Point of Care Testing : Rollout in NSW 6th Annual Emergency Care Symposium
November 2016 Andrew Sargeant
Director, PoCT Services
• Implementation of devices for Emergency Departments in rural and remote areas that do not have support of 24/7 laboratory onsite
• Initial test profile of UEC, Blood gases + lactate + haemoglobin, troponin, INR/PT
• Implement single management software
Project scope
1. Establish a framework to ensure quality and sustainability of service
2. Provide access to timely pathology results in rural, remote and small Emergency Departments
3. Monitor performance of all PoCT devices in use in EDs to ensure result accuracy
4. Transmit results electronically to LIS and then eMR 5. Establish a PoCT Program that can be expanded to
manage other PoCT devices (selected from an approved device list)
Project objectives
Project timeline
2016 2012 2013 2014 2015
Project planning
phase
First implementation
Implementations Last devices implemented
Macquarie Uni
evaluation complete
PoCT Device Locations
What we manage
Tender 1 – the Emergency Department Profile • Urea, electrolytes, creatinine • Lactate • Blood gases • CO-oximetry • Hemoglobin • Troponin • PT/INR
Tender 2 – Emergency and chronic care • HbA1C + ACR • ß -hCG • Neonatal bilirubin • Creatinine (standalone) • 5 part diff white cell count
(no device selected) • D-dimer (no device selected)
What we manage – cont.
Current test catalogue Manufacturer / Distributer Test code Abbott Roche Werfen
i-STAT Afinion ePOC Triage Meter Statsensor Statstrip ABL800 ABL825 ABL827 ABL835 ABL90 Flex or Flex Plus AQT 90 Flex Hemocue 201
DMCoaguChek
XS Pro DCA Vantage RapidPoint 500 GEM4000
Sodium (Na)Potassium (K)
Chloride (Cl)Anion Gap calc calc calc calc calc calc calc calc
Ionized Calcium (iCa)Base Excess (BE) calc calc calc calc calc calc calc calc
Glucose (Glu)Lactate (Lac)
pHpC02
p02Total C02
HC03 (Bicarb) calc calc calc calc calc calc calc calc
s02 calc calc calc calc calc calc calc calc
COHbO2Hb
HHbMetHb
Total BilirubinAlbumin
ALPALTAST
GGTTotal Protein
Haemocrit (HcT)Haemoglobin (Hgb) calc calc
Total WBCNeutrophils
LymphocytesMonocytesEosinophils
Basophils
Urea Nitrogen (BUN)Creatinine (Crea)
eGFR calc
PT/INRaPTT
D-dimer
cTnlcTnTBNP
NT-proBNP
ß-hCG
HbA1c
Metabolites
Renal Function
Alere Nova Siemens
Device Model
Test
s an
d Te
stin
g G
roup
ings
Electrolytes
Blood Gases
CO-oximetry
Liver Function
Radiometer
Haemotology
Coagulation
Cardiac Markers
Endocrinology
Diabetes care
Next tests to tender for Chemical Pathology Tests Lipids Amylase LFTs Renal profile ACR Glucose and ketones Urinalysis (SG pH LEU NIT PRO GLU KET UBG BIL B) Haematology ACT APTT Haemostasis testing
Application process
NOW
BEFORE 1. Vendors offer device free 2. Clinicians trial 3. Use of consumables
hidden from management 4. Becomes normal practice
Description Number
Active operators >18,000
e-learning courses - ABL 800 series - i-STAT - CoaguChek XS Pro
3
e-learning courses completed by operators (since May 2015)
>10,000
What we have to manage – cont.
Device Device usage Wastage rate % (Mar 2016)
Radiometer ABL 800 Regular usage, highly automated
2.7
i-STAT Occasional usage, manual 9 (was 7)
CoaguChek XS Pro Infrequent usage, fingerprick sampling
16
What we have to manage – cont.
Monitoring Systems
Monitoring Systems
Monitoring Systems
2016 Macquarie Uni Findings
Table courtesy of Andrew Georgiou
2016 Macquarie Uni Findings Result reconciliation Poor result reconciliation (29%)
Tests per patient presentation Significant decrease Lab staff recall Slight decrease
ED representations within 28 days
Decreased (0.8%)
Transfers Decreased (0.8%) – ARD 1 and 2 NEAT target Increased (1.8%)
Role Adding to workload TAT Across ARDs TAT was shorter by
•419 mins in ARD1 •405 mins in ARD2 •157 mins in ARD3 •78 mins in ARD4 •58 mins ARD5
2016 Macquarie Uni Findings cont. LOS (overall) Decrease for both discharged (3
mins) and admitted patients (9 mins)
LOS (troponin I part of diagnostics)
Decrease (55 mins)
LOS (circulatory illness) Decrease (14 mins)
2016 Macquarie Uni Findings cont. Results available before discharge
Graph courtesy of
Before 0 After
2016 Survey Results (704 responses) 95% Helped decision making 93% Helped improve patient outcomes 90% Changes patient management 20% Didn’t have all the required tests 93% Confidence in the results 86% Good value for money
Wanted • White cell counts • Better stock ordering systems • More training • Improved resources (fact sheets, tips, user guides, demo videos) • Results in the eMR more reliably
Name ID i-STAT Tests Time Name ID i-STAT Tests Time Name ID i-STAT Tests Time
Name ID i-STAT Tests Time Name ID i-STAT Tests Time Name ID i-STAT Tests Time
Admin section to configure location by location and site and includes login
Name ID i-STAT Tests Time
Latest results
Quick start videos
Videos for i-STAT and CoaguChek
Fact sheets Latest fact sheets for configured devices
Green folders Green folder contents
PoCT resource centre
1
2
3 4
5 Maintenance
checks
6
7
8
10
11
12
Operator list – recertification due
9
14
PREMS PROMS 13
2016 Pathology West Analysis
Graph courtesy of Juliana Iles-Mann – Pathology West, NSWHP
PoCT vs Lab - Sodium
Measurement Uncertainty mmol/L mmol/L
Level ± Level ± PoCT 122 1.5 131 1.5 Local Laboratory
123 2 145 2
Slide courtesy of Brian Heffernan– Pathology West, NSWHP
Sodium Patient Result Comparison to Lab Sodium – iSTAT v Dimension ExL mmol/L (2016)
120
125
130
135
140
145
150
120 130 140 150 160
Statistics • Slope = 1.013 • Intercept = -2.19 • R2 = 0.94 • Min = 121 mmol/L • Max = 151 mmol/L
Slide courtesy of Brian Heffernan– Pathology West, NSWHP
Measurement Uncertainty mmol/L mmol/L
Level ± Level ± PoCT 3.8 0.05 2.9 .05 Local Laboratory
3.9 0.1 6.4 0.1
PoCT vs Lab - Sodium
Slide courtesy of Brian Heffernan– Pathology West, NSWHP
Potassium Patient Result Comparison to Lab Potassium – iSTAT v Dimension ExL mmol/L (2016)
2
2.5
3
3.5
4
4.5
5
5.5
6
6.5
7
2 3 4 5 6 7
Statistics • Slope = 0.934 • Intercept = 0.196 • R2 = 0.898 • Min = 3.0 mmol/L • Max = 6.4 mmol/L
Slide courtesy of Brian Heffernan– Pathology West, NSWHP
TCO2
Measurement Uncertainty mmol/L mmol/L
Level ± Level ± PoCT 17.7 2 23.8 2 Local Laboratory
17 2 31 3
Slide courtesy of Brian Heffernan– Pathology West, NSWHP
TCO2 Patient Result Comparison to Lab TCO2 – iSTAT v Dimension ExL mmol/L (2016)
10
15
20
25
30
35
40
10 20 30 40 50
Statistics • Slope = 0.81 • Intercept = 1.59 • R2 = 0.827 • Min = 13 mmol/L • Max = 39 mmol/L
Slide courtesy of Brian Heffernan– Pathology West, NSWHP
iCa/Total Calcium
Measurement Uncertainty mmol/L mmol/L
Level ± Level ± PoCT 0.87 0.03 1.33 0.03 Local Laboratory
2.00 0.06 3.06 0.10
Slide courtesy of Brian Heffernan– Pathology West, NSWHP
Glucose
Measurement Uncertainty mmol/L mmol/L
Level ± Level ± PoCT 6.8 0.2 15.1 0.3 Local Laboratory
4.5 0.2 15.8 0.6
Both assays more precise than strip meter PoCT glucose meters.
Slide courtesy of Brian Heffernan– Pathology West, NSWHP
Glucose Patient Result Comparison to Lab Glucose – iSTAT v Dimension ExL mmol/L (2016)
1
3
5
7
9
11
13
1 3 5 7 9 11 13
Statistics • Slope = 0.983 • Intercept = 0.26 • R2 = 0.996 • Min = 3.7 mmol/L • Max = 11.3 mmol/L
Slide courtesy of Brian Heffernan– Pathology West, NSWHP
Creatinine
Measurement Uncertainty mmol/L mmol/L
Level ± Level ± PoCT 94 6 351 21 Local Laboratory
74 4 530 15
Slide courtesy of Brian Heffernan– Pathology West, NSWHP
Creatinine Patient Result Comparison to Lab Creatinine – iSTAT v Dimension ExL umol/L (2016)
0
50
100
150
200
250
300
350
400
0 100 200 300 400
Statistics • Slope = 0.992 • Intercept = 9.22 • R2 = 0.989 • Min = 46 umol/L • Max = 349 umol/L
Slide courtesy of Brian Heffernan– Pathology West, NSWHP
Hct
Measurement Uncertainty mmol/L mmol/L
Level ± Level ± PoCT 17 1 35 1 Local Laboratory
18 0.4 37 0.7
Common Interferences – PoCT, poorly mixed sample, extreme levels of lipid and protein. -
Slide courtesy of Brian Heffernan– Pathology West, NSWHP
Hct Patient Result Comparison to Lab Hct – iSTAT v Sysmex Cell Counter (2016)
0
0.1
0.2
0.3
0.4
0.5
0.6
0 0.1 0.2 0.3 0.4 0.5 0.6
Statistics • Slope = 1.107 • Intercept = 0.02 • R2 = 0.96 • Min = 0.19 • Max = 0.50
Slide courtesy of Brian Heffernan– Pathology West, NSWHP
Haemoglobin Patient Result Comparison to Lab Hb – iSTAT v Sysmex Cell Counter (2016)
0
20
40
60
80
100
120
140
160
180
200
0 50 100 150 200
Statistics • Slope = 1.066 • Intercept = 0.81 • R2 = 0.946 • Min = 56 g/L • Max = 169 g/L
Slide courtesy of Brian Heffernan– Pathology West, NSWHP
cTroponin-I Patient Result Comparison to Lab cTroponin-I – iSTAT v Dimension ExL ug/L (2016)
0
1
2
3
4
5
6
7
8
0 5 10 15
Statistics • Slope = 0.622 • Intercept = 0.0002 • R2 = 0.9996 • Min = 0 ug/L • Max = 12.13 ug/L
Slide courtesy of Brian Heffernan– Pathology West, NSWHP
cTroponin-I Patient Result Comparison to Lab cTroponin-I – iSTAT v Dimension ExL ug/L (2016) Log scale.
0.01
0.1
1
10
0.01 0.1 1 10 100
Statistics • Slope = 0.622 • Intercept = 0.0002 • R2 = 0.9996 • Min = 0 ug/L • Max = 12.13 ug/L (12,130
ng/L)
Slide courtesy of Brian Heffernan– Pathology West, NSWHP
INR
Measurement Uncertainty
Level ± Level ± PoCT 2.4 0.2 Local Laboratory
2.4 0.12
Slide courtesy of Brian Heffernan– Pathology West, NSWHP
Specimen transfer temperature issues?
iSTAT – CHEM8 Room Temp. tube
Refrigerated tube.
Sodium (mmol/L) 144
140 137
Potassium (mmol/L)
4.0 4.3 7.7 Low temperature puts the Na-K-ATPase
to sleep Chloride (mmol/L) 107 107 107
TCO2 (mmol/L) 22 20 21
Creatinine (umol/L)
82 79 72
Slide courtesy of Brian Heffernan– Pathology West, NSWHP
Other Initiatives
Test Device Blood gases + lactate + haemoglobin (CG4+ cartridge) i-STAT Urea, electrolytes, creatinine, glucose (Chem8 cartridge) INR CoaguChek XS Pro
Scope
• 5 Extended care paramedic vehicles • Vehicles stationed at Pt Claire (Gosford) and Hamilton (Newcastle) • 3 month trial period
• Patient, system benefits • Decision support for ambulance staff • Data linkage • Device utility
Objectives
Results
Cohort number = 84 Median age = 81 55% male cohort Main finding - Pathology results changed treatment or transport decision for 16 (24%) of patients
Contact Details, References and Questions [email protected]
0434 072 698
http://www.pathology.health.nsw.gov.au/key-projects/point-of-care-testing
Acknowledgements