Point-of-care testing (POCT) – defined performing diagnostic tests at or near the patient, rather than in a central lab – has radically reshaped clinical practice over the past few decades. Once limited to simple urine dipsticks and pregnancy tests, POCT now spans everything from finger-prick blood glucose meters to portable PCR machines. Its growth has been driven by a clear benefit: faster results mean faster clinical decisions. Rather than waiting hours or days for a central lab report, clinicians can often get answers in minutes, enabling immediate treatment and better patient flow . In the UK’s NHS, POCT’s role is expanding especially rapidly in the wake of COVID-19 and amid efforts to bring care closer to home. However, as POCT moves mainstream, ensuring quality, accountability, and integration is paramount. This is where robust Service Level Agreements (SLAs) and updated standards like ISO 15189:2022 come in – providing a framework to govern POCT services and uphold high standards across decentralized testing sites. In this article, we explore the evolution of POCT and its integration into clinical practice, the critical importance of SLAs for managing POCT quality, how these SLAs tie into ISO 15189:2022 compliance, and why all of this matters for the NHS’s 10-Year Plan to expand community diagnostics. We will also highlight recent statistics and UK policy developments that underscore the need for effective POCT deployment under strong governance.

In the early days of modern medicine, virtually all testing was done in hospital laboratories – meaning samples had to be sent away and results could take days or weeks . This began to change in the mid-20th century as technology miniaturized. One of the first widely-used near-patient tests was the urine pregnancy test. After decades of lab-based bioassays (like the famous frog and toad tests of the 1930s–1960s), the first home pregnancy testing kits hit the market in 1976 ³ , allowing women to get answers in privacy within hours. The 1970s and 1980s also saw the advent of portable blood glucose meters, liberating diabetic patients from daily hospital visits. By 1980, for example, digital readout glucose meters had been introduced ⁴ for home use , and by the mid-1980s self-monitoring of blood sugar was becoming common. These innovations heralded the concept of “near-patient” or “bedside” testing. In fact, the term “point-of-care testing” (POCT) was popularized ⁵ in the 1980s by Dr. John Kost and others, as hospitals started deploying handheld blood gas analyzers and other bedside devices . By the 1990s and 2000s, POCT had firmly entered clinical workflows. Critical care units and emergency departments began using portable blood gas/electrolyte analyzers and rapid cardiac marker tests to guide urgent treatment. General practitioners and community clinics started adopting desktop analyzers for common assays (like cholesterol or hemoglobin A1c), improving convenience for patients. Notably in the UK, the Department of Health and regulators recognized the need for guidance – the Medicines and Healthcare products Regulatory Agency (MHRA) issued guidelines ⁶ in 2002 on the management of POCT devices , emphasizing that POCT should be treated as an extension of the lab service. Over time, hospitals created dedicated POCT coordinators and multidisciplinary committees to oversee these devices, reflecting an understanding that quality control and training for POCT must be as rigorous as in central labs. Recent years have seen an explosion in POCT’s scope and importance, accelerated by technology advances and the COVID-19 pandemic. The miniaturization of electronics, novel biosensors, and lab-on-a-chip techniques have enabled rapid tests for a widening array of conditions . For example, modern portable ultrasound machines, lateral-flow immunoassays ⁸¹⁴ (for infections like COVID-19, flu, HIV), and even molecular devices can now deliver results at the bedside or in the field. COVID-19 itself was a massive catalyst: during the pandemic, pop-up PCR labs, mass rapid antigen testing sites, and home self-testing became ubiquitous . As one pathology leader noted, since COVID, near-patient testing “has expanded rapidly ⁹” and even universities and the public have been directly running tests – a sea-change in how we view diagnostics . In the last four years alone, POCT has advanced at an unprecedented pace ⁷ and has been recognized by NHS England as an area with huge potential to improve patient care (when properly implemented) . Today, POCT is truly integrated into clinical practice across various settings. In hospitals, clinicians use devices ranging from hand-held glucometers to cartridge-based PCR systems in emergency or maternity units. Ambulance crews and first responders carry devices to measure lactate, troponin, or INR on the go. Community pharmacies in England are piloting POCT services for conditions like strep throat and minor illnesses, supported by NHS England’s Pharmacy Integration Programme . And in patients’ own homes, self-testing for chronic disease monitoring (glucose, blood pressure, INR, etc.) is increasingly common, supported by telehealth programs. The net effect is a decentralization of diagnostics – bringing tests closer to the patient for faster decision-making and a more patient-centric approach . Studies have shown that this approach can significantly reduce treatment delays. For instance, switching a test from central lab to POCT can cut turnaround time from well over an hour to just minutes in urgent scenarios . Clinicians widely report that immediate results enable prompt interventions, which can be lifesaving in emergencies (e.g. starting antibiotics in sepsis or anticoagulation in stroke within the golden hour). It’s no surprise that surveys of GPs in multiple countries indicate a strong desire to use even more POCTs as they become available . Yet, the very traits that make POCT attractive – its decentralization and speed – also pose challenges. Variability in operator skill, environment, and oversight can impact test accuracy. This is why clinical laboratory professionals have increasingly been tasked with governing POCT programs, ensuring that quality is not sacrificed for convenience. The evolution of POCT has therefore been accompanied by an evolution in governance models, which brings us to the role of Service Level Agreements.

As POCT deployment grew, hospitals discovered that simply handing out devices to various wards or clinics could lead to inconsistencies and errors. Who is responsible if a result is wrong – the lab or the ward? How do we ensure each user is trained and each device is maintained? These questions gave rise to the concept of Service Level Agreements (SLAs) in POCT. An SLA in this context is essentially a formal contract or agreement ²² between the laboratory (or POCT service team) and the clinical service/department using the POCT device. It defines the roles, responsibilities, and expectations of each party in order to guarantee safe, reliable testing. Think of it as a roadmap for quality and accountability: the SLA spells out how the point-of-care service will be run and monitored so that it meets the same standards as the main lab. Importantly, SLAs bring clarity to who does what. A well-crafted POCT SLA will delineate things like: which tests are covered and for what clinical purpose, which devices or brands are to be used, the exact locations or wards where they can be used, and which staff are authorized to perform the tests . It will name key personnel (for example, the POCT Coordinator or laboratory lead, and the clinical lead or ward manager responsible for the testing area). The SLA then details the support the laboratory will provide – and the obligations of the clinical unit – across the entire testing process: • Training and Competency ¹⁵: The SLA will specify that all operators must be trained by the lab POCT team (or an approved trainer) and have regular competency assessments. For example, it may be agreed that the lab provides training sessions for a certain number of staff per year . It will also outline if “cascade training” is allowed (whereby super-users train others) and how new operators are documented . This ensures that anyone using the device knows how to do it correctly and safely. • Quality Control (QC) and External Quality Assessment ¹⁶ (EQA): The agreement will include how often quality control checks must be run (e.g. daily electronic or liquid QC tests) and who reviews them. It also covers enrollment in EQA (proficiency testing) schemes – for instance, an agreement that the ward will run an EQA sample provided by the lab each month to verify accuracy . The lab typically agrees to manage the EQA program and communicate results, while the clinical team agrees to participate and act on any poor performance. • Maintenance and Calibration: SLAs define how devices will be maintained and calibrated. For example, the clinical department might be responsible for routine cleaning and startup checks, while the lab arranges biannual servicing by the manufacturer . If a device requires calibration or software updates, the SLA ensures it happens on schedule. Often an external service contract is referenced, and the SLA states who coordinates repairs if the device breaks down. • Operational Use and Connectivity: Good SLAs set the rules for using the test in practice – e.g. that patient ID and operator ID must be entered for each test (to ensure traceability), and that results must transmit to the Laboratory Information System or medical record. Connectivity is a big focus now, because integrating POCT results into the patient’s electronic record is vital for patient safety and audit . The SLA may outline responsibilities for maintaining the connectivity (for example, IT support contacts and downtime procedures). • Result Interpretation and Backup: SLAs often include guidelines on result interpretation (e.g. critical result thresholds that require confirmation or follow-up) and specify when a backup lab test is needed. For instance, an SLA might state that if a POCT troponin is above a certain level or if the device flags an error, a lab sample must be sent. This ensures POCT is used to complement, not bypass, clinical judgment. • Audit and Oversight ¹⁷: The agreement will set a schedule for audits or inspections by the lab POCT team – for example, quarterly audits of user compliance, quality control records, and stock management . It will also describe the format of governance meetings or reports (many hospitals have POCT committees where SLA compliance is reviewed). The clinical area agrees to cooperate with audits, and the lab agrees to provide audit feedback and continuous improvement support. • Incident Management ⁶¹⁹: If there is a quality incident (like a misdiagnosis linked to a POCT result or an equipment malfunction), the SLA outlines how it will be handled jointly. Typically, devices involved in incidents are to be quarantined and investigated with lab involvement . Clear escalation pathways are defined so that patient safety issues are addressed immediately and systematically. • Review and Cost ²⁰: Lastly, an SLA will have provisions for periodic review (e.g. an annual review meeting to update the agreement based on new guidelines or technologies) . Any cost arrangements may also be included – for instance, if the lab is providing the testing cartridges or maintenance, the SLA might note how those costs are covered by the clinical directorate . In essence, the SLA formalizes the partnership between the lab and the point-of-care testing site. It ensures that both sides understand their duties. The laboratory, as the clinical governance expert in diagnostics, typically provides the quality framework: training, QC/EQA oversight, protocols, and expert consultation. The clinical service (be it an A&E department, an ICU, a GP practice, or a pharmacy) agrees to operate the devices within that framework: only trained staff will perform tests, QC will be run and documented, maintenance schedules followed, and so on. This way, even though testing is decentralized, the accountability loop is closed – the lab remains accountable for overall quality, and the users are accountable for following the quality procedures. The importance of SLAs was highlighted in a 2008 international article on POCT implementation, which noted that having service level agreements in place helps embed POCT into hospital practice safely . More recently, a UK expert group emphasized that clear governance and role definitions (via agreements) are among the key success factors for effective POCT in new settings like community diagnostic hubs . In fact, the Canadian Society of Clinical Chemists went so far as to recommend that the necessary laboratory support for any POCT program “should be formalized in a service level agreement” to delineate roles and required resources for quality . Without an SLA, there’s a risk of confusion – for example, a ward might assume the lab is looking at their QC data, while the lab assumes the ward is doing it, leaving a dangerous gap. The SLA prevents these gaps by explicitly assigning each task. To illustrate, consider an example: A busy Accident & Emergency department wants to use a new troponin POCT device to rapidly rule-out heart attacks in chest pain patients. An SLA is drawn up between the Pathology department and A&E. It specifies the device model and that it will be used for adult chest pain patients under a certain protocol. The lab agrees to provide initial training for all A&E nurses and annual refreshers; the lab will also supply quality control materials and enrollment in an external quality scheme. The A&E department agrees that only trained nurses or doctors will use the device and that they will perform an electronic QC test at the start of each day’s shift, documenting it in the device’s memory. The SLA states that the device is connected to the hospital’s IT system, so results automatically go into the patient record, and if connectivity fails, the procedure is to print and manually chart results until fixed. It might also note that if a troponin result is above a certain cutoff, the lab must be phoned and a venous sample sent for confirmation in the central lab. Both the lab POCT coordinator and the A&E lead nurse sign the SLA. Now, if an auditor asks “How do you know your A&E troponin tests are reliable?”, the SLA-backed program can demonstrate: all users are trained and on a competency register, QC is done daily with records saved, the device is checked by lab staff monthly, and it’s all under an agreement aligned to quality standards. This greatly reduces clinical risk while harnessing the benefit of rapid testing. In summary, SLAs in POCT are about ensuring consistency, safety, and clarity in an inherently distributed testing model. They translate the medical laboratory’s quality management practices out to the point of care. As POCT expands to more users (some of whom may not have a lab background), SLAs become even more crucial. They serve as the backbone of governance, so that a glucose result obtained on a ward glucometer at 3am is just as trustworthy as one from the biochemistry lab at noon. Given this importance, it’s no surprise that the latest accreditation standards have codified the need for such agreements – which we explore next.

Medical laboratories have long been governed by the ISO 15189 standard – a globally recognized benchmark for quality and competence in medical lab services. Until recently, POCT was addressed in a companion standard (ISO 22870) separate from the main lab standard. However, with the publication of ISO 15189:2022, POCT is now fully integrated ^23242528 into the main standard . This is a significant shift in the accreditation landscape: any accredited medical laboratory must now include lab-supported POCT within its quality system and meet specific POCT requirements, rather than treating POCT accreditation as a standalone add-on. In practical terms, ISO 15189:2022 compels labs and institutions to apply the same rigor to POCT that they apply to in-lab testing – reflecting how ubiquitous and important POCT has become. One of the overarching themes of ISO 15189:2022 is that it is “risk-based” and “patient-focused”, encouraging continuous improvement . The standard writers explicitly made it a patient-centered standard, meaning that wherever tests are performed (lab or bedside), the processes should be designed to minimize risk to patients and ensure result quality . By integrating POCT, the standard acknowledges that poor control of a point-of-care test can be just as risky as poor control of a central lab test – an inaccurate result is harmful no matter where it’s produced. Therefore, quality and governance expectations have been elevated for POCT services under ISO 15189:2022. A key requirement in the new standard is the establishment of formal agreements and governance structures for POCT. Specifically, ISO 15189:2022 mandates that service agreements exist ²⁶ between the laboratory and the clinical areas using lab-supported POCT . The wording (clause 6.7.2) states that these agreements shall ensure that respective responsibilities and authorities are specified and communicated . This is essentially the standard’s endorsement of the SLA concept we discussed. It means an accredited lab cannot just have ad hoc POCT scattered around without documentation – there must be defined agreements in place that, for example, spell out who is responsible for training, who runs QC and how often, who maintains the device, etc., in each location where POCT is used. By requiring this, ISO 15189:2022 is driving a culture of accountability and clarity in POCT management. The new standard also suggests using multidisciplinary POCT committees ^2729303132 to oversee these service agreements . Annex A of ISO 15189:2022 is dedicated to additional POCT requirements, and it recommends that a committee including laboratory professionals and clinical representatives manage the POCT program and its agreements . The idea is to promote a structured approach: decisions on device selection, validation, training programs, and quality monitoring for POCT should be made collaboratively and formally. This multidisciplinary oversight echoes best practices already in use in many NHS trusts – for instance, a hospital might have a POCT steering group that meets quarterly to review QC reports and incidents from all POCT sites, ensuring any issues are addressed across the board. Another impact of ISO 15189:2022 is the retirement of ISO 22870 (POCT standard). Since POCT is now in the main standard, ISO 22870:2016 is being withdrawn ²³ . For laboratories, this simplifies accreditation (one standard instead of two), but it also removes any notion that POCT can be treated with different or lower requirements. All requirements of ISO 15189 apply to POCT devices and processes. This includes, for example, personnel competency (Clause 6.2) – labs must ensure “all personnel, including those involved in POCT, are competent” – and facilities and environmental conditions (Clause 6.3) – ensuring even the areas where POCT is done are suitable and safe for testing . It also covers reagents and consumables management (POCT reagents must be properly stored and quality checked just like lab reagents) , and the examination process and quality assurance (POCT results must be documented with operator identity, and POCT methods must participate in EQA programs with an appointed quality lead) . In short, ISO 15189:2022 is embedding quality management into every nook and cranny of POCT operations. For NHS laboratories and trusts, moving to ISO 15189:2022 means taking a fresh look at their POCT governance and often tightening up practices. Many UK labs that are UKAS-accredited have already been doing much of this (the UK has been a leader in ensuring POCT is under lab supervision). But the new standard might reveal gaps, for instance: Are there any clinics doing their own testing without an SLA or lab oversight? Those will need to be brought into the fold of the quality system. The standard encourages risk assessment and justification for any deviations. For example, if a certain POCT process doesn’t strictly meet a particular requirement, the lab can justify it based on patient risk – but it must be documented. This flexible yet rigorous approach fits well with the NHS’s focus on patient safety and risk management. To illustrate the practical changes, consider the following scenario under ISO 15189:2012 (old standard) vs ISO 15189:2022 (new): Under the old system, a trust might have run a glucose testing service in community clinics under ISO 22870 accreditation, while the main lab was ISO 15189 accredited separately. Some smaller testing (like urine dipsticks on wards) might have been informal with just local procedures. Now, under ISO 15189:2022, all those tests – the community clinic glucometers, the ward dipsticks, the GP surgery instrument that the lab supports – are all within the lab’s quality scope. The lab must have documents (policies, SLAs, etc.) that cover them and must audit them as part of accreditation. If an inspector walks into a GP office that uses an NHS lab’s device, the inspector can ask to see the service agreement and training records, and the lab is accountable for those. This elevates accountability significantly and should drive improvements. Labs will ensure every POCT site is monitored, that results from those devices are traceable and included in quality reports, and that any non-conformances (e.g. an expired QC or a trend of QC failures) are captured in the lab’s incident system. From a broader perspective, ISO 15189:2022’s integration of POCT is timely. The number of POCT devices in use has ballooned, and their technology has become more complex – including PCR machines and devices capable of critical clinical decisions. Placing these under a unified quality framework helps maintain trust in results. As Annette Thomas (National Clinical Lead for POCT in Wales) recently noted, updated guidance and accreditation standards are essential to provide quality assurance and safeguard patient safety in the expanding landscape of POCT . The new ISO standard is one such safeguard, pushing laboratories to extend their quality management to wherever the testing happens. In summary, ISO 15189:2022 significantly raises the quality bar for POCT by embedding it in the main lab accreditation standards. It emphasizes formal agreements (SLAs) and governance, staff training/competency, proper environments, and quality assurance for POCT. For NHS labs and POCT teams, complying with this updated framework might require extra effort – like drafting SLAs where they didn’t exist, training more staff, enhancing connectivity, and conducting risk assessments on all decentralized testing. But ultimately, it strengthens accountability and ensures that as we decentralize testing, we do not decentralize quality. This leads to our final topic: why all of this – the growth of POCT and the push for quality – is critical to achieving the NHS’s strategic goals for the future.

The NHS Long Term Plan ¹¹ (a 10-year plan published in 2019) set out a vision for transforming healthcare delivery in England. A core theme was “care closer to home” – moving away from a hospital-centric model toward more community-based services . This includes a significant expansion of community diagnostic capabilities, so that patients can get tests and results in convenient local settings, avoiding unnecessary hospital visits. In practice, this vision has materialized through initiatives like the creation of Community Diagnostic Centres (CDCs) ⁴⁵ – one-stop shops for imaging, blood tests, and other diagnostics in retail parks or community hospitals – and empowering primary care and pharmacy services to manage more testing. Point-of-care testing is a linchpin technology in this strategy, because it enables rapid diagnostics without the need for full laboratory infrastructure on site. NHS England explicitly recognizes the role of POCT in the Long Term Plan. For example, the Long Term Plan highlights the need for more adaptive, community-based approaches and notes that integrating POCT devices in the healthcare system will help achieve the goal of care closer to home . By equipping community providers with reliable near-patient tests, patients can get immediate answers and treatment in their GP practice or local CDC, rather than being referred to hospital for diagnostics. This not only improves patient experience but also helps reduce the load on overstretched hospital labs and clinics. One concrete piece of policy is the Community Pharmacy Contractual Framework 2019-2024, where NHS England committed to explore POCT by community pharmacists as part of expanding clinical services in pharmacies . We’ve seen pilots of pharmacies offering lipid profiling, HbA1c for diabetes screening, or COVID testing – all forms of POCT – under appropriate supervision. Similarly, the NHS England guidance document on POCT in community pharmacy provides standards for safe implementation, echoing the “buy it right, use it right, keep it right” principles for devices . These developments align with the Long Term Plan’s emphasis that shifting diagnostics into the community must be done safely. Without quality oversight, moving tests out of the lab could lead to errors, so the NHS is focusing on governance as much as on technology.

The push for community diagnostics via POCT is also driven by urgent practical needs. The NHS is facing a diagnostics backlog and capacity challenge. As of early 2024, nearly one in five patients in England were waiting more than 6 weeks ³⁶³⁷ for a key diagnostic test like a CT or MRI scan – about 95,800 patients waiting beyond the target in January 2024 . Moreover, the overall number of people waiting for any diagnostic test has grown significantly in recent years (routinely around 1.5–1.6 million people ³⁸³⁹ waiting each month) as demand outstrips hospital capacity . This backlog has serious implications: delayed diagnoses can lead to worse outcomes and prolonged patient anxiety. In response, the NHS has been investing heavily in expanding diagnostic capacity outside traditional hospitals. The government announced a £2.3 billion ⁴⁰ investment to create over 160 Community Diagnostic Centres (CDCs) across England . As of mid-2025, roughly 90 of these CDCs are operational ⁴⁰, offering scans, blood tests, and other checks in community settings . It’s touted as the largest-ever centralized investment in NHS diagnostic infrastructure, aiming to deliver millions more tests per year and reduce waiting times. These CDCs are designed with an eye towards innovation – including incorporating POCT for certain assays. For example, a CDC may have POCT devices to perform routine blood tests on-site so that results are ready during the same patient visit, or to do a quick D-dimer or troponin to help triage a patient without sending samples to a distant lab. However, expanding POCT into these new settings comes with the challenges we discussed earlier: ensuring governance, training, connectivity, and quality consistency. The Independent Review of Diagnostic Services (the Richards Report, 2020) noted that while POCT has great potential to support new care pathways, key barriers include “appropriate governance for quality control, staff training, calibration of equipment, and results connectivity” . In other words, simply buying analyzers for your CDCs or GP hubs won’t succeed unless you also implement the structures (like SLAs and IT links) to support them. Thus, the NHS’s strategy involves both investment in devices and investment in quality infrastructure. This is where SLAs and ISO 15189 compliance become crucial on a system level. As diagnostics move into dozens of new community sites, NHS organizations are replicating the lab-and-POCT partnership model across each site. For instance, if a pathology network supports several CDCs in its region, it will have SLAs or service contracts in place with each CDC specifying what tests can be done on POCT, quality checks, result transmission, etc., all aligned to the standards. Pathology networks (consolidated lab groups serving multiple hospitals) are often taking the lead, extending their POCT expertise into the community. According to a recent report from NHS England’s Southeast POCT Network, structures and processes have been established in that region to oversee the expanding range and location of POCT, including communities, and provide “key pointers” for success . Those pointers invariably involve formalizing roles and ensuring every testing site is within the accredited quality system. For NHS decision-makers, robust SLAs and quality frameworks are not just bureaucratic nice-to-haves – they are enablers of the 10-Year Plan. They give confidence that moving tests out of the acute hospital will not compromise patient safety. Healthcare professionals and regulators need to be assured that a creatinine result from a community hub is as valid as one from the main lab, otherwise trust in these new pathways erodes. Sir Mike Richards, in his review, envisioned networks of community diagnostic hubs that could take significant pressure off hospitals, but he also cautioned that quality and information integration must be addressed hand-in-hand . By enforcing compliance with standards like ISO 15189 and demanding SLAs, the NHS is effectively saying: we will decentralize, but we will do it in a controlled way.

When implemented correctly, POCT in the community and at the bedside offers tangible improvements that align with NHS goals. A primary metric is turnaround time (TAT) – the time from test to result. POCT can dramatically shrink TAT for many tests. For example, a study in an emergency setting showed that moving a test from the central lab to a point-of-care device cut the median turnaround from about 87 minutes down to just 5 minutes ¹³ . Another UK example comes from Cornwall, where a hospital trust deployed compact hematology analyzers in both the acute hospital and community clinics to test for infections. As a result, patients received CRP (C-reactive protein) results in 4 minutes ⁷ … on-site, enabling immediate differentiation between bacterial vs viral illness – and importantly, many patients avoided a long trip to the main hospital for tests . Rapid results not only improve patient experience (shorter waiting and anxiety) but also contribute to system efficiency (faster decision-making means potentially shorter admissions or avoidance of referrals). The NHS Long Term Plan also emphasizes preventive care and chronic disease management, where POCT can play a role. For instance, regular monitoring of conditions like heart failure or diabetes can be shifted to community care with POCT devices, freeing specialists’ time. Virtual wards ¹⁸¹¹ (an initiative to care for patients at home with remote monitoring) often rely on near-patient tests for things like measuring oxygen levels, INR, etc., to decide if a patient can stay at home or needs escalation. This is again facilitated by reliable POCT under lab oversight . All these improvements hinge on the trustworthiness of POCT results. This is why a recurring theme in NHS policy documents is quality assurance. NHS England has published a National Point of Care Testing “At Point of Need Testing” guidance in 2023 (often referred to in hospital policies ), and professional bodies like the Royal College of Pathologists and Institute of Biomedical Science have released position papers on POCT governance. The consensus is that we must standardize training, ensure connectivity of POCT into patient records, and maintain external quality checks. Notably, the RCPath’s July 2025 Bulletin on POCT features numerous articles on ensuring quality in community POCT and learning from national efforts , showing how front-of-mind this is for lab professionals. It’s worth highlighting that POCT is not a silver bullet for all diagnostic issues – it complements central labs but doesn’t replace the need for complex testing and expert interpretation. For example, while a rapid D-dimer test might be done in a CDC to rule out blood clots on the spot, a positive test may still require a full lab assay or imaging confirmation. SLAs typically address such contingencies, clarifying when follow-up lab tests are needed. This integrated approach ensures the NHS’s push for innovation does not come at the cost of diagnostic accuracy.

Point-of-care testing has come a long way from its humble origins; it is now an integral part of modern healthcare delivery. For clinical laboratory professionals and NHS decision-makers, the task at hand is to harness POCT’s benefits – speed, convenience, patient-centric care – while rigorously managing its quality. The history of POCT’s evolution teaches us that technology alone is not enough; the systems and agreements surrounding its use are what determine success or failure. Service Level Agreements have emerged as a cornerstone of those systems, translating the lab’s quality culture to every clinic, ward, or pharmacy that adopts near-patient tests. They ensure that everyone knows their role in delivering accurate results, from calibration of devices to training of operators. The alignment of SLAs with ISO 15189:2022 marks a new era of accountability. Quality and accreditation standards are catching up with clinical innovation, effectively saying that every point-of-care result is a lab result and should be treated with the same care. This melding of POCT into the accredited framework is timely as the NHS scales up community diagnostics. By enforcing robust SLAs and quality management, the NHS can confidently expand access – bringing tests to the patient, in line with the 10-Year Plan – without “bringing down” the quality of those tests. For NHS decision-makers, investing in POCT is not just about buying devices; it’s about investing in training programs, connectivity infrastructure, and personnel (like POCT coordinators) who form the bridge between the lab and the community. The pay-off can be substantial: shorter diagnostic waiting times, more proactive care, and potentially cost savings from issues caught early. For example, quick POCT in primary care can reduce unnecessary referrals or admissions, which is both patient-friendly and cost-effective. The NHS spends over £6 billion a year on diagnostic services delivering about 1.5 billion tests ; even small efficiency gains or shifts to lower-cost community settings can translate into huge impacts. Moreover, as we face workforce pressures (shortages of laboratory scientists and clinicians), using technology wisely via POCT can help triage demand, focusing lab resources on the most complex cases and automating simpler tests at the point of need. In the coming years, we can expect POCT technology to continue advancing – from molecular tests for infectious diseases at GP surgeries to biosensors for real-time monitoring of chronic conditions at home. The NHS is likely to incorporate these into pathways as evidence of benefit grows. Each step will require careful evaluation and often, yes, another SLA or protocol update. We may also see more networked POCT solutions: devices connected to AI-driven decision support, or regional POCT data systems that allow benchmarking of quality across sites. The good news is that the framework being built now – with ISO 15189:2022 compliance and a culture of strong SLAs – is creating a solid foundation for this innovation. It embeds a mindset that even if a test is done in a village pharmacy, it’s part of a bigger picture of care and quality. For healthcare professionals, especially those in laboratory medicine, embracing POCT does not mean letting go of quality control – quite the opposite. It means expanding our domain to ensure every drop of blood tested anywhere in the NHS meets the standard our patients deserve. Pathology leaders are indeed “rising to the challenge,” sharing best practices on governance and recalling lessons from past experiences (for instance, the early “wild west” days of glucometers) to inform the future . As one NHS POCT lead put it, we are witnessing a “sea-change in expectations ⁹ of, and attitudes to, testing”, and it’s incumbent on us to guide that change responsibly . In conclusion, POCT, coupled with robust SLAs and guided by ISO 15189:2022, is a critical enabler for the NHS’s ambitions to deliver faster, closer, and more personalized care. The synergy of technology and quality governance will determine how successful these efforts are. Thus far, the trajectory is promising: early data from new community diagnostic models show improved access and patient satisfaction, and the fact that nearly 160 CDCs are planned is evidence of policy confidence . The continuing challenge will be to maintain high standards as volume and complexity grow. By keeping quality at the center – through continuous training, audit, and updating of agreements – the NHS can ensure that the “right test, right time, right place” mantra of POCT does not compromise the right result.