Standardizing point-of-care instrumentation: One Institutions - - PowerPoint PPT Presentation

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Standardizing point-of-care instrumentation: One Institutions - - PowerPoint PPT Presentation

Standardizing point-of-care instrumentation: One Institutions Experience Brenda Suh-Lailam , PhD, DABCC, FACB Ann & Robert H. Lurie Childrens Hospital of Chica go Feinberg School of Medicine, Northwestern University Learning Objectives


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SLIDE 1

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

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SLIDE 2

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

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SLIDE 3

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
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SLIDE 4

Point-of-Care Testing is Advantageous

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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
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SLIDE 5

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

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SLIDE 6

Different Device Types – Same Test

Blood gas analysis ACT testing

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Handheld Benchtop type 1 Benchtop type 2 Benchtop type 3 Handheld type 1 Handheld type 2 Benchtop

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SLIDE 7

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

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SLIDE 8

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

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SLIDE 9

Should we standardize our POC instrumentation?

  • A. Yes, absolutely
  • B. No, let sleeping dogs lie

9

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SLIDE 10

What challenges do you foresee?

  • Change management
  • Data collection
  • Cost of acquiring new instrumentation
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SLIDE 11

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

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SLIDE 12

Two POCT Instrumentation Standardization Projects

  • Blood gas analysis

– Goal: 4 → 1

  • ACT testing

– Goal: 3 → 1

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SLIDE 13

Case Study: Blood gas analysis

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SLIDE 14

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Blood Gas Analyzer Location Handheld Anesthesia/OR MRI ED/ Observation Transport PICU Benchtop 1 CICU NICU PICU Benchtop 2 Cath Lab Benchtop 3 CVS

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SLIDE 15

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

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American Productivity & Quality Center (APQC) Blog “For Change Management To Work The Reason Must Be Compelling” Rachele Collins, May 30, 2017

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SLIDE 16

Key Steps in Standardizing POCT Instrumentation

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https://www.aacc.org/publications/cln/articles/2017/november/from-many-

  • ne-a-case-study-on-standardizing-point-of-care-testing-instrumentation
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SLIDE 17

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

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SLIDE 18

Key Steps in Standardizing POCT Instrumentation

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Assess different aspects of the clinical departments and each POCT device being considered.

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SLIDE 19

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 performance

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SLIDE 20

Assessment of workflows – Respiratory therapy workflow

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23-27 steps 10 – 40 minutes Variable 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

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SLIDE 21

Assessment of quality – Pre-analytic errors

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

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SLIDE 22

Assessment of quality – Pre-analytic errors

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Ordered on wrong patient Wrong specimen type Error type not specified Month 1 Month 2 Month 3 Month 4 Month 5 Month 6 Month 7 Month 5 Month 6 Month 7 Incorrect result on an analyte Duplicate order

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SLIDE 23

Assessment of Analytical Performance

Direct 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 √

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SLIDE 24

Comparison of Na Values to Laboratory Method

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130 133 136 139 142 145 148 151 132 135 138 141 144 147 BGAs (mmol/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

Blood Gas Analyzers (mmol/L) Cobas 6000 (mmol/L)

n = 40 Sample type: Leftover whole blood and serum Population: CVS patients

Benchtop 1 Benchtop 2 Benchtop 3 Handheld

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SLIDE 25

Comparison of Na Values to Laboratory Method

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Mean bias = 3.3 mmol/L (2.4%)

Avg of Cobas 6000 & Benchtop 1 (mmol/L) Bias (mmol/L) Avg of Cobas 6000 & Benchtop 3 (mmol/L)

Mean bias = 1.3 mmol/L (1.0%)

Bias (mmol/L) Avg of Cobas 6000 & Handheld (mmol/L)

Mean bias = 2.8 mmol/L (2.0%)

Bias (mmol/L)

Mean bias =-1.1 mmol/L (-0.8%)

Avg of Cobas 6000 & Benchtop 2 (mmol/L) Bias (mmol/L)

Na, allowable total error (TEa) = ± 4 mmol/L

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SLIDE 26

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Comparison of K values to Laboratory Method

Benchtop 1 Benchtop 2 Benchtop 3 Handheld

Potassium, K

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SLIDE 27

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Comparison of K Values to Laboratory Method

Avg of Cobas 6000 & Benchtop 1 (mmol/L) Avg of Cobas 6000 & Benchtop 2 (mmol/L) Avg of Cobas 6000 & Benchtop 3 (mmol/L) Avg of Cobas 6000 & Handheld(mmol/L)

K, allowable total error (TEa) = ± 0.05 mmol/L

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SLIDE 28

Comparison of Hb Values to Laboratory Method

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7.5 8.5 9.5 10.5 11.5 12.5 13.5 14.5 9 10 11 12 13 14

BGAs (g/dL)

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

Blood Gas Analyzers (mmol/L) ADVIA 2120i (g/dL)

n = 40 Sample type: Leftover whole blood and serum Population: CVS patients

Benchtop 1 Benchtop 2 Benchtop 3 Handheld

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SLIDE 29

Comparison of Hb Values to Laboratory Method

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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%) Bias (g/dL) Avg of ADVIA & Benchtop 1 (g/dL) Bias (g/dL) Bias (g/dL) Bias (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%

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SLIDE 30

Comparison of Hb Values to Laboratory Method

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Hemoglobin, Handheld (g/dL) Bias (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

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SLIDE 31

Analytical Performance Assessment Summary

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Central Lab Analyzer Blood Gas Analyzers Benchtop 1 Benchtop 2 Benchtop 3 Handheld Na ? √ √ √ K √ √ √ √ Hb √ √ X ?

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SLIDE 32

Key Steps in Standardizing POCT Instrumentation

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Assess different aspects of the clinical departments and each POCT device being considered. Recommend POCT device type that best meets clinical and

  • perational needs. Pilot recommendation before

implementing.

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SLIDE 33

Recommendation

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Blood Gas Analyzer Location Handheld Anesthesia/OR MRI ED/Observation Transport PICU Benchtop 1 CICU NICU PICU Benchtop 2 Cath Lab Benchtop 3 CVS Blood Gas Analyzer Location Handheld Anesthesia/OR MRI ED/Observation Transport PICU NICU CICU Benchtop 2 CICU NICU Cath Lab CVS

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SLIDE 34

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

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SLIDE 35

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 created

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SLIDE 36

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

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Percent blood gas orders with co-ox per week CICU NICU PICU Pre-standardization 100% 100% 100% Post-standardization 93% 4% 0%

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SLIDE 37

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

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SLIDE 38

Key Steps in Standardizing POCT Instrumentation

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Assess different aspects of the clinical departments and each POCT device being considered. Recommend POCT device type that best meets clinical and

  • perational needs. Pilot recommendation before

implementing. Implement recommendation with processes in place for monitoring and maintaining compliance and quality.

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SLIDE 39

Implementation

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  • 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)

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SLIDE 40

What did we gain from standardizing?

  • Improved staff efficiency

– Increased personnel satisfaction - uniformity in practice across hospital departments – Increased provider satisfaction

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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

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SLIDE 41

What did we gain from standardizing?

  • Improved quality

– Decreased pre-analytic errors – fewer corrected reports – Increased regulatory compliance – Improved test utilization – All standardized POC instruments interfaced to the EMR

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Pre-standardization Post-standardization

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

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SLIDE 42

What did we gain from standardizing?

  • 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

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SLIDE 43

Summary

Prework Obtain data and identify stakeholders

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Assess different aspects of the clinical departments and each POCT device being considered. Recommend POCT device type that best meets clinical and

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

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SLIDE 44

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

  • A. Yes
  • B. No

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SLIDE 45

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Questions?