Current Status of PoCT Point of Care Testing in Australia - 23/07/2013

23/07/2013
Current Status of PoCT
Point of Care Testing in Australia Where are we up to and why do we
need it?
Rosy Tirimacco
Operations and Research Manager
Integrated Cardiovascular Clinical Network CHSA
• No mandatory standards or guidelines written specifically
for PoCT in Australia
• Responsibility lies with individual organisations running
PoCT to develop their own quality framework
• Most PoCT tests are not eligible for Medicare rebates
because they are performed at sites which are not
accredited
• Accreditation in its current format is prohibitive for most
non-laboratory users of PoCT
• Diverse views throughout stakeholders on how PoCT
should be implemented in Australia
AACB Webinar May 1st 2013
Where Is PoCT Performed?
•
•
•
•
•
•
•
Home and community environment
Community pharmacy
Primary Care
Disaster and Pandemic Scenarios
Rural and Remote
Paramedical vehicles
Hospitals – ED, ICU and operating rooms
Advantages & Disadvantages
PoCT Advantages
• Simpler sample
collection
• Simpler pre-analytical
process
• Faster test results
available leading to
more timely treatment
• Removes pathology
access barriers
• Increased patient
satisfaction
PoCT Disadvantages
• Increased workload
• Potential errors due to
lack of expertise and
quality control
• Potentially incompatible
to local laboratory
method used
• Increased cost
• Inadequate storage of
results
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23/07/2013
The total point of care testing
process
Minimise Potential Sources of Error
• To avoid or reduce likelihood of errors:
–
–
–
–
–
–
–
–
Follow manufacturers’ instructions
Perform all necessary maintenance procedures
Ensure correct sample collection
Perform minimum QC/QA requirements
Respond to out-of-control QC/QA situations
Document results in patients’ records
Evaluate operators’ ongoing competency
Observe safety requirements
Patient
Outcome
Question
Test
Decision
Action
A
B
Right question
Request
Right test performed
Test done
Specimen
Collection
Testing
cycle
Result
Reported
Right interpretation
Right decision
Change in patient
management
Analysis
Courtesy Andrew St John
Something to Consider
• Although PoCT may not be as accurate when
compared to traditional laboratory testing its
value in offering faster results in conventional
and unconventional settings cannot be ignored
PoCT Needs Analysis
Needs can be identified within several areas:
Clinical need and outcomes
Improved efficiency / workflow
Patient compliance / needs
Health system outcomes
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23/07/2013
Clinical Need / Outcomes
Improved Efficiency / Workflow
Provide clinically relevant data to the primary
practitioner at the point of care on a real-time
basis to improve delivery of evidence based
care and hence patient outcomes
Removes access barriers to necessary
pathology tests
Streamline diagnostic process – compliance
with best practice recommendations (eg
chest pain/ACS)
Allows the physician to gather, review and
feedback clinical information during a single
consultation (diabetes)
Can eliminate additional visits to physician’s
office or multiple calls to feedback or action
results (INR)
Health System Outcomes
Point of Care Testing in GP
Allow improved provision of necessary tests
regardless of geographic location or
size/resources of the health facility
Allow re-engineering of delivery of services to
improve patient safety and clinical outcomes
• Trial conducted between 2005 and 2007
• Department of Health and Ageing funded multi-centre,
cluster randomised controlled trial to determine the
safety, clinical effectiveness, cost-effectiveness and
satisfaction of PoCT in General Practice
26 practices randomised to the control group and 32
practices randomised to the intervention group
247 GPs participated
5,234 patients recruited from the practices of which 944
patients were on anticoagulant therapy, 1,967 had
established diabetes and 3,819 had established
hyperlipidaemia
HbA1c, urine albumin and albumin creatinine ratio, total
cholesterol, HDL-C, triglyceride and INR
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23/07/2013
Quality Management for Trial
Designed around Interim standards for point of
care testing in general practice which
incorporated PoCT trial guidelines
– Developed in collaboration between general practice
and pathology
– Combination of two different sets of standards RACGP
and NPAAC
PoCT Trial Standards
1.
2.
3.
4.
5.
Clinical governance
Analytical requirements
Staff training
Test implementation and performance
Quality outcomes
As part of accreditation practices were assessed by
surveyors to determine whether they comply with
standards and guidelines outlined
www.health.gov.au/internet/main/publishing.nsf/Content/health-pathology-poctt-info.htm
Accreditation Visits
Surveyor teams prepared
Teams of 3 – Scientist, GP/ PM and Trial Management
representative for each region
30 intervention practices surveyed over a 3 week period
Each visit 1 ½ - 2 hours
Follow up included provision of summary report and
detail of individual criterion
Certificate of Accreditation
Two rounds – Nov/Dec 2005 and Sep/Oct 2006
Safety and Quality Trial Conclusion
• 391 serious adverse events (SAE) were reported not attributable to the trial
• Acceptable QC/QA results
• High levels of concordance between PoCT and lab
results for all the tests and the mean differences in
results and the 95% limits of agreement were
clinically acceptable
http://www.health.gov.au/internet/main/publishing.nsf/
Content/health-pathology-poctt-index.htm
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23/07/2013
GP POCT Trial Model
•
•
•
•
“Rolls Royce” to ensure no confounding issues
due to quality
Face to face training and frequent consultation
Major resources devoted to compliance
Significant costs associated with training and
compliance
GP Trial Conclusions
• Analytical Performance
– Results non-inferior – for most analytes (not HDL)
• Clinical effectiveness – marginal improvements in more
patients in target ranges for HbA1c, ACR, Lipids - better
compliance
• More GP visits, more process of care, little impact on
prescribing patterns
• Except ACR, all POCT less cost effective than laboratory
testing
What is required for a future PoCT model
Extremities of opinion
“Anyone can perform
POCT - devices are
idiot proof”
Bridging the gap
POCT Practitioner
Network
“All testing should
be performed in
the laboratory”
Requirements of a Future POCT Model
• Must work within the framework of General
Practice
• Does not impose undue burden – regulation
light
• Has the same or similar quality framework as
laboratory testing
• Is cost and clinically effective
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23/07/2013
The Aims:
To provide a comprehensive and effective program for
training, certification and professional development for all
PoCT operators
This will ensure devices are operated to appropriate
clinical standards.
New content regularly being added to the site and existing
information updated.
• Competency tests are available for each clinical
presentation and PoCT device listed on the site
• 15 multiple choice questions (MCQs) per test, with
100% required pass rate
• Unlimited attempts
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23/07/2013
Distribution of Members (as of 4/3/13)
Occupation of Registered APPN
Members
Position
Medical Specialist
Medical Director
Pathologist
GP
Practice Manager
Nursing. GP Practice
Nursing. Hospital
Nursing. Community
Nursing. Flight
Nursing. Educator
Scientist/Lab Tech
Specimen Collector
PoCT Coordinator
Industry
Pharmacist
Allied Health
Dentistry
Student
Other
Total
Number of members
8
8
21
175
29
233
524
52
6
43
124
15
52
87
35
24
6
33
167
1642
Breakdown of Competency Tests
Performed and Passed
Sample Collection
Quality Assurance
Drug Treatment of Type II Diabetes
Basal-bolus Insulin Regimens for Management of
Hyperglycaemic Inpatients
Interference with Blood Glucose Measurements
Glucose Meters
HbA1c Clinical Targets, Units & Goals for Precision
Role of HbA1c in Diabetes Management
HbA1c Devices
INR Clinical Competency
INR Over- Anticoagulation
INR Devices
Albumin:Creatinine Ratio
Urinary ACR Devices
Lipids Devices
291
72
17
Cardiac Devices
TOTAL
31
1154
23
25
82
12
14
31
141
103
297
5
6
4
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How Easy is it to Navigate Around
Website Rating?
Easy
18
10
Easy
20
9
3
2
0
Adequate
Average Rating 7.98
1
1
Difficult
5
10
15
Number
20
25
30
Reliability of the Website Rating?
2
0
1
0
5
10
15
Number
20
25
30
How useful is our website?
1.4%
Slightly
useful
26
8
8.7%
4
7
Moderately
useful
4
6
3
5
3
0
2
0
17.4%
Extremely useful
Very useful
Average Rating 8.47
1
4
Difficult
0
31
9
Adequate
3
Not at all
useful
22
10
Difficult
Average Rating 8.26
2
4
1
0
Easy
3
5
1
0
2
6
11
5
4
26
13
7
2
6
25
8
10
7
20
10
9
29
8
Adequate
Quality of the Content Rating
Very
useful
Moderately useful
40.6%
Slightly useful
Extremely
useful
Not at all useful
31.9%
1
1
0
5
10
15
20
Number
25
30
35
0.0%
20.0%
40.0%
60.0%
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23/07/2013
Face to Face versus Online Training
Cholesterol
Number F2F
Mean F2F
SD F2F
CV F2F (%)
L1
178
3.90
0.22
5.7
L2
166
6.05
0.33
5.5
Trig
L1
L2
Number F2F
Mean F2F
SD F2F
CV F2F (%)
176
1.43
0.06
4.1
163
3.1
0.2
6.7
Number APPN
Mean APPN
SD APPN
CV APPN (%)
203
4.02
0.23
5.7
175
6.27
0.32
5.1
Number APPN
Mean APPN
SD APPN
CV APPN (%)
201
1.42
0.06
3.9
175
3.1
0.2
6.0
10 practices randomly selected for either face to face PoCT training or on-line training via APPN
The Use of Point of Care Tests for HIV in
Australia
17 December 2012
–After extensive evaluation of safety and performance the TGA has
registered a point of care test for HIV for use in Australia as a
preliminary screening test
–The test can be used outside the laboratory by appropriately
trained health professionals however all positive results must be
confirmed through referral to a laboratory
–In Australia the confirmed diagnosis of HIV can only be made
using laboratory tests that are authorised for use by the TGA
http://www.tga.gov.au/consumers/information-devices-hivrapid-tests.htm
Lessons Learnt To Date
• On-line education is well accepted by clinical
staff
• Webinars have been very popular with General
Practitioners
• Patients using service for glucose meters –
potential area of expansion including INR
• Need to accommodate CPD requirements for
different professional organisations to make it
more user friendly for stakeholders
Potential Advantages of HIV POCT
Australasian Society for HIV Medicine (ASHM)
–Improve HIV screening among at risk communities
–Improve rates of testing particularly in those that may
be reluctant to come forward
–Diagnosing HIV early is a priority as this is when the
infection is most contagious – early diagnosis means
earlier treatment, a healthier life and less risk of
transmission
Impt: Not an over the counter test – only available for use by
accredited locations and individuals with appropriate training to
interpret results and deliver a positive result.
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23/07/2013
Lloyd Sampson Review
• Review was announced late last year amid controversy over
continued deferral of PBS listing for dabigatran for stroke prevention
in AF. – 64 Submissions received.
“There are enough
unknowns at the present to
caution use of these agents
in areas where specialist
and pathology services are
not readily available. We
strongly believe that
although new anticoagulants
have some
advantages…warfarin is the
safest front-line option in
rural and remote areas”
Australian Doctor, 20 April 2012
Recommendation 10
•The use of point-of-care testing (PoCT) for the
measurement of INR values should be considered
as an option for warfarin management, particularly in
the community setting. Such testing could be
conducted at a medical practice or could involve a
collaborative shared-care arrangement between a
patient’s medical practitioner and other health
professionals with whom the patient has regular and
convenient contact.
•Uptake of PoCT in Australia, as a component of a
warfarin management program, should be
considered for government support.
Review of Anticoagulation
Therapies in Atrial Fibrillation
• Commissioned in Sept 2011
• Contains a number of suggestions for
development of an improved management of
anticoagulation in patients with atrial fibrillation
• Takes into account warfarin alternatives to
reduce risk of stroke eg Dabigatran – major cost
implications
• Highlights many patients not being treated with
warfarin because no access to regular
monitoring
PoCT INR
• First drop of blood should be used when test INR
at the point of care
• INR methods (both PoCT and laboratory) may vary
• Patients on warfarin should be monitored using the
same method – high PoCT results should be
confirmed by lab method if possible
• Performing PoCT INR within a quality framework
may be safer than new anticoagulants in rural and
remote areas
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23/07/2013
Intrasystem variability
Patient samples react differently to different PT reagents
Parallel INR Test
(12,13)
Stago Neo CI +
1.2
Pacific
Hemostasis DS
1.0
Ortho
Recombiplastin
1.0
Dade Innovin
1.0
Dade C+
1.8
Control 1
1.0
0.9
1.0
1.0
1.0
• INR results from stable anticoagulated patients should be
used
• ±10% variation acceptable for stable patients within
therapeutic range results. Results > 4.5 should be
repeated (PoCT/lab).
• For PoCT results > 8.0 venous sample sent to lab for
verification but appropriate treatment commenced
Control 2
2.6
2.1
1.9
2.5
2.4
I. Solvik, U.O et al. (2006). Scandinavian Journal of Clinical and Laboratory Investigation, 2006 66, 337–349.
Patient 1
2.5
2.6
2.3
2.8
3.1
II. Tripodi, A et al Quality assurance program for whole blood prothrombin time-international normalized ratio point-ofcare monitors used for patient self-testing to control oral anticoagulation. Thrombosis Research, 2004 , 113, 35–40.
Patient 3
1.8
1.7
1.8
2.0
2.2
Patient 4
4.0
3.7
3.1
4.3
5.2
Patient 11
4.5
4.9
3.6
5.2
5.8
Patient 15
4.2
5.3
3.7
5.6
5.7
Patient 23
2.1
2.1
1.9
2.2
2.2
• Plasma samples tested on the same instrument using 5 different reagents can differ by ≤ 2.2 INR
• Reagents differ in sensitivity to coagulation factors, causing INR variability; patients may react differently to these
factor levels (13)
Reagent
ISI
Low outliers
High outliers
iCCnet INR External QC Program
• Samples sourced from a third party
• One sample/month
– Reports sent back to sites every 2 months
• 4 levels
• Tested on the CoaguChek range of instruments
across iCCnet sites (same strip technology)
iCCnet CHSA
Jan
Feb
Mar
Total Results Submitted
98
101
101
87
Median
4.0
1.4
3.3
2.2
3.4-4.6
1.1-1.7
2.8-3.8
1.9-2.5
98%
96%
95%
95%
Allowable Limits
Results in Allowable Limits
Apr
*Allowable limits of performance: ±0.3 up to 2.0; ±15% >2.0
– XS
– XS Plus
– XS Pro
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23/07/2013
Decision Analytic Protocol (DAP) to
Guide the Assessment of HbA1c Testing
• Recommended HbA1c to be used as part of the
case detection pathway for diabetes – test
performed by NATA accredited labs OR
alternatively at the point-of-care
• To ensure high quality results test undertaken
within an accreditation framework
Patient at high risk of diabetes as per AUSDRISK or at risk according
to guidelines
HbA1c
<6.5% - no diabetes
Asymptomatic –
Retest according
to guidelines, not
more than 1/yr
<6.5% - no
diabetes
Symptomatic –
repeat HbA1c
≥6.5% - diabetes
confirmed
≥6.5% - diabetes suspected
Confirmatory HbA1c test
<6.5% - no
diabetes
Commence
management
≥6.5% - diabetes
confirmed
Commence
management
1267 Final Decision Analytic Protocol (DAP) to guide the assessment of HbA1c testing for the diagnosis of diabetes mellitus Jan 2013
http://www.msac.gov.au/internet/msac/publishing.nsf/Content/C312179D00DAFE11CA2579AD007FBA8A/$File/1267-HbA1c-FinalDAP.pdf
Glucose Systems – AACB
Recommendations (2012)
• 13 recommendations made
(www.aacb.asn.au/documents/item/157)
• It is recommended that glucose systems which have features
designed for professional use are implemented in acute hospital
facilities, not systems designed for home use
• Glucose systems used in hospital facilities should allow patient
identification as well as the capacity to be connected to other
systems and/or networks
• The health care professional managing the patient should decide on
the glucose system most suitable to the patient setting, taking into
account the relevant professional scientific advice available for each
device
• It is recommended that all incidents and adverse events are reported
to TGA through the IRIS system
(http://www.tga.gov.au/safety/problem-device.htm)
Glucose Interference Study
• Evaluated Nova StatStrip Xpress, Abbott Optium
Xceed and Roche Accu-Chek Performa glucose
instruments
– Correlation with laboratory analyser
– Precision analysis
– Investigated the effect of Haematocrit, Maltose,
Galactose & Ascorbic acid
• Results compared to the Roche Integra 400 plus
lab analyser
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23/07/2013
Precision
Hct Interference
Level 1
Performa
Number
10
10
10
Mean
3.3
2.7
2.5
SD
0.08
0.25
0.08
CV (%)
2.4
9.3
3.3
Level 2
Optium
Integra
Performa
6.00
5.50
5.00
4.50
4.00
25%
StatStrip
Number
Optium
Performa
10
10
10
Mean
15.8
17.4
16.9
SD
0.16
0.51
0.13
CV (%)
1.0
2.9
0.8
Hct Interference
Optium
Integra
Performa
21.00
20.00
19.00
18.00
17.00
16.00
15.00
14.00
25%
45%
Hct
65%
G lu c o s e m m o l/L
StatStrip
45%
Hct
65%
StatStrip
iSTAT
Integra
ePOC
3.50
3.00
2.50
2.00
1.50
25%
45%
65%
Hct
White Cell 5 Part Diff
HCT interference
G lu c o s e m m o l/L
HCT interference
StatStrip
G lu c o s e m m o l/ L
Optium
G lu co s e m m o l/L
StatStrip
StatStrip
iSTAT
Integra
ePOC
• Useful test at Point of Care for sites without
timely access to a laboratory
• We evaluated the HemoCue instrument
– EDTA whole blood samples after they had been
tested on laboratory analyser
18.00
17.00
16.00
15.00
14.00
25%
45%
65%
Hct
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23/07/2013
Neutrophils
25
25
20
20
PoCT Neut
PoCT WBC
Total White Cell Count
15
10
15
10
5
5
0
0
0
5
10
15
20
0
25
5
10
Lab WBC
y = -0.342222 + 1.022222 x
r2=0.99
n=80
20
r2=0.99
y = 0.0439024 + 0.975610 x
Lymphocytes
25
n=80
Monocytes
4.5
1.8
4.0
1.6
3.5
1.4
3.0
1.2
PoCT Mono
PoCT Lymph
15
Lab Neut
2.5
2.0
1.5
1.0
0.8
0.6
1.0
0.4
0.5
0.2
0.0
0.0
0
1
2
3
4
5
y = 0.100000 + 1.000000 x
r2=0.83
0.0
0.5
1.0
1.5
2.0
Lab Mono
Lab Lymph
n=80
y = 0.00588235 + 0.588235 x
r2=0.27
n=80
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23/07/2013
Eosinophils
White Cell 5 Part Diff
1.6
• Excellent correlation with lab for total WCC,
neutrophils and lymphocytes
• Poor correlation for monocytes and eosinophils
• Limited basophil range for comparison
• Need to understand potential limitations before
implementation
• Similar results to those obtained at Pathology
Queensland
• Need to evaluate finger-prick accuracy
1.4
PoCT Eosin
1.2
1.0
0.8
0.6
0.4
0.2
0.0
0.0
0.5
1.0
1.5
2.0
Lab Eosin
y = 0.000000 + 1.333333 x
r2=0.17
n=80
cobas b101
– Tests performed by practice nurses
– 15 patient comparisons with laboratory
• Finger prick PoCT
• Venous sample to lab
– 10 quality control tests at both levels
• Preliminary data
11
10
PoCT_HbA1c (%)
• PoCT HbA1c and lipids
• Evaluation currently being performed at 9 medical
centres throughout SA
cobas b101 – HbA1c
9
8
7
6
5
4
4
5
6
7
8
9
10
11
Lab_HbA1c (%)
y = -0.586667 + 1.133333 x
r2=0.95
n=91
15
23/07/2013
cobas b101 – HDL
6
3.0
5
2.5
4
PoCT HDL
PoCT Chol
cobas b101 – Total Cholesterol
3
2.0
1.5
1.0
2
0.5
1
1
2
3
4
5
0.0
6
0.0
Lab_Chol
1.0
1.5
2.0
2.5
3.0
Lab HDL
r2=0.98
y = -0.109444 + 0.977778 x
0.5
n=90
y = -0.322500 + 1.250000 x
cobas b101 – Triglycerides
r2=0.94
n=91
cobas b101 – Precision
7
Level 1
6
Site
(GP)
PoCT_Trig
5
4
3
2
1
0
0
1
2
3
4
5
6
7
Lab_Trig
y = 0.0911553 + 0.991288 x
r2=0.70
HbA1c Chol
Level 2
TG
HDL
Site
(GP)
HbA1c Chol
TG
HDL
1
6.24
1.27
1.48
3.60
1
2.44
1.77
1.81
2.03
2
2.52
1.63
1.20
2.99
2
5.86
2.14
1.20
2.20
3
3.90
1.64
0.72
2.54
3
1.69
1.60
0.76
2.25
4
5.59
2.07
2.74
3.48
4
2.29
1.99
1.28
2.53
5
5.03
1.92
1.09
2.42
5
1.57
1.90
1.21
2.56
6
2.76
1.56
1.52
4.37
6
1.74
1.62
1.48
2.72
7
4.25
1.21
2.46
2.12
7
1.66
1.70
1.22
1.33
8
2.11
2.67
1.44
2.13
8
1.65
1.46
0.72
5.26
9
2.14
1.43
1.61
3.54
9
1.18
1.49
0.87
2.24
Scientist
1.74
2.01
1.72
2.66
Scientist
1.16
1.41
1.25
3.15
n=91
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23/07/2013
Troponins at the POCT
Troponin Release Profile
Useful tool for clinicians for the early diagnosis of
and risk stratification of patients presenting to ED
with symptoms suggestive of ACS
Lack of high sensitive assays at the POC means
that diagnostic algorithms based on 8-12 hours
observation should be used until hs-POCT becomes
available
To achieve maximum benefit from introducing POC,
clinicians need to have a good understanding of
assay limitations and tests should be part of an
integrated systematic approach engaging all stake
holders
Troponin Release Profile
Cobas h232 vs hs-TropT
17
23/07/2013
Clinical Outcome: POCT TropT –
Initial <50 ng/L and 2 Hr 50-100 ng/L
AQT vs hs TropT
• 5 out of 237 (2%)
• 3/5 (60%) patients had a final diagnosis of ACS
Conclusion
Samsung LABGEO
•
Tests up to 22 tests relating to liver, lipid, kidney and diabetes including
AST, ALT, GGT, DBIL, TBIL, GLU, ALB, TP, BUN, CREA, ALP, Na, K, Cl,
CHOL, HDL (LDL), TG, UA, AMY, Ca, tCo2, HbA1c
70 ul blood
Insert the blood
into the
cartridge
Insert
cartridge
into
instrument
Results available –
7mins/test
• PoCT should be integrated into clinical care –
right question, right test, right interpretation, right
decision
• Implementation model needs to take into account
limited resources in general practice
• Wide range of tests available – some tests may
need more thought eg HIV counselling of positive
result
• 2 recent reports recommend use of PoCT in GP
• Strong consideration should be given to funding
PoCT in GP
http://www.samsung.com/global/business/healthcare/healthcare/in-vitro-diagnostics/BCA-PT10/DE-features
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