ICU Management & Practice, Volume 16 - Issue 3, 2016

POCTED: Use of Point of Care Test Devices in Emergency Department

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Use of point-of-care test devices in the emergency department has ‏shown significant benefits in patient management. A proper governance ‏policy will ensure credible, effective and safe practice.

 

Emergency Department (ED) practices have ‏evolved, modified and developed pathways ‏over the years to recognise and initiate ‏appropriate early treatment for acutely unwell ‏patients. One of the major contributing factors ‏has been the use of point-of-care test (POCT) ‏devices, which have the ability to provide drastic ‏improvement in the turnaround time (TAT) of ‏test results. Early goal-directed therapy in sepsis, ‏early recognition of neutropenic sepsis, acute ‏coronary syndrome, an unconscious patient ‏with suspected drug use needing antidotes: ‏the list is exhaustive where early test results ‏have shown appropriate treatment has been ‏initiated and has directly affected the outcome.

 

‏ED overcrowding is an international problem ‏and waiting times have been increasing over ‏time. France, Sweden, UK, New Zealand and ‏Canada have all passed explicit length-of-stay ‏time targets, requiring that patients leave the ‏department within 4-8 hours. Overcrowding ‏and prolonged wait times have been linked to ‏adverse clinical outcomes and decreased patient

satisfaction. While no one factor can be identified ‏as the root cause of this issue, decreased delays ‏in sample collection and test results can provide ‏healthcare professionals with the opportunity ‏to arrive at faster care management decisions, ‏resulting in increased patient throughput and ‏decreased average wait times. ED performance ‏is dependent on processes and capacity in other ‏hospital departments as well as other parts of ‏the health and care system (Kings Fund 2016; ‏Larsson et al 2015).

 

In the United Kingdom, the Medicines ‏and Healthcare Products Regulatory Agency ‏(MHRA) published a document in December ‏2013, which provides advice and guidance on ‏the management and use of point-of-care testing ‏(POCT) in in vitro diagnostic (IVD) devices ‏(Medicines and Healthcare Products Regulatory ‏Agency 2013). The MHRA guidance document ‏is a very helpful text to use to establish such a ‏service. In Europe POCT devices are regulated ‏under the 1998 European Directive 98/79/EC ‏on in vitro diagnostic medical devices (Council ‏Directive 1998).

 

Definition

POCT is defined as any analytical test performed ‏for a patient in primary or secondary care (ED) ‏settings by a healthcare professional outside the ‏conventional laboratory setting. ‏Other terms commonly used to describe ‏POCT include:

 

• Near patient testing (NPT)

• Bedside testing

• Extra-laboratory testing

• Disseminated/decentralised laboratory testing

 

What is Out There?
 

There has been a continual rise in the use of ‏POCT due to the drive to improve patient pathways ‏and as a result of technological advances. ‏Developments in fluid handling, microchip and ‏miniaturisation technology and improved manufacturing ‏processes are producing POCT devices ‏that are more robust and less prone to error ‏than previous generations.

 

The World Health Organization (WHO) has ‏provided ASSURED guidelines for those developing ‏new POCT devices for detecting sexually ‏transmitted infections (Figure 1).

 

This principle can be applied to develop any ‏new POCT device (St John and Price 2014). ‏POCT Systems can be categorised as:

 

• Non-instrumental systems: disposable ‏systems or devices. These vary from reagent ‏test strips for a single analyte to sophisticated ‏multi-analyte reagent strips incorporating ‏procedural controls, e.g. urine dipsticks, ‏urinary pregnancy tests and urine toxicology ‏screens.

 

• Small analysers, usually hand- or palm-held ‏devices, which can vary in size, e.g. blood ‏glucose meters, blood ketone meters.

 

• Desktop analysers are larger and include ‏systems designed for use in clinics or small ‏laboratories, e.g point-of-care haematology ‏analyser for full blood count, portable blood ‏analyser for measuring urea, creatinine, and ‏blood gas analysers.

 

MHRA documentation provides guidance on ‏how to implement POCT in a secondary setting ‏like the ED (Table 1) (MHRA 2013).

 


See Also: How useful is multi-organ point-of-care ultrasound?


Prior to Implementation of a POCT Service in the ‏Hospital

 

1.Involvement of local hospital pathology laboratory

 

It is very important in a secondary setting like ‏the ED to have a close liaison between users and ‏local pathology labs as they can provide advice ‏on a range of issues such as purchase, training, ‏interpretation of results, troubleshooting, quality ‏control, quality assessment and health and safety.

 
2. Identifying the need for POCT

 

It is essential to establish a clinical need and consider the benefit of introducing POCT. The motivation could be to improve the patient pathway and experience, for example.

 

3. Advantages and disadvantages of POCT

 

The obvious advantages are improved TAT, better monitoring for conditions requiring frequent testing, improved patient experience. The disadvantages may be poor quality analysis, poor record keeping, lack of results interpretation, inappropriate testing.

 

4. Costs
 

It is important to include cost analysis and it should be taken into consideration whether the hospital or healthcare organisation is in a position to include variable professional costs apart from capital costs.

 

5. Choosing the right equipment

 

There should be discussion between the clinical

users, laboratory, manufacturers, and the estates

department prior to finalising the equipment.

 

6. Clinical governance

 

It is important to set up a point-of-care committee who can regulate use of POCT as an alternative to laboratory testing. Use of POCT is a clinical governance issue and subject to examination of clinical effectiveness.

 

Management and Organisation of POCT

 

1. Responsibility and accountability

 

A POCT coordinator needs to be appointed who has the authority and overall responsibility for the service at the beginning of the development process. A multidisciplinary POCT committee who can oversee the POCT activity in secondary settings should also be established.

 

2. Training

 

Staff who have completed the mandatory training and achieved competency should be permitted to carry out POCT.

 

3. Instructions for use

 

Staff must be familiar with the manufacturer’s instructions for use and the instruction manual should be readily available.

 

4. Standard operating procedures (SOPs)

 

It is strongly recommended to have SOPs which are readily available alongside the manufacturer’s instructions.

 

5. Health and safety

 

Staff users must recognise the hazards of handling and disposing of body fluids and sharps outside a laboratory setting.

 
6. Infection control

 

Staff users should be reminded of the importance ‏of universal infection control precautions.

 

7. Quality assurance (QA)
 

This is an essential component of POCT and ‏encompasses proper training and review of ‏overall performance. The essential components of ‏QA are internal quality control (IQC), external ‏quality assessment (EQA), and parallel testing; ‏they can help ensure reliable results if applied ‏rigorously.

 

IQC methods primarily ensure that the results ‏obtained are accurate and consistent. This can be ‏achieved by analysis of a set of QC specimens ‏provided by the manufacturer. This can reassure ‏the user. A log of QC activity needs to be maintained ‏and reviewed by the POCT committee ‏on a regular basis.

 

EQA is performed by testing samples ‏containing an undisclosed value received from ‏an external source. EQA schemes may be operated ‏by the manufacturer or by dedicated EQA ‏providers.

 

Parallel testing of patient samples by the central ‏laboratory can provide additional confirmation of ‏device accuracy. This should be integrated in the ‏EQA practice when laboratory results are available. ‏

 

8. Maintenance

 

It is important to follow the manufacturer’s guidance ‏on maintenance for safe and effective use ‏of POCT devices.

 

9. Accreditation

 

This is an assessment by an external body of the competence to provide a service to a recognised ‏standard. Independent confirmation helps ‏provide reassurance to the users of this service.

 

10. Record keeping

 

It is important to keep accurate records of patient ‏results from POCT devices.

 

11. Information technology

 

Support from IT systems to manage data, workstations ‏and laboratory information is crucial ‏for successful use of POCT devices.

 

12. Adverse incident reporting

 

The MHRA has two parallel reporting systems ‏for device-related incidents, one for manufacturers ‏and the other for users.

 

Clinical Scenarios for Use of POCT in ED

 

Rooney and Schilling (2014) outline several ‏examples where use of POCT has led to ‏improved patient outcomes.

 

Acute coronary syndrome

 

Many patients present to the ED with symptoms ‏that suggest acute coronary syndrome (ACS). A ‏rapid rule-out protocol using a combination of ‏high-sensitivity cardiac Troponin I testing, risk ‏score and electrocardiogram has been shown ‏to be safe and effective in identifying low-risk ‏patients (Than M et al. 2012). A randomised ‏controlled trial that evaluated the performance ‏of POCT for cardiac biomarkers on patients ‏with suspected myocardial infarction showed ‏a 20% greater discharge rate during the initial ‏evaluation process when POCT was performed ‏(Goodacre et al. 2011). The follow-up study that ‏evaluated the financial implications of POCT ‏found variable results (Bradburn et al. 2012).

 

Venous thromboembolic disease

 

Patients who have low risk but are suspected ‏to have a venous thromboembolic disease have ‏a D-Dimer test to rule out the disease. Use of ‏POCT testing has shown a reduction in ED stay ‏by 60 minutes and a 14% reduction in admissions ‏(Lee-Lewandrowski et al. 2009).

 

Severe sepsis
 

Elevated blood lactate levels have been shown to ‏be a sensitive marker of impaired tissue perfusion ‏and of anaerobic metabolism in patients ‏with suspected sepsis. This is a valid identification ‏method for patients who will benefit from ‏early aggressive goal-directed therapy.

 

Stroke

 

Early thrombolysis in patients presenting with ‏ischaemic stroke has shown significant benefits. ‏It is very important to institute this treatment ‏as soon as possible. Apart from performing an ‏immediate CT scan it is important to know the ‏coagulation status, as there is an increased risk of ‏bleeding if they are deranged, which can cause ‏a potentially serious outcome. A POCT coagulation ‏test not only avoids unnecessary delay of a ‏time-critical intervention like thrombolysis, but ‏also ensures that the patient is safe to receive it.

 

Recognising substance abuse in an unconscious ‏patient, metabolic emergencies, ectopic ‏pregnancy—the list goes on of where POCT tests ‏have shown benefits by reducing the diagnosis ‏time and enabling initiation of treatment at ‏the earliest time.

 

Conclusion

 

The number of tests that can be performed ‏outside a conventional laboratory, especially in ‏the ED, has grown significantly over the past ‏two decades. This is primarily driven by the ‏idea that the care provided is brought closer ‏to the patient. There is substantial evidence of ‏where use of POCT devices has shown benefits ‏in recognising the ill patient, helped establish ‏immediate treatment thereby reducing the ‏waiting for diagnosis and also improved the ‏patient journey time from ED to acute medical ‏wards. All this will eventually accumulate into a ‏good patient experience. Patient satisfaction can ‏help gather political support to invest in development ‏and implementation of this technology. ‏However, it is of utmost importance that any ‏department or hospital that plans to invest in a ‏POCT device has a strict governance policy. ‏

 

Conflict of interest

 

Shashank Patil declares that he has no conflict of interest.

 

Abbreviations


ED emergency department

POCT point of care testing

MHRA Medicines and Healthcare products

Regulatory Agency

POCT point-of-care test

QA quality assurance

QC quality control

TAT turnaround time


References:

Council Directive (EC) 1998/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices. [Accessed: 26 August 2016] Available from eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:31998L0079

 

King’s Fund (2016) What's going on in A&E? The key questions answered. [Accessed: 26 August 2016] Available from kingsfund.org.uk/projects/urgent-emergency-care/urgent-and-emergency-care-mythbusters

Larsson A, Greig-Pylypczuk R, Huisman A (2015) The state of point-of-care testing: a European perspective. Ups J Med Sci, 120(1): 1–10.

PubMed

 

Medicines and Healthcare Products regulatory Agency (2013) Management and use of IVD point of care test devices. MHRA V1.1. [Accessed: 26 August 2016] Available from gov.uk/government/uploads/system/uploads/attachment_data/file/371800/In_vitro_diagnostic_point-of-care_test_devices.pdf


St John A, Price CP (2014) Existing and emerging technologies for point-of-care testing. Clin Biochem Rev 35 (3) 2014 155-167.

PubMed


Rooney KD, Schilling U. (2014) Point-of-care testing in the overcrowded emergency department-can it make a difference? Crit Care. 2014; 18(6): 692.

PubMed

 

Than M, Cullen L, Aldous S (2012) 2-hour accelerated diagnostic protocol to assess patients with chest pain symptoms using contemporary troponins as the only biomarker: the ADAPT trial. J Am Coll Cardiol, 59(23): 2091-8.

PubMed

  

Goodacre S, Bradburn M, Fitzgerald P et al. (2011) The RATPAC (Randomised Assessment of Treatment using Panel Assay of Cardiac markers) trial: a randomised controlled trial of point-of-care cardiac markers in the emergency department. Health Technol Assess, 15(23): iii-xi, 1-102.

PubMed

 

Bradburn M, Goodacre SW, Fitzgerald P et al. (2012) Interhospital variation in the RATPAC trial (Randomised Assessment of Treatment using Panel Assay of Cardiac markers). Emerg Med J, 29(3): 233-8.

PubMed

 

Lee-Lewandrowski E, Nichols J, Van Cott E et al. (2009) Implementation of a rapid whole blood D-dimer test in the emergency department of an urban academic medical center: impact on ED length of stay and ancillary test utilization. Am J Clin Pathol, 132(3): 326-31.

PubMed




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