Point-of-Care Testing in WA

and Future DirectionsLouisa MacDonald, Medical Scientist in Charge, POCT Department

Definition and scope of POCT

Testing that is performed on the ward (at or near the patient’s bedside) with

results being available immediately after testing that can be used in

patient care.

Scope: requirements are applied when PoCT is carried out in a hospital, clinic,

and by a healthcare organisation providing ambulatory care.

Patient self-testing in a home or community setting is excluded.

Management Requirements:

• Organisational Management: laboratory services plan and develop

processes for PoCT

• Quality Management: establish, document, implement, & maintain a QMS

• Control of Nonconformities, Corrective Actions, Continual Improvement

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ISO 22870:2006

Advantages of POCT

Clinically:

• Reduce turn around time for entire analytical process

– Sample collection, testing, result, decision making

• Modify patient care quickly

• Allows testing to be performed in remote areas

• Allows testing by mobile clinics (esp. remote Aboriginal communities)

Laboratory:

• Reduce number of samples going to laboratory

• Allow critical care PoC tests to be performed without lab involvement

• Reduce frequency and duration of out-of-hours call-outs for lab staff

• PoCT devices can be used by lab during equipment break-down

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Disadvantages of POCT

Clinically:

• Time to run test on ward (away from patient, esp. NICU)

• Quality of results

• Time to complete training & ongoing competency checks

Laboratory:

• Increased workload to manage PoCT devices

– Performing QCs and EQAP testing

– Resolving analyser problems

– Providing training and on-going support

• Higher cost-per-test compared to high-throughput lab analysers

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POCT needs vary depending on location

• Community Care

Glucose, HbA1c, microalbumin, electrolytes,

cholesterol, urinalysis, STDs, HIV, coagulation, influenza.

• Primary Care

Glucose, electrolytes, C-reactive protein, urinalysis, STDs,

HIV, INR testing, influenza.

• Emergency Department

Electrolytes, blood gases, glucose, creatinine, amylase, cardiac markers, INR testing,

pregnancy testing.

• Intensive Care Unit

Electrolytes, ionised calcium and magnesium, blood gases, glucose, lactate,

creatinine, haemoglobin, prothrombin time.

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photo: Kalumburu, WA, 4,729 km from Sydney; population ~400; they have an i-STAT.

Role of PathWest in Managing a POCT Service

• PathWest developed a managed service based on a state-wide POCT

policy

• PathWest ensures quality targets are applied to all aspects of the PoCT system

– Selection of devices: minimum testing requirements

– Validation of quality of results

– Quality control checks

– Operator training

– Review of operator errors

– Networking software to ensure results are captured electronically (LIS &

UMRN)

– Provide standardised operational procedures and reporting processes

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Amount of POCT in WA Health

• Radiometer ABLs: 75 in metro & large regional hospitals

• Werfen GEM3000 & 4000: 20 in regional hospitals

• Abbott i-STAT: 130 across all health sitesBlood gas analysis

• Abbott i-STAT; TropT discontinued 2014Troponin testing

• Roche CoaguChek; ~60 across all health sitesINR testing

• Roche cobas h232; 20 in regional hospitalsD-dimer

• Siemens DCA Vantage; 20 across WAHbA1c & ACR

• HemoCue; 12 across regional WAWCC (& 2-pt Diff)

• Orion Quikread go; 7 across regional WACRP

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Challenges for Managing a POCT Service

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Distance

Mobile population

Number and range of devices supported

Costs

Training

Managing errors

POCT Middleware

Distance

• Largest state in Australia

• Second largest state in the world

• Pop: 2.58 million

– QLD 4.91 million

– NSW 7.54 million

– VIC 5.79 million

• Size: 2,645,615 km2

• 0.97 km2 each

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Population change from 2001-2010

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Source: Australian Bureau of Statistics.

Working population 15 – 64 yo (2011 data)

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Source: Australian Bureau of Statistics.

Number and range of devices in use

• PathWest require specific basic criteria to be met before approving devices

– Patient ID: positive patient identification (limited by PAS)

– User ID: electronically linked to patient results & untrained user lock-out

capability

– Networkable for reporting results, monitoring errors, applying software upgrades.

– Must be evaluated against an accredited laboratory analyser (NATA requirement)

– The limitations of use must be defined (clinical requirement)

These testing device requirements exclude simple devices from our Managed PoCT

system (glucose, lactate & heamoglobin meters).

Devices in use that don’t comply with PathWest’s requirements are removed from use.

The amount of time and money required to maintain a PoCT system should not

outweigh the clinical usefulness of the test result.

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Controlling costs

• Direct Costs

– Cost of devices is relatively high for old technology

– Cost per test is higher compared to laboratory testing

– Maintaining a POCT service: providing training, reporting, regional lab

support

• Hidden benefits:

– Reduce number of regional transfers (RFDS, St John Ambulance) $$$

– Patient treated immediately (no return visit for test results)

– Patient treatment plan implemented sooner

Spending time performing PoC testing to save time & money

treating or transferring a patient is the balancing act of PoCT

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• Distance, Time, Cost

• Best training by users or ‘super-users’

• Training by PathWest is device and procedure focussed

• Training by company reps is device focussed

• Utilise Teleconferencing and TeleHealth system across regional WA

• Competency Review: review interval is related to device complexity

• Staff turn-over rates and increased utilisation of Agency Nursing Staff (non-Govt)

• Circulating trained user base:

– Across WA Health this will always be in development but every site that’s under

the PathWest system improves the overall quality and competency of the whole

system.

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Training

Managing Errors

• Managing Users and Device Access

– PathWest uses PoCT middleware to maintain a centralised user database that

can be electronically ‘pushed’ to devices as an operator list.

• Managing High User Error Rates:

– How should these be managed?

• Clinical staff performing PoC tests are responsible for the results they

produce.

• Utilise Nurse Managers and Senior Medical Staff for compliance

• Managing Untrained Users

– Untrained user lock-out on medium to high complexity devices is essential

– PathWest approved PoCT devices all have untrained user lock-out capability

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POCT middleware

PathWest PoCT installed the Radiometer AQURE middleware program to interface all our

PoCT devices (including non-Radiometer devices); replaced Radiance.

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• Results are available immediately

• Results are acted on immediately

• Devices must be smart enough to

detect a wide range of sample

problems

• Device operators must be trained how

to interpret these errors

Why are pre-

analytical

errors a

significant

problem for

PoCT

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Main pre-analytical errors

• Insufficient patient ID

• Air bubbles

• Clots

• Haemolysed

• Contaminated (drawn from drip line or contains flush solution)

• Insufficient sample

• Incorrect syringe used (balanced heparinised syringe/capillary)

Future Directions for POCT

Healthcare challenges:

• Escalating costs- global and local challenge

• Providing testing to patients with limited/no access to laboratory services

– Testing in resource limited settings and following natural disasters

Implementing POCT as a cost effective testing and monitoring strategy:

• Minimise reagent consumption and sample volume required

Goal of developments in POC Diagnostics (from NIH):

“Develop low cost technologies for multiple analyte testing in a self-contained,

portable device that non-specialists in a wide range of testing environments”

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Future Directions for POCT

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Peeling RW and Mabey D, 2010, Point-of-care tests for diagnosing infections in the

developing world, Clin Microbiol Infect 2010; 16: 1062–1069

Disease drivers for POC Diagnostics

Main diseases:

• Infectious Diseases

– Respiratory infections (Strep A, Influenza A/B, RSV):

– Real-time PCR: Roche cobas liat vs Alere I (FDA pending)

• Cardiac Disease

• Cancer: detection and monitoring

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Technology drivers for POC Diagnostics

Main technologies:

• Immunoassays: OPKO (in development)

• Microfluidics: i-STAT cartridges

• Nanofluidics: 100nm or smaller; academic & research development

• Biosensors

• Molecular Diagnostics

To boldly go…

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Microfluidics & Nanofluidics

Microfluidics and Nanofluidics

• Lab-on-a-chip

• Diagnose and treat cancer

– Separate circulating tumour cells from

whole blood

• ChipShop: German chip maker

developing a modular microfluidic

cartridge with universal diagnostics

including molecular DNA testing (TB),

immunoassays (HIV), and chemical tests;

<$5/test and <$10,000/device

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• Current areas being developed (microfluidics & nanofluidics):

– Integration of isothermal amplification methods in microfluidic devicesGiuffrida M & Spoto G,

– Blister pouches for effective reagent storage on microfluidic chips for

blood cell countingSmith S et al, Scientific and Industrial Research, South Africa

– Vacuum modules on biochips to generate droplets from small sample

volumesLee CH & Hong CC, BioMEMS and Nanobiosystems Lab, Taiwan

– Geometric design of herringbone structures for cancer cell capture in a

microfluidic deviceWang S et al, Lehigh University, USA,

Microfluidics & Nanofluidics

Biosensors and POCT

Biosensor: device for the detection of an analyte that combines a biological

component with a physio-chemical detector component

• Rapid analysis of several critical care assays including blood gases,

electrolytes, and haematology.

• Integration of flexible microfluidic wearable technologies have enabled

several biosensing applications (i.e.in situ sweat metabolites analysis, vital

signs monitoring, and gait analysis).

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Wearable

biosensors

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Molecular Diagnostics and POCT

• Integration of DNA biosensors with microfluidics

• Proof of concept: Cepheid GeneXpert (septicaemia)

• Lab-on-a-disc

• Influenza A/B, RSV, Strep A: Roche Liat; Alere-I; Quidel Solana

• HIV-1/2 detection: Alere q: qualitative measurement; reverse transcriptase

and real-time PCR

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Who is the PathWest POCT group

Louisa MacDonald – Medical Scientist in Charge – 6457 1838

Tharan Singh – Medical Scientist – 6457 3564

Margaret Andreoli – Medical Scientist – 6457 3564

PoCT Office: QEII Medical Centre, Nedlands, WA.

Thank-you and any questions

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