Read Point Of Care Testing (POCT) text version

Newcastle Upon Tyne Hospitals NHS Trust

POLICY FOR POINT OF CARE TESTING (POCT)

Published: Edition:

September 2004 2

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Contents 1 2 3 4 5 6 7 8 9 10 11 12 13 14 Introduction Management Structure for POCT Approval Process for POCT Requirements for Standard Operating Procedures Training and Certification of Authorised Users Data Management Quality, Clinical Governance and Risk Management Health & Safety, Infection Control POCT Support and Service Level Agreements Strategy for POCT within the Trust Audit Standards Summary of actions and responsibilities References Appendix: The role of the POCT Co-ordinator

Page 3 6 11 13 14 15 17 18 18 20 21 22 24 25

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1. Introduction 1.1. Definition of POCT Point of Care Testing (POCT) may be defined as "any analytical test performed for a patient by a healthcare professional outside the conventional laboratory setting". Other terms previously used to describe these tests include near patient testing (NPT), extra laboratory testing and bedside testing, the term POCT now being preferred. For the purposes of these guidelines, the word "device" includes the whole range of items from simple urine dip-stick tests to sophisticated analysers. POCT is usually performed by healthcare professionals in a primary or secondary care setting, in the public or private sector, but may also be undertaken in pharmacies, the workplace or by patients themselves (patient self testing). This policy concerns those tests performed in clinical areas within the Trust by non-laboratory staff on a sample taken from the patient, usually blood, urine or stool. General advice is included regarding the use of POCT by patients and in primary care or other settings where the POCT is not the direct responsibility of the Trust. 1.2. Role of POCT in delivery of modern, high quality care Rapid analytical technological advances in recent years, including solid phase reagents strips and microprocessor controlled portable analysers, have led to the development of many new POCT devices with a rapidly expanding repertoire of tests. While the latest POCT devices from leading manufacturers are generally more simple to operate and less prone to error than earlier versions, close attention to detail is required if POCT is to produce analytical results which are reliable enough for use in clinical decision making. If the instructions are followed carefully and with proper training, most grades of staff are capable of performing POCT to a satisfactory standard. Availability of high quality POCT test results can enhance patient care through improvement in turnaround time for obtaining results, smaller sample volumes and reduced patient discomfort, particularly where frequent testing is required (e.g. blood glucose monitoring).. 1.3. The need for a Trust-wide POCT Policy If not used appropriately there is a risk that patients may be put at risk

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from inappropriate testing or wrong results. Although infrequent, serious mishaps involving POCT devices continue to occur and remain a cause for concern, as highlighted in a recent bulletin from the Department of Health laboratory test watchdog, the Medical Devices Agency (now the Medical and Healthcare Products Regulatory Agency, MHRA). Mishaps are more likely to occur if POCT is introduced in a haphazard way and are usually the result of poor training, inadequate supervision, lack of quality control, failure to maintain equipment and meet health and safety requirements. The appropriate use of these tests should be considered as a Clinical Governance issue and subject to examination of clinical effectiveness. With adequate support and direction most problems can be avoided and it is therefore essential that all users of POCT have ready access to clear guidance on the procurement, installation, use and monitoring of POCT devices. Guidelines for POCT have been drawn up by a variety of national and international organisations, as recently reviewed and summarised by the MDA. The MDA have recommended the incorporation of their key recommendations into a locally agreed POCT policy in each NHS Trust, overseen by a multidisciplinary Trust POCT Committee and with full involvement of the local hospital laboratory to ensure satisfactory implementation. This Policy reflects these guidelines in the context of what has already been set up in Newcastle upon Tyne Hospitals NHS Trust. 1.4. Aim of the POCT Policy The aim of this policy is to provide the framework required for Clinical Governance of POCT and to define the roles and responsibilities of those involved in the management and use of POCT devices. Implementation of the Policy will ensure that the results obtained through the use of POCT devices are sufficiently accurate and reliable to be used for the intended purpose of clinical decision making, that the safety of both staff and patients is maintained and that optimum cost effectiveness is achieved in the use of POCT devices and associated resources. 1.5. Scope of POCT Policy The policy and its formulation will the responsibility of the POCT Committee but will address the following areas:

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· · · · · · · · ·

Management Structure for POCT and the POCT Committee Approval Process for POCT Requirements for Standard Operating Procedures (SOP) Training and Certification of Authorised Users Data Management Quality, Clinical Governance and Risk Management Health and Safety and Infection Control Budgetary Arrangements and Resource Management Strategy for POCT within the Trust

The policy will apply to Managers and any User in all wards and departments within the Newcastle upon Tyne Hospitals NHS Trust who are using POCT devices for the investigation, monitoring and management of patients. These principles apply equally to POCT performed for clinical research (see also Section 3. Approval Process). 1.6. Tests included in the POCT Policy While all tests and devices included under the definition given above are within the scope of the POCT policy, the following are the major categories of device in current use: Urinalysis Test Strips Blood Glucose meters Blood gas/electrolyte analysers Urine Pregnancy Test Kits Coagulation meters Faecal Occult Blood Tests Haemoglobin meters Bilirubin meters Microscope examination It will be the responsibility of the POCT committee to determine the repertoire of POCT devices which should be approved for use within the Trust. Each individual point of care application will have a specific policy document, detailing the arrangements agreed by the POCT Committee for appropriate implementation and authorised use within the Trust, incorporating best practice standards.

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1.7.

Advice to General Practitioners and other non-Trust sites. General Practitioners, Pharmacists and other Primary sector users are recommended to adopt the practices outlined for hospitals, including close liaison with the Laboratory Medicine Directorate. This would help ensure high quality results and manage the associated risks. Involvement of Laboratory Medicine Directorate in the oversight of EQA schemes would have resource implications.

1.8.

Advice on Patient Self Testing. When devices are issued to, or bought by patients for home monitoring or self testing, on the advice of the physician or GP responsible for care, he or she must ensure that the patient receives adequate training. This must cover all aspects of performance including the interpretation of results. The Health & Safety implications must also be explained to the patient. A specialist nurse who can work with the Laboratory Medicine Directorate would be an appropriate person to undertake this task. When patients are admitted to hospital it may be appropriate for the patient to continue with self-testing, in which case technique should be checked and support should be offered including provision of approved consumables if available. The manufacturers of devices designed specifically for patient use should supply suitable training materials which should have been developed in co-operation with experts in the relevant profession. Devices should not be purchased if such training materials are not available.

2. Management Structure for POCT 2.1. Trust POCT Committee The Trust POCT Committee will be responsible to the Trust Clinical Governance Committee for formulation of the Trust POCT policy and will advise the Trust Clinical Governance Committee on all aspects of POCT within the Trust. The Committee will be a multidisciplinary group which will represent all major stakeholders in POCT including laboratory staff, clinicians, nursing staff, specialist nurses, pharmacists, managers and purchasing/supplies agents, with an emphasis on those who are existing or prospective users of POCT. Involvement of these groups in formulation of

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policy is essential to ensure ownership by those who will be responsible for its implementation. 2.1.1. The membership of the Committee will be as follows: Chair: Consultant in Clinical Biochemistry Consultant Clinical Scientist Medical Consultant Representatives: Physicians, Paediatrician, Anaesthetists, Intensivists. Diabetic Specialist Nurse Representatives Infection Control Adviser Senior Nursing Representative. Training Department Representative Drugs and Therapeutics Committee Representative Pharmacy Representative Supplies Department Representative Risk Management Representative Laboratory Medicine POCT Co-ordinator 2.1.2. Although the major stakeholders are represented on the Committee, an essential function of the Committee will be, when necessary, to liaise with other Clinical Specialists and to co-opt additional members where appropriate. 2.1.3. The Committee shall meet every 3 months and minutes will be taken. The minutes will be submitted to the Trust Clinical Governance Committee. 2.1.4. The Committee shall be responsible for defining the scope of POCT to be made available within the Trust taking into consideration the financial implications, technical feasibility and organizational infrastructure. 2.1.5. The Committee shall consider all proposals (including clinical research proposals) to introduce any POCT device, product or system and shall ensure that no POCT Devices are used within the Trust unless approval has been obtained from the Committee (see also Section 3. Approval Process). 2.1.6. The Committee shall produce policies for the Management of POCT and the use of POCT Devices. These Policies will be submitted to the Trust Clinical Governance Committee for approval.

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2.1.7. The Committee will ensure that all staff are aware of the POCT policy and their roles and responsibilities as defined therein. 2.1.8. The Committee shall ensure that POCT policies are implemented and will be responsible for regular audit and review of the policies 2.1.9. The Committee will be responsible for ensuring implementation of a Quality Management System for the use of POCT Devices. 2.1.10. The MDA Notices and the Joint Working Group on Quality Assurance emphasize the central role that Pathology has in ensuring that POCT Devices are used appropriately. This Policy reflects that recommendation and Laboratory Medicine personnel working with appropriate personnel identified by the POCT Committee (e.g. Diabetic Nurse Specialists, Link Nurses, Medical Equipment Library personnel) will be the main agents of the POCT Committee for ensuring that the policies outlined in this document are carried out. 2.2. Responsibilities of Clinical Directors It is the responsibility of the Clinical Director to ensure that only approved POCT devices are used by staff within wards and departments for which they are responsible and that any new or replacement POCT devices are submitted to the POCT committee for approval. The Clinical Director must ensure that appropriate arrangements are in place for the management of POCT devices in accordance with the Trust POCT Policy and that the responsibilities of the user and the support to be provided by the Laboratory Medicine Directorate are as defined in the corresponding Service Level Agreement (SLA). 2.3. Responsibilities of Ward and Department Managers It is the responsibility of the Manager to ensure that all users of POCT devices have received appropriate training and have been certified as competent to use the POCT device safely and in accordance with the Trust POCT policy, the approved Standard Operating Procedure (SOP) and the manufacturer's recommendations. The Manager must ensure that an up to date User Register is kept at Ward level of all staff who have been trained and certified as competent to use each POCT device (Authorised Users). The Manager must designate one or more named individuals to act as POCT contact (or "Link Nurse") for their area with responsibility for co-

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ordination of POCT activities and regular communication with users. The manager must be fully conversant with provisions of the Service Level Agreements for each POCT device including the details of support arrangements and action to be taken in the event of equipment failure. 2.4. Responsibilities of the User Authorised users are only those who are named in the Ward level User Register, who have received up to date training, are certified as competent to use the POCT device and have maintained competency by regular use of the device. It is the responsibility of the User to use the POCT device safely and in accordance with the Trust POCT policy, the approved Standard Operating Procedure (SOP) and the manufacturer's recommendations. The User must have a clear understanding of the action required if abnormal or unexpected results are obtained on analysis of patient or quality control samples. The User must be aware of support arrangements for each POCT device as detailed in the Service Level Agreements including the details of action to be taken in the event of equipment failure. Users must not lend or pass on devices to other Departments which may not be approved or qualified to use them. The User is responsible for prompt reporting of adverse incidents via the Trust incident reporting procedure. 2.5. Responsibilities of Laboratory Medicine and POCT Support Staff The Laboratory Medicine Directorate will be responsible for providing advice and assistance with the evaluation, selection and procurement of POCT devices, in the negotiation of contracts and when required, with the cost-benefit analysis and development of a business case for approval by the POCT Committee. It is the responsibility of the Laboratory POCT Support Staff to provide appropriate support to User Departments as specified in the Service Level Agreement for each Service Level Agreements for each POCT device. This may include purchase and distribution of equipment and consumables, provision of training standard operating procedures, equipment maintenance, troubleshooting and repair, health and safety inspection, provision of internal quality control and external quality assessment samples, monitoring of internal quality control and external quality assessment results, inspection of instrument log

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books. The Laboratory Medicine will, as a minimum, provide a Laboratory based back-up analytical service in the event of POCT equipment failure and will provide appropriate advice regarding the comparability of results. 2.6. Responsibilities of Pharmacy Department It is the responsibility of Pharmacy Department to order and supply Trust approved POCT devices and consumable materials to authorised User Departments, as specified in the Service Level Agreements (SLA) for each POCT device. Requests for non-approved POCT devices or equipment must be referred to the POCT Committee. The Pharmacy Department will seek to standardise the products used and obtain products at the best price without compromising the quality of testing. Pharmacy will maintain records of when batches are received and, when required, inform the Laboratory Medicine Directorate and the POCT Co-ordinator when new batches have been issued. When acceptance testing is required, as specified in the SLA, Pharmacy Department will not issue devices until the batch is approved. 2.7. Responsibilities of Purchasing and Supplies Department It is the responsibility of Purchasing and Supplies Department to order and supply Trust approved POCT devices and consumable materials to authorised User Departments, as specified in the Service Level Agreements for each POCT device. Requests for non-approved POCT devices or equipment must be referred to the POCT Committee. The Purchasing and Supplies Department will inform the Laboratory Medicine Directorate and the POCT Co-ordinator if a product is unavailable and alternative replacement products need to be purchased. When acceptance testing is required, as specified in the SLA, Supplies Department will not issue devices until the batch is approved. 2.8. Responsibilities of Manufacturer It is the responsibility of Manufacturer to ensure that equipment and devices are CE marked and comply with currently applicable legislation and are safe to use when stored, maintained and used in accordance with their instructions. Suppliers will have incident surveillance procedures that comply with the MHRA guidelines, designed to minimize risks to

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users and patients. The Manufacturer will inform the relevant Laboratory Medicine Directorate and POCT Co-ordinator immediately about any modification to devices after placement. When required to do so as part of a contractual agreement, manufacturers will co-operate with the relevant Laboratory Medicine Directorate and POCT Co-ordinator to provide appropriate training for Users. 2.9. Compliance Compliance with this Policy will minimise clinical risk and address clinical governance issues. When operation of a POCT system is outside quality limits or is unsafe it will be withdrawn from service by the Laboratory Medicine Directorate POCT Co-ordinator following discussion with senior staff on the POCT site. Failure to resolve the situation at this level will necessitate negotiation with the Clinical Director and subsequently the Trust Medical Director/Head of Nursing. 2.10. Review This Policy will be subject to audit to ensure effective implementation and will reviewed annually by the POCT Committee and the Trust Clinical Governance Committee to ensure that the practice is up-to-date and complies with current published guidelines and standards. 3. Approval Process for POCT All POCT devices and testing sites must be registered and approved by the Trust POCT Committee. Proposals for implementation of a new POCT procedure or replacement of an existing device or procedure must complete the Application for POCT Approval form and submit this for consideration by the POCT committee. In order to meet the requirements of research governance, this requirement applies equally to POCT performed for clinical research purposes, in which case approval should be sought before submission of the proposal for ethical approval. It will not normally be allowable to accept offers of free equipment unless this is part of a formal equipment evaluation and the appropriate indemnities have been received from the supplier. The POCT Committee must be informed before an evaluation is undertaken and their expertise

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recognised as an integral part of the decision making process. In each case the following issues must be considered. 3.1. Identification of need It is critically important that the advice of Laboratory Medicine Directorate is sought on intended POCT equipment purchases. In general, POCT is considerably more expensive than testing in the main laboratory. It should be recognised that faster availability of results is only an advantage if availability of results is the rate limiting step in clinical care. It may be that the clinical requirements can be met by a modification of the laboratory process, at a lesser cost than POCT. There must therefore be a clear definition of the problem that the device would solve so that a full examination of all possible solutions can be made. 3.2. Cost Benefit Analysis Both economic and clinical outcomes need to be formally considered. The Laboratory Medicine Directorate and the User Department must be involved in the production and evaluation of the Cost-Benefit Analysis which will form part of a full business plan detailing all the financial consequences of the procurement and implementation. These will include the direct costs of running, maintenance, consumables, quality control and service contract. The Cost-Benefit Analysis must include the full indirect costs for the Laboratory Medicine Directorate involvement, including support, training and QC/QA monitoring, as well as the inevitable cost of replacement. The Cost Benefit Analysis must recognise the need for any device to be compatible with existing equipment, both in the laboratory and in other areas of the hospital. 3.3. Evaluation of equipment. The POCT Committee must be consulted in advance before an evaluation is undertaken. The relevant Laboratory Medicine Directorate Department must be involved in the evaluation of POCT devices. This includes any "field testing" or "pilot studies" undertaken within the Trust. An evaluation report will normally be prepared in collaboration with the POCT Co-ordinator and will include recommendations on the performance and suitability of the device. A comparison with the Any corresponding laboratory results must be formally undertaken.

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device being considered must have a CE mark to ensure it is fit for the purpose and of suitable quality. The Evaluation Report will be sent to the POCT Committee for approval or otherwise to purchase the device. The POCT Committee must consider the compatibility of all devices. The POCT committee will favour procurement of those devices which offer positive identification of patients and users, improved equipment standardisation and connectivity to other similar devices and information systems within the Trust. Formal Service Level Agreements (SLAs) will be agreed between the Laboratory Medicine Directorate and the User Department, and approved by the POCT Committee before the POCT device is commissioned. 4. Requirements for Standard Operating Procedures Each individual POCT device will have a specific policy document, detailing the arrangements agreed by the POCT Committee for the appropriate implementation and authorised use of that test within the Trust, incorporating best practice standards. The Laboratory Medicine Directorate and User Department will collaborate in production of the Policy document and Standard Operating Procedure (SOP) which will must be submitted to the POCT Committee for approval. 4.1. An SOP must be produced, written to the standard required by Assessors from Clinical Pathology Accreditation (UK) Ltd, or equivalent accreditation agencies. This must be available to and followed by all users of the device. Up to date versions will be maintained and made available to authorised users on the Trust Intranet. 4.2. The document will include instructions on safe working practice, the interpretation of error messages, the recording of data and the relevant Quality control procedures. The Laboratory Medicine Directorate will provide assistance with the production of these documents as specified in the relevant Service Level Agreement (SLA). These documents will refer to manufacturer's operating instructions as necessary while ensuring that there is no infringement of copyright. 4.3. A master copy of the SOP must be held by Laboratory Medicine Directorate and be available to accreditation agency Assessors.

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4.4.

The Standard Operating Procedure will be subject to regular review, at least annually.

5.

Training and Certification of Users. The Laboratory Medicine Directorate and the User Department should agree arrangements for the training and certification of Users, to be defined in the Service Level Agreement and approved by the POCT Committee.

5.1.

Only staff whose training and competence has been established and documented should use any device, including simple dip-stick tests. In the event of unavailability of suitably trained staff, alternative sites for the analyses should have been agreed, documented in the Service Level Agreement and made known to the users in the SOP and managers in departmental policies. Back-up arrangements should be in place for testing in both routine and emergency situations. In an emergency situation where the above standard cannot be met, for whatever reason, it is the final responsibility of the Clinical Director/Consultant in charge to consider the balance of risks versus benefits to the staff and the patient in deciding whether to allow POCT to be performed by unauthorised staff, in breach of this policy. In such cases a Trust Incident Report form must be completed regardless of the outcome.

5.2.

Tests using a particular device in the designated area of use may only be carried out by those on the corresponding "Register of Authorised Users". Devices incorporating facilities for electronic User identification and password protection will be favoured in policy for future procurements.

5.3.

Following procurement and installation, relevant staff must be trained in the safe and proper use of the device. The training course must be documented and approved by the POCT Committee and supervised by the relevant Laboratory Medicine Department or POCT Co-ordinator. If training is provided by the manufacturer, staff must be trained to the satisfaction of the relevant Laboratory Medicine Department or POCT Co-ordinator.

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5.4.

Clinical staff are not permitted to train each other unless designated as a "specialist nurse" or "Link Nurse" or otherwise authorized to do so by the POCT Co-ordinator on behalf of the POCT Committee.

5.5.

Training should cover the following issues: · Patient preparation · Collection, transportation and disposal of specimens · Quality Control requirements. · Step by step procedure · Recording of results · Interpretation of results · Troubleshooting · Maintenance of equipment.

5.6.

Once competence has been achieved and documented, the user can be added to the "Register of Authorised Users". This Register and associated competency records must be kept up to date by the User Department.

5.7.

Competency of trained staff must be reviewed at least annually by the POCT Co-ordinator,"specialist nurse" or "Link Nurse" authorized to do so by the POCT Committee

5.8.

For some devices regular or periodic update training is necessary to maintain the required standard of performance. This is particularly important for users who operate a device infrequently, or have had a break in the use of the device. This should be included in the Standard Operating Procedure.

6. 6.1.

Data Management It is currently a legal requirement that all patient results shall be kept in the patient's notes. The mechanism for the transfer of results, together with unambiguous patient identifiers, date and time of test, relevant QC results and the identity of the user, from the device to the patient's record must be as stated in the SOP and monitored by the Departmental Manager/ Link Nurse for compliance.

6.2.

In addition all patient and Quality Control/Quality Assessment (QC/QA) results must be recorded in a POCT device record. This record must include unique and unambiguous patient identifiers, date and time of test,

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the result, relevant QC results, batch number for consumables/strips/reagents and the identity of the user as specified in the SOP and compliance monitored by the Departmental Manager/ Link Nurse. Interfacing of the POCT equipment to the Laboratory Information System should be considered if technically feasible. 6.3. All patients' results must be treated as confidential and kept in a secure place. If patient results are stored in a computer system, rules on access to the system, whether stand-alone or networked, should be documented and adhered to. Users should have access to the system by password which must be regularly updated. The storage of results should be in line with the storage maintained by the laboratory and compatible with Trust IMT policy. 6.4. The POCT Co-ordinator, Laboratory POCT Support staff and individuals identified by the POCT Committee must have free access to QC/QA results. 6.5. Each device must have a "log-book' in either paper or electronic form in which details are recorded of maintenance, faults, corrective actions and repairs by named individuals. Laboratory Medicine Directorate, POCT Committee.and individuals authorised by the POCT Committee must have free access to carry out inspection of log books. The Log book and the POCT Device results record may be combined in a single volume. The device Log book must be retained for the lifetime of the equipment.

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7. 7.1.

Quality, Clinical Governance and Risk Management. Clinical Pathology Accreditation (UK) Ltd require that Pathology Departments participate in recognised External Quality Assessment schemes (QA) relevant to their test repertoires where these are available.

7.2.

The POCT Committee must be satisfied that there is a demonstrable link between the users of the device and the Laboratory Medicine Directorate to ensure the "Quality" aspects and reliability of the results produced. This "link" role may be fulfilled by a laboratory based "POCT Coordinator" and/or a ward-based "Link nurse".

7.3.

The Laboratory Medicine Directorate staff (POCT Co-ordinator) must be responsible for ensuring that the performance of the device is checked by appropriate internal QC and external QA assessments such as would satisfy the CPA Inspection criteria.

7.4. 7.5.

Management must be made aware of the legal exposure involved if there is no supervision of devices through external QA schemes. The Laboratory Medicine Directorate POCT Co-ordinator and the specialist/link nurses identified by the POCT Committee should be involved in clinical governance issues and should carry out regular audits of the reliability and effectiveness of the tests being carried out.

7.6.

None of the devices is totally foolproof. It is essential that the risks associated with the use and interpretation of results obtained are properly managed by training and support from the Laboratory Medicine Directorate and the POCT Committee.

7.7.

Adverse events occurring directly or indirectly as the consequence of the use of a POCT device, which may include equipment failure or inappropriate treatment arising from erroneous results, must be reported promptly via the Trust Incident Procedure on the approved Incident report form. The Risk Manager must forward copy to the POCT Co-ordinator and the POCT Committee. The POCT Co-ordinator should be involved at t he earliest stage to ensure that potentially unsafe devices or equipment are withdrawn from service until the error has been properly investigated. Devices which are considered unsafe must be added to the Trust's risk register. Where appropriate, the incident should be referred to the MHRA.

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8 8.1.

Health & Safety and Infection Control. Managers of the Clinical service involved together with the Laboratory Medicine Directorate and the POCT Committee must jointly develop and enforce policies consistent with current legislation and Guidance. For example: the Health & Safety at Work Act 1974, Consumer Protection Act 1987, the Control of Substances Hazardous to Health Regulations 1988, Safe Working and the Prevention of Infection in Clinical Laboratories ­ Model Role for Staff and Visitors, HSC 1981, Protection against Blood-born infections in the workplace: HIV and hepatitis (ACDP) 1995.

8.2. 8.3.

There should be close liaison between the Health and Safety Officers of the testing site the POCT Co-ordinator and the Link Nurse. A "Permit-to-work" certificate, providing evidence of appropriate decontamination, must be issued by the POCT Co-ordinator or other appropriately qualified member of staff, before servicing or repair of equipment by an external agent.

8.4.

The Infection Control Physician/Medical Microbiologist must be involved in decisions on placement and maintenance of equipment.

9. 9.1.

POCT Support and Service Level Agreements. There must be a service level agreement (SLA) between the users and the Laboratory Medicine Directorate defining the responsibilities for: · · · · · · · · · · Service planning Procurement and replacement of equipment Provision and storage and consumables and reagents Capital and revenue consequences Staffing User training and support Device management, maintenance, troubleshooting and repairs Quality System Management Audit and monitoring of activity Analytical back-up during down-time

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9.2.

Designated persons (e.g. Link Nurses on Wards or Pharmacy department for centrally held stocks) must be responsible for the day to day care of the device(s) and control of environment contamination, and for the maintenance of stocks of consumables and reagents within their shelf-life.

9.3. 9.4. 9.5.

A device that fails to perform to specification must be withdrawn immediately from service until full remedial action has been completed. The SOP and SLA must state who has the responsibility and the authority to withdraw the device from service. If devices are not used or cared for appropriately the Laboratory Medicine Directorate department, POCT Co-ordinator or appropriate specialist Nurse or link Nurse will generally have the responsibility and authority to removing the device from service as specified in the SLA.

9.6. 9.7.

The Laboratory Medicine Directorate and/or POCT Co-ordinator must be informed immediately of any equipment failure. In the event of device failure or unavailability of suitably trained staff, alternative sites for the analyses should have been agreed, documented and SLA and made known to the users in the SOP. Back-up arrangements must be in place for testing in both routine and emergency situations (see also Section 5.1).

9.8.

Prior to the procurement, there must be an agreement between the device's purchaser, its users the Pathology service and the Pharmacy department for the budgetary consequences of the purchase, defined in the SLA.

9.9.

Responsibility for the ordering of reagents, consumables, servicing, training, support, quality control and quality assessment must be defined in the SLA.

9.10. 9.11.

POCT instrumentation is owned by the users who are responsible for the operating costs. Operating costs include consumables, quality control and quality assurance materials, the manufacturer's service contract, repair costs and the Laboratory Medicine Directorate support staff costs.

9.12.

The responsibility for stock control and ordering for the non-pay components of the operating costs for standard POCT equipment and recharging of the costs to users will be specified in the SLA. This will

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generally be with Pharmacy Department or Purchasing and Supplies Department. 9.13. Special arrangements will need to be made for non-standard systems. The operating costs and other aspects of the SLA must be agreed with the Laboratory Medicine Directorate before POCT equipment is commissioned. 10. 10.1. Strategy for POCT within the Trust. The major considerations for the Trust POCT Strategy will be · · · · · · · 10.2. clinical risk minimisation through implementation of the Policy. achievement of quality standards. standardisation of equipment. networking of devices to support data capture and device monitoring. integration of POCT results with the electronic patient record (EPR). Cost effectiveness. The views of patients.

For many years, the Department of Clinical Biochemistry, more recently with the involvement of Haematology, has been proactively supporting POCT standardisation in Newcastle upon Tyne Hospitals NHS Trust. Standardisation of blood glucose meters has been achieved and further standardisation has the potential to yield substantial financial savings for the Trust. Standardisation will become more important as complexity of devices and the potential for IT connectivity increase.

10.3.

Standardisation of POCT devices across the Trust has considerable advantages: · · · · · staff · opportunities for financial discounts uniform quality of service standard operator procedures simplification of training procedures appropriate analytical back-up during down-time standard maintenance, calibration and support procedures for support

10.4.

There are considerable advantages in the uniform application of the principles of this policy, including standardization, in primary care, other

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trusts and in patient self testing. Successful implementation of this policy within the Trust should lead to the future development of joint policies between this Trust and others including Newcastle Primary Care Trust. In some cases, it may be more appropriate for managed POCT to be included in contracts in place of the corresponding laboratory tests (e.g. urine pregnancy testing). 10.5. The Laboratory Medicine Directorate should be closely involved in planning POCT services for the future. Advances in technology may lead to the viability of extended POCT options and this, together with IT considerations, such as connectivity, capture and recording of data in the EPR will require informed consideration and appraisal of relative costs and benefits to the Trust. 11. Audit Standards for POCT 1. 2. 3. All POCT devices and testing sites must be registered and approved by the Trust POCT Committee. Responsibility for each point of care test is defined All POCT devices must have Standard Operating Procedure (SOP) which has been approved by the POCT committee and is subject to regular review (at least annually). 4. All users of POCT devices must be authorised to do so by satisfactory completion of approved training and certification, reviewed on an annual basis. 5. Health and Safety regulations and Infection control requirements are followed during the performance of POCT and all POCT sites must be subject to regular inspection. 6. 7. 8. All POCT users must maintain satisfactory performance in an approved quality program. Arrangements are in place to deal with poor performers. All POCT results must be recorded as specified in the appropriate SOP, to ensure that documentation is adequate for timely and accurate reporting of results and to provide material suitable for audit ("audit trail"). 9. Action on abnormal results follows an agreed protocol.

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10. A complete and up to date maintenance record "log book" is kept for each POCT device. 11. Adverse incidents associated with POCT must be reported to the POCT Committee. 12. POCT: Summary of actions and responsibilities Table 1 is a summary of the main issues which need to be addressed in the provision of POCT. The table identifies who should perform the tasks and who should be responsible for ensuring that the issue has been properly addressed.

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TABLE 1 Issue Cost benefit analysis (business case) Health & Safety Training (including record of trained staff) Standard Operating Procedures Routine Operation

Process Coordination POCT Committee POCT Committee POCT Committee POCT Committee POCT Committee

Action by Clinical Directorate / Laboratory Medicine Clinical Directorate / Laboratory Medicine Clinical Directorate / Laboratory Medicine Clinical Directorate / Laboratory Medicine Users

Responsible for action Trust Management Trust Management Trust Management Trust Management Line Manager (e.g. Ward Sister through Link Nurse) Line Manager Trust Management

Evaluated by Trust Management/ POCT Committee Trust Management Trust Management CPA(UK) Ltd. Laboratory Medicine / POCT Committee Laboratory Medicine / POCT Committee Trust Management

Recording Results Support Quality Control & EQA Budgetary arrangements

POCT Committee POCT Committee POCT Committee POCT Committee

Users Laboratory Medicine Users Clinical Directorate/ Laboratory Medicine / Pharmacy/ Supplies

Laboratory Medicine Pathology Trust Management Laboratory Medicine / POCT Committee

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REFERENCES 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. Blood glucose measurements: reliability of results produced in extra-laboratory areas. Department of Health Hazard Warning HN(Hazard) (87)13. Blood gas measurements: the need for reliability of results produced in extralaboratory areas. Department of Health Warning HN(Hazard) (89)31. Association of Clinical Biochemists. Guidelines for Implementation of Near Patient Testing. September 1993. Guidelines for implementation of Near-Patient Testing. Association of Clinical Biochemists and The Royal College of Pathologists, 1996. Near-patient testing. Statement from the Council of the Institute of Biomedical Science. 1996 Extra-laboratory use of blood glucose meters and test strips: contra-indications, training and advice to the users. Safety Notice MDA SN 9616, Medical Services Agency Adverse Incident Centre, 1996. Extra-laboratory glucose meters: an assessment of sources of error. Evaluation Report, MDD/93/25, Medical Services Directorate, 1993. Medical Devices and Equipment Management for Hospital and Community based Organisations. MDA DB 9801, January 1998. Joint Working Group on Quality Assurance. Near to Patient or Point of Care Testing Guidelines. January 1999. Management and Use of IVD Point of Care Test Devices. Medical Devices Agency. MDA DB2002(03) March 2002 Clinical Negligence Scheme for Trusts (CNST) Clinical Risk Management Standards. NHS Litigation Authority June 2002 Luton and Dunstable Hospital NHS Trust. Point of Care Testing Policy. December 2001 International Organisation for Standardisation (ISO) ISO/WD 22870 Clinical Laboratory Testing ­ Quality Management of point-of-care testing (POCT). ISO/TC 212/WG1 N73. April 2002 Leeds Teaching Hospitals. Division of Laboratory, Radiology and Pharmacy Services. Trust Point of Care testing Policy. April 2002 Leeds Teaching Hospitals. Division of Laboratory, Radiology and Pharmacy Services. Point of Care Testing Service Level Agreement . April 2002 University Hospital Birmingham NHS Trust Point of Care Testing Policy August 2002

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Appendix:

The Role of the POCT Co-ordinator

In order to be effective in providing support to clinical User Departments, as specified in the service level agreements (SLAs), the Laboratory Medicine Directorate it will be necessary for an appropriately trained Biomedical Scientist to be designated as the POCT Co-ordinator. The role of the POCT Co-ordinator will be to liase with clinical staff and support the use of POCT equipment by providing assistance with: · · · · · · · · · · · · Identifying suitable POCT equipment for evaluation Performing an evaluation Installing POCT equipment Health & Safety inspections of testing sites Writing procedures (SOPs, SLAs, Training Manuals) Training staff, training trainers Preparing worksheets, log books etc Maintenance schedules QC programs Trouble shooting Monitoring and review of procedures Competency reviews

In addition to the POCT Co-ordinator other Laboratory medicine staff may be involved in specific support tasks e.g. maintenance of specific items of equipment or trouble shooting Training of large numbers of staff may require the designation of an appropriately trained nurse to undertake specific training tasks.

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Point Of Care Testing (POCT)

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