Introduction

Point of care testing (POCT) is defined as medical diagnostic testing at or near the point of care. This differs from medical laboratory testing, which entails sending specimens away from the point of care and then waiting hours or days to learn the results, during which time care must continue without the desired information.  Many devices are now available to carry out testing at the actual 'point of care' thus, avoiding delays in diagnosis. These range from simple battery operated strip devices, to more complex bench-top devices.

Point of care diagnostics can integrate biochemical testing alongside physiologic measurements. Blood Analysis can be carried out by the patient's bedside very quickly, and using low blood sample amounts. POCT may deliver results for blood gases, electrolytes, chemistries, haematocrit, and other calculated parameters used to test human samples to assist clinical diagnosis or decisions concerning clinical management.

There are advantages with POCT when compared with conventional laboratory testing. For example, results are available more quickly as time is not lost by transporting samples to the laboratory. This can be vital when managing critically ill patients. Also, in some settings, particular POCT results can be used to adjust patient’s medication resulting in the convenience of less frequent clinic appointments.

Disadvantages with POCT compared with conventional laboratory testing such as the cost per test being more expensive for POCT. Therefore, any new POCT service must provide significant patient benefits to ensure resources are used appropriately. The quality of results can also be affected by inadequate training or inappropriate use of devices and failure to carry out with recommended quality control procedures and inadequate servicing and checking of equipment where indicated.

Purpose

The purpose of this policy is to provide standardised management of POCT devices and procedures throughout the organisation, as recommended by the Medicines & Healthcare products Regulatory Agency (MHRA) thereby providing a cost efficient and clinically effective analytical service. This policy should be read in conjunction with the organisation’s Medical Devices Policy. Each Standard Operating Procedure (SOP) specific to POCT must be read in conjunction with this policy prior to use.

Duties and Responsibilities

The Chief Executive

The Chief Executive has overall responsibility for the implementation of all measures needed to ensure safe working with POCT devices. These duties are delegated through the Chief Executive to Clinical and Service Directors for their areas of responsibility.

The Director of Clinical Governance

The Director Clinical of Governance and the Medical Devices Management Group are responsible for the monitoring of all medical devices, risk assessments relating to medical devices and will also highlight areas where equipment may need reviewing. They must ensure adequate arrangements are implemented to ensure the safe management of all medical devices e.g. procurement, maintenance, disposal etc. The POCT lead is responsible for reporting to / attending the Medical Devices Group meetings. The Medical Devices Assurance Manager is designated as the Medical Devices Safety Officer (A designated position recommended by the Medicines and Healthcare products Regulatory Agency - MHRA)

Point of Care Testing Lead and Medical Devices Group

The POCT Lead is the Senior Nurse for Clinical Practice. The Medical Devices Management Group is responsible for considering the clinical equipment needs for all POCT services along with their benefits and disadvantages to patients and the organisation, and standardising POCT devices and Internal Quality Control (ICQ) and External Quality Assessment (EQA) procedures.

The systems and processes for monitoring and improving services for POCT will be considered through the Lead for Point of Care Testing. All incident reports relating to POCT devices and or procedures will be discussed through the Medical Devices Management Group (MDG). Where necessary, POCT adverse events will be reported to the MHRA where applicable, by the Lead for Point of Care Testing.

The Local pathology laboratories can play a key role in the development and management of POCT services, providing advice on a range of issues including purchasing of devices, quality control, training, interpretation of results, troubleshooting, quality assessment and health and safety. Line Managers should be aware of their responsibility for clinical governance and of the medical-legal implications of an erroneous result. Liability under the Consumer Protection Act (1987) will only remain with the manufacture or supplier if the user can demonstrate that the equipment has been used in strict accordance with the manufactures instructions.

All staff using POCT devices/systems have a responsibility to ensure they have received appropriate training and competency assessment specific to the POCT device/system being used. The user must also ensure they have received continual support and update where necessary. The Training Department are responsible for monitoring of mandatory Medical Devices training, and training rates are monitored through the Medical Devices Management Group.

It is important to:

• Ensure that manufacturers have the correct contact details for users of the device. Users should automatically be sent copies of revised instructions.
• Check with the manufacturer that revised instructions are appropriate to the products in service – there may have been software upgrades or changes.
• Have a procedure for keeping track of all the sets of instructions in use, and for replacing them with revised versions when necessary.
• Ensure that all instructions deemed necessary by the manufacturer are provided in written form by the manufacturer using a formalised mechanism.

Explanations of Terms Used

The MHRA (2010) definition of POCT as “any analytical test performed for a patient by healthcare professionals outside the conventional laboratory setting. This may comprise of; non instrumental systems that are disposable systems or devices that vary from reagent test strips for single analyte to sophisticated multi-analyte reagent strips; small analysers usually hand or palm held devices such as blood glucose meters; and desktop analysers which are larger and include systems designed for use in clinics or small laboratory”.

Quality Assurance (QA) – includes all the measures taken to ensure that investigations are reliable. It also incorporates Internal Quality Control (IQC) and External Quality Assessment (EQA).

Internal Quality Control (IQC) – is a means of checking that patient results are reliable before they are issued. The analysis of an appropriate control material or result, before analysing a set of specimens to provide reassurance that systems are working correctly.

External Quality Assessment (EQA) – involves analysis of samples with unknown values from an external source or provider. Results are subject to peer group assessment and statistical analysis to compare results across different sites.

Standard Operating Procedures (SOP) - SOPs are in place for all specified POCT tests performed throughout the organisation. The purpose of a SOP is to carry out the operations correctly and consistently. A SOP is a compulsory instruction.

Point of Care Testing (POCT)

POCT users

POCT may be undertaken by diagnostic laboratory personnel, by non-laboratory trained health care practitioners and by lay individuals, for personal or commercial purposes. The user may be a person responsible for the care of a patient or otherwise acting on the carer’s behalf.

External Quality Assurance

The organisation must have a contract in place with all EQA providers which includes responsibility for the appointed laboratory in the management and process of the EQA service.

Consent

Prior to undertaking any Point of care testing on a patient, health care practitioners must ensure the patient is able to understand the information given to them and are able to give their informed consent. This may necessitate the use of a professional interpreter and the translation of written information (Interpreting and Translation Policy). A capacity assessment should be considered for those patients who are unable to consent to the procedure and reference should be made to the Consent and Capacity to Consent to Examination and Treatment Policy.

Standard Operating Procedure (SOP)

It is the responsibility of Line Managers to ensure staff using POCT devices follow the specific SOP which has been written to the standard of Clinical Pathology Accreditation (UK) (Royal College of Pathologists, 2004) is in place for each POCT device and procedure.

SOPs for each device will cover;

• clinical background
• analytical principle
• health and safety, including: COSHH (Control of Substances Hazardous
• to Health); safe disposal of waste; infection control; adverse incident reporting
• pre-analytical considerations
• equipment
• reagents, standards, controls and quality assurance
• test procedure
• sample
• analysis
• calculation of results
• assay performance
• record keeping

Heads of Service / Managers must ensure that all staff receive training on all relevant medical devices before staff are able to use the devices / equipment. Managers / team leaders must ensure that manufacturers’ instructions are available locally for staff to access.

Procurement of all new devices must comply with organisational procedures and involve discussion with the Medical Devices Group. POCT devices have software components, stakeholders involved in purchasing must ensure that it is compatible with other organisational software with which it may be required to interface, such as laboratory information system (LIS) or hospital information systems (HIS). The costs of such interfacing also need to be considered during the pre-purchase process. Stakeholders who make POCT purchasing decisions must take account of the implications of all the relevant technical information.

Documentation

Where achievable, results from POCT devices should be integrated with the laboratory record. Procedures should be in place to clearly identify those generated at the point of care and these results must not be overwritten by the laboratory generated results on the same specimen. Where this is not achievable, results must be recorded as recommended by the device specific SOP and service specific policy.

Quality Assurance

The desired technical specification in terms of sensitivity and specificity should be drawn up and compared with the performance claims made by the manufacturer. Stakeholders should compare the manufacturer’s claims with the actual data from which the claims have been derived. A record of the claimed performance at the time of the purchasing agreement should be kept. Stakeholders must assess the instructions for use prior to purchasing to ensure that the method advised, and therefore validated by the manufacturer, is appropriate to the intended use of the device. Results derived from POCT home devices/patient’s own may not be entered into documentation in the patient's record or used for any decision making or treatment, as there is no way to determine what quality control processes have taken place. POCT devices approved for home use may be used to educate patients for home testing and monitoring only.

Internal Quality Control (IQC)

The analysis of an appropriate control material (often supplied by the manufacturer) before analysing a set of specimens can provide reassurance as to the quality and accuracy of the results obtained, thus ensuring patient safety. It is essential that the specific IQC procedures set out in each POCT SOP are followed and are carried out at an appropriate frequency.

Each POCT SOP will detail:

• the provider of IQC materials (if being used) or other IQC methods if appropriate
• department/individual responsible for providing support to ensure any results outside of acceptance limits are investigated
• guidelines for interpretation of results
• procedures to deal with IQC results that fall outside the specified limits for the ICQ materials being used

All test results from calibrations, controls and patient samples must be recorded as instructed by the POCT device SOP. Details must include:

• the name of the patient, hospital number, date and time of analysis, sample type, analyser ID, result (with units) and operator ID
• in some situations the batch number of reagents may need to be recorded
• the device Quality Control book, if recommended, should be used or procedures put in place to enable full audit trails in the event of a product recall
• patient confidentiality must be maintained at all times

External Quality Assessment (EQA)

EQA schemes may be operated by the manufacturer or by a dedicated EQA provider such as a local acute Hospital Laboratory. The MHRA recommends EQA participation from all managers of POCT, as part of Clinical Governance.

Each POCT SOP will detail the specific EQA arrangements (if required) for the device and must be followed at all times.

Infection Control

The use of POCT requires clearly defined procedures for infection control, storage and disposal of clinical waste, needle stick injuries and spillages, hand washing etc. Each device manufactures’ instructions on infection control procedures must be followed, in conjunction with the organisation’s policies for Infection control, needle-stick and contamination injury, sharps and blood borne viruses.

Maintenance

During the procurement process, stakeholders must carefully consider the implications of the servicing and response times on offer, the implications of this to the testing service, and whether there are alternative ways in which the testing service can be provided during unavoidable down-time. Regular planned preventative and user maintenance should follow manufacturer’s guidelines. This is essential for the safe and effective use of POCT devices. The organisation’s policy for Medical Devices and each specific device SOP will detail actions to be taken in the event of the POCT device becoming damaged or unable to use. A maintenance record book should be kept for each POCT device which includes a record of regular maintenance checks, faults and repairs. Each POCT SOP will give details for how the manufacturer can be contacted in the event of a technical problem or breakdown.

Incidents

All accidents or incidents with POCT devices must be reported to the health care professional in charge and reported on the organisation’s incident reporting system, in line with organisational Incident Reporting policy, clearly identifying ‘POCT’ device. Incidents involving user error or a device malfunction must all be reported. Services will report any adverse events relevant to POCT devices to the MHRA using the Yellow Card reporting system.

Register of POCT Equipment

All POCT medical devices must be labelled and entered onto the organisation-wide computerised asset management system, with the following information:

• device name, serial number, supplier (contact name and phone
• number) and purchase date
• date of installation
• location (Clinical Unit)
• designated Trainer
• unit Clinical Manager
• link person (contact name & phone number)
• dates of service

Lay person use for self-testing (end-users)

This policy is not primarily intended for health care practitioners educating their clients/end users in the use of ‘self-testing’ and ‘direct to consumer testing’. However this policy and the associated SOPs may be useful to support health care professionals involved in patient education. Health care practitioners using lay person POCT results to aid their clinical decision making must consider the following before interpreting the results:

• issues such as quality control and assurance
• limitations of the device, the test and device user
• quality of sample and result
• general maintenance of the device and associated components

Where POCT is being used directly by patients or their carers, they must be provided with the necessary information and training so that they can perform the test and interpret the results. Staff providing patient education in self-management using POCT devices, must themselves have completed the necessary training and competency assessment.

Training Requirements

The organisation will work towards all staff being appropriately trained in line with the organisation’s Staff Mandatory Training Matrix (training needs analysis). All training documents referred to in this policy are accessible to staff within the Learning and Development Section. Users of POCT must receive formal training and competency assessment (where risk assessment indicates the need for competency to be assessed) in the operation of POCT devices to ensure quality results, and have an understanding of the results obtained appropriate to their medical use (please refer to specific POCT SOP).

Users of POCT devices must also ensure they have completed mandatory training on Medical Devices and completed the Medical Devices competency assessment located on the Intranet.

All staff performing POCT must be familiar with manufacturer’s instructions for use and the specific SOP to that device and procedure, with particular reference to:

• The intended purpose of the device
• Performance characteristics
• Interpretation of results
• Limitations of use
• Infection control and disposal of POCT equipment
• Sampling requirements, including sample type
• Storage or reagents and samples
• Expiry dates
• Quality assurance procedures
• Health and safety issues

Note: Inappropriate storage conditions can render devices unserviceable – inappropriate physical conditions (such as temperature, humidity, and presence of sunlight for some reagents) and stock rotation failures are some examples. Apart from possible dangers to the end users of the equipment, poor storage conditions also put the organisation at legal risk. Manufacturer’s information and instructions both on storage conditions and shelf life should be followed.

Equality Impact Assessment

All relevant persons are required to comply with this policy and must demonstrate sensitivity and competence in relation to the nine protected characteristics as defined by the Equality Act 2010. In addition, the organisation has identified Learning Disabilities as an as an additional tenth protected characteristic.

Monitoring Compliance and Effectiveness

This policy must be reviewed on a regular basis. Incidents, complaints and feedback relating to POCT devices or processes will be monitored by the Medical Devices Management Group, and themes reported to the Quality committee. Good practice and lessons learned will be shared with the appropriate stakeholders.

Every other month EQA results and non-returns will be monitored by the Senior Nurse for Clinical Practice. Poor results and poor compliance will be followed up by the appropriate operational lead. Consistent non-compliance will be raised as a risk on local and the organisational corporate risk register, supported by an action plan. This will be overseen by the Point of Care Testing Group, and appropriate risks reported to Clinical Governance group.

Counter Fraud

The organisation is committed to the NHS Protect Counter Fraud Policy – to reduce fraud in the NHS to a minimum, keep it at that level and put funds stolen by fraud back into patient care. Therefore, consideration has been given to the inclusion of guidance with regard to the potential for fraud and corruption to occur and what action should be taken in such circumstances during the development of this procedural document.

Relevant Care Quality Commission (CQC) Registration Standards

Under the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (Part 3), the fundamental standards which inform this procedural document, are set out in the following regulations:

• Regulation 9: Person-centred care
• Regulation 10: Dignity and respect
• Regulation 11: Need for consent
• Regulation 12: Safe care and treatment
• Regulation 15: Premises and equipment
• Regulation 16: Receiving and acting on complaints
• Regulation 17: Good governance
• Regulation 18: Staffing
• Regulation 19: Fit and proper persons employed
• Regulation 20: Duty of candour
• Regulation 20A: Requirement as to display of performance assessments.
• 10.2 Under the CQC (Registration) Regulations 2009 (Part 4) the requirements which inform this procedural document are set out in the following regulations:
• Regulation 18: Notification of other incidents
• 10.3 Detailed guidance on meeting the requirements can be found at http://www.cqc.org.uk/sites/default/files/----PUBLISHING.pdf

MHRA Top Ten POCT Tips

1. Involve your local hospital laboratory - Your local hospital pathology laboratory can play a supportive role in providing advice on a range of issues including the purchase of devices, training, interpretation of results, troubleshooting, quality control, and health and safety.
2. Management - Many people will be involved in the creation, implementation and management of a POCT service. It is vital that an appropriate POCT coordinator is identified and a POCT committee established.
3. Health and safety - Be aware of the potential hazards associated with the handling and disposal of body fluids, sharps and waste reagents outside of a laboratory setting.
4. Training - Training must be provided for staff who use POCT devices. Only staff whose training and competence has been established and recorded should be permitted to carry out POCT.
5. Always read the instructions …and be particularly aware of situations when the device should not be used.
6. Standard operating procedures (SOPs) - SOPs must include the manufacturer’s instructions for use.
7. Assuring quality - The analysis of quality control (QC) material can provide assurance that the system is working correctly.
8. Results - Results should be reviewed by appropriately qualified staff with particular reference to the patient’s history.
9. Record keeping …is essential and must include patient results, test strip lot number and operator identity.
10. Maintenance - In order that devices continue to perform accurately they must be maintained according to the manufacturer’s guidance.

References, Acknowledgements and Associated Documents

Medical Devices Agency (2013). Management and Use of IVD Point of Care Test Devices.
https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/371800/In_vitro_diagnostic_point-of-care_test_devices.pdf

Managing Medical Devices, Guidance for healthcare and social services organisations, April 2015.
https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/421028/Managing_medical_devices_-_Apr_2015.pdf

Official Journal of the European Communities L331, 7.12.98 p1-37 Directive 98/79/EC of the European Parliament and of the Council of 27th October 1998 on in vitro diagnostic medical devices.
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31998L0079:EN:NOT

The Medical Devices Regulations 2002 Statutory Instrument 2002 No. 618. ISBN 0110423178
http://www.opsi.gov.uk/si/si2002/20020618.htm (as amended).

In vitro diagnostic medical devices: guidance on legislation
https://www.gov.uk/government/publications/in-vitro-diagnostic-medical-devices-guidance-on-legislation

Medicines and Healthcare products Regulatory Agency. In vitro diagnostic medical devices used in combination, DB 2008(04), 2008.
http://www.mhra.gov.uk/Publications/Safetyguidance/DeviceBulletins/CON02572