This Guidelines summary covers NHS England and NHS Improvement guidance supporting community pharmacy providers to develop point-of-care testing (POCT) services. It outlines equipment selection, service delivery, and governance. The guidance is endorsed by the Royal Pharmaceutical Society and the General Pharmaceutical Council.
Reflecting on Your Learnings
Reflection is important for continuous learning and development, and a critical part of the revalidation process for UK healthcare professionals. Click here to access the Guidelines Reflection Record.
Overview of POCT
- POCT includes both quantitative and qualitative tests. Equipment can be divided into small, portable, hand-held devices and larger bench-top or standalone devices. Some can be used by individuals in their home and others only by competently trained healthcare professionals
- POCT technology can also be broadly categorised into the type of diagnostics it enables:
- screening and monitoring devices, for example:
- non-invasive blood pressure monitors
- pulse oximeters (oxygen saturation monitors)
- portable spirometers
- diagnostic test kits, for example:
- blood glucose meters
- urinalysis test strips
- cholesterol tests
- screening and monitoring devices, for example:
- Since POC tests are carried out close to a patient, the time it takes to test and obtain the results can be significantly shorter compared to standard methods of testing in a laboratory and clinic environment
- Potential benefits for NHS services and/or patients include faster decision-making and triage, reduced operating times, fewer outpatient clinic visits, increased access to and convenience of diagnostics, optimal use of professional time, and reduction in antimicrobial medication.
Selection of Equipment and Technology
- The selection of equipment and technology—the first step—is critical to the success of the service and needs careful planning. The stages to follow in planning are:
- Needs assessment —establishing what is already available at the community pharmacy and what would be needed to deliver the patient service improvements
- Options appraisal —assessing whether POCT technologies on the market are suitable for the service and of good quality, and meet the identified needs. A risk assessment should be performed for each POCT technology under consideration
- Budgeting and financing —estimating the budget for equipment purchase and ongoing associated costs during its entire lifecycle. The source of funding for and the available acquisition of equipment need to be determined. The aim is to put a financial value on the lifecycle costs of the service for each option, to identify the most cost-effective POCT method.
How to Develop a Desired Device Specification
- A specification should be developed to ensure the equipment fulfils its purpose and is appropriate for use in the setting. The more detailed and clearly defined a specification, the easier it will be to narrow down the list of models for consideration
- The specification should address aspects such as:
- purpose of use
- technical characteristics
- physical chemical characteristics
- utility requirements
- accessories, consumables, spare parts
- other equipment needed to ensure end-to-end process (dedicated reader, laptop, smartphone)
- environmental requirements
- training, installation, and utilisation
- warranty and maintenance
- safety and standards
- Stakeholders’ opinion can be valuable in defining the requirements specific to the environment and the context in which equipment will be used. To ensure the POCT device’s diagnostic performance is clinically acceptable compared to its ‘gold standard’, minimum acceptable values for at least four attributes should be verified as part of determining a device’s technical characteristics in the specification:
- limits of detection (where relevant)
- For genomic tests, the evaluation criteria are:
- analytical validity
- clinical validity
- clinical utility
- associated ethical, clinical, legal, and social implications
- Minimum acceptable values for the above attributes/criteria should be defined using NICE guidelines, International Organization for Standardization standards, and other scientific literature.
How to Assess and Compare POCT Devices
- A manufacturer’s performance claims for a device should be compared against the desired technical specification
- As part of your enquiries, it is a good idea to share your technical specification with suppliers of POCT technology when requesting evidence, data from clinical evaluations, documents, and other information regarding their device’s performance
- Suppliers/manufacturers should be able to provide much of the information you need to assess a device against the desired technical specification. Where possible, they should also provide sample equipment for practical testing and trials and/or contact details of UK-based organisations with similar equipment for their feedback
- As well as cost, the aspects to consider are:
- clinical performance
- patient comfort and acceptance
- design and usability
- quality of construction and robustness
- service and maintenance requirements
- MD/IVD-MD UKCA, CE, UKNI marking
- environmental impact/carbon footprint.
Operational Management System
POCT Equipment Installation, Acceptance, and Commissioning
- Most POCT equipment in community pharmacy settings will require nothing more than unpacking (for example, single-use testing kits). However, more complex devices will need to be assembled, set up (for example, activating specific software options for ambulatory blood pressure monitors), and validated through appropriate testing
- A trained technician—preferably the supplier’s representative—should carry out acceptance testing (or verification of performance); they will perform functional and safety tests (for example, checking that the device is electrically safe to use)
- An information record of new POCT equipment should as a minimum provide the following information:
- contact information for the local representative and customer service
- serial number/lot/batch number of the devices received
- warranty expiry date
- stocks of consumables, accessories, and spare parts received
- results of inspection tests undertaken on commissioning
- frequency of planned preventive maintenance and/or calibration required
- details of any maintenance contract and maintenance contractor
- end of life/expiration date, if specified.
- Good training is the most effective factor in decreasing the risk of device-related incidents and is a necessary part of best practice. Furthermore, liability under the Consumer Protection Act (1987) will only remain with the manufacturer/supplier if the user can demonstrate that equipment has been used in strict accordance with the manufacturer’s instructions
- Pharmacy professionals should also be able to advise patients on the safety and use of the self-care equipment they sell and help them to recognise signs of malfunction or faults. Training should be both theoretical and practical (see Table 1).
Table 1: What User Training Should Cover
|Pre-checks||Ensuring a device is safe to use, performing any maintenance checks required|
|Patient preparation||Explaining to patients and giving them instructions on, e.g., the correct use of consumables and preparation for taking samples|
|General use||Device capabilities, its intended clinical use, how to check it during use, consideration of all aspects of risk management, e.g., ensuring all sharps are disposed of appropriately|
|Faults/alarms||Common faults and errors in use and actions to take in the event of an alarm|
|Cleaning||Suitable decontamination processes between uses|
|Troubleshooting||Detecting and resolving the most frequent problems that occur when using equipment|
|Consumables||How to obtain device accessories|
|Reporting incidents and concerns||Process for reporting incidents, including through the MHRA Yellow Card Scheme, and any continuous faults and errors|
|Contacts||Numbers for routine and emergency contacts in case of faults and errors that cannot be resolved locally|
|Abbreviation: MHRA=Medicines and Healthcare products Regulatory Agency|
- Staff should be trained in use of equipment and procedure between installation and commissioning. There should be a plan for refresher training as well
- Training may be provided by a manufacturer, a third-party provider, or the facility staff trainers (who have undertaken ‘train-the-trainer’ training)
- Best practice recommends undertaking and documenting a competency assessment after training, including a written and practical assessment of the trainee’s understanding
- A record needs to be kept of staff training to identify who is competent to deliver the service. The National Association of Medical Device Educators and Trainers offers free membership and support, including e-learning training modules and regular meetings about medical device safety and training
- Another crucial aspect of POCT user training is patient preparation for a procedure, including how to explain the testing/measurement process and discuss the results (with consideration of the different communication needs of protected characteristic groups and others who experience health inequalities)
- The Health Education England e-learning platform offers free training modules on a range of topics that can assist with this, from medical conditions to how to undertake various aspects of professional practice.
Operation, Maintenance, and Repair
- The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014: Regulation 15 places a legal responsibility on healthcare providers to ensure that equipment used to deliver care and treatment is:
- suitable for intended purpose
- used safely by trained people
- maintained and stored securely
- Community pharmacy professionals delivering POCT services are expected to:
- follow good practice and behaviour around the use of equipment
- ensure they have the necessary skills to operate and look after equipment correctly
- follow correct safety procedures for themselves and patients
- provide regular checks on the performance of equipment in use and ensure equipment is in a functional state
- validate performance of the device against the instructions for use criteria when a new batch or lot number of consumables is put into use
- follow good practice around the withdrawal of equipment from service and its safe disposal
- monitor how effectively equipment is used and keep robust up-to-date records of each device’s history and of patient results.
- They are also expected to challenge poor practice.
Routine User Maintenance
- Trained pharmacy staff should regularly perform routine user maintenance, according to the manufacturer’s instructions
- Regular cleaning, visual checks, and performance verification enable users to check that a device is working properly and safely before it is used on patients
- Frequent performance checks and calibration (where relevant) help staff identify when a device’s performance is deteriorating and needs correcting
- Regular maintenance is the most effective way of spotting faulty devices early and identifying a need to get it repaired.
- The manufacturer or third-party engineers usually perform planned maintenance as part of a service level agreement.
Breakdown Maintenance (Repairs)
- Users can often be trained to perform some first-line fault finding and troubleshooting. However, if they cannot resolve an issue, faulty equipment should be removed from use and clearly labelled as ‘faulty’. It should also be decontaminated in accordance with manufacturer instructions as soon as possible.
Health and Safety and Infection Control
- When a POCT service involves handling and disposing of biomedical waste (including bodily fluids and sharps), infection prevention and control procedures and goods management policies must be in place to meet the requirements of regulators (for example, the General Pharmaceutical Council Care Quality Commission)
- Good practice is for the nominated pharmacy lead to be responsible for managing relevant aspects of health and safety and infection control in the community pharmacy
- Health and Safety at Work legislation requires provision of a written risk assessment identifying the hazards and infection control measures implemented in the workplace.
Decommissioning and Disposal of POCT Technology
- Decommissioning aims to remove unsafe or unusable devices with minimum damage to the environment. It is advisable to contact the manufacturer for information on decommissioning.
Clinical Governance and Assurance
- Clear lines of responsibility and accountability are central to providing a quality service
- The nominated pharmacy lead is responsible for ensuring the programme for clinical governance is in place and is monitored. They should be aware of their responsibility for clinical governance and of the medical and legal implications of an erroneous test result
- Liability under the Consumer Protection Act (1987) will only remain with the manufacturer or supplier if the user can demonstrate that the equipment has been used in strict accordance with the manufacturer’s instructions
- The POCT service’s clinical governance structure should clearly define lines of accountability in its local policies and procedures.
Standard Operating Procedures
- A nominated pharmacy lead in the community pharmacy should work under the direct supervision of the responsible pharmacist, and will be appropriately trained and responsible for ensuring that staff using POCT devices follow the standard operating procedure (SOP) for each device
- A copy of the SOP should be available to all staff using POCT and kept close to the equipment being used
- SOPs must be reviewed on a regular basis (at least every 2 years) and always when procedures change. They should also be reviewed following an incident or poor audit result, when changes to improve processes and prevent future errors may be required
- SOPs should be version controlled and maintained as part of an appropriate quality management system.
- Where tests are performed at the point of care, it is crucial that the results are incorporated into a patient’s health record. The Professional Record Standards Body has published a digital data standard for community pharmacy
- The nature of consultation-related data records, including records of test results, will depend on the treatment pathway and should be defined by the commissioners as part of the service specification.
- The most significant risk associated with POCT is the failure of users to follow POCT procedures
- All elements of use, maintenance, repair, record generation, and storage should be regularly audited to ensure the correct procedures are in place and being adhered to
- Staff with appropriate knowledge and experience of POCT service delivery and management of POCT devices should carry out the audits
- Audit results should be reviewed and acted on
- Community pharmacies should also ensure there is a mechanism to obtain regular feedback from technical service contractors on the repair and maintenance process. This should include reporting even what appear to be minor problems, as without remedy these may lead to a major failure.
- POCT activities outside diagnostic laboratories are not subject currently to the same level of regulation and accreditation as conventional medical laboratories. This makes quality assurance all the more important
- Quality assurance covers all the processes that help ensure a test gives the correct result. It is an essential component of clinical governance and includes internal quality control (IQC) and external quality assessment (EQA)
- Each POCT SOP should detail the specific IQC and EQA arrangements for associated equipment and procedures and these must be followed at all times
- IQC is checking that equipment results are reliable before it is used on patients. For POCT diagnostic tests, this usually involves analysing a sample of known concentration (often supplied by the manufacturer) and ensuring the result obtained falls within acceptable performance limits
- EQA involves analysing samples with unknown values from an external source or provider. The manufacturer or a dedicated EQA provider, such as a local acute hospital laboratory or national external quality assurance provider, may operate EQA schemes. The Medicines and Healthcare products Regulatory Agency recommends all POCT services participate in EQA as part of clinical governance, but a pragmatic approach should be taken when deciding on participation in EQA for community pharmacy settings and for what type of diagnostic services.
Risk Management and Adverse Incident Reporting
- Appropriate reporting of identified risks and an escalation process need to be established for all clinical services delivered by community pharmacies. This should cover any POCT device used as part of that service
- A device-related adverse incident is an event that produces, or has the potential to produce, unwanted effects for the safety of patients, users, or other people
- An adverse incident can result from a shortcoming in:
- the device
- its accessories
- software failure
- the instructions for use
- user practice
- servicing and maintenance
- conditions of use
- An incident report should include the following information:
- date and time of the incident
- device settings, if relevant
- details of the incident (how it happened and any outcomes for the person affected)
- details of the device involved (type, make, model, and serial number)
- details of any error message or failures observed
- root cause analysis of the fault from investigation
- Equipment involved in the incident should be removed from use and quarantined for further investigation, together with any packaging, consumables, and accessories
- Where user error is identified as causing the incident, training needs should be defined and appropriate re-training sessions arranged.
- Accreditation is available to providers of diagnostic services and tests through the United Kingdom Accreditation Services. At present, accreditation is not mandatory for community pharmacies delivering POCT.
For more detail on accreditation, refer to the full guideline.