Pharmacy point of care testing UK: governance and results flow

The context: Pharmacy First, blood pressure checks and prescribing

Community pharmacy in England has taken on clinical work that would have been unusual ten years ago. Four developments explain why point-of-care testing (POCT) is now a live question for pharmacy owners and superintendent pharmacists.

Pharmacy First

NHS England launched Pharmacy First in January 2024. It allows pharmacists to assess and, where appropriate, supply prescription-only medicines for seven conditions: acute otitis media, impetigo, infected insect bites, shingles, sinusitis, sore throat and uncomplicated urinary tract infection in women. The pathways are clinical assessment protocols and do not require laboratory tests, but they have put pharmacists in the position of making decisions that a test could inform.

Blood pressure checks and hypertension case-finding

The NHS Community Pharmacy Blood Pressure Check Service offers clinic blood pressure measurement to adults, with ambulatory blood pressure monitoring where the clinic reading suggests it, and referral to the GP where hypertension is suspected. Results go to the patient's GP practice. It is the largest case-finding programme run through pharmacies and the one that has done most to make routine reporting from pharmacy to practice a normal part of a service.

Independent prescribing

From 2026, under the General Pharmaceutical Council's (GPhC) revised initial education and training standards, newly registered pharmacists are expected to qualify as independent prescribers at the point of registration. NHS England's Community Pharmacy Independent Prescribing Pathfinder Programme has tested prescribing services in pharmacies ahead of that change. A prescriber who can start or adjust treatment has more reason to want a test result at the counter than a pharmacist who can only refer.

Sore throat testing

In Wales, the national Sore Throat Test and Treat service has combined a clinical score with a rapid antigen test for group A streptococcus in pharmacies for several years. In England, the Pharmacy First sore throat pathway is based on a clinical score, and rapid testing has been explored in pilots rather than commissioned nationally. Details of what is commissioned change; check the current NHS England service specifications rather than relying on a summary.

Which point-of-care tests are realistic in a community pharmacy

A pharmacy has a consultation room, a pharmacist and a technician, no laboratory, and a footfall that makes testing commercially interesting. Not every test that exists in a portable format belongs on that counter. The realistic list is short.

• Blood pressure. A validated upper-arm monitor, and an ambulatory monitor for the blood pressure check service. Not an in vitro diagnostic (IVD) test, but it raises the same questions about identity, records and reporting to the GP.
• Lateral flow tests. Rapid antigen tests for group A streptococcus, influenza, COVID-19 and respiratory syncytial virus, read visually or on a small reader. Simple to run, easy to misread, and the result still needs to be recorded somewhere.
• CRP. C-reactive protein on a small analyser or cartridge, used in pilots to support respiratory infection consultations. This is a quantitative IVD test and carries the full governance load described below.
• HbA1c, lipids and glucose. Glycated haemoglobin and a lipid profile on a benchtop analyser, mostly for private health checks and for NHS Health Check delivery where a pharmacy is commissioned to provide it.
• INR. A small number of pharmacies run anticoagulation monitoring under a local agreement with the practice or the anticoagulation service.
• Urinalysis. Dipsticks, visually read or on a reader, for private services and some local pathways.

What is not realistic is any test where the pharmacy cannot show a verified device, a trained operator, a quality control (QC) record and a route for the result to reach the patient's GP. The next section explains why that bar exists.

The governance gap

In a hospital, point-of-care testing is supervised by the pathology laboratory, which is accredited by the United Kingdom Accreditation Service (UKAS) against ISO 15189:2022. Annex A of that standard makes the laboratory responsible for the POCT it supports. A community pharmacy usually has no host laboratory. Nobody is verifying the analyser, running the external quality assessment (EQA) programme or reviewing QC unless the pharmacy arranges it. That is the gap.

The Medicines and Healthcare products Regulatory Agency (MHRA) guidance Management and use of IVD point of care test devices applies regardless. It is written for any organisation that uses IVD devices outside a laboratory, and it expects a named person responsible for POCT, documented training and assessment of operators, internal QC, participation in EQA, maintenance, and a means of recording every result against the patient, the operator and the device. The GPhC's standards for registered pharmacies require that services are delivered safely and that staff are competent for the tasks they perform, which is the same expectation stated in the pharmacy regulator's terms.

Four things are harder in a pharmacy than in a hospital.

• Competency. The pharmacist trained on the analyser is the pharmacist on duty most days, until a locum covers. Training records need to exist per person, per device, with reassessment, and the locum should not run patient tests unless they are on the list.
• QC on a single device. With one analyser there is no second device to compare against when a result looks wrong. Internal QC with two levels of control, charted over time, is the only evidence the device is behaving. Storing control material within its temperature range is a real problem in a pharmacy without a monitored fridge.
• Verification. Before the first patient test, someone has to show the analyser performs as the manufacturer claims in that pharmacy's hands. Without a laboratory, this is usually done with control material and an EQA sample, and it needs to be written down. Our guide on verifying a new POCT analyser describes the minimum.
• Lot traceability. When a manufacturer recalls a cartridge lot, the pharmacy needs to list the patients tested with it. That means recording the lot against every result, not on the box.

Some pathology laboratories offer POCT support to pharmacies under a service agreement, covering verification, EQA registration and QC review. Where that is available it closes most of the gap and is worth asking the local laboratory about before buying a device.

How results reach the GP record today

A test result that stays in the pharmacy is of limited value and a risk if the patient later presents elsewhere. The routes available today are uneven, and they depend on the service, the pharmacy's clinical system and the GP practice's system.

• Paper. A printout or a handwritten card given to the patient to take to their practice. Still common for private tests. It relies on the patient and it arrives, if at all, as a scanned document.
• NHSmail. A message from the pharmacy's shared NHSmail account to the practice's generic mailbox, which the practice then codes into the record by hand. This is the fallback for most commissioned services and it works, at the cost of practice staff time and transcription risk.
• GP Connect Update Record. NHS England has been introducing GP Connect Update Record so that a pharmacy's clinical system can write a structured consultation record directly into the patient's GP record, in EMIS Web or SystmOne, for services such as Pharmacy First and the blood pressure check service. Where it is available and enabled at both ends, it removes the retyping. Its coverage of test results, as opposed to consultation summaries, depends on the service specification and on what the pharmacy's system sends; confirm the current position with the system supplier rather than assuming a numeric result will file as a result.
• Direct integration. For private services, some pharmacies use a platform that produces a structured result message and a letter to the GP. Whether the practice files it as a pathology result or as a document is a local decision.

The practical point is that the result should be recorded once, in the pharmacy, against a verified NHS number, with operator, device and lot attached, and then sent onwards by whichever route is available, without being typed a second time. Our guide to connecting POCT to UK clinical systems sets out the messaging routes and what each requires.

What good looks like

A pharmacy that runs POCT well looks like a small laboratory site in its records, even though it has no laboratory. In particular it has the following.

• A device register listing each analyser, its serial number, its verification file and its service history.
• A standard operating procedure for each test, covering patient identification, sample collection, running the test, what to do when the device flags an error, and how the result is recorded and sent on.
• A named POCT lead, usually the superintendent or a designated pharmacist, who reviews QC and EQA and owns the incident process.
• A competency record for every person who runs a patient test, with the assessment date and the reassessment due date, and a rule that locums are added before they test.
• Internal QC run on a defined schedule and on every new lot, charted, with a written response to any failure and the device out of use until it is resolved.
• Registration with an EQA scheme for each quantitative test, with returns made on time and performance reviewed.
• Every result recorded against the patient's NHS number with the operator, device, lot and time, and sent to the GP by the best available route within a defined period.
• A monitored fridge for controls and reagents that need one, with a temperature log.
• An incident procedure that includes reporting device faults to the MHRA.

None of this requires a laboratory. It requires a decision to treat testing as testing, and a system that makes the records a by-product of doing the work rather than a separate job.

A checklist for pharmacy POCT

The table gives a minimum and a better position for each area. The minimum is what an inspector or an investigating body would expect to see; the better column is what makes the service sustainable once volumes grow or a second branch starts testing.

Where software helps

POCT software for a pharmacy has to do what a laboratory's middleware does for a hospital, without a laboratory behind it. That means capturing the result from the analyser so nobody types it, holding competency and QC rules that stop a test being run when they are not met, tracking lots and expiry, and producing the message or letter that goes to the GP. For a group of pharmacies it also means one view across every branch, so the superintendent can see QC status and EQA deadlines without phoning each shop.

Catenix is designed for testing sites that do not have a laboratory on the premises. It connects analysers over the standard messaging protocols, captures QC as it happens with Westgard rules and lockouts, records operator competency against the person who ran the test, tracks inventory by lot and expiry with a recall impact report, and produces GP letters and structured results that are designed and ready to connect to EMIS Web and SystmOne over open standards. The community and distributed diagnostics page describes the model. Pricing is a subscription per site with no per-test fee, which matters for a service whose volumes are uncertain at the start.

Whichever product a pharmacy chooses, the checklist above is the specification. A system that cannot capture the result electronically, hold QC and competency, and get the result to the GP without retyping will leave the governance gap open.

Questions people ask

Can a community pharmacy in the UK do point of care testing?

Yes. There is no rule preventing it, and NHS services such as the blood pressure check service and Pharmacy First already involve measurement and assessment at the counter. What applies is the MHRA guidance on IVD point of care test devices and the General Pharmaceutical Council's standards for registered pharmacies, which together expect a responsible person, trained operators, quality control, EQA participation, maintained devices and a record of every result.

Does the MHRA guidance on point of care testing apply to pharmacies?

Yes. The guidance, Management and use of IVD point of care test devices, is written for any organisation that uses in vitro diagnostic devices outside a laboratory, and a pharmacy is one. It is guidance rather than regulation, but it is the standard an inspector, a commissioner or an investigator will apply if a result is wrong or a device fails.

How do pharmacy test results reach the GP?

By paper given to the patient, by NHSmail to the practice's generic mailbox, or, for services where it is enabled, through GP Connect Update Record, which writes a structured record from the pharmacy's system into EMIS Web or SystmOne. Coverage varies by service and by system. The safest approach is to record the result once in the pharmacy against the NHS number and send it onwards without retyping.

Do pharmacies need to run quality control on a CRP or HbA1c analyser?

Yes. Define the QC levels, frequency and lot-change checks from the manufacturer's instructions and a documented quality plan (two levels on a set schedule and at each new reagent lot is a common pattern), and keep and review the results. With only one device in the pharmacy, QC is the only evidence that the analyser is performing, so a failed QC should take the device out of use until it is resolved. EQA registration is expected as well.

Is a blood pressure check a point of care test?

Not in the in vitro diagnostic sense, because no sample is taken from the body. A blood pressure monitor is a medical device rather than an IVD, so the MHRA POCT guidance is not written for it. The governance questions are the same, though: a validated device, a trained operator, a verified patient identity, a recorded result and a reliable route to the GP record.

Sources and further reading

• NHS England, Pharmacy First
• NHS England, Community Pharmacy Blood Pressure Check Service
• MHRA, Management and use of IVD point of care test devices
• ISO 15189:2022 Medical laboratories: requirements for quality and competence
• General Pharmaceutical Council, Standards for registered pharmacies