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 Andrew.Sargeant@health.nsw.gov.au

0434 072 698

http://www.pathology.health.nsw.gov.au/key-projects/point-of-care-testing

Acknowledgements