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

Standardizing point-of-care instrumentation: One Institution’s Experience Brenda Suh-Lailam , PhD, DABCC, FACB Ann & Robert H. Lurie Children’s Hospital of Chica go 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 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 4

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 Handheld type 1 Handheld Benchtop type 1 Handheld type 2 Benchtop type 2 Benchtop Benchtop type 3 6

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? • Creating uniformity in practice Improve • Reduced learning curves efficiency • Reduced changes • Improved test utilization Improve • Decrease in pre-analytic errors • Increase regulatory compliance quality • Increased patient safety • Personnel (more efficient Cost workflows) • Decreased supply expenses – price savings 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

Blood Gas Location Analyzer Anesthesia/OR MRI Handheld ED/ Observation Transport PICU CICU Benchtop 1 NICU PICU Benchtop 2 Cath Lab Benchtop 3 CVS 14

In the Beginning, Data and Ground Work American Productivity & Quality Center (APQC) Blog • Outlined issues identified “For Change Management To Work The Reason Must Be Compelling” Rachele Collins, May 30, 2017 • 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

Key Steps in Standardizing POCT Instrumentation https://www.aacc.org/publications/cln/articles/2017/november/from-many- 16 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

Key Steps in Standardizing POCT Instrumentation Assess different aspects of the clinical departments and each POCT device being considered. 18

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 19

Assessment of workflows – Respiratory therapy workflow Order placed in EMR Workflow with RN collects sample and contacts RT benchtop analyzers - Critical care units RT picks up sample and walks it to blood gas lab RT assigns accession and prints label from LIS 23-27 steps 10 – 40 minutes RT scans barcode, enters patient info and runs Variable processes 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 20

Assessment of quality – Pre-analytic errors Month 1 Month 2 Month 3 Month 4 Month 5 Month 6 Month 7 21

Assessment of quality – Pre-analytic errors Ordered on wrong patient Wrong specimen type Incorrect result on an analyte Duplicate order Error type not specified Month 1 Month 2 Month 3 Month 4 Month 5 Month 6 Month 7 Month 5 Month 6 Month 7 22

Assessment of Analytical Performance Direct measurement Benchtops Handheld √ √ pH √ √ pCO 2 √ √ PO 2 √ √ Na + √ √ K + √ CL - √ √ iCa √ √ Glu √ √ Lac √ √ Hct √ tHb √ O 2 Hb √ COHb √ MetHb √ HHb Calculated √ √ sO 2 √ √ HCO 3 √ BE √ √ TCO 2 √ √ tHb 23 √ Hct

Comparison of Na Values to Laboratory Method Blood Gas Analyzers (mmol/L) y = 1.14x – 16.4 151 y = 1.05x – 4.6 148 y = 0.99x + 2.5 BGAs (mmol/L) 145 y = 0.88x + 15.1 142 139 136 n = 40 Sample type: Leftover 133 whole blood and serum Population: CVS patients 130 132 135 138 141 144 147 Cobas 6000 (mmol/L) Cobas 6000 (mmol/L) Handheld Benchtop 3 Benchtop 2 Benchtop 1 24

Comparison of Na Values to Laboratory Method Bias (mmol/L) Bias (mmol/L) Mean bias = 3.3 mmol/L Mean bias =-1.1 mmol/L (2.4%) (-0.8%) Avg of Cobas 6000 & Avg of Cobas 6000 & Benchtop 1 (mmol/L) Benchtop 2 (mmol/L) Bias (mmol/L) Bias (mmol/L) Na, allowable total error (TEa) = ± 4 mmol/L Mean bias = 1.3 mmol/L Mean bias = 2.8 mmol/L (1.0%) (2.0%) Avg of Cobas 6000 & 25 Avg of Cobas 6000 & Handheld (mmol/L) Benchtop 3 (mmol/L)

Comparison of K values to Laboratory Method Potassium, K Handheld Benchtop 3 Benchtop 2 Benchtop 1 26

Comparison of K Values to Laboratory Method Avg of Cobas 6000 & Avg of Cobas 6000 & Benchtop 2 (mmol/L) Benchtop 1 (mmol/L) K, allowable total error (TEa) = ± 0.05 mmol/L Avg of Cobas 6000 & Avg of Cobas 6000 & 27 Benchtop 3 (mmol/L) Handheld(mmol/L)

Comparison of Hb Values to Laboratory Method Blood Gas Analyzers (mmol/L) 14.5 y = 1.03x – 0.08 13.5 y = 0.94x + 0.71 y = 1.16x – 2.22 12.5 BGAs (g/dL) y = 0.98x – 0.78 11.5 10.5 n = 40 9.5 Sample type: Leftover whole blood and serum 8.5 Population: CVS patients 7.5 9 10 11 12 13 14 ADVIA 2120i (g/dL) ADVIA 2120i (g/dL) ABL90 GEM4000 GEM3000 I-STAT Handheld Benchtop 2 Benchtop 3 Benchtop 1 28

Comparison of Hb Values to Laboratory Method Bias (g/dL) Spectrophotometry Bias (g/dL) Mean bias = 0.25 g/dL Mean bias = 0.06 g/dL (2.28%) (0.54%) Avg of ADVIA & Benchtop 2 Avg of ADVIA & Benchtop 1 (g/dL) (g/dL) Mean bias = -1.02 g/dL Mean bias = -0.49 g/dL (-9.21%) (-4.38%) Bias (g/dL) Bias (g/dL) Conductivity Hb TEa = ± 7% Avg of ADVIA & Handheld Avg of ADVIA & Benchtop 3 29 (g/dL) (g/dL)

Comparison of Hb Values to Laboratory Method Hemoglobin, Handheld (g/dL) Bias (g/dL) y = 1.107x – 0.93 Mean bias = 0.34 g/dL (2.88%) Hemoglobin, ADVIA (g/dL) Avg ADVIA & Handheld (g/dL) n = 21 Sample type: Leftover whole blood Population: Samples sent to lab for routine testing 30

Analytical Performance Assessment Summary Central Lab Blood Gas Analyzers Analyzer Benchtop 1 Benchtop 2 Benchtop 3 Handheld √ √ √ Na ? √ √ √ √ K √ √ Hb X ? 31

Key Steps in Standardizing POCT Instrumentation 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. 32

Recommendation Blood Gas Location Analyzer Blood Gas Location Anesthesia/OR Analyzer MRI Anesthesia/OR ED/Observation MRI Handheld Transport Handheld ED/Observation PICU Transport NICU PICU CICU CICU CICU Benchtop 1 NICU NICU PICU Benchtop 2 Cath Lab Benchtop 2 Cath Lab CVS Benchtop 3 CVS 33