Community diagnostic centre POCT: what good looks like

What community diagnostic centres are

A community diagnostic centre (CDC) is an NHS site that carries out planned tests, checks and scans away from an acute hospital. The programme was set up by NHS England after the 2020 independent review of diagnostic capacity, published as Diagnostics: Recovery and Renewal, which recommended separating planned diagnostics from emergency work so that waiting times could come down. NHS England's guidance on the planning, design and implementation of CDCs describes them as additional, digitally connected diagnostic capacity that gives patients a co-ordinated set of tests in as few visits as possible.

In practice a CDC is a building on a hospital campus, in a community hospital, in a shopping centre or on a retail park, with imaging, physiological measurement and phlebotomy under one roof. It is commissioned through the integrated care board (ICB) and usually run by an acute trust, sometimes with a community provider or an independent sector partner delivering part of the service. A hub and spoke model is common: one large site with a full range of tests and smaller spokes that run a narrower list.

The phrase "digitally connected" is doing a lot of work. For imaging it means the scan lands in the picture archive of the referring trust. For point-of-care testing (POCT) it should mean the same thing: a result produced in the CDC reaches the laboratory information management system (LIMS) and the referring clinician without anybody retyping it. That is the standard the rest of this article works to.

Which point-of-care tests CDCs run

Most CDCs take blood and send it to the host laboratory. Point-of-care testing comes in where a same-visit result changes what happens next, where the pathway is designed as a one-stop review, or where the CDC is far enough from the laboratory that sample transport would delay the answer. The examples below are categories, not a recommended menu. What a given centre runs depends on the pathways it serves and on what its POCT committee has approved.

• Blood sciences. Small benchtop or cartridge analysers for a limited chemistry and haematology panel, used where a result is needed before the patient leaves, for example before a contrast scan or as part of a one-stop clinic.
• Cardiorespiratory. The CDC typically runs spirometry, ECG and echocardiography as physiological measurements. Some also run a cartridge blood test alongside a heart failure or breathlessness pathway.
• HbA1c. Glycated haemoglobin on a point-of-care analyser so that a diabetes review can be completed in one visit.
• Lipids. A lipid profile as part of a cardiovascular risk check, often paired with HbA1c.
• INR. International normalised ratio for patients on warfarin, where the CDC hosts an anticoagulation clinic.
• Urinalysis and pregnancy testing. Simple tests that are easy to overlook in governance terms because they look simple. A pregnancy test before imaging is a clinical decision that needs a traceable record.

Two features of a CDC make this list harder to govern than the same tests on a hospital ward. First, the centre serves patients referred from many practices and several trusts, so the result has to find its way into more than one record system. Second, the staff running the tests are often not laboratory staff and may work across several sites, so training and competency have to travel with the person, not the building.

Governance: who is accountable for POCT in a CDC

Three things set the rules for POCT in a CDC in England: the laboratory standard, the MHRA guidance, and the arrangement between the host laboratory and whoever runs the centre.

ISO 15189:2022 Annex A

ISO 15189:2022 is the standard against which the United Kingdom Accreditation Service (UKAS) accredits medical laboratories. The 2022 edition absorbed the old point-of-care standard, ISO 22870, into Annex A, "Additional requirements for point-of-care testing". Annex A makes the laboratory responsible for the POCT it supports: governance arrangements, a quality assurance programme, training and competence of the people who run the tests, and the documentation that shows all of this is happening. Confirm which accredited organisation and which scope cover the CDC's POCT; in most models the host laboratory's accreditation is extended to the CDC rather than the CDC holding its own. Where the host laboratory includes POCT in its UKAS scope, the CDC's testing is assessed as part of that scope, and the assessor will expect to see the CDC's devices, operators, quality control (QC) records and external quality assessment (EQA) performance on request. Where POCT is outside the scope, Annex A and the MHRA guidance still expect the laboratory to govern it. Our guide to ISO 15189:2022 and POCT goes through the clauses in more detail.

MHRA guidance

The Medicines and Healthcare products Regulatory Agency (MHRA) publishes Management and use of IVD point of care test devices. IVD stands for in vitro diagnostic, meaning a test performed on a sample taken from the body. The guidance is not law, but it is what a coroner, a commissioner or an incident investigator will hold an organisation to. It expects a POCT committee, a named POCT coordinator, a device selection and evaluation process, documented training, internal QC and EQA, maintenance records, a procedure for reporting adverse incidents to the MHRA, and a means of recording every result so that it can be traced to a patient, an operator and a device.

The host laboratory and the POCT committee

Accountability follows the laboratory, not the building. If a CDC is run by an acute trust, the trust's pathology service is the accountable laboratory, and its POCT committee should have approved every device before the first patient was tested. If an independent sector partner runs part of the CDC, the contract has to say which laboratory is accountable for the POCT that partner performs, who trains and assesses its operators, and where the results are held. Leaving this to be worked out later is the most common governance gap in new centres.

The POCT committee should include the laboratory, the clinical leads for the pathways that use the tests, nursing, IT, procurement and clinical governance. Its job is to approve devices and connectivity, sign off the standard operating procedures, receive QC and EQA reports, and review incidents. Where the CDC spans several sites, the committee needs a view of all of them, which is where the connectivity requirements below come in.

What the connectivity has to do

A POCT result that lives only on the analyser, or only on a printout in the patient's notes, does not meet the standard NHS England set for CDCs, and it makes the governance above impossible to evidence. The connectivity has five jobs.

Results into the LIMS and the referring clinician's record

The result should arrive in the LIMS as a result, not as a scanned document, so that it appears in the patient's pathology history next to laboratory results and so that the laboratory can see what its CDC is producing. From the LIMS, the existing laboratory-to-practice results messaging carries the result into EMIS Web or SystmOne at the referring practice, and into the electronic patient record (EPR) at the referring trust. This route is usually better than building a separate feed from the CDC to each practice, because the practice already knows how to file a pathology result. The analyser sends the result in HL7 v2, POCT1-A2 or ASTM, the three messaging standards used by point-of-care devices; our guide to connecting POCT to UK clinical systems explains the routes.

Patient identity

Every result must carry a verified NHS number, ideally scanned from the appointment list or a wristband rather than typed at the device. Where a device allows free-text patient identifiers, the middleware should reject or hold results that cannot be matched to a booked patient. Results with an unmatched identity are the main reason POCT results fail to file in the record.

Operator identity and lockout

The device should require an operator identifier, and the operator list should be managed centrally, so that someone whose competency assessment has lapsed cannot run patient tests on any device at any CDC site. Operator identity travels with the result into the record, which is what allows an incident to be investigated.

QC and EQA evidence across sites

Internal QC results should be captured from the analyser as they happen, with the control lot, and plotted on Levey-Jennings charts with Westgard rules applied. A failed QC should lock the device until it is resolved and the resolution recorded. EQA returns for each device at each site should be tracked against the scheme's deadlines and the performance reviewed at the POCT committee. All of this should be visible per site and across the network, because a laboratory that supports four CDC spokes cannot collate four paper QC folders every month.

Resilience and audit

Assess network reliability and downtime risk at each site rather than assuming hospital-grade connectivity. Connectivity should store results locally and forward them when the link returns, without losing time stamps or duplicating results. Every change to a result, an operator record or a QC record should sit in an audit trail that cannot be edited.

What goes wrong when a CDC runs POCT on paper

Centres that go live with POCT on paper, or with the analyser connected to nothing, tend to run into the same problems within the first year.

• Transcription errors. A result read from the screen and typed into a record has a known error rate. HbA1c and INR are both numbers where one wrong digit changes a treatment decision.
• Results that never reach the referrer. The CDC records the result in its own spreadsheet or in the patient's paper notes and the GP practice never sees it. The test is repeated at the laboratory, which defeats the purpose of running it at the point of care.
• QC that cannot be evidenced. Each site keeps its own QC log. Nobody collates them, so nobody notices the spoke site where QC has not been run for three weeks until the UKAS assessor asks.
• EQA registered to the wrong device. The laboratory registers the scheme, the samples go to the main site, and the analyser at the spoke never runs an EQA sample.
• Competency held by the wrong organisation. Staff employed by a partner are trained by the partner. The laboratory cannot show who is competent on which device.
• No lot traceability. When a manufacturer issues a field safety notice for a cartridge lot, the CDC cannot say which patients were tested with it.
• Audit preparation that takes days. Everything above comes together when the assessment date arrives, and the POCT coordinator spends a week assembling evidence that should have been available on demand.

None of these is a technology problem in origin. They are consequences of treating POCT in a CDC as a local convenience rather than as laboratory testing that happens to take place somewhere else.

A readiness checklist for CDC POCT

Use this table before the first patient test. Each row is a question the POCT committee should be able to answer with a document, not an assurance.

If a row has no document behind it, that is the work to do before go-live, not after.

Where software helps

POCT middleware is the layer between the analysers and the LIMS. It exists because analysers speak different protocols, because laboratories need a single place to manage operators, QC and EQA across sites, and because results need to be validated before they reach a record. For a CDC, the useful test of any product is whether it lets the host laboratory run the centre's POCT to the same standard as testing on its own wards, from a distance. The multi-site POCT management guide sets out what that means in practice.

Catenix is built for this arrangement. It connects analysers over HL7 v2, POCT1-A2 and ASTM, with an on-site gateway that stores and forwards if the network drops, and it is designed and ready to connect to the LIMS and to EMIS Web or SystmOne over open standards. Operator competency is recorded against the person who ran the test, QC is captured as it happens with Westgard rules and lockouts, EQA deadlines and investigations are tracked per device, and every site in a network is visible from one administration view. The page for hospital and public health teams describes how a pathology service uses it to support sites it does not own.

Whatever software a CDC chooses, the questions in the checklist above are the ones to put to the vendor. If a product cannot show QC evidence across sites, hold competency against people rather than devices, or put a result into the LIMS as a result, it will not close the gaps described in this article.

Questions people ask

Do community diagnostic centres need their own ISO 15189 accreditation?

No. A CDC does not hold its own laboratory accreditation. Point-of-care testing at a CDC is governed by the host pathology laboratory, which is accredited by UKAS against ISO 15189:2022. Annex A of that standard makes the laboratory responsible for governance, quality assurance, training and records for the POCT it supports. Where the laboratory includes POCT in its accreditation scope, the CDC's devices and operators are assessed as part of the laboratory's assessment.

Who is accountable for POCT when a private partner runs part of a CDC?

The contract should name the accountable laboratory. In most arrangements the host trust's pathology service remains responsible, and the partner's staff are trained, assessed and listed as operators under the laboratory's POCT policy. If the partner brings its own laboratory support, the ICB and the trust need to agree in writing where results are held, who reviews QC and EQA, and who reports incidents to the MHRA.

How do POCT results from a CDC reach the patient's GP?

The most reliable route is analyser to middleware to the laboratory information management system, then out to the practice through the existing laboratory results messaging that EMIS Web and SystmOne already receive. This avoids building a separate feed to every practice. The result files as a pathology result with the correct NHS number, operator and device recorded, rather than as a scanned letter.

Which point-of-care tests do community diagnostic centres run?

It depends on the pathways the centre supports. Common categories are small blood science panels, HbA1c and lipids for diabetes and cardiovascular reviews, INR where an anticoagulation clinic is hosted, urinalysis, and pregnancy testing before imaging. Physiological tests such as spirometry and ECG are also run but are not IVD point-of-care tests. Each test needs approval from the POCT committee and the same governance as testing on a hospital ward.

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

Yes. The MHRA guidance, Management and use of IVD point of care test devices, applies to any healthcare organisation that uses IVD devices outside the laboratory, which includes a CDC. It expects a POCT committee, a named coordinator, trained operators, internal QC and EQA, maintenance records, incident reporting and a record of every result traceable to the patient, operator and device.

Sources and further reading

• ISO 15189:2022 Medical laboratories: requirements for quality and competence
• MHRA, Management and use of IVD point of care test devices
• NHS England, Community diagnostic centres: guidance for planning, design and implementation
• NHS England, Diagnostics: Recovery and Renewal, independent review of diagnostic services for NHS England (2020)