POINT OF CARE TESTING (POCT) GUIDELINES
These Guidelines underpin section 3.14: POCT in the Medical Devices Policy
1. INTRODUCTION/PURPOSE OF THE GUIDELINES
1.1 Definition of Point of Care testing
1.1.1 Point of care Testing (POCT) is defined as any analytical test performed for a patient by a healthcare professional outside the conventional Pathology laboratory setting and is a valuable procedure used in patient care.
Examples of POCT include: -
o Blood glucose monitoring
o Blood gas/ co-oximetry analysis
o Electrolyte analysis
o Blood coagulation measurement
o Blood HbA1c analysis
o Urine analysis
o Rapid tests for infectious disease markers
o Pregnancy testing
1.1.2 POCT is now an established part of clinical practice. However it is important that it is viewed as part of an integrated activity in which the objective is caring for the patient in the best clinical and most cost-effective way.
The main strengths and weaknesses of POCT are summarised as follows: -
Strengths / WeaknessesImproved turnaround time allowing
rapid therapeutic intervention
informed counselling for therapeutic management
Smaller sample volumes reducing iatrogenic blood loss
Economic benefits associated with reduced length of stay in hospital
Possibility for reduced sample transport costs. / Duplication of testing and equipment
Cost-per-test invariably greater than equivalent laboratory tests
Incompatibility with laboratory results leading to clinical confusion
Tests performed by staff with a non-analytical background – leads to increased risk of adverse incidents
May encourage inappropriate testing
These strengths and weaknesses must be carefully considered when addressing whether POCT should be implemented and in reviewing situations in which POCT has grown in an unregulated and uncontrolled manner.
1.2 GUIDELINES FOR POCT
1.2.1 In 1999, the Joint Working Group on Quality Assurance (JWG) published guidelines highlighting that POCT is a Clinical Governance issue and emphasising the central role that Pathology must have in the implementation and management of POCT.
1.2.2 The MDA Device Bulletin (2002), Management and Use of IVD Point of Care Test Devices are consistent with and based on the JWG Guidelines. It provides definitive guidance on all issues relevant to implementation and management of POCT.
1.2.3 These above guidelines are used as standards for POCT by Clinical Pathology Accreditation UK Ltd that is an independent body that assesses the standard of Pathology services, including POCT.
1.2.4 The European In Vitro Diagnostic Medical Devices Directive 18 regulates most of the equipment used for POCT. The Directive, which came fully into force on 7th December 2003, aims to ensure that; devices will not compromise the health and safety of patients and users; devices are designed and manufactured to achieve the performance specified by the manufacturer for the stated medical purpose. Devices that meet the relevant essential requirements of the Directive will carry a CE mark to denote compliance.
1.3 Aim of the Guidelines
1.3.1There is a requirement to ensure that all POCT equipment used within the Trust: -
o Is suitable for its intended purpose
o Meets safety and quality assurance standards
o Can be supported adequately
o Is operated only by appropriately trained staff
1.3.2 This requirement can only be met by Trust-wide Guidelines on POCT based on the JWG and MDA guidelines which will ensure consistent procedures are in place throughout the Trust. These Guidelines will facilitate adherence to the principles of Clinical Governance by defining responsibility and procedures for:
o Training, certification and proficiency testing of POCT operators
o Standardisation of equipment where practical thereby facilitating use, training and maintenance
o Effective risk management
o Compliance with Health and Safety legislation and infection control measures
1.3.3 If not used appropriately there is a risk that patients may be put at risk from inappropriate testing or wrong results. Therefore for the successful use of POCT devices it is essential that the purchase, implementation and quality assurance assessment be carried out appropriately.
1.3.4 The appropriate use of these tests should be considered as a Clinical Governance issue and subject to examination of clinical effectiveness.
1.3.5 To achieve the best possible results from POCT devices it is essential that there is the closest possible liaison with the Pathology services relating to all aspects of such tests.
To ensure reliable performance and manage the risks associated with point of care testing, the Pathology laboratory must have a central role in management of these devices.
o On-going quality control, quality assurance and auditing of POCT
o Negotiation of cost effective bulk discounts with suppliers of equipment and consumables
o Networked IT support to facilitate audit trails and faster troubleshooting.
2. APPLICATION: TO WHOM THESE GUIDELINES APPLY
These guidelines apply to all those working in the Trust, in whatever capacity. A failure to follow the requirements of this procedure may result in investigation and management action being as considered appropriate. This may include formal action in line with the Trust’s disciplinary or capability procedures for Trust employees; and other action in relation to other workers, which may result in the termination of an assignment, placement, secondment or honorary agreement.
3. SUMMARY OF THE GUIDELINES
These guidelines are set out to ensure complete quality assurance with regards to all issues surrounding Point of Care Testing.
Roles and responsibilities are set out and lines of accountability are clearly defined.
4. THE GUIDELINES
4.1 Trust POCT Committee
4.1.1 The Trust POCT Committee is a sub committee of the Medical Devices Committee and will oversee POCT across the Trust to ensure that POCT is appropriate and accreditable. It is chaired by the Consultant Chemical Pathologist with responsibility for POCT and has a wide membership to ensure all relevant expertise is incorporated, as follows:
o Trust POCT Co-ordinators
o Trust Risk Management
o Pathology Laboratory Management
o Diabetes Nurse Specialists
o Medical Representatives (Consultant Physician)
° Nursing Representatives (Medicine and Critical Care)
o Pharmacy/Supplies Representative
o Medical Engineering and Maintenance
4.1.2 The Committee will co-opt additional members where appropriate as the practice of POCT expands e.g. Primary Care Representative
4.1.3 The Committee will co-opt representatives from additional fields on a temporary basis to ensure that there can be an informed discussion on agenda items. This will particularly apply to Infection Control and Medical Audit representatives.
4.1.4 The Committee shall ensure that POCT Devices are implemented and used appropriately. The POCT committee will report to the Medical Devices Group, which itself reports to the Clinical Governance committee. These report to the Trust Board.
4.1.5 The MDA Notices and the Joint Working Group on Quality Assurance emphasise the central role that Pathology has in ensuring that POCT Devices are used appropriately. This subcommittee reflects that recommendation.
4.1.6 No POCT Devices should be used within the Trust unless approval has been obtained from the POCT Committee.
4.1.6 The POCT committee will have responsibility for: -
o considering the case for introduction of POCT in a particular location prior to procurement.
o determining budgetary responsibility for individual POCT services.
o ensuring compatibility between instrumentation (POCT and laboratory) in use Trust-wide.
o establishing the presence of a link nurse at ward level.
o ratifying Standard Operating Procedures (SOPs), Service Level Agreements (SLAs), Risk Assessments and COSHH assessments.
o ascertaining the complexity of a device and therefore grades of staff that would be authorised to use that device following training.
o internal quality control material and participation in external quality assessment scheme
o accreditation scheme compliance e.g. CPA (UK) Ltd
o consumables
o record keeping e.g. data handling system
o cleaning and waste disposal
4.2 Cost Benefit Analysis and Procurement.
4.2.1 All POCT devices are subject to the criteria described in this document irrespective of whether the equipment has been purchased (including from endowment funds), hired, loaned or received as a donation
4.2.2 Proposals to introduce POCT must be supported by a Cost Benefit Analysis, which includes a clear definition of the problem that a POCT device would solve so that a full examination of all possible solutions can be made.
4.2.3 The Pathology Department will, in conjunction with the requesting clinical department, be responsible for the production of the Cost Benefit Analysis, which will be presented to the POCT committee for evaluation and approval before submission to the Trust for financial support.
4.2.4The Cost Benefit Analysis must detail all the financial consequences to Pathology and the proposed POCT site. These will include capital and revenue costs associated with the equipment itself and all staffing resources required by both the laboratory and the clinical area to provide the service. These costs can be further broken down as follows:
o initial purchase of equipment and accessories.
o provision of a safe environment e.g. health and safety improvements
o site alterations to accommodate POCT
o interfacing with information management systems
o staff time (clinical and laboratory) required for patient analysis, support, training, quality assurance and audit.
o routine and preventative maintenance e.g. external service contracts with manufacturers
o internal quality control material and participation in external quality assessment scheme
o accreditation scheme compliance e.g. CPA (UK) Ltd
o consumables
o record keeping e.g. data handling system
o cleaning and waste disposal
4.2.5 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. The Pathology Department will address issues of compatibility and be responsible for producing a shortlist of potential suppliers.
4.2.6 The Pathology laboratory will evaluate the technical quality of the equipment and any interfacing requirements. Short-listed suppliers will be invited to submit their equipment for demonstration and/or trial.
4.2.7 When funding has been identified, an operational specification will be drawn up jointly by Pathology and the clinical users and companies will be invited to tender. The final selection will be made by a panel composed of representatives from Pathology and the clinical unit and will be ratified by the POCT committee.
o ensuring that all users are trained and certified in the use of POCT devices.
o ensuring that internal quality control (IQC) and external quality assessment (EQA) schemes are employed effectively.
o ensuring that all POCT services within the Trust are assessed for CPA Accreditation in conjunction with the relevant Pathology Department,
o monitoring and recording all adverse incidents involving POCT devices.
4.3 Risk management
4.3.1 It is essential that training and support from the Pathology departments and the POCT Committee properly manage the risks associated with the use and interpretation of results obtained. No POCT devices are totally fail-safe.
4.3.2 In accordance with current guidelines, POCT devices with network connectivity are the preferred option. Instruments that can be connected directly to the Point of Care Connectivity system allow transfer of data directly to the laboratory computer, ensuring accountability and a complete audit trail. It is for this reason if a connectivity version is available this is what must be purchased.
4.3.3 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. The Pathology Department will address issues of compatibility and be responsible for producing a shortlist of potential suppliers. The Pathology laboratory will evaluate the technical quality of the equipment and any interfacing requirements. Short-listed suppliers will be invited to submit their equipment for demonstration and/or trial.
4.3.4 When funding has been identified, an operational specification will be drawn up jointly by Pathology and the clinical users and companies will be invited to tender. The final selection will be made by a panel composed of representatives from Pathology and the clinical unit and will be ratified by the POCT committee.
4.3.5 Lines of accountability should be clearly written into local policies and procedures. (see appendix A)
4.4 Health & Safety
4.4.1 Managers of the Clinical service involved together with the Pathology service 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 (COSHH) 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.
4.4.2 There should be close liaison between the Safety Officers responsible for the testing site and Pathology.
4.4.3 A Decontamination certificate (see Trust Policy), providing evidence of appropriate decontamination, must be issued before servicing or repair of equipment.
4.4.4 The Infection Control Physician/Medical Microbiologist must be involved in decisions on placement and maintenance of equipment.
4.4.5 The manufacturer prior to installation must provide a Master Indemnity Agreement.
4.5 Budgetary Management and Stock Control
4.5.1 The designated budget holder for each particular POCT service will be ultimately responsible for managing the budget.
4.5.2 The clinical department will, jointly with Pathology, agree necessary measures to resolve budgetary problems.
4.5.3 The clinical department will ensure that there is a rotation system in operation and that all reagents are within their shelf life.
4.6 Maintenance
4.6.1 It is mandatory that all POCT devices must be regularly maintained. The POCT Co-ordinator will be responsible for overseeing the maintenance of all such devices and the POCT Co-ordinator will be responsible for training designated operators as necessary. Responsibility of the ward and the laboratory for carrying out maintenance procedures will be outlined in the SOP for each device.
4.6.2 The manufacturers’ engineers according to the company service schedule will perform Service visits. The POCT Co-ordinator will determine responsibility and procedures for liasing with the manufacturer regarding all equipment problems and failures.
4.6.3 Each device must have a “Device Record Book” or logbook in paper or electronic form in which maintenance records, faults, corrective actions and repairs by named individuals are documented. These records are the management responsibility of the Pathology laboratory and must be accessible for inspection at all times.