- What is POCT and Why It Matters?
- Global and UK Market Growth of POCT
- NHS Strategy: POCT in the Long Term Plan and Community Diagnostics
- Key POCT Device Categories and Tests
- Best Practices for POCT Operations and Governance
- and Governance
- Quality Standards: ISO 15189:2022 and ISO 22870 Accreditation
- Challenges and Barriers to POCT Implementation
- Scaling POCT Safely: Strategies for Trusts and Labs
- Sources:
- Downloadable PDF Version
Point-of-care testing allows healthcare staff to perform diagnostic tests at the patient’s side, leading to immediate results that can inform urgent clinical decisions.
Point-of-Care Testing (POCT) in pathology refers to diagnostic tests performed near or at the site of patient care rather than in a central lab. From blood gases in the ICU to rapid infectious disease kits in clinics, POCT brings critical tests directly to the patient. This immediacy offers significant clinical and operational value – results are available within minutes, enabling faster treatment decisions and more patient-centered care. In this introductory post of our weekly series, we provide an expert overview of pathology-based POCT: what it is, why it’s valuable, how the market is evolving, relevant NHS policies, key device categories, best practices for managing POCT services, quality standards (ISO 15189:2022 and ISO 22870), challenges to implementation, and strategies for scaling POCT safely.
What is POCT and Why It Matters?
Pathology POCT (also called near-patient or bedside testing) means performing laboratory assays at the point of need, by trained operators, instead of sending samples to a lab and waiting hours or days for results. Common POCT uses include measuring blood analytes (like glucose or electrolytes) at the bedside, performing rapid antigen or molecular tests for infections in clinics, or checking critical care parameters in real time. The goal of POCT is to obtain accurate results more quickly and conveniently for patients. By delivering results within minutes, POCT allows clinicians to diagnose, monitor, and treat patients in a more timely manner, which can improve outcomes in acute situations (for example, earlier antibiotic administration in sepsis, or faster rule-out of a heart attack in the ED). When implemented correctly, POCT has been shown to speed up clinical decision-making and even reduce overall costs of care by enabling more efficient treatment and reducing unnecessary hospital admissions. In essence, POCT extends the laboratory’s reach to wherever the patient is – whether that’s an ICU bed, a GP surgery, or a community pharmacy – ensuring that vital diagnostic information is available on the spot.
Beyond individual patient impact, POCT holds broader operational value for healthcare systems. It can relieve pressure on central laboratories by handling rapid tests on the wards or in clinics, thus reserving lab resources for complex testing. It also aligns with modern care models that emphasize patient-centric and decentralized healthcare. For instance, providing rapid tests in community settings can prevent patients from needing to travel to hospital for basic diagnostics, improving convenience and satisfaction. Overall, pathology POCT is a key enabler of faster diagnostics and a more agile healthcare delivery model, making it an increasingly critical component of both routine and emergency care.
Global and UK Market Growth of POCT
The adoption of POCT has accelerated worldwide, reflected by strong market growth. The global point-of-care diagnostics market was estimated around $50 billion in 2024 and is on track to double by 2033, reaching over $105 billion (about an 8.6% CAGR). This robust growth is driven by technological advancements (like miniaturized devices and connectivity), rising demand for rapid results, and the need for accessible testing in both developed and resource-limited settings. Demographic trends such as aging populations and the prevalence of chronic diseases (e.g. diabetes, cardiovascular conditions) are also fueling demand – POCT devices for glucose, cardiac markers, etc., support ongoing monitoring and early intervention in these conditions. Notably, the COVID-19 pandemic further spotlighted POCT’s value, as mass deployment of rapid tests demonstrated how on-site diagnostics can expand testing capacity and accessibility in urgent times.
Closer to home in the UK, the POCT sector has likewise grown substantially. According to the British In Vitro Diagnostics Association (BIVDA), the UK’s point-of-care testing activity was estimated at roughly £500 million annually in 2022 (including widespread use of glucose testing). This reflects a return to steady growth after surges during the pandemic. The UK makes up a significant share of Europe’s POCT market – on the order of £1 billion worth of POCT devices/tests, approximately one-fifth of the European market by value. Overall UK in-vitro diagnostics (lab tests) market size is about £1.2 billion, so POCT constitutes an important and growing segment. The trajectory is clear: POCT is no longer a niche adjunct to the lab, but a mainstream diagnostic approach with expanding investment. Industry forecasts and funding initiatives reflect this; globally, continuous innovation (e.g. handheld molecular devices, smartphone-based diagnostics) and healthcare strategies are pushing POCT into more settings than ever before. For POCT professionals, staying abreast of this growth and innovation is critical, as it heralds both opportunities (to improve patient care and service delivery) and responsibilities (to maintain quality at scale).
NHS Strategy: POCT in the Long Term Plan and Community Diagnostics
In the UK, national policy has explicitly recognized the value of POCT in transforming healthcare delivery. The NHS Long Term Plan (2019) calls for shifting care “closer to home,” moving away from a hospital-centric model toward more community-based services. Point-of-care testing is highlighted as a key enabler of this shift. By integrating POCT devices into primary care, community clinics, and pharmacies, patients can get timely tests without needing hospital referrals – aligning with the Long Term Plan’s emphasis on accessibility and earlier diagnosis. For example, NHS England’s Community Pharmacy Contractual Framework (2019–2024) included exploring POCT by community pharmacists, recognizing that adopting POCT in primary care could reduce strain on GP surgeries and hospitals while providing quick answers for patients. NHS England guidance for community pharmacies implementing POCT emphasizes that devices must be “fit for purpose, used correctly by trained staff, and kept in safe working condition” – encapsulating the buy it right, use it right, keep it right mantra for POCT programs.
A flagship initiative born from these policies is the rollout of Community Diagnostic Centres (CDCs). In late 2021, the UK government announced 40 CDCs to open across England by 2022 as one of the recommendations of Professor Sir Mike Richards’ review of NHS diagnostics. These centers are designed as one-stop shops for early diagnostic tests for common conditions, located in shopping centers or community venues to make access easier. While many CDC services focus on imaging (MRI, CT, X-rays), there is a clear opportunity for pathology testing at these sites via POCT solutions. Decentralizing key blood tests and infectious disease assays to CDCs can facilitate faster diagnosis and initiation of treatment at the community level. This aligns with programs like “Get It Right First Time (GIRFT)” and the drive to catch illnesses earlier. By providing lab-quality tests on-site – from full blood counts to HbA1c to D-dimer – CDCs with POCT could improve patient outcomes, relieve pressure on acute hospital labs, and meet patient expectations for convenient care.
Notably, implementing POCT in new settings also requires ensuring quality and safety. The NHS’s diagnostics strategy (Richards’ Diagnostics: Recovery and Renewal report) stressed that expanding diagnostics must go hand-in-hand with maintaining standards and interoperability of results. Thus, NHS Trusts are encouraged to involve their pathology experts when setting up community testing services. Overall, POCT’s role in the Long Term Plan and community diagnostics is both strategic and pragmatic: it’s about bringing the right test to the right place at the right time, whether in a hospital ward or on the high street, to achieve faster diagnoses and more efficient care pathways for patients.
Key POCT Device Categories and Tests
Pathology POCT spans a wide array of tests and technologies. It’s helpful to group them into key categories by the type of test or clinical area:
- Clinical Chemistry and Critical Care: Portable analyzers can measure blood gases, electrolytes, and metabolites (like glucose, lactate) at the bedside – essential in emergency and ICU settings. Handheld blood gas machines and glucometers are ubiquitous examples. Cardiac biomarker tests (e.g. troponin, BNP) and metabolic panels run on cartridge-based devices (such as the i-STAT) also fall here, enabling rapid diagnosis of myocardial infarction, heart failure, and other acute conditions.
- Hematology and Coagulation: These include hemoglobin tests (for anemia screening) and coagulation monitors. Devices like INR meters (for anticoagulation monitoring) let clinicians check clotting times in clinics or even patients’ homes. Some POCT analyzers can do complete blood counts or at least hemoglobin and hematocrit. HbA1c tests for diabetes management, while technically chemistry, are often a separate category – portable HbA1c analyzers allow immediate assessment of long-term glucose control during a patient’s visit, improving diabetes care.
- Infectious Disease and Microbiology: A major growth area in POCT, these tests detect pathogens quickly. Rapid antigen tests (such as for COVID-19, influenza, strep throat) and molecular point-of-care tests (e.g. cartridge-based PCR for flu/COVID, GeneXpert for TB, etc.) enable on-site infection diagnosis within minutes to an hour. Lateral flow immunoassays have become common for respiratory viruses, HIV, malaria, and other infections, providing results in a visually read format. The COVID-19 pandemic greatly expanded this category, familiarizing both professionals and the public with the concept of quick lateral-flow tests.
- Urinalysis and Other Miscellaneous Tests: Urine dipsticks for chemistry (glucose, ketones, etc.) are classic POCT. There are also POCT kits for pregnancy testing (urine hCG), drugs of abuse screening, fecal occult blood (for colorectal cancer screening), and even emerging tests for cholesterol and lipid profiles. Novel devices are bringing traditionally lab-bound tests (like CRP for inflammation or procalcitonin for sepsis) to the point of care. Even imaging adjuncts like handheld ultrasound or portable X-rays sometimes get lumped into “point-of-care diagnostics,” but strictly speaking, POCT usually refers to in vitro tests.
Indeed, POCT now covers everything from blood glucose to COVID-19 tests to complex molecular assays. A succinct summary from one review lists that POCT includes blood glucose and blood gas analyzers, rapid coagulation and cardiac marker tests, urine test strips, pregnancy tests, fecal occult blood, infectious disease kits, cholesterol tests, and more. This breadth of devices underscores why managing POCT is a multidisciplinary endeavor – the technologies range from simple dipsticks to sophisticated lab-on-a-chip systems. Each category brings its own requirements for quality control, result interpretation, and connectivity. For POCT professionals, understanding the device landscape (e.g. knowing the difference between a lateral flow antigen test and a PCR-based platform) is essential to selecting the right tool for each clinical need. It’s also important to stay updated on new emerging technologies (such as microfluidic lab-on-chip devices, smartphone-based readers, or biosensor wearables) which continue to expand what can be done at the point of care.
Best Practices for POCT Operations and Governance
and Governance
Implementing POCT in a healthcare organization requires robust governance and quality management to ensure these decentralized tests are as reliable and safe as those in the main lab. Over years of experience, the pathology community and regulators have established key operational best practices for POCT services:
- Clear Governance Structure: Every Trust or lab offering POCT should have a defined governance framework. This typically includes a POCT Committee or steering group with representatives from the lab (pathologists or clinical scientists), clinicians, nurses, quality managers, and IT. Lines of accountability must be crystal clear – for example, the POCT coordinator (often a senior biomedical scientist) might oversee day-to-day quality, while departmental leads ensure their staff follow procedures. The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) advises that managers of POCT services must be fully aware of their responsibilities under clinical governance, and accountability for POCT should be clearly assigned within the organization. In practice, this means having designated persons responsible for each POCT device or service, and an organogram showing how POCT oversight ties into the hospital’s clinical governance structure.
- Service Level Agreements (SLAs) with Clinical Areas: Since POCT devices often reside in wards, clinics, or GP practices, formal agreements help set expectations. An SLA between the laboratory POCT team and the user department will outline roles (who maintains the devices, who orders supplies, how results are recorded), quality requirements, and turnaround time expectations. For example, a ward may agree to perform daily quality control on their blood gas analyzer and the lab POCT team agrees to provide training, maintenance, and external quality assessment. Clearly defining these parameters ensures everyone knows how the service should run and can be held accountable to those standards.
- Training and Competency Assessment: Only trained personnel should perform POCT, and their competencies must be assessed regularly. Because POCT is often carried out by non-laboratory staff (nurses, doctors, healthcare assistants), training is absolutely critical. The MHRA guidance emphasizes arranging proper training and regular re-training at specified intervals for all POCT operators. Many organizations use online learning modules plus practical training sessions for each device. Competency assessments (e.g. annual quizzes or direct observations) help ensure that operators not only know how to run the test, but also how to maintain the device and troubleshoot errors. Documentation of training and competency is important both for patient safety and for accreditation/audit purposes.
- Device Selection and Validation: Before introducing a POCT device, there should be a documented evaluation of the clinical need and evidence for the test’s performance. As the MHRA states, “consider the available evidence for the performance of the test” and ensure it meets the clinical requirements. Once a device is chosen, method verification/validation must be done – typically the POCT team will test the new device against laboratory methods to confirm it produces accurate, reliable results in the field. This initial validation (and documentation of it) is not only a best practice but is required for ISO accreditation. Buying the “right” device (fit for purpose) and validating it is the first step in the POCT quality lifecycle.
- Quality Control and Quality Assurance: Just like in the lab, POCT devices require ongoing internal quality control (IQC) and external quality assessment (EQA). Internal QC involves running control samples (with known expected values) on the device at regular intervals (daily, or before each use, depending on the test) to ensure it’s performing within specifications. External QA (or proficiency testing) means the POCT site tests blind samples from an outside provider periodically to compare their results against a peer group or reference lab. Participating in EQA schemes is strongly recommended and often mandated – it provides an objective check that each device (and operator) is producing correct results. The importance of QA/QC is highlighted in all guidance: arrangements for QC and EQA must be in place and reviewed regularly. When QC results fall out of range or an EQA returns an outlier, there should be defined procedures for corrective action (e.g. stop patient testing, troubleshoot, alert the POCT team, etc.). Consistent QC/EQA practices give confidence that POCT results are trustworthy and comparable to lab results.
- Documentation and Records: Rigorous documentation is a cornerstone of POCT management. This includes keeping Standard Operating Procedures (SOPs) for each test (detailing how to perform the test, safety precautions, maintenance, etc.), logbooks or electronic records of instrument maintenance and QC results, records of operator training and competency, and patient result records (preferably integrated into the main laboratory or hospital information system). The MHRA guidance explicitly calls out that “clear, comprehensive record keeping and documentation is vital” for POCT. In practice, many Trusts use middleware or POCT data management systems that automatically store QC data and transmit patient results to the laboratory information system or electronic health record. Documentation also extends to incident reporting – any adverse incidents or errors involving POCT devices must be recorded and reported (for example, to the MHRA if it’s a device malfunction).
- Continuous Audit and Improvement: Regular audits of the POCT service help ensure compliance and identify areas for improvement. This might involve periodic audits of user compliance with SOPs (are ward staff doing QC correctly?), inventory audits (are test kits within expiration date?), or clinical audits on how POCT results are being used (are they improving patient pathways?). External assessments are also key: accreditation bodies (like UKAS in the UK) can assess the POCT service against ISO standards, and the MHRA recommends seeking such external accreditation of POCT services. Audit readiness should be an ongoing state – meaning the POCT program operates under the same quality ethos daily, not just scrambling when an inspection is due. Many POCT teams hold regular quality meetings to review QC trends, incident reports, user feedback, etc., to drive continuous quality improvement.
These best practices are well-recognized in the field. In fact, a 2021 review of POCT accreditation efforts highlighted that crucial areas for successful POCT management include method verification, internal/external quality assurance, operator training and competency assessment, and continuous improvement processes. In summary, a robust POCT service is one that is well-integrated with the main lab’s quality system. It benefits from laboratory expertise and oversight, even though tests are done outside the lab. By adhering to these operational best practices – clear governance, training, QC/EQA, SOPs, documentation, and regular audit – POCT services can deliver rapid results without compromising on accuracy, safety, or regulatory compliance.
Quality Standards: ISO 15189:2022 and ISO 22870 Accreditation
Quality in POCT isn’t just a local concern – it’s codified in international standards. The primary standard for medical laboratories, ISO 15189, now explicitly encompasses point-of-care testing. The latest 2022 edition of ISO 15189 has integrated the previously separate POCT standard (ISO 22870:2016) into its requirements. In other words, there is a clear expectation that accredited laboratories include their POCT activities under the same quality system umbrella. According to UKAS (the UK Accreditation Service), with ISO 15189:2022 now covering POCT, it is expected that laboratory services will extend their accreditation to include POCT, as ISO 22870 is being phased out. This is a significant development that elevates POCT to equal footing with central lab testing in terms of quality oversight.
What do these standards entail for POCT? ISO 15189:2022 (and formerly ISO 22870) lay out requirements for the competence and quality of medical testing, whether done in a lab or at the point of care. Key areas include: having a quality management system, document control, roles and responsibilities defined (e.g. a POCT manager), proper training and competency records, equipment maintenance and calibration, pre-analytical and post-analytical procedures, result reporting and data management, and participation in interlaboratory comparisons (EQA). For POCT specifically, the standards recognize the challenges: many devices across multiple sites, often operated by non-lab staff, performing tests 24/7 in various clinical settings. Therefore, the lab’s oversight and the POCT committee’s role are vital to coordinate these activities and ensure consistency.
Being “ISO accredited” for POCT means an external assessor has verified that the POCT service meets all these stringent requirements. This gives confidence to clinicians and patients that the point-of-care tests are reliable and comparable to central lab tests. It also forces an organization to keep POCT practices up to scratch – from documentation to user competency – since accreditation is an ongoing process with periodic reassessments. Many NHS Trusts and private labs in the UK are now pursuing or have attained ISO 15189 accreditation that includes their POCT scope. Laboratory accreditation used to be focused on traditional labs only, but now POCT is firmly in scope, with ISO standards driving a higher level of quality assurance across the board. For POCT professionals, familiarity with ISO 15189:2022 is increasingly important, as it essentially provides a checklist of best practices and is often used as the benchmark during audits (whether by UKAS or internal auditors). Key tips include ensuring meticulous record-keeping, risk assessments for new POCT implementations, and ongoing training/evaluation programs, all of which are emphasized by the standard.
Lastly, preparing for audits – either for accreditation or other regulatory inspections – should be part of the POCT program’s routine. This means conducting internal audits of POCT against the ISO criteria, staying updated on any changes in standards or guidelines, and fostering a culture of quality among all operators (so that, for example, a nurse on a ward understands why QC is critical and performs it correctly even when nobody is watching). In summary, ISO 15189 and 22870 frameworks provide the blueprint for a high-quality POCT service. Adhering to them is not just about getting a certificate on the wall; it’s about ensuring patient safety and confidence in every POCT result produced.
Challenges and Barriers to POCT Implementation
While the benefits of POCT are clear, implementing and expanding these services comes with a set of challenges. Professionals in the field must navigate technical, logistical, and cultural barriers to make POCT successful:
- Ensuring Analytical Quality: A persistent concern is the accuracy and reliability of some point-of-care tests compared to laboratory analyzers. In the past, certain rapid tests or small devices were less sensitive or precise, which led to skepticism among clinicians. Although technology has improved (many POCT devices now approach lab analyzer performance), perception of inaccuracy remains a barrier for adoption. Rigorous validation and correlation studies are needed to build trust in each test’s performance. Moreover, maintaining quality day-to-day is challenging when tests are run by a wide range of staff. Without strict QC and EQA, results can drift or errors go unnoticed, potentially compromising patient care.
- Integration into Clinical Workflows and IT Systems: Perhaps the biggest implementation barrier identified is integration – both into workflow and into data systems. A systematic review of POCT barriers found that the majority (59%) were related to integrating POCT into clinic/hospital workflows and systems, whereas fewer (41%) were related to test device issues like accuracy. If POCT results aren’t seamlessly integrated into the electronic health record and visible to all clinicians, they can be underutilized or even ignored. Connectivity solutions (middleware that transmits POCT results to the lab information system) are vital, but can be technically complex and costly to set up across numerous devices. Workflow integration is equally critical – for example, ensuring that when a GP or nurse gets a POCT result, there is a clear protocol on what action to take next. Lack of clear protocols, communication channels, and result linkage can impede effective use of POCT. In busy settings like emergency departments, if a POCT is not embedded in the standard process (e.g. if clinicians forget to use the device, or don’t trust its result without lab confirmation), the benefit is lost. Overcoming this requires change management – training clinicians on how to incorporate POCT into their decision-making, and adjusting workflow so that POCT becomes routine (for instance, triage nurses automatically doing a fingerstick test on certain patients).
- Regulatory and Compliance Challenges: On the regulatory side, getting new POCT devices approved and keeping up with compliance can be an obstacle for manufacturers and adopters alike. Regulatory approvals (like UKCA marking or CE marking in the UK/EU, FDA approval in the US) require evidence of safety and efficacy, which can delay the availability of new tests. For healthcare providers, compliance with regulations (for example, the UK’s Medical Devices Regulations and the in vitro diagnostic device regulation) means ensuring all POCT devices are properly validated, maintained, and used according to the manufacturer’s instructions. There may also be liability and governance issues – if a test is done at the point of care and something goes wrong, who is accountable? Organizations sometimes face internal hesitancy due to these compliance complexities. Additionally, meeting accreditation standards (as discussed above) is challenging and requires ongoing effort; some hospitals may be slow to embrace POCT because they fear they cannot meet the necessary quality requirements with current resources.
- Cost and Funding Constraints: While POCT can reduce costs downstream (by improving efficiency), the upfront costs of devices and test consumables can be higher per test than central lab tests. Analyzers or handheld devices can be expensive to deploy at scale, and each test cartridge might cost significantly more than a lab reagent test. In budget-constrained environments like the NHS, convincing finance departments to fund POCT initiatives can be difficult unless a strong business case is made. Furthermore, in some healthcare systems, lack of reimbursement for POCT (in fee-for-service contexts) is a barrier– though in the NHS this is less of an issue since it’s about internal budgets rather than billing. Still, demonstrating the health economic value of POCT (e.g. shorter hospital stays, avoided outpatient visits) is often necessary to justify the investment.
- Training and Personnel Issues: POCT decentralizes testing to many staff, and often those staff have high turnover or competing duties. Keeping hundreds of nurses across different wards consistently trained and competency-assessed is a logistical challenge. There can be resistance or human error – a busy nurse might skip a QC step or mis-time a test development, especially if they’re not fully comfortable with the device. Also, 24/7 coverage means new or junior staff on night shifts might be doing tests without immediate supervision. Ensuring a robust training program and a supportive culture where staff feel ownership of “their” POCT device is not easy. Some organizations address this by appointing “POCT champions” in each ward who act as liaisons with the lab and help keep colleagues up to standard. Nonetheless, user variability remains a risk – unlike in the lab where a small group of technicians do all tests, here a large distributed workforce is involved.
- Resistance to Change and Stakeholder Buy-In: Introducing POCT can upset established routines. Laboratory professionals may worry about losing control over testing quality, physicians may doubt results, and nurses may view it as added work. It’s not uncommon to encounter skepticism: “are these fingerprick tests really accurate?” or “we’ve always sent this to the lab, why change now?”. Cultural barriers and silo mentalities can slow adoption. Overcoming this requires engaging stakeholders early – explaining the clinical benefits, involving end-users in device selection, and demonstrating success through pilot programs. Showing data (for example, how a POCT reduced ED waiting time by 30 minutes, or how many lives were saved by quicker diagnosis) can convert skeptics into champions.
In summary, implementing POCT is not just a technical deployment, but a change management process. The challenges span technology, process integration, compliance, cost, and people factors. However, these challenges are surmountable with careful planning and support. Many early adopters have shared lessons: prioritize integration (both IT and workflow), invest in training, maintain strong lab oversight, and communicate the wins. As one study noted, improving integration of POCT into health systems – with clear protocols, QA training, and result linkage – is key to realizing its full benefits. By acknowledging and proactively addressing these barriers, healthcare organizations can avoid pitfalls and ensure their POCT services deliver on their promise.
Scaling POCT Safely: Strategies for Trusts and Labs
Given the growth of POCT and pressure to expand testing closer to patients, a common question is: how can NHS Trusts and private laboratories scale up POCT services safely and effectively? Scaling up means increasing the number of test sites, devices, and types of tests, while maintaining quality and oversight. Here are some strategies to achieve this:
- Develop a Clear POCT Strategy and Governance Early: As a Trust plans to roll out more POCT (for example, adding devices to all GP practices or community clinics), it’s crucial to have a documented strategy that aligns with clinical goals and quality requirements. This strategy should be endorsed at the executive level and tie into the organization’s overall clinical governance. It might outline which tests are prioritized for POCT (based on clinical need and evidence), how new POCT proposals are evaluated, and how the POCT service will be structured as it grows. Part of this plan should be scaling the POCT governance framework itself – e.g. ensuring the POCT committee has representation from any new areas coming on board, and that the POCT team (coordinators, quality managers) is appropriately staffed to handle a larger program. Strong governance from the start prevents the “wild west” scenario of ad hoc devices appearing without oversight. As the IBMS (Institute of Biomedical Science) noted in its national guidance, we need strategic planning to deliver POCT within a “safe, high quality and accreditable framework”, ensuring patient benefit while controlling risks. In essence, think big, but plan methodically and formalize the management structure.
- Standardize and Centralize where Possible: One way to keep scale manageable is standardization of devices and processes. If a Trust decides to deploy glucose meters trust-wide, using the same model everywhere (and linking them to a central data system) makes training and quality control much easier than juggling multiple brands. Similarly, having central oversight of inventory (so that all wards get supplies from a central stock) can ensure consistent quality of reagents and reduce costs via bulk purchasing. Connectivity should also be standardized – ideally, all POCT devices report results into the same laboratory information system or middleware, which a central team monitors. A POCT data manager system can allow a small lab team to remotely review QC, lock out devices that are due for maintenance, and gather statistics across the network. This central visibility is crucial for safe scaling; it’s not sustainable to rely on paper records scattered across many sites once POCT grows beyond a handful of instruments.
- Phase Implementation and Pilot New Tests: When expanding, it’s wise to phase the roll-out and pilot in controlled ways. For example, if introducing a new POCT (say a new troponin test in A&E), start with one or two sites, closely monitor performance and issues, refine protocols, then expand further. This allows learning and adjustment before full scale. It also prevents overwhelming the POCT team – scaling in stages ensures training and support can be given adequately at each step. Consider using early adopter sites as centers of excellence that can then mentor others (the “train the trainer” model). By piloting and gradually expanding, Trusts can scale volume without a proportional increase in errors or problems, since they are identifying and fixing issues in smaller batches.
- Invest in Training and Support Resources: A larger POCT footprint means more operators to train and more devices to maintain. Trusts should plan for sufficient POCT personnel – for instance, adding more POCT coordinators or field technicians who can visit sites, perform maintenance, and deliver training refreshers. Some large networks have regional POCT trainers who travel between community sites. Also, consider 24/7 support: if a device alarms at 2 AM in ICU, is there someone on-call who can advise? Scaling safely may require setting up a support hotline or on-call rotation for POCT issues. On the training side, leverage e-learning for basic theory, but don’t skimp on hands-on practice sessions for each device. With hundreds of users, maintaining competency is a continuous process – a learning management system can help track who has done their annual competency and send reminders. The more users and sites, the more important it is to have robust training administration.
- Maintain Rigor with Quality and Accreditation: As POCT scales, the quality management system must scale with it. This means continuing (and actually intensifying) the QC and EQA programs – more devices = more data to review. Automation can help here: use middleware that flags QC exceptions in real time so the POCT team can intervene. Regular internal audits should be scheduled across all POCT sites (perhaps using a risk-based approach to focus on the busiest or most critical ones more often). Also, ensure new devices/tests are brought under the accredited quality system. With ISO 15189:2022, when a lab extends into POCT, they will be assessed on those activities as well. Thus, when scaling, involve your quality manager and UKAS (or other accreditor) early – you may need to amend your scope of accreditation to include new POCT sites or tests. Having an accredited framework instills discipline that aids safe expansion. It forces the question “are we ready to add this test at 10 more sites while still meeting all quality requirements?” If not, slow down and fix the gaps.
- Foster a Culture of Safety and Continuous Improvement: At larger scale, the only way POCT remains safe is if the frontline operators embrace the culture of quality. Encourage feedback from users – they will often spot issues first (like a cartridge batch giving odd results). Create channels for them to report problems or suggest improvements. Perhaps hold an annual “POCT forum” where all the point-of-care staff and champions come together to share experiences and updates. Celebrating successes (e.g. “our POCT service did 50,000 tests this quarter with 99% QC pass rate”) can motivate staff and reinforce the importance of their role. Conversely, transparently addressing errors or near-misses (in a non-punitive way) will help everyone learn. The larger the POCT network, the more critical it is to have everyone pulling in the same direction on quality. Leadership should continuously reinforce that while POCT brings speed, it never compromises accuracy – both elements are essential for patient care.
Scaling up POCT is a journey many organizations are now undertaking, especially with the push for community diagnostics and rapid service delivery. Done correctly, scaling can extend the benefits of POCT to more patients and clinical areas safely. As a consultancy focused on POCT, we at POCTIFY advocate for this balanced approach: grow access to testing, but do so within a strong quality and governance framework. In practice, that means meticulous planning, adequate resourcing, and adherence to best practices and standards at every step. The payoff is huge – a scalable, high-quality POCT service can truly transform care pathways, bringing faster diagnoses and treatments to patients when and where they need them.
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