This guideline was compiled according to the BSH process at https://b-s-h.org.uk/guidelines/proposing-and-writing-a-new-bsh-guideline/. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) nomenclature was used to evaluate levels of evidence and to assess the strength of recommendations. The GRADE criteria can be found at http://www.gradeworkinggroup.org.

Literature review details

Search terms used included: “Point of Care” AND: “HAEMATOLOGY”; “International Organization for Standardization” accreditation; “Wells score” AND “D-DIMER”; DVT AND “D-dimer”; coagulation tests POC; blood gas AND limitations; HbA1C AND limitations; governance; haemoglobinopathy testing; coagulation testing AND (sensitivity OR specificity OR reliability); haematology testing AND (sensitivity OR specificity OR reliability).

Filters were applied to include only publications written in English, studies carried out in humans, and studies published between 1 January 2009 and 1 November 2017, inclusive. A total of 357 publications were identified; 87 articles were excluded because they were duplicates between the different searches. The search was conducted on 11 November 2017. A further search was conducted on 1 August 2019 to review recent advances in point of care testing since the 2017 search.

Review of the manuscript

Review of the manuscript was performed by the British Society for Haematology (BSH) Guidelines Committee – General Haematology Task Force, the BSH Guidelines Committee and the members of the sounding board of the BSH. It was also placed on the members section of the BSH website for comment.

Introduction

This guideline is an update of the BSH 2008 Guideline for point of care testing: haematology (Briggs et al, 2008). Point of care testing (POCT) refers to any testing performed outside the hospital laboratory, near or at the site of the patient where the result influences patient management (ISO 15189:2012; ISO 22870:2016). There has been a major expansion in POCT since the publication of the 2008 BSH guideline (Briggs et al, 2008). In the intervening period, the range and complexity of POCT technologies and the repertoire of POCT assays has grown, both in primary care (pharmacies, general practice surgeries and community clinics) and hospital-based settings. A major driver of this growth has been the development of relatively simple testing methods, which allow the generation of results close to the patient for both therapeutic monitoring and diagnostic purposes. At the same time, the accreditation requirements for clinical laboratories, specified in the International Organization for Standardization (ISO) 15189:2012 and ISO 22870:2016 standards (ISO, 2012, 2016), have driven the development of comprehensive clinical, financial and quality governance.

The aim of this guideline is to provide an overview of point of care (POC) assays available, and a framework for implementing and maintaining a POCT service compliant with international standards (ISO, 2012, 2016). This guideline does not specifically encompass POCT systems in a primary/community setting; however, the same principles may be applied. This guideline does not apply to general medical devices in a ‘near patient’ setting, such as blood pressure monitors, pulse oximetry and thermometers (https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/iv-diagnostic-medical-devices_en, last accessed 8 June 2018).

Clinical utility of POCT

Hospitals in the UK are experiencing increasing pressure to turn around patients safely and in a timely manner. Quality and efficiency of patient care depend directly on timely, accurate laboratory results. For clinicians and allied healthcare professionals, quality results with rapid turnaround times (TATS) are essential to determine prompt, effective management plans, administer immediate treatments in life-threatening conditions and meet waiting time targets in a safe and effective manner. POCT is a proven, powerful tool that can facilitate patient flow and turn around accurate results in a timely manner (Lenman, 2004).

Range of equipment and assays

The range of POCT and clinical utility is broad. An example of the Haematology POC tests in use at the time of writing is listed in Table 1.

Table 1. Currently available point of care tests and the clinical utility/setting.

POC test	Clinical utility	Common locations	Examples of POCT devices
FBC (with 3-part differential and 5-part differential)	Trauma (David et al 2012; Tongtoyai et al, 2014; Beynon et al, 2015) Haematology patients	Emergency department operating theatre, Haematology clinics, GP (Celenza & Skinner 2010; Beynon et al, 2015)	Pentra 60 (Horiba), XN-L450, XN-L 550 (Sysmex) (Kapuya et al, 2017)
PT/INR	Trauma (Dionizovik-Dimanovski et al, 2015) Patients on warfarin Stroke- thrombolysis (Celenza & Skinner, 2010; Beynon et al, 2015; Dionizovik-Dimanovski et al, 2015)	Emergency department, Coronary care units, Anticoagulant clinics, Operating theatres, ICU (Beynon et al, 2015)	CoaguChek XS series (Biedermann et al, 2015) i-Stat (Abbott) (Kapuya et al, 2017)
aPTT	Factor deficiency, haemostatic assessment	Acute and intensive care settings	CoaguChek Pro II (Roche Diagnostics Ltd)
Hb	Exclusion of anaemia	Operating theatres, Clinics, GP, Obstetrics	HemoCue (Kapuya et al, 2017)
D-dimer	To exclude pulmonary embolism/DVT (Michelson & Bhatt, 2017)	Emergency department, Primary care clinics, Medical assessment units	AQT90 (Kapuya et al, 2017) Alere (Abbott) Clearview (Abbott)
Viscoelastic assays	Trauma Obstetrics (Dionizovik-Dimanovski et al, 2015)	Operating theatres, Emergency department (Beynon et al, 2015)	Rotational thromboelastometry (ROTEM) (ROTEM®). Thromboelastography (TEG) (TEG®)
ACT	DIC, Monitoring heparin	Cardiothoracic theatre	Sonoclot system (Sienco)
Malaria antigen	Malarial screening	Malaria screening and identification laboratories, rural settings	CareStart (CareStart™) Optimal (BioRad), Clearview (Alere)

ACT, activated clotting time; aPTT, activated partial thromboplastin time; DIC, disseminated intravascular coagulation; DVT, deep vein thrombosis; FBC, full blood count; GP, general practice; Hb, haemoglobin; ICU, intensive care unit; INR, international normalised ratio; POC(T), point of care (testing); PT, prothrombin time.

Full blood count (FBC) and automated differential

Portable haemoglobin meters and small bench top analysers providing haemoglobin concentration (Hb), total white cell (WBC) count, three- or five-part differential and platelet count, are common in a variety of clinical settings.

Several trials have demonstrated accurate and reproducible FBC results using POCT devices compared to central laboratory instruments (Briggs et al, 2012; Kapuya et al, 2017).

An array of technologies are employed to measure stand-alone Hb in a non-invasive manner, including near-infrared spectroscopy, white light to capture reflected transmission data in capillary measurements, and multiple wavelength light absorption. Studies have shown this methodology useful for trending Hb measurements, but variable agreement for the accuracy of Hb measurements has been demonstrated with central laboratory analysers (Butwick et al, 2012; Kato et al, 2017; Adel et al, 2018).

Prothrombin time (PT)

Various POC PT analysers operate with different analytical principles of clot formation including optical, electromechanical and electrochemical clot detection (Harris et al, 2013). Samples for testing may be venous or capillary blood, with a sample volume of less than 10 µl to greater than 1 ml required, depending on the device used (Harris et al, 2013).

Measurement of the PT in the POC setting is most often reported as the International Normalised Ratio (PT/INR) used for the monitoring of vitamin K antagonist oral anticoagulant therapy.

Some INR analysers are specifically designed for patient use and others are designed specifically for healthcare professionals. The analysers utilise an enclosed system of disposable test strips or cartridges with an in-built quality control test. Knowledge of the comparability of the INR results of the POC analyser with the laboratory result over the measuring range for the INR is invaluable. This will allow the development of an algorithm for confirmation of laboratory-defined supra-therapeutic INR results from the POC analyser with the standard laboratory method (Biedermann et al, 2015).

Activated clotting time (ACT)

The ACT has proven beneficial in the setting of cardiothoracic surgery, extracorporeal membrane oxygenation (ECMO) and haemodialysis, where high doses of heparin, exceeding the linearity and the heparin dose response of the standard activated partial thromboplastin time (aPTT) assay, are used (Zehnder 2018).

aPTT

The use of aPTT for monitoring Heparin in a POC setting is yet to be established (Ferring et al, 2001; Douglas, 2009).

In a study of 390 patients in acute and intensive care settings, Niederdöckl et al (2016) reported an acceptable correlation between POC PT and aPTT compared to laboratory-based methods.

In a prospective study of patients on heparin in surgical intensive care, Ferring et al (2001) demonstrated a poor agreement between POC aPTT and central laboratory aPTT, and a poor correlation with anti-Xa activity. These findings were compounded in a study by Surman et al (2018), which demonstrated a poor correlation between POCT and laboratory-based testing for aPTT on patients receiving heparin. The authors of the study recommended that POCT should not be used for cardiac surgery patients (Ferring et al, 2001; Surman et al, 2018).

D-dimer

D-dimer measurement, in combination with a validated pre-test probability score and a well-established clinical cut-off level, allows assessment of patients for the exclusion of venous thromboembolism (VTE), the diagnosis and monitoring of disseminated intravascular coagulation (DIC), and predicting the likelihood of recurrent VTE (Giannitsis et al, 2016; Antovic et al, 2012). There are several POCT methods available for the measurement of D-dimer levels, which utilise various sample types and have different preparation requirements (Antovic et al, 2012). For the exclusion of VTE, the specific characteristics of the test method, including sensitivity, negative predictive value and precision at the cut-off level, should be well understood and appropriate (Antovic et al, 2012).

Viscoelastic assays

Proactive management of trauma-related coagulopathy requires early identification and rapid assessment in order to allow targeted resuscitation (Ten Cate-Hoek et al, 2009; Urwyler et al, 2009; Ebner et al, 2017). Viscoelastic tests include thromboelastography (TEG), thromboelastometry (ROTEM) and Sonoclot. Viscoelastic technology measures the clot firmness changes in a sample of citrated whole blood as the sample clots, retracts and lyses in real time. The ROTEM utilises various reagents associated with the testing of various classical coagulation pathways; INTEM tests the intrinsic pathway, EXTEM tests the extrinsic pathway, HEPTEM tests the intrinsic pathway when heparin is present and FIBTEM measures the level of fibrinogen. The ROTEM^® platelet module measures platelet function and aggregation by electrical impedance based on impedance aggregometry (Cardinal & Flower, 1980; Weitzel, 2014; Hanke et al 2017).

TEG 5000 is a cup and pin method while TEG 6s is a cartridge method. A major drawback with the TEG 5000 is that it requires manual pipetting. The TEG 6s cartridges are preloaded and contain 4 channels, each with a different reagent that measure clot formation, detect the presence of heparin, assess both intrinsic and extrinsic pathway and measure fibrinogen.

Thromboelastography is not a substitute for conventional laboratory testing, such as INR, but it offers additional information and may guide blood transfusion at the POC (Michelson & Bhatt, 2017). The use of viscoelastic assays during major haemorrhage in obstetrics, liver disease, cardiac surgery and trauma is covered in detail in the recent BSH guideline; ‘The use of viscoelastic haemostatic assays in the management of major bleeding’ (Curry et al, 2018).

Direct oral anticoagulants (DOACs) and monitoring anti-platelet medications

While routine drug monitoring for DOACs is generally not required, rapidly available assays quantifying DOAC effects have proven beneficial in cases of renal impairment, bleeding, obesity, paediatric patients and in patients prior to urgent surgery. Studies are ongoing to develop suitable assays for measuring the effect of DOACs at the POC. A study by Ebner et al (2015) suggested that, if an anti-Xa test is not available, the use of CoaguChek POC to guide thrombolysis decisions after individual risk assessment in rivaroxaban-treated patients with acute ischaemic stroke is recommended. CoaguChek correlated well (r = 0·82, P < 0·001) with rivaroxaban concentrations but did not accurately reflect the effect of dabigatran and apixaban (Ebner et al, 2015). The Hemochron® Signature has demonstrated a good correlation with rivaroxaban and dabigatran measurement by liquid chromatography-tandem mass spectrometry (Ebner et al, 2017). Similarly, TEG and ACT have been shown to be useful in the detection and reversal of dabigatran-induced coagulopathy, and the former in the detection of DOACs with high specificity and sensitivity (Bianchi et al, 2017; Dias et al, 2019).

The increasing use of aspirin and oral P2Y inhibitors in the prevention and management of arterial thrombosis, and whether or not a patient is aspirin "resistant" or clopidogrel "resistant", has promoted extensive research into development of POC devices for measurement of platelet inhibition by said anti-platelet medications (Dionizovik-Dimanovski et al, 2015). However, many studies have failed to show a true benefit, therefore the clinical utility of POC systems in this area is yet to confirmed (Ebner et al, 2015; Michelson & Bhatt, 2017).

Blood gas and Hb/haematocrit measurement

To date, there is a lack of data supporting the reliability of blood gas analysers (BGAs) in the measurement of Hb and haematocrit (Hct) in the POC setting. All analytical methods are subject to inaccuracies caused by in vitro and in vivo factors. This should always be considered when interpreting POC results. Most modern blood gas analysers measure Hb spectrophotometrically and Hct by conductivity or through calculation. Some studies show agreement between Hb measurement performed on the BGA via spectrophotometry compared to its measurement by the central laboratory method (Bloom et al, 2014; Koazci et al, 2015). However, some authors have reported significant underestimation of Hb and Hct by the above methods when compared to measurement in the central laboratory, including one study where Hct was measured on a BGA through the technique of centrifugation, the Clinical & Laboratory Standards Institute (CLSI) recommended reference method for determination of Hct (Steinfelder-Visscher et al, 2006; Gavala & Myrianthefs, 2017). Underestimation of Hb/Hct may lead to erroneous transfusion trigger activation and inappropriate transfusion with packed red cells. Conversely, some authors report overestimation of Hct and Hb when measured by BGAs. One study concluded 21% of patients in the study would not have been transfused based on the Hct calculated by the BGA while the laboratory method would have indicated transfusion (Bosshart et al, 2010). Similarly, a 2017 publication investigating the comparability of a blood gas analyser to the central laboratory method concluded that the methods could not be used interchangeably for Hb measurement where Clinical Laboratory Improvement Amendments of 1988 proficiency testing criteria (Centers for Medicare & Medicaid Services, 2019) was used to define interchangeability. The authors reported that Hb was systematically overestimated by the BGA by a mean of 8 g/l (Allardet-Servent et al, 2017).

Recommendations

A new point of care (POC) device should be assessed for reproducibility against a central laboratory analyser or other established technology (1A).
The sensitivity and specificity of the D-dimer test method should be established such that, when combined with the pre-test probability score, the test can be used as a test of exclusion for venous thromboembolism or as a diagnostic tool used in conjunction with diagnostic imaging (1A)
Users should be aware of the method employed by a point of care testing (POCT) device to measure parameters and the possible limitations of the method (1A).
International normalised ratio POCT methods should be assessed for comparability with central laboratory analysers using warfarinsed samples in order to establish a reflex testing algorithm for confirmation of supra-therapeutic levels (1B)
The activated clotting time (ACT) should be used for monitoring high doses of heparin where standard activated partial thromboplastin time (aPTT) methods are insensitive. (1A)
POC aPTT measurement should not be used for monitoring heparin unless the method has been shown to correlate with an established proven method (1C).
In the absence of an established direct oral anticoagulant (DOAC) assay, thromboelastography (TEG) and ACT, once verified, can be used to detect dabigatran-induced coagulopathy and guide the reversal of same, and the TEG 6s for detection and classification of DOACs (1C).
Haemoglobin concentration and/or haematocrit measured via non–invasive methods and blood gas analysers should only be used where an acceptable correlation has been demonstrated with an established method (1A)

Quality assurance in POCT

A quality assurance (QA) programme encompassing training, personnel, equipment, appropriateness of testing, pre-analytical, analytical and post analytical aspects of POCT from sample collection to recording of the final result in the patient’s chart, is key to the delivery of an accurate and reliable POCT programme (Royal College of Physicians of Ireland, 2017).

A QA programme ideally will be led and governed by the quality manager and implemented by all staff using the service.

A quality manual (QM) for the delivery of POCT services must be prepared, reviewed regularly and referenced to the appropriate standards by which the service aspires to be delivered. The QM should be maintained by the quality manager responsible for advising the service. This document will inform users of the structure that has been agreed for implementing and maintaining the safe delivery of the service.

The activities within the POCT service will be subject to an annual management review where the performance and quality of the service is assessed, improvements required are identified and objectives for the coming year described (ISO 2012, 2016). The delivery of these objectives is key to continual improvements in the service.

Recommendations

The POCT quality assurance (QA) framework should include (1B):

Internal quality control (IQC) and external QA (EQA) programmes
An internal audit schedule
Accreditation to the ISO 15189/22870 standards by the appointed national accreditation bodies
Document control including standard operating procedures (SOPs)
Regular review of the service for continual improvement

Internal quality control (IQC) programme

An IQC programme should aim to control accuracy, within and between-day variability, drift, and potential bias of a POC system.

IQC should encompass controls that parallel clinically significant thresholds, e.g. normal and abnormal Hb controls where the abnormal control is close to the transfusion trigger concentration defined by the local clinical policy.

IQC should be analysed at a frequency based on patient analysis activity, and if used daily, should not be any greater than every 24 h. Records of lot numbers, target values and IQC results should be fully traceable in electronic or written form. Analysis of IQC for drift should be undertaken at intervals defined by local policy (ISO, 2012; Lehe et al, 2012).

Internal QC and calibration checks should, where possible, be used in conjunction with commercially available QC material to allow for independent verification of device performance. IQC should be used post-instrument maintenance or calibration, and to verify new reagents/consumables (batch acceptance) (ISO, 2012).

There should be a policy in place to handle IQC failure and a contingency plan in the event of system failure (ISO 2012, 2016).

External quality assessment (EQA)

External quality assessment data complements, but does not replace, performance obtained in real time from an IQC programme. An EQA programme provides samples of known but undisclosed analyte concentration, at both clinical decision levels and levels that reflect the linearity of a device, at varying frequencies depending on the programme design and the device.

The EQA report provides users with peer reviewed assessment by means of numerical or qualitative scoring for device performance relative to other users of the same device/method, thus providing the user with a long-term, retrospective review of system performance.

As for an IQC programme, there should be record keeping and a documented system for handling out-of-consensus EQA results.

It is worth noting that, occasionally, a result may be out-of-consensus statistically for a difference from the target value that is not of clinical significance. This should be observed by the device user but interpreted in light of the overall, long-term analytical performance, the clinical significance of the difference from the target and the analyte concentration.

Where an EQA programme is not available for a device or analyte, alternate options can be explored, e.g. an inter-laboratory exchange programme of blinded samples within a Trust, or taking a venous and a capillary sample simultaneously for analysis on multiple devices (Perry et al, 2010). Limits of agreement should be set according to local clinical and analytical thresholds and should take into account the recognised difference in Hb in sample types e.g. venous versus capillary samples. Testing of the POCT device against the main laboratory method should also be undertaken periodically.

Everyday users of the device, in both primary and secondary healthcare, should be encouraged to analyse both EQA and IQC material.

Accreditation/audits

In order to improve the quality of service and ensure delivery of prompt, reliable results, internal audits should be carried out according to a schedule covering all aspects of clauses 4 and 5 of ISO22870, including evaluation of user/patient/client feedback (ISO, 2016).

Findings from these audits may be incorporated into POCT policy or procedures, thus allowing for a quality system with continuous improvement.

If it is not possible for a POCT site to undergo ISO accreditation by UK's National Accreditation Body (UKAS) it is recommended that the supervising laboratory supports and validates the local POCT service and its accreditation application. The haematology laboratory clinical and quality governance would then cover the primary care Trust, or individual general practice surgery (Briggs et al, 2008).

Standard operating procedures (SOP)

Standard protocols should be written and made available to both laboratory personnel and end users.

Practice points

The SOP structure, content and format should meet the requirements outlined in the ISO 15189:2012 and ISO 22870:2016 (ISO 2012, 2016), and should include the following:

Training and competency requirements including frequency of proficiency assessment for end users
Outline of roles and responsibilities including who can analyse and interpret results
Guidelines on the interpretation and troubleshooting of device flags and error codes
Details of a contingency plan in the event of instrument malfunction
Reporting, documenting/transmission and interpretation of results and criteria for reflex testing
Handling and communication of critical results

Patient results should be filed permanently in the patient electronic patient record if available, or paper records, and clearly identified as a POCT result along with the operator who performed the test.

Training and development

Laboratories should aspire to meet the requirements outlined in ISO 22870 and ISO 15189:2012, which require an integrated training and development (T&D) framework.

Recommendations

The appointed POCT manager or training and development coordinator, shall develop, implement and maintain an appropriate theoretical and practical training programme for all POCT personnel (1B).
The content of the training programme and the knowledge/skills level assessment process shall be documented. Knowledge/skills requirements include the ability to demonstrate an understanding of the appropriate use of the device, the theory of the measurement system, and appreciation of the pre-analytical aspects of the analysis, including (1B):
1. Sample collection
2. Clinical utility and limitations
3. Expertise in the analytical procedure
4. Reagent storage and stability
5. Quality control and quality assurance
6. Technical limitations of the device and reflex testing
7. Response to results that fall outside predefined limits,
8. Correct documentation and maintenance of devices/results

Retraining intervals and a continuing education programme must be established by the management group (ISO, 2016).

The training and development programme should be subject to annual internal audit for compliance to ISO standard. User feedback should be captured to allow for objective review and continuous improvement of the programme.

Management and governance

Clear accountability for the clinical and operational management of a POCT service is key for the effective delivery of the service.

Standalone POCT services are rare and most are sub-sections of an accredited pathology laboratory with a clinical directorship (ISO, 2012)^. Responsibility for the day to day running of the POCT service may be delegated to a POCT coordinator or manager.

A multidisciplinary POCT committee or governance group^, with appropriate membership, accountability and terms of reference, provides a means of effective governance of the service. This group must be accountable to a higher-level governance group within the organisation, to which issues can be escalated (ISO, 2016).

Membership of the governance group should include key healthcare staff, including clinicians, laboratory scientific staff, nurses, healthcare support staff and management as well as the POCT coordinator. The membership of the group must demonstrate knowledge and expertise in quality management and medical device training and have access to advice on finance and procurement.

If POCT extends to the community, the committee should include professional representation from (i) the community (e.g. a pharmacist, general practitioner or practice nurse) who can inform the group of the clinical needs in the community and (ii) the clinical commissioning group.

Where the POCT service coverage is provided outside of the accredited organisation, a Service Level Agreement must be in place to detail the responsibilities and expectations of all parties involved in delivering the service (Briggs et al, 2008; ISO 2012, 2016).

Recommendation

A member of the POC committee should be assigned to the task of liaising with clinical users, to whom POC concerns can be communicated/ escalated. Said role may also include training of end users and troubleshooting POC systems (1B).

Finance and cost-benefit analysis

All organisations offering POCT to patients must have structures in place that ensure that all costs are evaluated and that the financial impact is understood. This may take different forms depending on how the POC test or service is utilised. For instance, an analyser in an emergency department with high throughput will have a different impact on real costs to patient care than a low use Hb, INR or glucose meter in a clinic, but the impact on patient management outcomes may be equitable.

Equipment selection and verification

In England, the Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices and equipment used in healthcare to ensure that they work as intended and are safe.

Once a device has been licensed by the MHRA and is approved for use within the National Health Service (NHS,) procurement decisions are made by individual NHS trusts.

POCT devices should be assessed for suitability by means of a systematic, well-defined process incorporating user needs, fitness for purpose and financial/resource limitations. Many POCT devices have been evaluated by the Centre for Evidence-based Purchasing (CEP), which is part of the Purchase and Supply Agency (previously undertaken by the MHRA), at the Department of Health and information. If a device has not been evaluated by the CEP, a scoring/evaluation system may be generated locally (MHRA, 2007; Osei-Bimpong et al, 2009).

Recommendations

A POC device must be Conformité Européenne (CE) marked; medical devices in the European community carry a CE mark to indicate that the performance claims have been validated by the manufacturer (1A).
Linearity, carry-over, limitations and interfering substances should be documented and if not made available by the manufacturer they should be established in-house (1B)
Interfering substances, if not already provided by the manufacturer, should be estimated for haemolysis, lipaemia and hyperbilirubinaemia. QC or patient samples spiked with interfering substances in volumes <10% of the sample volume may be used. Haemolysis may be simulated by freezing and thawing packed red cells, giving a concentration of 5000 mg/l, the lysate can be centrifuged and diluted to concentrations of 10, 30 and 50 g/l. Lipaemic specimens can be prepared with a lipid suspension, such as Liposyn, diluted in saline to concentrations of 1, 3 and 5 g/l, and unconjugated bilirubin dissolved in dimethyl sulfoxide to concentrations of 85·5, 171 and 256·5 µmol/l. Adulterated and unadulterated samples (diluted in saline to comparable concentrations of interfering substances in adulterated samples), should be run in triplicate and averaged (ClinLabNavigator, 2019) (1C).
Where there is a large number of the same model/make of POCT devices on one site, a minimum of one POCT device should be chosen for an extensive verification as per ISO minimum verification requirements for ISO 17025 and ISO 15189 testing laboratories.
It is the author’s view that subsequent devices of the same type/methodology, enrolled in the same IQC/EQA schemes, may only require a reduced verification, the extent of which will be decided at a local level (2B).
Correlation and precision studies: 20–25 samples should be used for correlation studies from patients best representing the population that will be tested when the device is in service. Precision studies, encompassing repeatability and within-laboratory precision, should be performed with at least two test materials at or as close as possible to important medical decision point concentrations, by running five replicates of each level over five days. The number of samples/replicates required will be dependent on the nature of the sample and the practicalities of collecting same (Bonet & Wright, 2000; CLSI, 2017; Chesher, 2019)(2B).
In order to control for both pre-analytical and analytical variables, attempts should be made to compare different sample types, i.e. capillary POCT samples with venous blood, to allow comparison of POCT vs central laboratory result (Urwyler et al, 2009) (1B).

Health and safety

All aspects of the Hospital Health and Safety policy, and the ISO 15189 and 22870 standards should be met with regards to general health and safety (ISO 2012, 2016).

Recommendations

Risk assessments should be conducted on new items of equipment before commissioning (1A)
A policy for high risk samples should be considered (2A)
Closed vial sampling is recommended where this is a choice and the use of personal protective equipment should be considered in all testing locations (2B)
Reagents must be risk/ Control of Substances Hazardous to Health Regulations assessed or registered and filed (1A)
A Health and Safety officer should regularly assess the POC testing site for adherence to the relevant national Health and Safety legislation/local Health and Safety policy (1A)

Reflex testing

Due to the inherent risk of pre-analytical errors associated with sample collection and the standard risk of error in the analytical and post-analytical phases, each institution should establish a cut-off value for retesting in a central laboratory, or, in a primary care setting, patient referral to a larger facility for immediate retesting/evaluation.

Cut-offs, or trigger values should be agreed by scientific and clinical staff and take into account the limitations of the assay and the threshold for management in relation to the analyte, e.g. an Hb of 65 g/l in a symptomatic patient where the threshold for transfusion is less than 70 g/l. The test should be repeated in the core laboratory, or in the absence of core laboratory support, by another user in tandem with IQC and a repeat specimen where appropriate.

Adverse event reporting

An adverse event in POCT is an event that causes or has the potential to cause an unexpected or unwanted effect on patients and/or service providers (Briggs et al, 2008).

Adverse events should be raised locally as a laboratory non-conformance (including root cause analysis, immediate remedial action, corrective and preventive action) as per ISO 15189 (ISO, 2012) and/or reported to the organisation’s clinical risk department. Documentation should be traceable, with evidence of clinical review where required.

In England, the manufacturer has legal responsibility to report an adverse event to the MHRA, although end users may also do so (MHRA, 2007). Incidents occurring in Scotland, Northern Ireland and Wales have their own guidance on reporting adverse incidents, available on the respective NHS websites.

Data protection, documentation and recording of results

Storage and retrieval of data should conform to the requirements outlined in the General Data Protection Regulation (GDPR, effective May 2018) (https://www.eugdpr.org/).

Data relating to a generated result should be recorded and a permanent record kept, including data pertaining to the following:

The initial request and the requestor
The operator identification
Patient identity (full name, medical record number, date of birth,location, date, time).
The final result in the patient chart (paper or electronic)
Biological reference ranges or the source employed for the given result
A clear indicator that the result was derived by means of POCT analysis

Document storage and archiving

Practice points

Maintenance records should be kept for the life time of the instrument and a minimum of 4 years thereafter
POCT patient records should be kept permanently on the patient chart
Training records, IQC and batch acceptance records should be kept for a minimum of 8 years (Wilkins, 2015).

Access to the POCT data should be restricted according to the degree of training provided to the user and password protected to prevent unauthorised access.

In a primary care/home environment setting, patients should be advised of the importance of self-held records in terms of unauthorised access and the role of the results as a component of their medical record.

Key Recommendations

A POCT service should have in place a system for clinical, quality and managerial governance with responsibilities of all participating staff clearly identified (1A).
Only trained and fully competent staff should perform POCT. Training and competency assessment should be on an ongoing basis (1A).
Patient, training, and instrument-related data/records should be maintained and kept as per Data Protection Act 2018, the UKs implementation of GDPR 2018 (UK Government, 2018) (1A)
Samples should be appropriately mixed if taken into a primary tube (1A)
Limitations of POCT should be conveyed to end users through training and competency assessment. The importance of following correct pre-analytical procedures should also be reinforced to end users (1B).
Quality Manual governance should ensure there is an internal and external (where applicable) audit schedule and risk management policy in place (1A).
Where possible, IQC material separate from in-built internal checks should be used (1C).
There should be a clear concise protocol for result interpretation, reflex testing and referral of results and patients for confirmation to a central or satellite laboratory (1B).
A POCT service should aspire to meet the requirements set out in the ISO 15189:2012 and ISO 22870:2016 quality standards (ISO 2012, 2016) (1A)

Summary

Point of care testing is a rapidly expanding auxiliary of the central laboratory and will continue to grow in diversity and scope. POCT should not be used as a replacement for conventional laboratory testing but rather to supplement it. The clinical utility, cost-benefit, rapid turnaround times and advantages of near-patient testing in terms of increased clinical effectiveness and improved patient outcomes, are of little relevance unless the quality of the final result is guaranteed. A POCT service is resource intensive, therefore careful planning and evaluation of the initial and ongoing requirements for such a service is critical.

Acknowledgements

The authors wish to thank Dr Gareth Hardy for help in undertaking the initial literature review. The BSH General Haematology task force members at the time of writing this guideline were Wayne Thomas, Ciaran Mooney, Mamta Garg, Carol D’Souza, Barbara de La Salle, Emmy Dickens, Noemi Roy, Charlotte Bradbury, Savio Fernades, John Grainger, Nicola Svenson, Shivan Pancham and Sarah Lawson. The authors would like to thank them, the BSH sounding board, and the BSH guidelines committee for their support in preparing this guideline.

Conflict of Interest

The BSH paid the expenses incurred during the writing of this guidance. All authors have made a declaration of interests to the BSH and Task Force Chairs which may be viewed on request. The following members of the writing group: CM, LP, MB, KP, TC and DF have no conflicts of interest to declare.

Review Process

Members of the writing group will inform the writing group Chair if any new evidence becomes available that would alter the strength of the recommendations made in this document or render it obsolete. The document will be reviewed regularly by the relevant Task Force and the literature search will be re-run every 3 years to search systematically for any new evidence that may have become available. The document will be archived and removed from the BSH current guidelines website if it becomes obsolete. If new recommendations are made an addendum will be published on the BSH guidelines website (https://b-s-h.org.uk/guidelines/).

Disclaimer

While the advice and information in this guidance is believed to be true and accurate at the time of going to press, neither the authors, the BSH nor the publishers accept any legal responsibility for the content of this guidance.

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Citing Literature

Volume187, Issue3

November 2019

Pages 296-306

Point of care testing in general haematology

Methodology

Literature review details

Review of the manuscript

Introduction

Clinical utility of POCT

Range of equipment and assays

Full blood count (FBC) and automated differential

Prothrombin time (PT)

Activated clotting time (ACT)

aPTT

D-dimer

Viscoelastic assays

Direct oral anticoagulants (DOACs) and monitoring anti-platelet medications

Blood gas and Hb/haematocrit measurement

Recommendations

Quality assurance in POCT

Recommendations

Internal quality control (IQC) programme

External quality assessment (EQA)

Accreditation/audits

Standard operating procedures (SOP)

Practice points

Training and development

Recommendations

Management and governance

Recommendation

Finance and cost-benefit analysis

Equipment selection and verification

Recommendations

Health and safety

Recommendations

Reflex testing

Adverse event reporting

Data protection, documentation and recording of results

Document storage and archiving

Practice points

Key Recommendations

Summary

Acknowledgements

Conflict of Interest

Review Process

Disclaimer

Audit Tool

References

Citing Literature

References

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