SOUTH EASTERN TRUST. Point of Care Testing (POCT) Policy Ellie Duly, Chair POCT Committee. Approval date: Operational Date: November 2014

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1 Policy Code: SET/PtCtCare (186) 2014 SOUTH EASTERN TRUST Title: Author(s) Point of Care Testing (POCT) Policy Ellie Duly, Chair POCT Committee Ownership: Approval by: South Eastern Trust Ratified Directors as per signatory list December 2014 Approval date: Operational Next Date: Review: Version No. 3 Supercedes SET/PtCtCare (94) 2012 Links to other policies November 2014 December INTRODUCTION / PURPOSE OF POLICY 1.1 Point of Care Testing (POCT) refers to analytical tests undertaken by nonlaboratory staff outside a recognised diagnostic laboratory. These range from disposable hand-held strip readers to desktop analysers. 1.2 The Trust has an obligation to ensure that implementation of POCT conforms to current standards. The appropriate use of POCT as an alternative to central laboratory testing should be considered as a clinical governance issue and therefore be subject to examination of clinical effectiveness. Where possible, analytical investigations should be performed in clinical laboratories or other suitable environments by suitably trained and registered laboratory staff. Before deciding whether to implement POCT it is essential for potential users to establish a clinical need, including an examination as to whether reconfiguration of a central laboratory service would be a viable option. The clinical need should be evidence based, clearly identifying the risks and benefits of introducing a POCT service. 2.0 DEFINITIONS/SCOPE OF THE POLICY 2.1 To ensure the appropriate use of POCT systems, that the principles of best practice are followed and that demonstrable standards of testing are maintained. 2.2 The policy is applicable to all South Eastern Health and Social Care Trust staff, (excluding Down and Lisburn area which is managed by the Belfast trust,) who are involved with managing, procuring, training, performing tests or interpreting results produced by POCT systems. It also applies to POCT systems that are given to patients by Trust staff. Page 1 of 16

2 3.0 ROLES/RESPONSIBILITIES 3.1 Corporate Responsibility The Chief Executive is part of the Trust Executive Management Team. On behalf of the Trust Board, he carries overall responsibility for Risk Management, including the effective use of POCT systems within the Trust. Figure 1: Relationships of the POCT Committee within the SEHSCT 3.2 The Laboratory The Laboratory Director will appoint a multidisciplinary POCT Committee to Advise on the provision of POCT. The Laboratory Director will appoint a POCT Manager who, along with the Laboratory POCT Co-ordinators, and with assistance from the Laboratory Quality Co-ordinator and Quality Officers, will ensure that standards for POCT are maintained according to Trust POCT policy and Health and Safety Policies POCT aims to comply with the Standards for the Medical Laboratory and Additional Standards for POCT Facilities set by CPA (UK) Ltd, as well as ISO 22870: Point-of-care testing (POCT) Requirements for quality and competence. The details of the quality management system for POCT is documented in the POCT Quality Manual [POCT MAN-3]. 3.3 The POCT committee The POCT committee is responsible to the Chief Executive, through the Women & Acute Child Health Governance Meeting, which has ultimate responsibility for defining the scope of POCT, taking into consideration the clinical need for POCT, its financial implications, technical feasibility, and in ensuring that appropriate measures are in place to monitor the accuracy and quality of POCT and the ability of the organisation to fulfil the needs and requirements of the user. Page 2 of 16

3 3.3.2 The POCT committee will assist in evaluating, selecting and implementing POCT devices and systems both at Trust and Regional level. Performance criteria for POCT systems will include consideration of accuracy, correlation with laboratory method, precision, detection limits, interferences and practicability. The POCT committee is responsible for implementing the terms of reference listed in Appendix 1 and the Chair of the POCT committee will provide a quarterly report for discussion at the Women and Acute Child Health Governance Meeting. Minutes are stored in Q pulse The committee holds an annual management review. POCT MAN Service Managers 3.5 Staff Service managers have responsibility for the management of POCT devices within the specific area of their remit and control and for ensuring that this policy is fully implemented as part of the Trusts governance arrangements. They must ensure staff are competent and that all incidents involving medical devices are reported via the Trust Incident Reporting system, and also to the POCT Co-ordinators. Copies of risk assessments for the devices are held by the managers It is the responsibility of Trust staff to ensure that: They only use POCT systems if they have received appropriate training, as defined by the Laboratory POCT Manager/ Co-ordinators and that they are competent and authorised to do so. They follow procedures and protocols regarding the use and management of POCT systems. They report any defects, faults or near misses that involve POCT systems immediately and inform their line manger which may result in instrument being taken out of use. Such Incidents must be reported by the line manager via the Trust incident reporting system, and also to the POCT co-ordinators. Personal operator identification numbers/barcodes are only to be used by the individual to whom they are issued, who are then responsible for the result. Sharing of barcodes is not permissible and may be subject to disciplinary proceedings. Loss of personal operator identification numbers must be reported immediately to the laboratory POCT co- coordinators. Results from POCT devices are transmitted electronically or written in patient notes. 4.0 KEY POLICY PRINCIPLES An effective quality management system must be set up to ensure that POCT is carried out according to applicable National and International guidelines 1-11,23,24, including Clinical Pathology Accreditation (UK) Ltd (CPA) standards and additional Page 3 of 16

4 standards for POCT testing 12, as well as ISO 22870: Point-of-care testing (POCT) Requirements for quality and competence and Health & Safety policies The Trust management of POCT should be assessed as part of the Pathology accreditation process as carried out by CPA (UK) Ltd and UKAS. 4.2 The details of the quality management system will be recorded in the POCT Quality manual [POCT MAN-3]. 4.3 The Trust POCT service should be clinically and professionally lead by a senior member of laboratory staff. 4.4 A multidisciplinary POCT Committee must be formed within the Trust. The Trust POCT Committee should consist of the representatives from the laboratory and from other stakeholders for the use of POCT. The committee should appoint a Chairperson; ideally this should be the laboratory POCT clinical lead. The POCT Committee should be positioned within the Trust s management structure and report as such. A representative of the Trust s committee should attend and report to the Regional POCT committee meetings and to the Northern Ireland Pathology Network via the Regional Chair of POCT. A POCT Manager and Co-ordinators should be identified within the Trust to provide specialist knowledge and advice to the POCT Committee and users of POCT devices. This manager should have the authority to regulate and oversee the POCT quality management system. 4.5 Regular audit of POCT must form an integral part of any quality management system. 4.6 Trust specific POCT procedures, based upon those described above, should be commissioned and approved by the Trust s POCT Manager. 4.7 All requests for POCT equipment must be submitted to the POCT committee for approval with details of clinical need and assessment of outcomes including costs on the Proposal for New or Replacement Point of Care Testing Applications in the South Eastern Health & Social Care Trust Form (Appendix 2). The POCT committee should decide on the appropriateness of any request, the reliability and robustness of the equipment available, the interfacing requirements, the riskbenefit and cost-benefit analyses, quality assessment and compliance with Trust policies including infection control and COSHH 17. Advice should be sought from the Trust s Infection Control Team and POCT departmental leads. The approval process, as detailed in the Medical Devices & Equipment Procurement Form (Appendix 3), must be followed. POCT devices must be procured according to the Trust s standing financial Instructions in the Medical Devices Policy. 4.8 POCT must not be considered where a laboratory can provide a result in a timely manner appropriate to clinical need. 4.9 All POCT devices adopted must: Be evaluated and procured in collaboration with Trust POCT committee and the POCT manager to ensure satisfactory standards of performance and safety. Conform to the requirements of the In Vitro Diagnostics Directive 18. Align with laboratory-based methods, where possible and practical, in current practice in the Trust. Page 4 of 16

5 Where possible have connectivity to appropriate specification to allow central management of POCT devices and documentation of results. Be used in accordance with manufacturer s or suppliers instructions. Be registered by serial number and decommissioned following laboratory guidelines Be subject to regular maintenance as specified by the supplying manufacturer. Have details of maintenance performed, faults and corrective action taken, documented. Only be used for the purpose for which it has been evaluated All POCT must be enrolled in an External Quality Assurance scheme (if available), or, if this is impractical, arrangements for parallel testing with the local laboratory should be considered. Internal Quality Control must be performed according to the test specific Standard Operating Procedure (SOP) Where possible and practical electronic devices rather than devices requiring a subjective visual read by the user should be used (it is recommended that where such visual read devices are in use, the results are checked by at least two trained members of staff) Where possible IT Connectivity should be made available and resourced to appropriate specification to allow central management of POCT devices and documentation of results in accordance with robust quality management. The Trust has recently procured Conworx IT system 4.13 If a device or part of a device is an ICT asset, or relies on ICT infrastructure, it should be procured in line with ICT procurement guidelines. It should adhere to minimum technical requirements as appropriate, particularly with regards to patching/antivirus/wireless specification, and meet relevant security requirements in accordance with all local, regional and other applicable policies Device specific Standard Operating Procedures (SOPs) must be developed by laboratory staff, and made available to all POCT users Only trained, certified and competent staff should use POCT equipment. Where possible such equipment should be password-protected and only accessible to trained/certified users. Passwords are unique to each trained operator, and must not be used by any other member of staff All patient and quality control testing results must be recorded. Patient results must be recorded in such detail as to allow unequivocal patient identification, the result, date and time of analysis and the name of the analyst. This record must be in addition to records made in the patient notes, and where available should be electronic. Such records should be kept according to guidelines issued by the RCPath All reagent/cartridge/consumable lot numbers must be recorded to facilitate patient tracking in the event of product recall All adverse events relating to POCT must be reported back to the POCT Committee through the IR1 system, which must have the authority to withdraw or suspend service in the event of a safety-related or performance issue or lack of Page 5 of 16

6 clinical or cost effectiveness. The committee should report any such issues to the Regional POCT Committee and NIAIC All staff who recommend the use of POCT systems or devices for use by patients must ensure that the devices have been approved by the Trust POCT committee or by the NI Regional POCT committee. 5.0 IMPLEMENTATION OF POLICY 5.1 Dissemination This policy has relevance to a wide group of staff including Medical, Nursing, Auxiliary Healthcare assistants, ambulance, Laboratory, Pharmacy, Procurement and Infection Control. It is the responsibility of managers and supervisors to ensure that this policy has been brought to the attention of all relevant staff who are then responsible for complying with its contents. 5.2 Resources POCT Co- ordinators will assist the commercial companies in ensuring staff are trained. Service managers or their delegated staff must ensure competencies are assessed and maintained. Up-to-date SOPs provided by POCT co- coordinators will be available to all staff via iconnect (Hospital Services Laboratories POCT Useful Documents). These should include all aspects of testing including quality control. 5.3 Exceptions All POCT devices in the Trust, excluding Downe and Lisburn area, are subject to the policy. 6.0 MONITORING Regular audits of POCT devices are a vital part of the POCT Quality Management System. The audits will be carried out in order to ensure processes are being carried out in line with operating procedures and that the procedures meet national requirements/standards (CPA/UKAS). 7.0 EVIDENCE BASE / REFERENCES 1. Point of Care Testing (Near Patient Testing) Guidance on the Involvement of the Clinical Laboratory, Institute of Biomedical Science, Device Bulletin DB2010 (02) Management and Use of IVD Point of Care Test Devices, February MHRA 3. Guidelines for point-of-care testing: Haematology. British Journal of Haematology 2008; 142: Guidelines on point-of-care testing. Royal College of Pathologists Code of practice for clinical biochemists/chemical pathologists POCT March Guidelines for Safe and Effective Management and Use of Point of Care Testing. Academy of Medical Laboratory Science, Association of Clinical Page 6 of 16

7 Biochemists in Ireland, Irish Medicines Board and RCPI Faculty of Pathology. November, Price CP, St John A, Hicks JM. Point of Care Testing, Washington, DC: AACC Press, 2nd edition BS EN ISO 22870:2006 Point of Care Testing Requirements for Quality and Competence. 8. BS EN ISO 15189:2007 Medical laboratories Particular requirements for quality and competence. 9. Depart Department of Health (1999) Clinical Governance: in the New NHS. Department of Health (Health Service Circular: HSC (99) 065), London. 10. Clinical Governance of NHS Staff in Single-Handed Practice with Particular Reference to Point-of-Care Testing. The Royal College of Pathologists, Health Professions Order 2001 Consolidated text incorporating repeals and amendments made up to 1st July Available from Clinical Pathology Accreditation (UK) Ltd (Version 2.02 Nov 2010) Standards for the Medical Laboratory. CPA Ltd, Sheffield, UK., Additional standards for Point of Care testing (POCT) (Version 1.01 Nov 2010) 13. Health and Safety at Work Order Department of Health Advisory Committee on Dangerous Pathogens (2003) Infection at work controlling the risk. Department of Health, London. 15. Biological Agents: Managing the risks in laboratories and healthcare premises. HSE / ACDP Health Services Advisory Committee (2003) Safe working and the prevention of infection in clinical laboratories and similar facilities. Health and Safety Executive, ISBN HSE Books, Sudbury. 17. Health and Safety Executive, Control of Substances Hazardous to Health (COSHH) 2002 (as amended ) Fifth edition ) 2005 Approved Code of practice and Guidance 18. In-vitro Diagnostics Medical Devices Directive 98/79/EC. 19. Royal College of Pathologists and Institute of Biomedical Science. The Retention and Storage of Pathological Records and Archives, 4 th Edition (2009). 20. SEHSCT Medical Devices Policy 21. SEHSCT Operation Guidelines for Management of Medical Devices 22. SEHSCT ICT Security Policy 23. Point of Care Testing Cholesterol Testing. Medicines and Healthcare products Regulatory Agency, Top 10 Tips. Medicines and Healthcare products Regulatory Agency, CONSULTATION PROCESS SEHSCT POCT committee 9.0 APPENDICES / ATTACHMENTS Appendix 1: Terms of Reference and Membership Appendix 2: Proposal for New or Replacement Point of Care Testing Applications in the South Eastern Health & Social Care Trust Appendix 3: Medical Devices & Equipment Procurement (MD1) Page 7 of 16

8 10.0 EQUALITY STATEMENT In line with duties under the equality legislation (Section 75 of the Northern Ireland Act 1998), Targeting Social Need Initiative, Disability discrimination and the Human Rights Act 1998, an initial screening exercise to ascertain if this policy should be subject to a full impact assessment has been carried out. The outcome of the Equality screening for this policy is: Major impact: Minor impact: No impact: X SIGNATORIES Page 8 of 16

9 Appendix 1: Terms of Reference and Membership Name: Point of Care Testing (POCT) Committee Purpose: The purpose of the committee is to develop and promote patient safety and risk management strategies in the South Eastern Health and Social Care Trust for the safe, effective and efficient utilisation of POCT devices including those given by staff to patients. The Committee is to identify any potential risks or problems associated with POCT devices and ensure risk management is implemented and monitored Roles and responsibilities: This committee shall: Ensure that the responsibilities and authorities necessary for quality management of POCT as defined by CPA (UK) Ltd. and/or UKAS are defined and communicated within the Trust. Assist in evaluating and selecting POCT equipment and systems, using defined healthcare and patient outcomes, consistent with the Regional Policy for POCT Testing in Northern Ireland, the Medical Devices Agency Device Bulletin (MDA DB2002(03)), and the Joint Working Group on Quality Assurance guidelines. Evaluate and approve end-user POCT proposals for the installation of POCT systems. Ensure that appropriate systems are in place for: o Monitoring the training, certification and re-certification of POCT system operators o Maintenance of equipment and supply of consumables and reagents o Appropriate quality assurance and record keeping o Monitoring, review and audit o Security from unauthorised or inappropriate use of POCT devices Provide input for the identification of POCT improvement opportunities, including equipment upgrades and replacement, connectivity options and documentation requirements. Advise changes to POCT policies, processes and procedures when appropriate. Advice on corrective actions required for incidents and alerts relating to the use of POCT systems, as appropriate. Report quarterly to the Women and Acute Child Health Governance meetings on any POCT related governance issues Hold an annual management review of POCT services Membership: This committee shall consist of representatives of the stakeholders for the use of POCT systems. This will include representatives from the laboratory; including POCT Coordinators, laboratory management including quality management; pharmacy, ambulance, IT, risk governance, nursing, infection control, procurement, finance, Medical Technology,, clinicians. Additional members may be co- opted where appropriate. Meetings will be chaired by the laboratory POCT Manager. Meetings will be considered quorate if there are 50% members present. Document approval can take place virtually via . Frequency of meetings: The POCT committee will meet quarterly (minimum 3 meetings per year). Accountability: Page 9 of 16

10 The Chair of the committee will report to the Laboratory Operational Committee, which reports via the Directorate of Women and Acute Child Health to the senior management of the Trust. The committee reports quarterly to the Women and Acute Child Health Governance meetings on any POCT related governance issues Communication: The POCT committee will circulate minutes of its meetings as soon as possible after meetings to the committee membership. Reports will be to laboratory management for the annual management review. The Chair of the committee and POCT Co-ordinators will attend The NI regional POCT committee. Page 10 of 16

11 Appendix 2: Proposal for New or Replacement Point of Care Testing Applications in the South Eastern Health & Social Care Trust PROPOSAL FOR NEW OR REPLACEMENT POINT OF CARE TESTING APPLICATIONS IN THE SOUTH EASTERN HEALTH & SOCIAL CARE TRUST Introduction The South Eastern Health & Social Care Trust (SET) policy for Point of Care Testing (POCT) describes the principles of how the Trust will discharge its responsibilities with regard to the governance of POCT. One important aspect of this is the role of the POCT committee in assessing new and existing POCT applications within the Trust. Scope and Purpose This checklist is intended to prompt consideration of the various elements required for a new or replacement POCT application in order that the POCT committee can assess compliance with Trust policy and relevant guidelines. The information supplied should be supported if possible by additional literature from peer reviewed publications and suppliers. It is recommended that the SET POCT policy and referenced POCT guidelines are reviewed and appropriate Laboratory specialists consulted in completing this pro forma. 1. BASELINE INFORMATION Proposed Location of Testing: Clinical Speciality: Analyte(s) or Test(s) Proposed Purpose of Test Diagnosis, screening, monitoring (disease or treatment) Specimen Requirements (circle): Whole blood Serum Plasma Urine Other: Patient Groups to which POCT would be Applicable: Estimated Test Numbers: Daily: Weekly: Describe briefly the current limitations of the conventional laboratory service for the proposed testing: Confirm that the relevant Laboratory discipline is unable to meet clinical or operational requirements for the proposed testing: 2. OBJECTIVES Summarise the main objectives for the POCT service and how it will impact on patient care: Turnaround time of current test: 3. TESTING (Indicate how the following task will be addressed) Testing: Training: Competency Testing: Maintenance: Page 11 of 16

12 Reagent storage Risk Assessment: Adverse Incident Reporting: Control of Infection: Quality Assurance: Audit: Record Keeping, including competencies: Troubleshooting: 4. ACCOMMODATION Candidate Instrument: Operator Space Required: Storage Space for Device(s), Consumables and Reagents: Services Required (i.e. power, water, refrigeration, etc.): Health & Safety / Control of Infection Issues: 5. COSTS (Approximate) Has recurrent funding been identified? Initial Purchase Cost: Consumables Cost: IT & Other Installation Costs: Internal Quality Control Costs: External Quality Assurance Costs: Audit Costs: Maintenance/Service Contract: Waste Disposal Costs: Laboratory Costs: Pharmacy Costs: Portable: Yes / No If No, i.e. Static (give footprint): Will Pharmacy store reagents? Yes / No If Yes, please give source: Signed Consultant Date Assistant director Date Page 12 of 16

13 Appendix 3: Medical Devices & Equipment Procurement (MD1) Medical Devices & Equipment Procurement MD1 Request for purchase 1) Location Directorate Department Contact name to be Used by purchasing 2) Equipment Description of equipment Estimated cost of equipment 3) Finance Funding method Capital/E&G put in full then abbreviate/ other Procurement complies with Standing financial instructions 4) Procurement method Standardisation Fast Track < 2,000 Procurement Group > 2,000 Pre purchase check list has been completed and is attached No Yes If no why Approved by Assistant Director Signature Page 13 of 16

14 Date Requisition Number Pre purchase checklist Consideration has been given to Trust standardisation and staff training Discussion has taken place with estates regarding accommodation of equipment Consideration has been given to the full life cost of equipment E.g. Service costs, maintenance, consumables Consideration has been given to type or method of decontamination MD1 Is a formal maintenance contract required? If after sales service is needed has due regard been given to who will carry this out? Is the equipment part of a wider project that has cost implications, if so have these been taken into account? E.g. Building, flooring, engineering works Yes No N/A If POCT Device has approval been obtained from Trust? Yes No N/A POCT committee Checklist completed by Name Designation Signature Date Page 14 of 16

15 For supplies use only Requisition Number Order Number Date Post Purchase check list MD1 Equipment has been delivered intact Yes No Commissioning has been carried out i.e. installation, safety checks Has a WIMS Asset form has been completed to generate an ID number and trigger a service contract at end of warranty Staff training has been commenced or put in place Operator /instruction manuals have been received Has a capital asset form been completed? If replacement has service contract on previous equipment been cancelled? Checklist completed by Name Designation Signature Date Requisition Number Order Number * This form is to be attached to the blue buying order Page 15 of 16

16 Customer Care Where page 3 of MD1 is attached to blue receipt copy of order, completion and sign off is required before goods are receipted. Confirmed by Name Designation Signature Date Page 16 of 16