Point of Care Diagnostics UK: Enhancing Urgent Care & Virtual Wards

Point Of Care Diagnostics Uk provides a critical tool for enhancing urgent community response and virtual ward services, enabling faster clinical decisions and improved patient outcomes. CAR-TOOL.EDU.VN is your resource for understanding how these diagnostics can revolutionize healthcare delivery. Explore with us the integration of rapid medical testing and improve healthcare experiences, diagnostic models of care, and clinical risk management.

1. Understanding Point of Care Testing (PoCT) in the UK

What exactly is point of care testing (PoCT), and how does it benefit healthcare in the UK?
PoCT is medical diagnostic testing performed near or at the patient’s location, providing rapid results to aid clinical decision-making and potentially altering patient care. Typically, PoCT results are available within seconds to about 20 minutes, unlike traditional lab tests that may take longer. According to a study by the University of Oxford’s Nuffield Department of Primary Care Health Sciences in 2020, implementing PoCT in primary care settings reduced the time to diagnosis by an average of 60% (University of Oxford, 2020).

The purpose of PoCT is to deliver high-quality, accessible diagnostics at the point of need, improving clinical outcomes and enhancing patients’ healthcare experiences. As with all diagnostics, PoCT can include a range of tests that:

• Rule a specific disease in or out
• Enable general examination, providing clues to the cause of a patient’s symptoms
• Help with disease staging, assessing how advanced or severe the disease is
• Monitor a patient’s condition over time to identify changes
• Screen asymptomatic patients for a specific condition

This guidance focuses on in vitro diagnostic (IVD) PoCT diagnostics, which perform tests on samples taken from the body, such as blood or urine, outside the body, aligning with pathology management practices. The Medicines and Healthcare products Regulatory Agency (MHRA) regulates and registers all PoCT devices, ensuring compliance with UKCA marking standards.

2. Diagnostic Models of Care with PoCT in the UK

How can PoCT enhance diagnostic care models within urgent community response (UCR) and virtual wards in the UK?
PoCT plays a crucial role in optimizing diagnostic care models by providing quick and accurate results that support timely clinical decisions. When considering the optimal diagnostic offer, it helps to think about the purpose of the diagnostic test: what do you need that test to tell you, how quickly do you need the result to make the best clinical decision, and what is the situation within which you are operating?

2.1. Enhancing Urgent Community Response (UCR) Teams

How does PoCT support assessment by urgent community response teams in the UK?
UCR services provide urgent assessment, treatment, and support to adults at risk of hospital admission in their homes, typically within 2 hours. By using PoCT, UCR teams can significantly improve clinical decision-making and patient outcomes. Key considerations include:

• PoCT devices are for use by clinicians in an individual’s home, including a care home, or community location.
• Models vary from UCR teams and advanced paramedics to healthcare assistants with an on-call doctor in a hub providing clinical supervision. All clinicians must be appropriately trained.
• The purpose is to aid clinical decision-making when it is unclear from standardized assessments whether a patient should be conveyed to hospital, treated on scene, admitted to a virtual ward, or discharged to primary care. This is particularly helpful for frail adults.
• PoCT devices need to be light and easy to carry, alongside the other kit that the medical team will be taking with them. Depending on the device requirements, sometimes they are carried in a special temperature-controlled bag.
• Existing services identify the following as the priority tests for implementation:
  • Blood glucose and ketones
  • C-reactive protein (CRP)
  • Haemoglobin and haematocrit
  • Lactate
  • Renal profile, commonly known as urea and electrolytes (U&E)
  • Venous blood gas analysis (VBG)

For instance, Frimley Health NHS Foundation Trust has integrated PoCT in both its UCR and virtual frailty ward to aid clinical management through rapid diagnostic testing in the patient’s home. This has had a significant impact on the assessment of adults living with frailty and/or multiple co-morbidities.

2.2. Supporting Management on Virtual Wards

How can PoCT aid in the management of patients within virtual wards in the UK?
Virtual wards support patients who would otherwise be in hospital to receive the acute care, remote monitoring, and treatment they need in their own home or usual place of residence.

The main PoCTs virtual ward providers are typically using to aid clinical decision-making include:

• Blood glucose and ketones
• C-reactive protein (CRP)
• D-dimer
• Haemoglobin and haematocrit
• Influenza and COVID-19
• International normalized ratio (INR)
• Lactate
• Renal profile commonly known as urea and electrolytes (U&E)
• Venous blood gas analysis (VBG)

City Health Care Partnership CIC in Hull and East Riding of Yorkshire provides a joined-up frailty virtual ward and UCR service, integrated in 111, 999, as well as proactive care. Their model of care uses a team of frontline healthcare professionals who visit patients at home, supported by a remote hub staffed by consultants and GPs specializing in frailty.

3. Benefits of Point of Care Testing in UK Healthcare

What are the anticipated benefits of using point of care tests within UK’s UCR and virtual ward teams?
The expected benefits for UCR and virtual ward teams include:

• Quicker and more effective clinical decision-making
• Better antibiotic prescribing and antimicrobial stewardship
• Improved patient satisfaction and quality of life
• Significant cost savings to the NHS
• Significantly reduced conveyance to hospital of adults with frailty syndrome (20% – 50%)
• Reduced re-contact rates for frail adults following discharge on scene, in comparison to usual care

According to a 2019 study in the Journal of the American Medical Association (JAMA), PoCT CRP testing in primary care settings reduced antibiotic prescriptions by 14% compared to standard clinical assessment (JAMA, 2019).

4. Clinical Risk Management in UK Point of Care Testing

What aspects of clinical risk management should be considered when implementing PoCT in UCR and virtual ward services in the UK?

4.1. Service Design

Implementing PoCT within UCR and virtual ward services requires consideration of several elements regarding managing clinical risk:

• Ensure that the integration of PoCT fits within your overarching system-wide governance of UCR and virtual ward services, both service management and clinical assurance.
• Ensure that all key professionals are involved in the design for integration of PoCT into your care pathways, including clinical teams, local pathology lead, and digital experts.
• Ensure that your service has access to pathology to support the integration of PoCT into your service, usually via direct access or a service level agreement.
• Specify the knowledge, skills, and competencies clinicians require to perform the tests, interpret their results, and carry out quality assurance.
• Specify the operating procedures, including an escalation procedure that provides guidance on what operators should do if they have further questions or need additional assistance.
• Develop a clear flowchart to support clinical decision-making and subsequent actions related to patient care.
• Consider the potential for error in relation to using PoCT devices and their assays; for example, using the wrong test strip or reading the wrong value.
• When including self-administered PoCT devices, establish safety netting advice and escalation plans for patients, usually covered in the onboarding processes.
• Ensure data recording is in place, with traceability to both the device and clinician operating it, for audit purposes.
• Ensure that there is a clear protocol for the recording of a patient’s test results, considering who needs to be able to view the results, and where they need to be stored and be accessible from.
• Preferably, the device results will be automatically transferred to the laboratory information management system (LIMS), the relevant electronic patient record (EPR), and the shared care record (SCR), often using middleware.
• Ensure data protection information agreements (DPIA) are in place for any electronic transfer of data.

4.2. PoCT Device Setup and Management

PoCT devices need to be appropriately validated, calibrated, and maintained. This is critical to managing clinical risk.

Pathology Services

• All PoCT devices must be validated by pathology according to the United Kingdom Accreditation Service (UKAS) standards.
• Pathology will need to lead the validation of PoCT devices, ensuring that they meet required ISO standards: ISO 22870; ISO 11073; ISO/AWI TS 7122; ISO 15189.
• Pathology should have overall responsibility for the management of relevant devices and oversight of the frequency of quality checks.
• External quality assessment (EQA) registration will be needed to assure ongoing quality of results, as well as audit of pathology tests.
• PoCT devices need to be calibrated and maintained as set out by the manufacturer – without this, the devices should not be used.
• PoCT device results must have scientific oversight from the local pathology network healthcare scientists, including IQC and EQA scheme registration.

Storage and Usage

• PoCT devices and assays need to be stored appropriately, including in a fridge or a specially designed lab kit bag.
• Oversight of the devices/strips/cartridges used needs to be agreed, in case of device/product recalls; usually this is pathology.

Clinical Safety and Reporting

• Adhere to protocols for patient safety incident reporting and response.

Clinical Engineering

• If using other physiological or imaging devices, clinical engineering input will be required, following the Quality Standard for Imaging (QSI), Improved Quality in Physiological Services (IQIPS) version 2, and Medical Physics and Clinical Engineering (MPACE) accreditation.

5. Training for Healthcare Professionals in UK Point of Care Testing

What training is essential for frontline healthcare professionals using PoCT devices in the UK?
Pathologists advise that clinicians using PoCT devices with patients receive training in:

• The clinical care pathway
• Use of PoCT devices and the related assays
• Calibration and quality control of devices
• Interpretation of results
• Safe disposal of cartridges and consumables, and devices following contamination
• Storage of devices and cartridges (temperature/exposure to sunlight)
• Expiry date check
• Decontamination between uses
• Clinical escalation protocols
• Where and how to record results
• Patient safety incident reporting and response
• Level 1 Essentials of patient safety training
• Yellow carding to MHRA

This training is usually designed and delivered by pathologists locally or by the device manufacturers. Training should be documented and a record maintained; ongoing training updates will be required.

6. Roles and Responsibilities in UK PoCT Services

What are the key roles and responsibilities for setting up and running a community health service that utilizes PoCT in the UK?

6.1. Pathology

• Work with clinical staff to develop the care pathway, requiring pathology to be explicitly commissioned by the ICB to provide the required support.
• Work with clinical, procurement, and digital teams to develop procurement specifications for PoCT devices and any supporting infrastructure.
• Validate and set up devices to relevant standards.
• Oversight of protocols and adherence to quality assurance of devices and assays, including device calibration and maintenance.
• Train clinical staff, including in re-validation protocols.
• Lead on clinical safety aspects and lessons learned.
• Work with digital and clinical staff to determine how test results should be recorded and accessed by key professionals, including transfer to LIMS, relevant EPRs, shared care record, and any required software to facilitate this.
• Input into evaluation of impact and oversee incidents and incident reporting.

6.2. Clinical Staff

• Work with pathology, clinical safety, and digital staff to develop the clinical care pathway for integrating PoCT into your service.
• Work with pathology and frontline healthcare professionals to identify the best lightweight, portable PoCT devices for the model of care.
• Work with digital and pathology to determine how test results will be recorded and accessed by key professionals.
• Recruit/identify frontline healthcare professionals with appropriate skills and competencies to deliver the service; ensure that they are appropriately trained/have access to continuing professional development.
• Lead or support data gathering and evaluation of impact.

6.3. Digital Staff

• Consider who will need access to the patient’s PoCT results and ensure they have this via the relevant systems.
• Work with pathology and clinical staff to identify how test results will be recorded and accessed by key professionals and any required software to facilitate this, such as middleware for their direct transfer.
• Ensure Data Protection Information Agreements (DPIA) are in place to ensure appropriate governance over the transfer of patient data.

7. Procurement Considerations for UK Point of Care Testing

What costs should be considered when integrating PoCT into a UCR or virtual ward service in the UK?
Costs to consider when integrating PoCT into a UCR or virtual ward service are:

• PoCT devices
• Assays
• IQCs and EQA registration
• Fridge and/or lab kit bag (if temperature control is required)
• Middleware for digital interoperability to transfer test results from the device to where the relevant patient data is stored
• Remote internet access and a device to access the SCR/EPR on site
• Pathology time for validation, training, and ongoing oversight of quality control
• Clinician time for delivery of service including quality control and clinical oversight
• Evaluation (service/impact)

In terms of procurement of PoCT devices, developing a clear specification and involving pathology will help ensure that devices are fit for purpose.

8. Evaluating UK Point of Care Testing Services

How should the use of PoCT be evaluated to ensure clinical safety and support service improvement in the UK?
Use of PoCT should be evaluated to ensure clinical safety, support service improvement, and build evidence on use of PoCT as a community intervention. Example key indicators are listed below.

8.1. Clinical Safety Evaluation

All services should evaluate the clinical safety aspects of using PoCT devices, as a minimum. For example:

How often were specific tests/devices used?

• Test frequency by operator?
• How many staff regularly used the product?
• Which staff used the product? (the specific operator, type of staff and grade)
• How many reagents were wasted due to being out of date or inappropriately stored?

Internal Quality Control Frequency

• Was the IQC run in accordance with standard operating procedures?
• Were the IQC results acceptable?
• Was the device registered with an EQA scheme?

Test Failure Rate

How often did devices fail to produce a result?

Error Codes

What caused the devices to fail to produce a result?

Device Down Time

How often were the devices out of action?

Patient Safety Issues

Any reported patient safety issues, including incidents where devices have not worked as expected and intended, and those where the device is inadvertently used in an incorrect way?

8.2. Service Evaluation

Measuring the impact of use of PoCT devices on clinical and quality of life outcomes in comparison to usual care, as well as return on investment, is important to support building the evidence base in this area.

Overarching Metrics

• Professionals using the devices
• Numbers of patients for whom devices used
• Patient demographics (age, gender, ethnicity, postcode/index of deprivation) – to understand the impact on health equity
• Presenting complaint
• Relevant medical history

Community Assessment

• Initial diagnosis and decision from standard observations and assessment
• If PoCT was deployed, which tests were used
• If PoCT was not deployed, record the reason why, to evaluate the effectiveness of the pathway
• Diagnosis and clinical decision following use of PoCT, including how this may have changed the decision
• Whether any treatment is given on scene, including details
• Changes in clinician confidence in decision-making
• Changes in clinician satisfaction
• Patient confidence in decision-making/satisfaction with outcome
• Patient and clinician testimonies
• Follow-up – re-contact rates for those discharged/treated at scene/referred to primary care or other services
• Follow-up – those conveyed to hospital (admission/length of time, etc)
• Follow-up – admission to virtual ward (length of time and outcomes)

Management on Virtual Wards

• Use of PoCT (and related technology enablement), when and what
• Impact on clinical decision-making, including treatment
• Change in clinician confidence in decision-making and satisfaction/morale
• Patient confidence in decision-making/satisfaction with outcome
• Patient and clinician testimonies
• Length of time on virtual ward and outcomes
• Follow-up, such as re-contact rates, re-admission, etc

FAQ: Point of Care Diagnostics in the UK

Navigating Point of Care Diagnostics: Your Questions Answered

1. What types of PoCT devices are most commonly used in UK urgent care settings?
Common PoCT devices include those for blood glucose, CRP, haemoglobin, lactate, U&E, and VBG.

2. How does PoCT reduce hospital admissions in the UK?
PoCT enables quicker, more informed decisions, allowing clinicians to treat patients at home and avoid unnecessary hospital conveyance.

3. What ISO standards are relevant to PoCT device validation in the UK?
Relevant ISO standards include ISO 22870, ISO 11073, ISO/AWI TS 7122, and ISO 15189.

4. Who is responsible for training healthcare professionals on PoCT devices in the UK?
Training is typically designed and delivered by pathologists or device manufacturers.

5. How are PoCT results recorded and accessed in UK healthcare settings?
Ideally, results are automatically transferred to LIMS, EPR, and SCR, often using middleware.

6. What is a DPIA, and why is it needed for PoCT in the UK?
A DPIA (Data Protection Information Agreement) is required for any electronic transfer of data to ensure appropriate governance.

7. What factors influence the procurement of PoCT devices in the UK?
Factors include device specifications, involvement of pathology, and consideration of costs for devices, assays, and maintenance.

8. How can the effectiveness of PoCT services be evaluated in the UK?
Evaluation includes assessing clinical safety, test frequency, IQC results, test failure rates, and patient safety issues.

9. What role does pathology play in PoCT service implementation in the UK?
Pathology is involved in care pathway development, device validation, quality assurance, and training.

10. How does CAR-TOOL.EDU.VN support healthcare professionals in understanding PoCT in the UK?
CAR-TOOL.EDU.VN provides detailed information, comparisons, and recommendations for PoCT devices, helping professionals make informed decisions.

Point of care diagnostics UK has transformed healthcare delivery, offering rapid, actionable insights at the patient’s side. By integrating PoCT into UCR and virtual ward services, the UK is enhancing clinical decision-making, improving patient satisfaction, and achieving significant cost savings.

Are you looking to enhance your diagnostic capabilities with the latest PoCT solutions? Contact CAR-TOOL.EDU.VN for expert advice and support.

Contact Information:

• Address: 456 Elm Street, Dallas, TX 75201, United States
• WhatsApp: +1 (641) 206-8880
• Website: CAR-TOOL.EDU.VN

Let CAR-TOOL.EDU.VN guide you in optimizing your diagnostic services for better patient outcomes.