policy on diagnostic testing (a) all diagnostic services must be undertaken according to protocols and guidelines recognised by accrediting bodies (b) all diagnostic investigations must be undertaken by appropriately accredited professionals after appropriate training (c) all diagnostic tests must be undertaken in an accredited laboratory environment unless the service is unable to meet clinical and/or organisational requirements (d) any diagnostic testing undertaken outside of the laboratory environment, i.e. POCT, must be undertaken in accordance with this Trust policy (e) the quality of all pathological investigations is ultimately the responsibility of the Pathology Directorate. 5 Pages printed from this document are uncontrolled - For latest versions please refer to electronic laboratory handbook

REF: CORP/RISK 8 v.2 SECTION 3 MANAGEMENT The management of point of care testing must be in accordance with recognised guidelines and involve all those parties involved in the use and delivery of POCT. A Point of Care Testing Governance Committee has been established within the Trust to undertake this management. 3.1 Accountability The POCT Governance Committee is accountable to the Medical Director and the Trust Operational Board for ensuring the delivery of a high quality POCT service. 3.2 Officers The committee should appoint: Chair Secretary Point of Care Testing Co-ordinator Pathology Quality Manager 3.3 Committee members In addition to the officers the committee should comprise representatives from: (a) all specialties within the Pathology Directorate for which point of care testing is performed (b) the nursing and/or clinical support teams from each of the clinical directorates which undertake POCT (c) an individual involved in equipment maintenance (d) the Pathology Directorate management team (e) the clinical staff - preferably individuals involved in the use of POCT (f) PCT representative(s) - preferably an individual able to represent all PCTs and either involved in, or with an interest in, POCT. (g) the clinical governance lead for the pathology directorate (h) representation from supplies, finance and information technology 6 Pages printed from this document are uncontrolled - For latest versions please refer to electronic laboratory handbook

REF: CORP/RISK 8 v.2 3.4 Terms of reference The POCT Governance Committee is responsible for overseeing all aspects of the delivery of point of care testing within the Trust. It may also be asked to take a similar responsibility for point of care testing in other environments where the Trusts Pathology Directorate is responsible for the delivery of the pathology services. Specifically it should: (a) be responsible for reviewing all business cases associated with the implementation of POCT (b) be responsible for agreeing the use of POCT (c) work with the Trusts supplies department to ensure consistency of procurement in relation to harmonisation of technology and value for money, whilst ensuring the needs of clinicians are always met (d) validate the standard operating procedures associated with each individual test or technology used in POCT (e) ensure that all relevant standard operating procedures are followed (f) ensure that all equipment is properly maintained (g) identify suitable trainers for all point of care procedures (h) oversee the training and certification procedures for all operators (i) oversee the maintenance of appropriate health and safety procedures in environments where POCT is performed (j) review the results of all quality control and quality assurance procedures associated with POCT (k) ensure that appropriate corrective action is taken in the event of poor performance being exposed (l) undertake audits of point of care testing as appropriate to the needs of the Trust (m) be responsible for the introduction of user or working groups for specific areas of POCT e.g. blood glucose analysis (n) have the authority to withdraw a POCT device if the agreed standards of operation are not met despite adequate training (o) report on a quarterly basis to the Pathology Directorate Management Team 7 Pages printed from this document are uncontrolled - For latest versions please refer to electronic laboratory handbook

REF: CORP/RISK 8 v.2 (p) submit minutes of meetings and an annual report to the Trust Operational Board (q) disseminate information regarding contraindications / interferences in POCT systems in use within the Trust and community. 3.5 Responsibilities It is the responsibility of the POCT Co-ordinator to ensure that systems are in place to enable quality standards to be maintained and to sign and date all standard operating procedures. He/she will also work with the Quality Manager to ensure that any problems identified by quality control and quality assurance procedures are rectified. It is the responsibility of the POCT Co-ordinator to ensure that quality control and quality assurance procedures are in place and followed by all those involved in point of care testing. He/she will identify a member of the local clinical team to review all quality control data on a daily basis and will personally review all results on a weekly basis. 3.6 Meetings The POCT Governance Committee should meet quarterly to: (a) review new business cases for POCT (b) review quality control and quality assurance performance data (c) review incident reports and action taken to rectify any issues that may arise or have arisen (d) review status of staff training, certification and recertification requirements (e) review all standing operating procedures and modify as appropriate (f) review suitable trainers for each POCT procedure (g) review feedback from user or working groups (h) consider any other relevant business 3.7 Role of POCT Co-ordinator The POCT Co-ordinator will be responsible for day-to-day operational matters of all the point of care testing equipment sited within Doncaster and Bassetlaw NHS Foundation Trust. This will include the co-ordination and supervision of all point of care testing and the supervision, training and development of staff from various professions throughout 8 Pages printed from this document are uncontrolled - For latest versions please refer to electronic laboratory handbook

REF: CORP/RISK 8 v.2 the Trust in the use of POCT equipment to national standards in compliance with CPA accreditation of laboratory services. The post holder will also be responsible for the coordination, documentation and planning of the future POCT requirements of the Trust, on behalf of the Trust Point of Care Governance Committee. The post holder will maintain effective communication within the Pathology Directorate and with clinicians, nurses, support staff, the Trust Medical Technical Services Manager and the Trust Supplies Manager. 9 Pages printed from this document are uncontrolled - For latest versions please refer to electronic laboratory handbook

REF: CORP/RISK 8 v.2 SECTION 4 EQUIPMENT AND CONSUMABLE PROCUREMENT 4.1 Criteria for procurement The procurement of equipment and consumables should meet the following criteria: (a) the clinical needs detailed in the business case (b) production of results that are comparable to results produced by the laboratory (c) production of results that are comparable to results produced by similar POCT systems available in the Trust (d) adherence to the protocol established by the Trusts Supplies Department (e) the economic aspects identified in the business case. (f) ideally meet connectivity requirements to ensure that results can be automatically entered into the patients (electronic) record 4.2 Process of procurement A business case for the introduction of all point of care testing should identify the performance criteria required for the proposed service. The process of procurement should be conducted in line with the protocol established by the Trusts Supplies Department. Tenders for the business should be reviewed by a sub-group of the Point of Care Testing Governance Committee which may co-opt members from the relevant clinical team to ensure that the quality criteria are met. The economic aspects should be reviewed in consultation with the Trusts Supplies Department. 10 Pages printed from this document are uncontrolled - For latest versions please refer to electronic laboratory handbook

REF: CORP/RISK 8 v.2 SECTION 5 STANDARD OPERATING PROCEDURES All techniques employed in the delivery of each point of care testing service are subject to adherence to a CPA accredited standard operating procedure or protocol. Each SOP should include: (a) details on the correct preparation of the patient (b) details on the correct storage of the reagents and devices and any procedure required to make them ready for use e.g. warming reagents up to room temperature before use (c) details on the correct preparation of any equipment used in the production of the result (d) details of the analytical performance of the test (e) details of the quality control procedures that must be adhered to (f) details on the correct documentation of the result of the patients test result as well as that of the quality control results if appropriate (g) details of the correct disposal of the consumables used in the test procedure, and cleaning of the equipment and any surfaces that might have been contaminated by patient sample (h) details of the significance of the results produced and the appropriate action to be taken, including the identification of abnormal results that must be brought to the immediate attention of a clinician and results that are indicative of an error or failure in the procedure Examples of standard operating procedures used in this Trust are given in Appendix 1. A copy of the standard operating procedure must be kept close to the equipment used and/or the place at which the test is performed. An abbreviated form of the standard operating procedure that clearly sets out the procedural details may be kept close to where the test is performed. All standard operating procedures must be dated and signed by the Point of Care Testing Co-ordinator. A procedure may only be modified after review by the Point of Care Testing Governance Committee; the committee may call upon the advice of an external expert in devising a standard operating procedure and/or its modification if appropriate. Each certificated operator must sign a statement to the effect that they have read and understand the procedure that they use. A library of current standard operating procedures must be kept in a central location known to all of the operators and their supervisors. 11 Pages printed from this document are uncontrolled - For latest versions please refer to electronic laboratory handbook

REF: CORP/RISK 8 v.2 SECTION 6 TRAINING AND CERTIFICATION OF STAFF There is a need to identify and define those staff groups able to undertake the various types of point of care testing. All staff within those groups who undertake point of care testing must have been trained and certificated as competent to perform the test. Competence to perform the test will be regularly monitored. 6.1 Training Training will be undertaken by certified on-site trainers who will have been trained and certified by either the equipment manufacturer or by qualified laboratory staff. The training programme will be tailored to the technology and its complexity, but should include understanding of: (a) the basic principles of the analytical method, its limitations and the clinical relevance of the results produced; the latter should include knowledge of results that must be made known to the clinician immediately and results which are indicative of an error or failure in the procedure or of a possible interfering substance (b) the correct procedure for preparation of the patient and the potential for production of an erroneous result that may arise from incorrect preparation of the patient or incorrect sample type (c) the correct procedure for preparation of the reagents, devices and/or equipment e.g. warming of reagents stored in the refrigerator to room temperature before use, to ensure correct performance of the test (d) the correct procedural way of performing the test (e) the most common incorrect procedural steps that may lead to the production of an erroneous result (f) the correct way for documenting and reporting a result, including the identification of results that must be brought to the immediate attention of a clinician or are inappropriate and indicative of an error or failure in the procedure and the correct way to identify his/her unique ID as part of the patients record of the result (g) the correct quality control procedures, recording of such data and its interpretation - all of which must be completed and validated before release of the patient result (h) the correct procedure for disposal of consumables, reagents and used analytical devices and any decontamination procedure required 12 Pages printed from this document are uncontrolled - For latest versions please refer to electronic laboratory handbook

REF: CORP/RISK 8 v.2 6.2 Certification When a member of staff has completed a training course the trainer must test the individuals competence to perform the POCT procedure. This test will be very dependent on the procedure. The trainee must only be deemed competent, and therefore certificated, when the trainer is confident the individual has completed the test satisfactorily. A central record should be maintained of all those who have been shown to be competent to perform the POCT procedure. This record should be kept up to date and any individual whose competence fails should be removed from the register until their competence has been re-established. A copy of this record should be kept with the standing operating procedure. Each certificated operator must be given a unique ID registration, which must be entered into the record of the completed test/log of point of care tests performed and also entered into the patients record of the result. No operator should: (a) give their ID to another person in order for a test to be undertaken (b) use another persons ID (c) perform a point of care test without proper certification and ID 6.3 Recertification If any operator is shown to be performing below the required standard, a supportive course of action should be implemented; if this fails then certification must be withdrawn until competence can be demonstrated. The following guidelines should be followed and documented: (a) in the first instance of poor performance the operator in question should be contacted by the POCT Governance Committee and an informal review of performance standard instituted through discussion of the issues and concerns, usually with the identified trainer (b) additional quality control procedures and/or training should be implemented as appropriate (c) closer monitoring of performance should be implemented 13 Pages printed from this document are uncontrolled - For latest versions please refer to electronic laboratory handbook

REF: CORP/RISK 8 v.2 (d) if there is a further instance of poor performance a formal discussion with the operator must be set up to review the issues; a retest of competence should be considered (e) if there is a third instance of poor performance then the certification of the operator must be withdrawn (f) the operator should be offered additional training and an opportunity to demonstrate his/her competence by retest (g) the operators supervisor/manager should be informed of the removal of certification, and the removal recorded in the register of certificated operators 14 Pages printed from this document are uncontrolled - For latest versions please refer to electronic laboratory handbook

REF: CORP/RISK 8 v.2 SECTION 7 QUALITY CONTROL AND QUALITY ASSURANCE All POCT must be subjected to both quality control and quality assurance. The exact nature of the procedures will depend very much on the nature of the technology and the individual detail will be documented in the standard operating procedure for each method/device. 7.1 Quality control/assurance procedures Examples of suitable procedures are: (a) performance of a test on a quality control sample of known concentration, ensuring that the result obtained falls within acceptable performance limits; such a test should be performed once per shift, by each operator on a particular day or by the laboratory as detailed in the standing operating procedure (b) sending of any remaining patient sample to the laboratory for analysis at a set frequency e.g. once a week to ensure that agreement with the laboratory method is being maintained (c) close documented adherence to the method standard operating procedure, including patient and reagent preparation 7.2 Documentation and review It is important to record all quality control data at the interval detailed in the standard operating procedure. The place for recording data should also identify the tolerance limits of acceptable performance against which the result is judged before release of the patients result i.e. acceptable upper and lower limits around a mean value. These results should be reviewed on a daily basis by a member of the local clinical team designated for the purpose and by the POCT Co-ordinator or nominated deputy on a weekly basis. The quality performance will be reviewed by the Point of Care Testing Governance Committee at quarterly intervals, but more frequently if an acute performance problem has been identified. Performance of POCT should be reported on a quarterly basis to the Pathology Directorate Management Team. Any adverse incidents associated with POCT should be reported to the Director of Pathology immediately. 15 Pages printed from this document are uncontrolled - For latest versions please refer to electronic laboratory handbook

REF: CORP/RISK 8 v.2 SECTION 8 HEALTH AND SAFETY PROCEDURES All POCT should be undertaken in a way that does not put the patient or any member of the Trusts staff at additional risk. All Trust health and safety policies must be strictly adhered to. The standard operating procedure should identify all specific health and safety precautions that must be taken to protect both patients and staff. The health and safety aspects of point of care testing procedures should be reviewed by the Health and Safety Committee of the Pathology Directorate, as well as satisfying any health and safety legislation that pertains to the area where the test is performed. Any health and safety incidents must be reported to the Health and Safety Committee of the Directorate of Pathology as well as that pertaining to the area where the test was performed. 16 Pages printed from this document are uncontrolled - For latest versions please refer to electronic laboratory handbook

Directorate of Pathology Standard Operating Procedure Pathology Abbott Optium Xceed Glucose Meter SOP No. SOP-POCT-013 Date of Issue: 1/1/2008 Ver 1.0 Abbott Optium Xceed Glucose Meters Version 1.0 Date of Issue 1/1/2008 Review Interval Annual Author Helen Chapman Authorised By David Norcliffe Copy Number 1 of 2 Location of Copies 1 2 Quality Manager Laboratory Handbook Review date Document Review History Reviewed by Cross Reference Documentation Filename Document Title SOP-POCT-014 Optium Xceed User s guide As per Batch in use Optium H Test strip insert SOP-POCT-015 Optium Xceed cascade training pack ver 1.1 QF-POCT-007 Abbott Glucose QC Record Book Author Helen Chapman Page 1 of 6 Title Abbott Optium Xceed Glucose Meter Pages printed from this document are uncontrolled - For latest versions please refer to electronic laboratory handbook

Pathology Abbott Optium Xceed Glucose Meter SOP No. SOP-POCT-013 Date of Issue: 1/1/2008 Ver 1.0 Hazard / Risk Data Introduction The Abbott glucose meters are Point of Care (POCT) devices. POCT is laboratory testing outside the central laboratories and is subject to the same professional, judicial and public scrutiny as that of all laboratory devices. Therefore it must comply with all standards of laboratory accreditation, the Trust POCT policy and the guidelines issued by the Medicines and Healthcare products Regulatory Agency (MHRA). It is a requirement of Clinical Pathology Accreditation (CPA) that operators are familiar with the standard operating procedure. The standard operating procedure explains the protocol for using the Abbott glucose meters. This includes the operator responsibility for checking sample suitability, correct functioning of the device and recording all details. Failure to follow these procedures may be detrimental to patients, operators and managers if there is an adverse incident or litigation. If the device is not used appropriately the manager of the clinical area will be informed and if the problem is not rectified the device will be withdrawn from the area. Principle of Examination When blood is applied to the test strip the glucose in the blood reacts with the chemicals on the test strip producing a small electrical current. This current is measured and then a result displayed by the meter. The size of the current is related to the amount of glucose in the blood sample. (For more details see test strip insert) Clinical relevance /purpose of examination Abbott Xceed meters are used in all wards and clinical areas to quantitatively measure glucose in fresh capillary, venous or arterial blood. The meters are also capable of measuring ketones and appropriate locations may have a separate dedicated meter for this. Although the meter itself will prompt the operator for a strip lot code, these meters will also be clearly labelled to avoid potential use of ketone strips in a meter calibrated for glucose Specimen Requirements/ Means of identification Capillary, venous or arterial whole blood sample see users guide for recommendations for obtaining a blood drop and applying it to the test strip. Materials, Equipment and special supplies Specimen reception and other laboratory staff on both sites are trained in use of the meters and can help with investigation of potentially faulty meters. Replacement Xceed Meters, spare batteries for the meters, Quality Control solutions and QC books are obtained from the local Path Lab reception. All suspected faulty meters should be returned to the laboratory for exchange with details of the fault given. Patient testing strips and lancets are obtained from RDC via the normal ward ordering procedures. Item Pack quantity RDC order code Optium H Glucose Test strips 100 HHD075 Lancets - Neonatal Size FTM004 Lancets - Comfort Size (This one recommended for normal use) Lancets - Normal size (Usually used for A&E or MAU for a good yield in an emergency). FTM054 FTM001 Author Helen Chapman Page 2 of 6 Title Abbott Optium Xceed Glucose Meter Pages printed from this document are uncontrolled - For latest versions please refer to electronic laboratory handbook

Pathology Abbott Optium Xceed Glucose Meter SOP No. SOP-POCT-013 Date of Issue: 1/1/2008 Ver 1.0 Hazard / Risk Data Operators Only staff that have been formally trained and certified as competent should use the device (Master log on QF- POCT-004). A record of those trained must be maintained on a master list by the POCT Co-ordinator. Operators need to participate in the proficiency testing scheme at least once a year to maintain their operator status. Cascade Trainers The designated cascade trainers are responsible for overseeing the training of further operators of the meter and overseeing the quality assurance processes locally. They should liaise with the Manager of the clinical area and the Point of Care Co-ordinator regarding any problems with operators or other quality assurance or governance issues. Calibration The Optium Meter must be calibrated so it can recognise the test strip being used. It must be calibrated when: the meter is used for the first time, each time you open a new box of test strips if the meter has been dropped To Calibrate: Open calibrator package Hold calibrator strip with Lot number facing you Insert the calibrator into the strip port until it stops Display Check shows Lot number on the display window Check Lot number matches on o Display window o Test strip calibrator o Test strip foil package o Test strip insert Remove calibrator strip from meter and retain in workstation until all that box of test strips is used Method for testing samples - Refer to Users Guide (SOP-POCT-014) Results must be written in the patient s notes and signed by the operator Internal Quality Control Programme The need for quality control to ensure acceptable performance of testing on a daily basis is recognised. This check applies to meters which are not regularly used for patients, without this regular check you cannot be sure that the meter and its associated test strips are functioning correctly. Medisense Quality controls are available at low and high levels. Expected values are quoted on the test strip insert. QC results and expected values must be written in the blue QC book (QF-POCT-007) and the strip insert kept for reference until all that batch of strips is used. QC must be done: daily if in use or weekly if meter not in use, however meter must be QC d before next patient sample and then every day for as long as it is being used for patients. Author Helen Chapman Page 3 of 6 Title Abbott Optium Xceed Glucose Meter Pages printed from this document are uncontrolled - For latest versions please refer to electronic laboratory handbook

Pathology Abbott Optium Xceed Glucose Meter SOP No. SOP-POCT-013 Date of Issue: 1/1/2008 Ver 1.0 Hazard / Risk Data If acceptable limits cannot be obtained the meter should not be used for testing a patient, the POCT Coordinator should be contacted and a sample from the patient should be sent to the laboratory. Once opened the QC solutions are useable for 90 days write the date of opening and expiry on each bottle Completed QC books must be returned to Clinical Biochemistry for review and permanent storage. External Quality Assurance The Trust has a responsibility to ensure that the performance of any POCT device and the proficiency of the operators is independently assessed and documented regularly. Therefore all staff who use the device must participate in the External Quality Assessment scheme at least annually to remain on the database of Named Operators. The EQA samples originate from a National Scheme and are distributed by the POCT Co-ordinator each quarter. The correct result for this sample is not known to the operator at the time of testing. The results obtained are recorded in the results table and returned to the POCT Co-ordinator. The results are compared with those from other sites in the country who analysed the same sample. The performance of the Abbott Glucose meter and the proficiency of the operators are then documented in POCT. Storage and stability Store the test strips at room temperature between 4 C and 30 C. Keep away from direct sunlight and heat. Do not use strips beyond the expiry date written on the foil packet and outer box Use test strip immediately after opening foil packet Do not use wet, bent or damaged test strips Use the test strip only once and then discard Do not use the test strip if the foil packet has a puncture or tear Once open the QC solutions expire after 90 days Measuring Range 1.1 27.8 mmol/l Results of less than 1.1mmol/l give a display reading of LO Results of greater than 27.8mmol/l give a display reading of HI or an error code E4 Reference Range for non-diabetic, non-pregnant adults Fasting sample: 4.1 5.9 mmol/l One to two hours after meals: less than 8.9 mmol/l Limitations of method Ward glucose meters are capable of giving reliable and rapid results provided the users are adequately trained, the testing protocol is strictly adhered to and limitations of the method are fully appreciated by users, clinicians and laboratory staff. Liability under the Consumer Protection Act (1987) will only remain with the manufacturer or supplier if the user can demonstrate that Point of Care Testing (POCT) equipment has been used in strict accordance with the manufacturer s instructions. Therefore individual operators / clinicians may be responsible for any medico-legal problems arising from use of meters outside these limitations. 1. Ward glucose meters are intended for monitoring the patient's treatment and are approved by the MHRA only for this application. Laboratory results must be used as the basis of diagnosis and determining appropriate treatment. Diagnostic cut-offs (e.g. WHO criteria) are defined with respect to laboratory analysers which have very little variation in results between manufacturers. Ward glucose meters will not give the same values and there is often considerable variation between results for the same sample analysed on different meters. Author Helen Chapman Page 4 of 6 Title Abbott Optium Xceed Glucose Meter Pages printed from this document are uncontrolled - For latest versions please refer to electronic laboratory handbook

Pathology Abbott Optium Xceed Glucose Meter SOP No. SOP-POCT-013 Date of Issue: 1/1/2008 Ver 1.0 Hazard / Risk Data 2. Any sample reading less than 3mmol/L or above 20 mmol/l must be verified by sending venous blood to the laboratory for random blood glucose. The results obtained from glucose meters deviate from the laboratory values by an unacceptable amount outside these limits. 3. Any patient being monitored at frequent intervals each day must have venous blood checked daily by the laboratory. 4. Results may be unreliable in some commonly encountered clinical situations due to physiological or instrument related problems. The following list gives guidance on the most commonly encountered problems. Please see the manufacturer's training documentation for further details of performance of the current version of the individual meter which is in use. Always use laboratory results in place of meter results if any of these contraindications are present. Contraindication Severe jaundice Severe dehydration Peripheral circulatory failure Variations in blood oxygen tension High concentrations of non-glucose reducing substances in the blood Extremes of haematocrit Dialysis treatment Example of clinical causes Bilirubin > 340 µmol/l Including DKA, vomiting or diarrhoea, prescription drugs, e.g. diuretics, inability to recognise or respond to thirst sensations Severe dehydration, hyperglycaemic-hyperosmolar state with or without ketosis, hypotension, shock, peripheral vascular disease Patients receiving intensive oxygen therapy Intravenous infusion of ascorbic acid Neonatal blood samples Troubleshooting For understanding and troubleshooting Error messages - See Chapter 8 of Users Guide (SOP-POCT-014) Routine Maintenance and Cleaning Cleaning the meter use a damp cloth and mild soap or 10% solution of bleach. Important: Do not attempt to clean the strip port Do not pour liquid into the strip port or buttons Do not place the meter in water or ant other bath Replacing the battery Page 55 Users Guide If battery is low you may still use the meter but the display will show a battery sign as well as the result it is recommended that the battery is replaced at this time If all the display shows is a battery it has run out and must be replaced. Important Do not remove the old battery until you have a new battery to install. It may be necessary to reset the date and time after a new battery is installed or if Error E6 occurs - (see Users Guide SOP-POCT-014 Chapter 2 for instructions) Author Helen Chapman Page 5 of 6 Title Abbott Optium Xceed Glucose Meter Pages printed from this document are uncontrolled - For latest versions please refer to electronic laboratory handbook

Pathology Abbott Optium Xceed Glucose Meter SOP No. SOP-POCT-013 Date of Issue: 1/1/2008 Ver 1.0 Hazard / Risk Data Health and Safety All blood samples should be handled as high risk. Gloves should be worn or hand gel used when handling blood and hands should be washed when gloves are removed. COSHH Assessment Hazard Entry route and first aid Blood Biohazard Skin. Wash and use hand gel Author Helen Chapman Page 6 of 6 Title Abbott Optium Xceed Glucose Meter Pages printed from this document are uncontrolled - For latest versions please refer to electronic laboratory handbook

133-243 Manual,G3b,Eu,En 5/17/04 3:10 PM Page 1 Table of Contents Welcome 1 1 Important Things to Know about Your Optium Xceed Diabetes Monitoring System 3 Intended Use 3 How Your Optium Xceed Diabetes Monitoring System Works 4 Optium Xceed Kit Contents 5 Getting to Know Your Meter s Features 6 2 Setting Up Your Optium Xceed Meter 9 Buttons to Use 9 Setup Options 9 How to Set the Beeper, Date, Time, & Measurement Units 11 Set Beeper 11 Set Time 13 Set Date 15 Set Time Format 18 Set Date Format 19 Set Blood Glucose Measurement Units 20 3 Calibrating Your Optium Xceed Meter 22 Why Calibrate Your Meter? 22 When to Calibrate Your Meter 22 What You Will Need 23 How to Calibrate Your Meter 23 How to Recall the LOT Number or Calibration CODE 28 4 Monitoring Your Blood Glucose 30 What You Will Need 30 Important Information about Monitoring Your Blood Glucose 30 How to Monitor Your Blood Glucose 31 Understanding Your Result 39 5 Monitoring Your Blood ß-Ketone 43 What You Will Need 43 Important Information about Monitoring Your Blood ß-Ketone 44 How to Monitor Your Blood ß-Ketone 45 Understanding Your Result 52

133-243 Manual,G3b,Eu,En 5/17/04 3:10 PM Page 2

133-243 Manual,G3b,Eu,En 5/17/04 3:10 PM Page 3 6 Doing A Control Solution Test 55 Why Do A Control Solution Test? 55 When Is Doing A Control Solution Test Recommended? 55 Important Information about Control Solution Testing 55 What You Will Need 57 How to Do Control Solution Testing 57 Understanding Your Result 64 7 Reviewing & Using Your Results 65 What Can Your Meter Show You? 65 How to See Results in Memory 66 How to See Averages 69 Transferring Your Results to A Computer 71 8 Understanding & Troubleshooting Error Messages 72 What An Error Message Means & 72 What You Need to Do 9 Your Meter s Specifications & Limitations 77 Important Information about Using Blood 80 Samples from the Forearm, Upper Arm, or Base of the Thumb 10 Caring For Your Meter 82 Cleaning Your Meter 82 Replacing Your Meter s Battery 83 11 Support & Guarantee 87 References 89 Appendix 90 Glossary of Symbols 90

133-243 Manual,G3b,Eu,En 5/17/04 3:10 PM Page 4 Welcome Thank you for choosing the Optium Xceed Diabetes Monitoring System. Important steps for using the System are inside this guide. Please read it carefully. Your new Optium Xceed Diabetes Monitoring System is an important tool that can help you better manage your diabetes. The System measures both blood glucose (sugar) and blood ß-Ketone. Blood glucose and blood ß-Ketone results can help you understand your diabetes and what happens with: Food Exercise Stress and illness Diabetes medications Always monitor your blood glucose and blood ß-Ketone according to your healthcare professional s recommendations. 1

133-243 Manual,G3b,Eu,En 5/17/04 3:10 PM Page 5 Call Customer Service in the UK at 0500 467 466, or in Ireland at 1800 776633 with any questions you may have about the Optium Xceed Diabetes Monitoring System. If you cannot reach Customer Service, contact your healthcare professional. Outside the UK and Ireland, please contact your local Abbott Laboratories, MediSense Products office or distributor. Please read the following items before using your Optium Xceed Diabetes Monitoring System: User guide Blood glucose test strip instructions for use Blood ß-Ketone test strip instructions for use Lancing device instructions for use and other information Warranty card IMPORTANT: Any user guide text shown in a shaded box like this one is important information. Please pay special attention to these boxes. 2

133-243 Manual,G3b,Eu,En 5/17/04 3:10 PM Page 6 Important Information CHAPTER 1 Important Things to Know about Your Optium Xceed Diabetes Monitoring System Questions? Call Customer Service. See page 87. Intended Use Your Optium Xceed System: Is indicated for home (lay user) or professional use in the management of Patients with diabetes. Is for self testing or healthcare professional use outside the body (in vitro diagnostic use). Is for monitoring glucose in fresh whole blood (for example, from the fingertip). Is for monitoring ß-Ketone in fresh whole blood from the fingertip. Measures ß-hydroxybutyrate (ß-Ketone), the most important of the three ketone bodies circulating in the bloodstream. Is for use only with MediSense Optium TM Plus Blood Glucose Test Strips and MediSense Optium TM Blood ß-Ketone Test Strips. 3

133-243 Manual,G3b,Eu,En 5/17/04 3:10 PM Page 7 Healthcare professionals: Please refer to the test strip instructions for use for more information about sample types. Potential Infection Risk: Healthcare professionals performing blood tests with this system on multiple patients must always wear gloves and should follow the infection control policies and procedures approved by their facility. Important Information How Your Optium Xceed Diabetes Monitoring System Works When you insert a test strip into your meter, the Apply Blood message shows on your meter s display window. When a blood sample or control solution sample is applied to the test strip, the glucose or ß-Ketone reacts with the chemicals on the test strip. This reaction produces a small electrical current that is measured. The result shows on your meter s display window. 4

133-243 Manual,G3b,Eu,En 5/17/04 3:10 PM Page 8 Important Information Optium Xceed Kit Contents Optium Xceed Meter Optium Xceed User s Guide Contains system information and directions. Carrying Case Use this to store and carry your meter and other monitoring supplies. Your kit may also contain: Optium Xceed Quick Reference Guide Gives the basic steps to calibrate your meter and monitor your blood glucose. Logbook Use this to record your test results, activities, and medications. Limited Warranty Card Please fill this out and return to the address provided to start your warranty. Filling out this card helps to ensure that you receive any updates regarding your Optium Xceed meter. Lancing Device, Lancets, Instructions for Use and Other Information Blood Glucose Test Strips and Instructions for Use 5

133-243 Manual,G3b,Eu,En 5/17/04 3:10 PM Page 9 Display Window Back Button Strip Port Mode Button Backlight Button Forward Button Items not included: MediSense Control Solutions Blood ß-Ketone Test Strips and Instructions for Use Data Management System Getting to Know Your Meter s Features Display Window This shows: Blood glucose and blood ß-Ketone results Glucose LOT numbers and ß-Ketone calibration CODEs Previous test results and error messages Blood glucose averages Important Information IMPORTANT: Each time you turn your meter on, a full display shows. This is called a Display Check. Look at the Display Check each time it appears on your meter s display window, especially before you monitor your blood glucose or blood ß-Ketone. The Display Check shows on the display window briefly. Display Check 6

133-243 Manual,G3b,Eu,En 5/17/04 3:10 PM Page 10 Important Information Do not use the meter if the meter Display Check does not exactly match the picture here (for example, if you see a "3" instead of an "8"). The meter may show an incorrect result when you use it. Please call Customer Service for assistance. Strip Port This is where you insert: A blood glucose test strip A blood ß-Ketone test strip A glucose calibrator A ketone calibrator Data cable (not included) for uploading results to a computer Mode Button Use this button to: Turn meter ON and OFF Access meter setup options Access and save meter settings Access previous results and averages 7

133-243 Manual,G3b,Eu,En 5/17/04 3:10 PM Page 11 Forward Button Back Button Use these buttons to: Review and select meter settings Review results and averages Important Information Backlight Button Use this button to: Turn backlight ON and OFF Battery Compartment This is where the battery is installed. If your meter does not turn on, check that your battery is installed properly. For new battery installation, see Chapter 10. 8

133-243 Manual,G3b,Eu,En 5/17/04 3:10 PM Page 12 Setting Up Your Meter CHAPTER 2 Setting Up Your Optium Xceed Meter Buttons to Use Mode Button Forward Button Back Button Setup Options Questions? Call Customer Service. See page 87. Set Beeper If the beeper is set ON, it will beep when: The calibrator is fully inserted The test countdown starts The test countdown finishes Set Time, Set Date Important: Set the correct time and date before you use the meter for the first time. This will help you keep records of when you monitor and will help you and your healthcare professional make informed decisions about your care. You must set the time and date to review averages. 9

133-243 Manual,G3b,Eu,En 5/17/04 3:10 PM Page 13 You may need to re-set the time and date: After you replace the battery. When you travel between time zones or when the time zone you are in changes. In "Set Date", you set the year, month, and day. Setting Up Your Meter Set Time Format In "Set Time Format", you choose how the time shows on the meter s display window. Set Date Format In "Set Date Format", you choose how the month and day show on the meter s display window. Set Measurement Units Consult your healthcare professional before changing the blood glucose measurement units. Blood glucose measurement units are in mg/dl or mmol/l. Blood ß-Ketone measurement units are in mmol/l only. 10

133-243 Manual,G3b,Eu,En 5/17/04 3:10 PM Page 14 Setting Up Your Meter How to Set the Beeper, Date, Time, & Measurement Units To begin, pull the battery tab out. Your meter should be turned OFF. You will automatically be prompted to set the time and date the first time you press the mode button to turn your meter on (see Set Time and Set Date sections in this chapter. Before you start, please note: "Press and Hold" means that you press the button in for at least 2 seconds. "Press and Release" means that you press the button and let it go quickly. Press and Hold the button to turn the meter off and save your settings at any time. The meter automatically turns off after 30 seconds of no action. If you like the setting that you see on your meter and do not want to change it, Press and Release the button to move to the next setup option. Set Beeper The means the beeper is ON. The means the beeper is OFF. Beeper ON Beeper OFF 11

133-243 Manual,G3b,Eu,En 5/17/04 3:10 PM Page 15 1To turn your meter ON, Press and Hold the button. The beeper ON message shows on the display window. The musical notes flash on and off, and the meter beeps. Setting Up Your Meter 2To change the beeper setting, Press and Release the button or the button once. 3Press and Release the button to save the beeper setting and to move to Set Time (Hour). 12

133-243 Manual,G3b,Eu,En 5/17/04 3:10 PM Page 16 Set Time Hour: Setting Up Your Meter The Hour flashes on and off. 1Press and Release the button to move the hour forward. 2If you go past the correct hour, Press and Release the button to move the hour back. 3Press and Release the button to save the hour and to move to Set Minutes. 13