STRATEGY OF HOSPITAL

CLINICAL LABORATORY
EXAMINATION FULFILLMENT
WITH QUALITY, TIME AND COST
EFFICIENCY.
A CASE STUDY – BLOOD GAS &
ELECTROLYTE TESTING IN RSUI

Dr. dr. Astuti Giantini, Sp.PK (K), MPH

Clinical Laboratory RSUI
 Role of laboratory testing
• Represents 5% of health system's costs, yet it affects 95% of the remaining costs
• Contributes 80% of objective data in the clinical record
• Influences 60%–70% of critical decision making

-1996, Forsman, Mayo Clinic USA

CLINICAL PATHOLOGY LABORATORY OF RSUI

Testing Number by
Clinical Pathology Lab RSUI
180.000

160.000

>64
140.000

120.000

100.000

80.000
testing types
60.000
performed daily
40.000

20.000

2020 2021 2022 (Jan-May)

CLINICAL PATHOLOGY LABORATORY OF RSUI
 Resources:
 5 clinical pathologists
 22 medical technologists
 >20 analyzers with IT supported system
 Scope of activities:
 Pre-analysis - Sampling
 Analysis
 Post-analysis - Reporting
 Others:
 Manage internal logistics
 Quality management for accreditation
LAB QUALITY INDICATORS

• Critical result reporting rate

Critical values should be reported < 30 minutes → 100%
• Turn-around-time (TAT)
TAT minimum 80% laboratory testing achieves its standard reporting time
• Customer Satisfaction on Laboratory Unit’s Service
90% of respondents enrolled in survey is satisfied with laboratory service
• Accreditation
SNARS, ISO 17025
 CASE STUDY – BLOOD GAS & ELECTROLYTE TESTING
WHY BLOOD GAS?
• High demand during Covid-19’s pandemic peak.
• Important to manage the disease

• It is critical clinical usage

• Short stability samples for blood gas (ideally analyzed not more than 30 minutes after sample collection)
CASE STUDY – BLOOD GAS & ELECTROLYTE TESTING
CHALLENGES IN BLOOD GAS TESTING

• Limited resources in sampling

• Special technique for arterial puncture
• Sampling service in wards only possible in morning shift
• Pre-analytic issues (around 60% problems comes from this
phase)
• blood clot in samples
• lysis
• Air bubble
• Analytic issues
• QC result problem
• unpredicted consumables replacements, delayed time
CASE STUDY – BLOOD GAS & ELECTROLYTE TESTING
HOSPITAL MANAGEMENT PRESPECTIVE
• Option to perform blood gas testing in hospital:
• Central lab
• Satellite labs
• Point-of-care
• Improved patient-outcome in critical care is a goal, through a balance between:
• Assurance in quality of (blood gas) testing result
• Time affecting medical decision
• Cost effectiveness

• GEM Premier 3500 is a system that promotes quality, simplicity in use, and
potentially improve cost effectiveness in performing blood gas, electrolyte (also
lactate) and we were interested to observe more.
BLOOD GASES & ELECTROLYTES ANALYZER IN RSUI

 20 available parameters (pre-selected):

pH, pCO2, pO2, SO2%, Na+, K+, Ca2+, Mg2+, Cl-, Glu, Ureum, Creatinine,
Lactate, Hct, Hb, O2Hb, HHb, COHb, MetHb, and tBIL.
 Sample volume: 120 µl without Co-oximetry

 Analysis time: ±2 mins

 Methodology: Ion Selective Electrode, traditional

 More than >16 types of consumables and many manual maintenance

procedures to do.
Nova Phox Ultra by Nova Biomedical, USA
NEW CONCEPT OF BLOOD GAS & ELECTROLYTE TESTING:
GEM PREMIER 3500
 Parameters (auto-generated):
pH, pCO2, pO2, SO2% (calc.), Na+, K+, Ca2+, Glu, Lactate, Hct
 Sample volume: 150 µl (whole blood)
 Analysis time: 85 seconds
 Methodology: Ion Selective Electrode, micro-censored
 iQM – patented intelligent quality system that allows analyzer to actively
detect problems (including interferences in samples), repair, ensure and
maintain the system within specified allowable range automatically.
 Simplicity with single cartridge, with flexible options 150 to 450 test for 21
days. Cartridge replacement and validation is the only maintenance to do.
GEM Premier 3500, Werfen, USA
NEW CONCEPT OF BLOOD GAS & ELECTROLYTE TESTING:
GEM PREMIER 3500
iQM
 For detection of interference (ie. clot), after checking 1 sample, iQM uses PCS B control to find out
whether it is in the range.
 If it does not meet the threshold, it checks with the second material, PCS A

 There is a sequence or confirmation mechanism automatically by iQM

 From the threshold pattern, iQM recognizes the type of interference (confirmation step)

 After confirming, iQM will take appropriate action

 iQM declares the tool is safe to use if PCS B’s threshold returns to normal
NEW CONCEPT OF BLOOD GAS & ELECTROLYTE TESTING:
GEM PREMIER 3500

iQM, automatically:

1. 4.
2. Fixing 3. Ensuring
Recognizing Documenting
error repair status
error point 1-3
STUDY FOR COMPARISON
85 DAYS OBSERVATION, SIDE-BY-SIDE
11 Oct 2021 to 3 Jan 2022
 Analytical performance
 Within run precision
 Patient sample comparison
 Time efficiency
 Reducing manual work of operator for consumables replacement, preventive maintenance, troubleshoot
 Reducing manual work for QC process
 Cost efficiency
 Total cost per test
 User experience survey
COMPARISON OF ANALYTICAL PERFORMANCE
Within run precision (n=20), both methods are within their manufacturer technical specification

GEM Premier 3500

pH pO2 pCO2 Na K Ca Laktat Hct
No
CVP 1 CVP 2 CVP 1 CVP 2 CVP 1 CVP 2 CVP 1 CVP 2 CVP 1 CVP 2 CVP 1 CVP 2 CVP 1 CVP 2 CVP 3 CVP 4
Mean 7,22 7,56 56 140 70 33 128 155 2,9 6,5 1,55 0,44 0,9 6,1 23 43
SD 0,00 0,00 1,00 1,10 1,11 0,33 0,80 0,49 0,03 0,00 0,01 0,01 0,04 0,06 0,00 0,00
CV% 0,1% 0,0% 1,8% 0,8% 1,6% 1,0% 0,6% 0,3% 1,1% 0,0% 0,5% 1,3% 4,5% 0,9% 0,0% 0,0%
Ref CV% <5% <5% <5% <5% <5% <5% <5% <5% <5% <5% <5% <5% <5% <5% <5% <5%

Nova Phox Ultra

No pH pCO2 pO2 Na K Ca Lac Hct
CCX Control Level 1 Level 2 Level 3 Level 1 Level 2 Level 3 Level 1 Level 2 Level 3 Level 4 Level 5 Level 4 Level 5 Level 4 Level 5 Level 4 Level 5 Level 1 Level 2 Level 3
Mean 7,179 7,384 7,56 71,7 47 25,9 61,4 100,8 138,7 140,1 112,7 3,99 6,19 0,96 1,49 2,01 6,92 34,3 - 48,4
SD 0,004 0,004 0,007 1,51 0,61 0,38 1,74 2,14 2,07 0,22 0,47 0,04 0,03 0,01 0,03 0,04 0,32 0,64 - 0,3
CV% - - - 2,1% 1,3% 1,5% 2,8% 2,1% 1,5% 0,2% 0,4% 0,9% 0,5% 1,5% 2,2% 2,0% 4,6% 1,9% - 2,2%
COMPARISON OF ANALYTICAL PERFORMANCE
Patient sample comparison (Bland-Altman) for Nova pHox
Ultra vs GEM Premier 3500
Most parameter correlate well (>95%)

Parameters Diff Mean Lower Limit Upper Limit n %concordance

pH -0,01 -0,1 0,1 58 97%

pO2 -3,01 -43,5 37,4 58 95%
pCO2 -6,03 -13,9 1,9 58 95%
Na 5,50 3,0 7,8 58 93%
K 0,24 0,0 0,4 58 97%
Ca 0,02 -0,1 0,2 58 97%
Laktat -0,86 -1,5 -0,3 38 97%
Hct 1,79 -3,8 7,4 58 97%
COMPARISON OF ANALYTICAL PERFORMANCE
Patient sample comparison (n=85), all observed parameters correlates well with r2 >0,8
 COMPARISON OF TIME EFFICIENCY IN 85 DAYS Manual time (mins)

GEM Premier 3500 reduces 88% of manual work-time GEM Premier 3500

NovaPhox Ultra

0 100 200 300 400 500 600

due to less item of consumables, less frequent to do replacement, maintenance, and troubleshot that require manual work
Type of consumables (items)
Frequency of manual activities (times)

GEM Premier 3500

GEM Premier 3500

NovaPhox Ultra
NovaPhox Ultra

0 2 4 6 8 10 0 50 100 150
COMPARISON OF QC SYSTEM (FREQ. & MANUAL TIME) IN 85 DAYS
QC is an important daily activity to ensure the validity of all laboratory analyzers.
No patient result will be analyzed or reported if QC result is considerably out.

Nova Phox Ultra GEM Premier 3500

 Maintain 2 types of QC material:  Included in the cartridge.

 QC for blood gas (2 levels)  Consist of 3 levels for all parameters, performed
 QC for electrolytes (3 levels) automatically by analyzer:
 PCS A, every 4 hrs
 Performed 1x/day for:
 PCS B, each sample analysis or every 30 minutes
 1 level electrolyte  PCS C, every 24 hrs
 1 level blood gas
 If QC result not within the allowable range, need to  If one PCS result not in allowable range, iQM will fix
re-analysis or troubleshooting. it automatically.
 Total QC data: 337 data  Total QC data: 6.912 data
 Manual time for QC: 0 minute
 Manual time for QC: approx. 1.000 minutes
COMPARISON OF COST EFFICIENCY IN 85 DAYS

Calculating consumables consumed in the same Parameters Nova Phox Ultra GEM Premier 3500
period with comparable patient samples generated
pH Available Available

GEM Premier 3500 is 35,9% more cost-efficient pCO2 Available Available

per sample analysis compared to Nova Phox Ultra pO2 Available Available
with parameters HCT Available Available
SO2% Available Available
Na+ Available Available
K+ Available Available
Ca2+ Available Available
Cl- Available Not available
Glucose Available, but not used Available
Lactate Available Available
USERS’ EXPERIENCE IN 85 DAYS
Through survey, 6 users as responder give score (1=very difficult; 5=very easy) on easiness in daily operation

4,3 3,7
for GEM Premier 3500 for Nova Phox Ultra
SUMMARY OF BOTH METHODS SYSTEM COMPARISON
GEM Premier 3500 Nova Phox Ultra

Analytical performance Within manufacturer spec. Within manufacturer spec.

Manual work time Minimum, 85% more efficient

Daily or internal QC Fully automated, Manual,

1 level in every sample analysis 1 level once per day
1 level every 4 hours
1 level every 24 hours
Number of consumables 2 10

Cost per test 36,9% more efficient

Easiness (survey from users) 4,3 over 5,0 (easier) 3,7 over 5,0
CONCLUSION
From our 85 days observation, GEM Premier 3500 gives good analytical performance for blood gas, electrolyte
and lactate, improve working efficiency of 88% by reducing manual work with 36% less cost and easier to use
by operator than Nova Phox Ultra.

SUGGESTION
Due to its good analytical performance and quality system, simplicity in use and potentially increase time
efficiency of our staff, complete panel (excluding ion Cl-) GEM Premier 3500 is suitable for either central
laboratory or POC setting.
In adopting a new technology, it’s important to consider not only the functionality but also the comprehensive
positive impacts especially to laboratory or hospital and in general to patient care.
RUMAH SAKIT UNIVERSITAS INDONESIA
We Provide Outstanding Care