Pathology diagnostic pillar

The pathology diagnostic pillar consists of pathology test requests and orders made electronically only.

It does not include:

• pathology test requests and orders made via manual/paper methods
• pathology diagnostic devices that do not connect to the clinical network

Pathology refers to the study of the causes and diagnosis of diseases by examination of surgically removed organs, tissues (biopsy samples), bodily fluids and, in some cases, the whole body (autopsy). These samples are collected from patients and sent to laboratories for testing. On completion, the results are sent back to the request originator. The process can be done electronically or manually (paper) but this pattern will focus only on electronically transmitted pathology test data flows.

Pathology test requests and orders fall into 1 of 4 use cases.

GP/primary care to laboratory

Orders are sent electronically from the surgery via an interoperability licence web portal into the local order and results system - for example, CliniSys Integrated Clinical Environment (ICE). Orders are then passed to the laboratory information management systems (LIMS). The connected medical device (CMD) identified in this use case is the LIMS which is delivered either as an on-premises solution or as a cloud-based software as a service solution.

Testing for inpatient samples can be undertaken within the hospital – orders may be sent electronically from the trust's electronic patient record (EPR) system to their in-house lab LIMS systems, or via an order and results middleware. Samples (with appropriate documentation) are sent to the lab by internal handling processes. Once the lab has performed the test(s) the results are returned to the requesting department, electronically if possible.

Outpatient tests

Outpatient test requests (orders) can also be sent following a process similar to that of inpatients (see above). There is no CMD identified as part of this use case.

Laboratory to laboratory

Test requests (orders) received at one lab may be referred to second lab because, for example, specialist tests are not available at the first lab or because there are advantages (such as cost savings) in collaborative working between labs using National Pathology Exchange (NPEx) as message translation middleware. The CMD identified in this use case is the laboratory LIMS.

Point-of-care testing (POCT)

POCT can be performed by the patient, carer or health professional in any location using a kit or small handheld analyser. These can be used, for example, to measure blood glucose or warfarin levels. Connected devices transfer result information from the device into either the LIMS or directly into the EPR via a device manager/POCT middleware system. In some cases, result information may be imported into a POCT middleware system via a mobile app or integrated telephony system. The POCT in this use case is the CMD.

The pathology diagnostic pillar or pathology 'ecosystem' consists of all components that are involved in the end-to-end pathology diagnostics data flow. This comprises ordering, sample collection and transmission, and reporting. To improve the security posture of the clinical network, these components should be segmented on the network.

These components can be grouped in the following categories:

Pathology application services – Consist of order request systems used by patient care teams to request pathology testing for a patient.

Message Exchange for Social Care and Health (MESH) – NHS England supports the digital reporting of pathology test results from NHS laboratories to GPs with MESH. This is the main file transfer service used to send large files (20GB+) across health and social care organisations that cannot be sent over NHSmail.

National Message Assurance Service (NMAS-R) – NMAS-R is a fully automated service that checks the validity of incoming messages and performs clinical governance message checking. There is only one NMAS-R instance in the NHS. NMAS-R is a Data Transfer Service.

Order and results application - An order and request system (ICE for example) is a software application used to manage requests and orders for various patient related tasks made by entities such as GP surgeries or NHS trusts. In pathology they are used to manage test requests/orders sent to laboratories, the testing process, and distribution of the test result to the requestor. It links your GP practice directly to test laboratories, electronically.

Patient administration systems (PAS) – Hospital systems provide patient demographic information and administrative discharge and transfer messaging. A PAS records all patient engagement across the trust, including inpatient, outpatient and emergency cases, and also manages patient demographics, referrals, appointments and waiting list data.

National Pathology Exchange (NPEx) – The NPEx is used to send pathology test requests and results between UK laboratories. It currently connects 65 English and Scottish hospital trusts to each other (around 50% of UK NHS laboratories).

Pathology analysers – An automated analyser is a medical laboratory instrument designed to measure different chemicals and other characteristics in a number of biological samples quickly, with minimal human assistance. These measured properties of blood and other fluids may be useful in the diagnosis of disease.

Point-of-care testing (POCT) devices – POCT devices are simple to use analytical equipment designed to produce rapid results at the point of care provision. Examples of rapid testing include glucose, blood gasses and respiratory viral PCR analysis.

Laboratory information management system (LIMS) – LIMS is software used in laboratories and hospitals for the effective management of requests/orders, samples and reports. Its core functions are the:

• reception and log in of a sample and its associated customer data
• assignment, scheduling, and tracking of the sample and the associated analytical workload
• processing and quality control associated with the sample and the utilized equipment and inventory
• storage of data associated with the sample analysis
• inspection, approval, and compilation of the sample data for reporting and/or further analysis

External specialists laboratories – For some tests/diagnoses, the results may be shared with external specialist clinics and services, such as cancer screening registries or antenatal clinics.

Below is a breakdown of various properties of the components identified in the pathology diagnostics pillar:

A typical pathology diagnostic pillar process flow can be summarised in the following 4 stages.

1. Order request

Typically, an order for laboratory testing can be generated from different sources (such as a GP system or hospital PAS). It is sent via an order and reporting system, such as ICE, by a clinician who completes a request form with all necessary patient information.

2. Sample collection and transportation

A pathology sample (such as blood samples and cultures, urine, swabs, fluids, sputum) is collected from the patient and sent to the laboratory for testing with the appropriate shipping manifest documentation. This means ensuring that the container and request form:

• are labelled with the patient’s name, date of birth, unit number, and date and time of sample
• contains adequate clinical information

The pathology sample is sent to the external laboratory by post or courier.

3. Laboratory receipt

The pathology service is made up from a number of different disciplines and upon receipt, the sample is directed to the appropriate department for analysis.

Blood sciences

A combination of the historic pathology departments (listed below) who predominantly specialise in the analysis of blood.

Typically, the blood sciences laboratory would comprise of all of the high-throughput automated instrumentation from the chemical pathology, haematology, immunology and serology departments all linked together by a common robotic laboratory automation system (LAS) and middleware systems. Combining as many tests as possible onto a smaller number of analytical systems significantly improves the efficiency of the laboratory.

Chemical pathology

Used to analyse fluids in the body (blood, urine, cerebral spinal fluid, and collections in joints, abscesses and body cavities). Besides establishing a diagnosis, they can also be used for tracking the progress of disease management.

Haematology

Analysis of blood specimens (blood and bone marrow) for the full blood count.

Blood transfusion

Analysis of blood specimens to determine blood group and antibody status to enable the safe transfusion of blood and blood products to a patient.

Microbiology

Sample specimens are analysed and tested for specific bacteria, viruses, fungi and parasites that may be causing a patient’s symptoms.

Immunology

Run automated biochemical tests to detect the presence and concentration of substances in the samples.

Serology

Examine blood serum for antibodies to infections such as colds and flu, Epstein Barr virus (glandular fever), rubella (measles) and Ross River fever.

Molecular pathology and cytogenetics

Specialists use advanced technology to investigate genes and chromosomes. They could be looking for gene mutations and chromosomal abnormalities caused by an inherited condition.

Cellular pathology and cytology

Involves the study of body organs and tissues (groups of cells) to determine the cause of certain diseases and the effects they are having on the body. This informs the choice of treatment that will be given, helps in giving a prognosis and in determining what may have caused a person’s death.

4. LIMS

The laboratory information management system (LIMS) is integral to every process in the laboratory. It has an audit system that records and timestamps all interactions with the system and/or patient record against the user.

The LIMS tracks all specimens through the pathology service by means of a unique laboratory number and ensures all samples and results are completed in a timely manner and, in some cases, records all locations that the samples are stored in until disposal. Generally, the LIMS will also manage blood bank stock and mortuary occupancy for the local pathology service as well.

At the point of specimen receipt, the LIMS records the current patient demographic data directly from the request and matches it to the historic dataset held for the patient in the database. The LIMS will record the source of the request, relevant requesting clinician, date and time of sample collection and receipt, and any relevant clinical details in relation to the various combinations of tests requested.

The LIMS controls all messaging to downstream systems and middleware to ensure the correct tests are ordered on the relevant instrumentation for analysis.

When analysis is complete, the results are transferred from the middleware back to the LIMS where a number of validation rules, calculations and ranges are applied. If all of the results in the request pass these criteria, they are automatically released back to the HIS/EPR and/or GP system.

Any results which fail the rule criteria are filtered into various authorisation queues to ensure they can be checked by a qualified member of staff and, if necessary, communicated directly to the requesting clinician. An example would be where a result requires further investigation or may be considered life threatening for the patient.

Figure 2: Sample pathology diagnostics testing end-to-end flow.

Table 2: Sample asset inventory list for a medium sized trust.

OUI - organisationally unique identifier

VLAN - virtual local area network

Table 3: Sample pathology components communication information.

Table 4: Sample logical grouping of connected medical devices in a medium sized trust.