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TRANSCRIPT
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
Key Steps in Standardizing POCT Instrumentation
18
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.
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)
Mean bias = 1.3 mmol/L
(1.0%)
Bia
s (m
mol/
L)
Avg of Cobas 6000 &
Handheld (mmol/L)
Mean bias = 2.8 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
Benchtop 1 Benchtop 2 Benchtop 3 Handheld
Potassium, K
27
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
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
Benchtop 1 Benchtop 2 Benchtop 3 Handheld
Comparison of Hb Values to Laboratory Method
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%
Comparison of Hb Values to Laboratory Method
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
Benchtop 1 Benchtop 2 Benchtop 3 Handheld
Na ? √ √ √
K √ √ √ √
Hb √ √ X ?
Key Steps in Standardizing POCT Instrumentation
32
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.
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
Key Steps in Standardizing POCT Instrumentation
38
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.
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
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
41Pre-standardization Post-standardization
Month 1 Month 2 Month 3 Month 4 Month 5 Month 6 Month 7 Month 1 Month 2 Month 3
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
42
SummaryPrework
Obtain data and identify stakeholders
43
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-instrumentationhttps://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?