Standardizing point-of-care instrumentation: One ... · one-a-case-study-on-standardizing-point-of-care-testing-instrumentation. Who did we include in a multidisciplinary team? •key

Standardizing point-of-care instrumentation:

One Institution’s Experience

Brenda Suh-Lailam, PhD, DABCC, FACB

Ann & Robert H. Lurie Children’s Hospital of Chicago

Feinberg School of Medicine, Northwestern University

Learning Objectives

At the completion of this session, participants will be able to:

1. Describe the process of standardizing point-of-care instrumentation

2. List the challenges associated with standardizing point-of-care instrumentation

3. Discuss advantages of standardizing point-of-care instrumentation

2

Speaker Financial Disclosure Information

• Grant/Research Support: None

• Salary/Consultant Fees: None

• Board/Committee/Advisory Board Membership: None

• Stocks/Bonds: None

• Honorarium/Expenses: None

• Intellectual Property/Royalty Income: None

Point-of-Care Testing is Advantageous

4

Fast

•Quick turnaround time = faster clinical decision-making

• Supports efficient workflow

Portable

• Can be taken where needed

• Increase global access to care

Affordable

• Infrastructure costs are minimal

• Fewer steps involved

Reliable

• Results are comparable to lab

•No regular servicing required

Do you have different device types for the same test at your institution?

A. Yes, for multiple tests

B. Yes, only for one test

C. No

5

Different Device Types – Same Test

Blood gas analysis ACT testing

6

Handheld

Benchtop type 1

Benchtop type 2

Benchtop type 3

Handheld type 1

Handheld type 2

Benchtop

Challenges - Multiple Device Types – Same Test• May confound the interpretation of the status of the patient

– Anticoagulation status – ACT

– Need for transfusion – Hemoglobin

• Decreased efficiency of operators and POC staff

– Different processes, steps and workflows – decreased compliance

– Maintaining inventory for different device types

• QC, calibration verification materials

– Performing instrument to instrument comparisons

– Keeping procedures updated

• Increased operating costs

– Having to interface each device type

– Low order volumes

– Maintenance fees for each device type

Advantages - Why Standardize?

Improve efficiency

• Creating uniformity in practice

• Reduced learning curves

• Reduced changes

Improve quality

• Improved test utilization

• Decrease in pre-analytic errors

• Increase regulatory compliance

• Increased patient safety

Cost savings

• Personnel (more efficient workflows)

• Decreased supply expenses – price reduction

• Decreased maintenance and data management costs

Should we standardize our POC instrumentation?

A. Yes, absolutely

B. No, let sleeping dogs lie

9

What challenges do you foresee?

• Change management

• Data collection

• Cost of acquiring new instrumentation

What challenges do you foresee?

• Change management

– Choosing an instrument that meets the needs of every area

• Getting everyone to agree on one instrument

– Personnel learning to use new instrumentation

– Identification of all stakeholders

Two POCT Instrumentation Standardization Projects

• Blood gas analysis

– Goal: 4 → 1

• ACT testing

– Goal: 3 → 1

12

Case Study:

Blood gas analysis

13

14

Blood Gas

AnalyzerLocation

Handheld

Anesthesia/OR

MRI

ED/ Observation

Transport

PICU

Benchtop 1

CICU

NICU

PICU

Benchtop 2 Cath Lab

Benchtop 3 CVS

In the Beginning, Data and Ground Work

• Outlined issues identified

• Data collection

– Compiled non-compliance and error data

– Existing cost and potential savings info from manufacturers

– Determined test volumes

• Alerted hospital compliance officer

– Risks associated with status quo

• Identified and talked individually to stakeholders

15

American Productivity & Quality Center (APQC) Blog

“For Change Management To WorkThe Reason Must Be Compelling”Rachele Collins, May 30, 2017

Key Steps in Standardizing POCT Instrumentation

16

Assess different aspects of the clinical departments and

each POCT device being considered.

Recommend POCT device type that best meets clinical and

operational needs. Pilot recommendation before

implementing.

Implement recommendation with processes in

place for monitoring and maintaining compliance

and quality.

https://www.aacc.org/publications/cln/articles/2017/november/from-many-one-a-case-study-on-standardizing-point-of-care-testing-instrumentation

Who did we include in a multidisciplinary team?

• key decision makers from all affected areas – Providers

– Directors/managers

• Nursing directors

• Respiratory therapy director

– Instrument operators

• Clinical educators

• Nurses

• Respiratory therapists

• Technicians

17


18





implementing.



and quality.

What did we assess?

• Clinical need

• Workflows

• Current regulatory compliance/quality

• Test utilization

• Test volumes

• Cost

• Ease of use

• Available infrastructure to support use of instrument

• Analytical performance19

Assessment of workflows – Respiratory therapy workflow

20

23-27 steps10 – 40 minutesVariable processes

Workflow with benchtop analyzers- Critical care units

Order placed in EMR

RN collects sample and contacts RT

RT picks up sample and walks it to blood gas lab

RT assigns accession and prints label from LIS

RT scans barcode, enters patient info and runs test

RT logs into different system, links EMR orders to LIS accession

RT enters test results into LIS

RT double checks correct results in EMR

RT prints results and walks them to provider

Assessment of quality – Pre-analytic errors

21

Month 1 Month 2 Month 3 Month 4 Month 5 Month 6 Month 7

Assessment of quality – Pre-analytic errors

22

Ordered on wrong patient

Wrong specimen type

Error type not specified

Month 1 Month 2 Month 3 Month 4 Month 5 Month 6 Month 7Month 5 Month 6 Month 7

Incorrect result on an analyte

Duplicate order

Assessment of Analytical PerformanceDirect measurement Benchtops Handheld

pH √ √

pCO2 √ √

PO2 √ √

Na+ √ √

K+ √ √

CL- √

iCa √ √

Glu √ √

Lac √ √

Hct √ √

tHb √

O2Hb √

COHb √

MetHb √

HHb √

Calculated

sO2 √ √

HCO3 √ √

BE √

TCO2 √ √

tHb √ √

Hct √23

Comparison of Na Values to Laboratory Method

24

130

133

136

139

142

145

148

151

132 135 138 141 144 147

BG

As (

mm

ol/

L)

Cobas 6000 (mmol/L)

y = 1.14x – 16.4

y = 1.05x – 4.6

y = 0.99x + 2.5

y = 0.88x + 15.1

Blo

od

Gas

An

aly

zers

(m

mol/

L)

Cobas 6000 (mmol/L)

n = 40

Sample type: Leftover

whole blood and serum

Population: CVS patients

Benchtop 1 Benchtop 2 Benchtop 3 Handheld

Comparison of Na Values to Laboratory Method

25

Mean bias = 3.3 mmol/L

(2.4%)

Avg of Cobas 6000 &

Benchtop 1 (mmol/L)

Bia

s (m

mol/

L)

Avg of Cobas 6000 &

Benchtop 3 (mmol/L)


(1.0%)

Bia

s (m

mol/

L)

Avg of Cobas 6000 &

Handheld (mmol/L)


(2.0%)

Bia

s (m

mol/

L)

Mean bias =-1.1 mmol/L

(-0.8%)

Avg of Cobas 6000 &

Benchtop 2 (mmol/L)

Bia

s (m

mol/

L)

Na, allowable

total error (TEa)

= ± 4 mmol/L

26

Comparison of K values to Laboratory Method


Potassium, K

27

Comparison of K Values to Laboratory Method

Avg of Cobas 6000 & Benchtop 1 (mmol/L)



Avg of Cobas 6000 & Handheld(mmol/L)

K, allowable

total error (TEa)

= ± 0.05 mmol/L

Comparison of Hb Values to Laboratory Method

28

7.5

8.5

9.5

10.5

11.5

12.5

13.5

14.5

9 10 11 12 13 14

BG

As (

g/d

L)

ADVIA 2120i (g/dL)

ABL90 GEM4000 GEM3000 I-STAT

y = 1.03x – 0.08

y = 1.16x – 2.22

y = 0.98x – 0.78

y = 0.94x + 0.71

Blo

od

Gas

An

aly

zers

(m

mol/

L)

ADVIA 2120i (g/dL)

n = 40

Sample type: Leftover

whole blood and serum

Population: CVS patients



29

Mean bias = 0.25 g/dL

(2.28%)

Mean bias = -1.02 g/dL

(-9.21%)

Mean bias = 0.06 g/dL

(0.54%)

Mean bias = -0.49 g/dL

(-4.38%)

Bia

s (g

/dL

)

Avg of ADVIA & Benchtop 1

(g/dL)

Bia

s (g

/dL

)

Bia

s (g

/dL

)

Bia

s (g

/dL

)

Avg of ADVIA & Benchtop 2

(g/dL)

Avg of ADVIA & Handheld

(g/dL)Avg of ADVIA & Benchtop 3

(g/dL)

Spectrophotometry

Conductivity

Hb TEa = ± 7%


30

Hem

oglo

bin

, H

andheld

(g/d

L)

Bia

s (g

/dL)

Hemoglobin, ADVIA (g/dL) Avg ADVIA & Handheld (g/dL)

n = 21

Sample type: Leftover whole blood

Population: Samples sent to lab for routine testing

Mean bias = 0.34 g/dL (2.88%)y = 1.107x – 0.93

Analytical Performance Assessment Summary

31

Central Lab

AnalyzerBlood Gas Analyzers


Na ? √ √ √

K √ √ √ √

Hb √ √ X ?


32





implementing.



and quality.

Recommendation

33

Blood Gas

AnalyzerLocation

Handheld

Anesthesia/OR

MRI

ED/Observation

Transport

PICU

Benchtop 1

CICU

NICU

PICU

Benchtop 2 Cath Lab

Benchtop 3 CVS

Blood Gas

AnalyzerLocation

Handheld

Anesthesia/OR

MRI

ED/Observation

Transport

PICU

NICU

CICU

Benchtop 2

CICU

NICU

Cath Lab

CVS

Drivers for Recommending 2 Blood Gas Analyzers

Handheld

• Near patient testing

• Improved efficiency with RT workflow

• Infrastructure already in place (Interfaced and wireless)

• PICU and NICU - Cardiac status monitoring with SO2

Benchtop

• Need for co-oximetry

– CCU - Patients on NO

– NICU – Sample volume considerations

• Ease of instrument maintenance (no troubleshooting necessary)

• Cost of interfacing instruments

• Personnel satisfaction

34

Pilot• PICU - 5 months

• Handheld for near patient testing

• Performed by nurses

• Benchtop when CO-OX is needed

• Benchtop removed from floor

• Benchtop on alternate floor used when needed

• Widespread education of providers– Only results on ordered tests provided

• Separate test orders created35

What Data was Collected from PICU Pilot?

• How often co-ox was tested

– Significant decrease in co-ox measurements in PICU

• If benchtop needed on floor

– None needed

36

Percent blood gas orders with co-ox per week

CICU NICU PICU

Pre-standardization 100% 100% 100%

Post-standardization 93% 4% 0%

What Data was Collected from Pilot?

• How many handhelds needed in each unit

– 8/unit

• Efficiency of new workflow and concerns

– Working relationship between nurses & RTs

• New handheld and benchtop analyzer volumes

– New cost of supplies, instruments

37


38





implementing.



and quality.

Implementation

39

• Provider and personnel education

• Operator training

• Sufficient instruments available for use

• Tests correctly built in the EMR and LIS

• Set go live date– Approved by all stakeholders

• Engage stakeholders and personnel at every step (collaborative effort)

What did we gain from standardizing?

• Improved staff efficiency

– Increased personnel satisfaction - uniformity in practice across hospital departments

– Increased provider satisfaction

40

Post-standardization

Pre-standardization

10-40 minutes <5 minutes

“…this is POCT at its best…”

Order placed in EMR

RN collects sample and contacts RT

RT picks up sample and walks it to blood gas lab

RT assigns accession and prints label from LIS

RT scans barcode, enters patient info and runs test

RT logs into different system, links EMR orders to LIS accession

RT enters test results into LIS

RT double checks correct results in EMR

RT prints results and walks them to provider


• Improved quality

– Decreased pre-analytic errors – fewer corrected reports

– Increased regulatory compliance

– Improved test utilization

– All standardized POC instruments interfaced to the EMR

41Pre-standardization Post-standardization

Month 1 Month 2 Month 3 Month 4 Month 5 Month 6 Month 7 Month 1 Month 2 Month 3


• Cost savings

– More efficient workflows for personnel

– Decreased supply expenses due to increased test volume

– Decreased maintenance and data management costs

• Fewer vendor fees – eliminated one vendor fee

– Department reached goal for sustainable savings initiative

42

SummaryPrework

Obtain data and identify stakeholders

43





implementing.



and quality.

https://www.aacc.org/publications/cln/articles/2017/november/from-many-one-a-case-study-on-standardizing-point-of-care-testing-instrumentationhttps://www.aacc.org/community/aacc-academy/publications/scientific-shorts/2018/is-standardizing-poct-instrumentation-worth-the-challenge

https://www.aacc.org/publications/cln/articles/2017/november/from-many-one-a-case-study-on-standardizing-point-of-care-testing-instrumentation

https://www.aacc.org/community/aacc-academy/publications/scientific-shorts/2018/is-standardizing-poct-instrumentation-worth-the-challenge

Are you up for the challenge of standardizing your POC instrumentation?

A. Yes

B. No

44

45

Questions?

Standardizing point-of-care instrumentation: One ... · one-a-case-study-on-standardizing-point-of-care-testing-instrumentation. Who did we include in a multidisciplinary team? •key

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