Managing Preanalytical

Quality in NP/POC
Testing

Ana K. Stankovic, MD, PhD, MSPH

WW VP, Medical Affairs
BD Life Sciences - PAS

March 20, 2015

 Definition

Near Patient Testing (NPT)/Point of Care

Testing (POCT):
 Any testing that is not conducted in the core lab,
or a “core-like” lab
 Testing that is being performed at the bedside,
clinic, or by the patients themselves at home
 Most Laboratory Testing Errors Occur Before
The Sample is Placed on the Analyzer

Perceived need for test

Test request requisition
Patient preparation Pre-analytical
32-
Specimen acquisition phase
75%
Specimen transport
Specimen processing
4-32% Specimen analysis Analytical phase
Report generation Post-analytical
9-55%
Report retrieval phase
Report interpretation
Howanitz and Howanitz, Clin. Lab. Med, 3:541-551, 1983
Bonini et al., Clinical Chemistry 48:5, 691-698, 2002
 Question for the audience:

Are there differences in preanalytical factors

for NP/POC testing vs. those for the core lab?
Analytical Errors Are the Most Common
POCT Errors
 Why Is the Number of Preanalytical Errors in
POCT Lower Than In Core Lab Testing?

Preanalytical factors of altered sample

integrity (e.g hemolysis, lipemia, icterus,
etc.) that would be identified and
considered as causes of preanalytical error
in laboratory setting where serum or
plasma samples are tested, often go
unrecognized in POCT systems that use a
whole blood sample or do not have a
defined mechanism for assessing sample
integrity.
 Preanalytical Factors

Fixed Variable
Biological Technical
Beyond control of Within control of
phlebotomist/laboratory staff phlebotomist/laboratory staff
 Variable Preanalytical Factors
(Core Lab)

 Patient Identification  Sample Handling

 Collection Related  Mixing
 Collection Time  Centrifugation
 Collection Site  Sample Transport and
 Phlebotomy Technique Storage
 Sample ID
 Question for the audience:

Does the variability in NP/POC testing

lead to preanalytical errors?
 Variable Preanalytical Factors
(NP/POC Testing)

 Patient Identification  Sample Handling

 Collection Related  Mixing
 Collection Time  Centrifugation
 Collection Site  Sample Transport and
 Phlebotomy Technique Storage
 Sample ID
 Sample related
 Type/additive
 Blood-to-additive ratio
 Sample volume
 Core Lab Specimen Workflow Is Complex

Transport Receive Prepare Transport

Collect Sample to Sample in Sample for Sample to
Order Test
Sample Lab Lab Testing Lab Section
Inventory Management
• Select test • Locate • Prioritize • Accession • Centrifuge • Send sample to
patient sample for appropriate lab
• Complete transport • Apply/verify • Aliquot section
order form • Prep patient sample label
• Send sample • Pre-treat • Main lab
• Receive • Draw sample to lab • Bar code for
test order testing • Re-rack • Reference
• Bedside • Pneumatic lab
• Deploy tube • Identify STAT
staff for • Home tests • Re-rack
collection • Doctor’s • Robot
• Rack sample
• Note office • Hand carry
urgency • Draw
level • Courier
station
• Collect • Label
supplies
• Dispose of
supplies
 NPT/POC Specimen Workflow Is Simpler

Transport Receive Prepare Transport

Collect Sample to Sample in Sample for Sample to
Order Test
Sample Lab Lab Testing Lab Section
Inventory Management
• Select test • Locate • Prioritize • Accession • Centrifuge • Send sample to
patient sample for appropriate lab
• Complete transport • Apply/verify • Aliquot section
order form • Prep patient sample label
• Send sample • Pre-treat • Main lab
• Receive • Draw sample to lab • Bar code for
test order testing • Re-rack • Reference
• Bedside • Pneumatic lab
• Deploy tube • Identify STAT
staff for • Home tests • Re-rack
collection • Doctor’s • Robot
• Rack sample
• Note office • Hand carry
urgency • Draw
level • Courier
station
• Collect • Label?
supplies
• Dispose of
supplies
 Or Not?
Heparinized Syringe

A 4 5 6 7

IV Line Prep Test

Access Device Evacuated Tube Transfer Cap

1 2 3 B 4 5 6 7 8

Syringe Transfer Device Evacuated Tube Transfer Cap

1
C 4 5 6 7 8 9
0
11
 Reasons for Rejecting Chemistry and
Hematology Specimens

 CAP Q-Probe 95-02,  CAP Q-Probe 92-05,

Chemistry Specimen
Acceptability, 1995
(n=461 labs)
 60% Hemolyzed
 11% Insufficient quantity
 7% Inadequately labeled
 3.5% Improper collection
tube
 2 % Clotted
Hematology Specimen
Acceptability, 1993 (n=604
labs)
 65% Clotted
 10% Insufficient
 5% Unacceptable variance (delta
check)
 5% Inadequately labeled
 2% Platelet clumps
 2 % Hemolyzed
 Preanalytical Errors in Stat Laboratory Testing
( Carraro P. and Plebani M. Errors in stat laboratory testing: types and frequencies 10 years later. Clin
Chem 2007;53:1338-1342.)

Types of preanalytical errors Number %

Specimen collected from infusion route 3 1.9
Sample contaminated 1 0.6
Tube filling error 21 13.1
Empty tube 11 6.9
Inappropriate container 13 8.1
Nonrefrigerated sample 3 1.9
Missing tube 5 3.1
Digoxin test timing error 1 0.6
Patient identification error 14 8.8
Request procedure error 12 7.5
Data communication conflict 6 3.8
Physician’s request order missed 3 1.9
Order misinterpreted 2 1.3
Check-in not performed (in the Laboratory Information Systems) 4 2.5

Subtotal 99 61.9
 Modified Kost POCT Preanalytical Errors

Preanalytical Steps Step-by-Step Defect

Test ordering Excessive/mistimed orders
Patient/specimen identification Wrong patient/wrong specimen; erroneous
patient/specimen information entry
Specimen collection Inappropriate/inconsistent specimen type,
volume or application to testing surface/chamber

Specimen evaluation Attributes compromising patient ID/collection

quality not recognized

Meier FA and Jones BA. Point-of-care testing error. Arch Pathol Lab Med 2005;139:1262-1267.
 Impact of POCT Quality Errors
On Patient Care

Score A score, n (%) P score, n (%)

1 116 (51.2) 6 (2.7)
2 109 (48.4) 175 (77.8)
3 0 (0) 3 (1.3)
4 0 (0) 33 (14.7)
5 0 (0) 8 (3.6)

A Score = actual; P score = potential

O'Casey MJ, McManus P, McGowan N, Lynch PLM. Quality error rates in point-of-care
testing. Clin Chem 2011;57:1267-71.
 Question for the audience:

What NP/POC tests are most prone to errors?

 POCT Quality Errors By Test Type

Number of Defect, % of
Test type Number of tests
defects total tests

Blood gas/electrolytes 22 687 119 0.52

Blood
5809 10 0.17
gas/electrolytes/troponin I
Pregnancy 8879 14 0.158
Glucose 303 389 71 0.02
Drugs of abuse 247 1 0.4
Hb A1c 1236 8 0.65
Urinalysis 64 370 2 0.003
Blood ketones 1087 0 0
O'Casey MJ, McManus P, McGowan N, Lynch PLM. Quality error rates in point-of-care
testing. Clin Chem 2011;57:1267-71.
Repeated POCT (<60 min): All Locations
(Courtesy of Visiun, Inc. Ann Arbor, MI)
POCT POCT Repeats
All Patient Types POC Test Description Frequency (<60 min)
*PC CBG PC CBG 83.2% 4.59%
POC Troponin I 4.3% 0.00%
POC BMP 4.1% 0.18%
POC BN Peptide 2.0% 0.00%
POC HCG 1.6% 0.00%
*PC UA DIPSTICK *PC UA Dipstick 1.4% 1.09%
POC Lactate 0.9% 0.00%
*PC ACT KAOLIN P PC ACT Kaolin Prewarm 0.6% 45.89%
*PC CG8 *PC CG8 0.6% 60.27%
*PC TROP-I PC Troponin-I 0.3% 0.00%
*PC ACT CELITE P PC ACT Celite Prewarm 0.3% 33.80%
*PC CBC 0.2% 0.00%
*PC CMP 0.1% 0.00%
*PC PT PC Prothrombin trime 0.1% 0.00%
POC Ionized Magnesium 0.1% 0.00%
POC Hemoglobin 0.0% 0.00%
*PC ACT KAOLIN PC ACT Kaolin 0.0% 10.00%
*PC BMP,Hct+Hgb 0.0% 0.00%
POC Hematocrit 0.0% 0.00%
*PC Potassium/Sodium 0.0% 16.67%
POC Potassium 0.0% 0.00%
*PC Creatinine *PC Creatinine 0.0% 0.00% www.visiun.com
POC BUN 0.0% 0.00%
POC Creatinine 0.0% 0.00%
POC Ionized Calcium 0.0% 0.00%
*PC Hgb PC Hemoglobin 0.0% 0.00%
POC Glucose 0.0% 0.00%
POC Ph 0.0% 0.00%
 Repeated POCT (<60 min): ED
(Courtesy of Visiun, Inc. Ann Arbor, MI)

POCT POCT Repeats

Test Name
Frequency (<60 min)
POC Troponin I 25.9% 0.00%
POC BMP 24.7% 0.19%
PC CBG 15.5% 6.04%
POC BN Peptide 11.8% 0.00%
POC HCG 8.1% 0.00%
PC UA DIPSTICK 5.6% 0.41%
POC Lactate 5.2% 0.00%
PC TROP-I 1.8% 0.00%
POC Ionized Magnesium 0.8% 0.00%
POC Hemoglobin 0.3% 0.00%
POC Hematocrit 0.2% 0.00%
POC Ionized Calcium 0.1% 0.00%
POC Potassium 0.1% 0.00% www.visiun.com
POC Creatinine 0.0% 0.00%
POC Glucose 0.0% 0.00%
POC Ph 0.0% 0.00%
 Impact of Preanalytical Variables on
Critical Care Testing (CCT)
Test Normal Value Preanalytical
Variable
pH 7.35-7.45 Air bubbles
PO2 75-95 mm Hg Air bubbles
PCO2 32-45 mm Hg Air bubbles
Na 135-145 mmol/L Na-Heparin
K 3.2-5.0 mmol/L Heparin binding;
Hemolysis
Cl 97-111 mmol/L Heparin binding
Glucose 75-110 mg/dL Dilution
Hct 35-50% Mixing/clots
Bun 7-25 mg/dL Dilution
Ionized Ca 1.17-1.29 mmol/L Heparin binding
Ionized Mg 0.70-0.91 mmol/L Heparin binding
Effect of Unbalanced Lithium Heparin

As specimen volume falls and

lithium heparin concentration
increases, apparent iCa++ levels
fall significantly. Modest
decrease in apparent iMg++
with increased concentration of
lithium heparin.
Use of Balanced Heparin Stabilses
iCa Levels
 Specimen Collection Requirements
For CCT

 No contact with air

 Air bubble up to 10% of the sample volume is tolerated if expelled
before mixing

 The sample must be anticoagulated at once

 Clots obstruct the analyzer probes (fully or partially)
 Clots can affect Hct results

 Avoid damage to the cells (hemolysis)

 Increases potassium
 Other analytical changes
 Specimen Mixing is Crucial For
Accuracy of CCT

Incomplete re-suspension of 10 X 10 X
the blood cells is the most
frequent cause of inaccurate
hemoglobin determination.
 Careful remixing is necessary
before analysis
 10 inversions and 10 rolling
 Extremely important when
hemoglobin concentration,
hematocrit or oxygen
concentration is to be
determined
 Error Messages in Blood Gas Testing

Error messages OR NICU Core Lab

Obstruction 15 71 905
Probe Error 0 0 30
Reagent Error - Reagent 0 0 62
Cartridge
Reagent Error - Tubing 0 0 1072
Reagent Error - Wash Cartridge 0 0 527
Total error messages 15 71 2596
Total number of samples tested 103 607 9015
Error messages/100 samples 14.46 11.7 28.8

Instruments: RAPIDPOINT (OR, NICU), RAPIDLAB (Core Lab)

Courtesy of Dr Adil Khan, Temple University
 Frequency of Hemolysis in CCC

Salvagno et al. reported hemolysis frequency

of 4%
 Whole blood arterial blood gas samples
 N=478
 Cutoff HI>60
 Emergency Department higher than Clinical
Wards (6% vs 3%)
 All collections arterial puncture
 Whole Blood Hemolysis Detection

K+ elevated, centrifuged, visually

3%
inspected

K+ elevated,other tubes evaluated 3%

After analyses centrifuged, visually

21%
inspected
After analyses stored, visually
10%
inspected

Not Determined 56%

0% 10% 20% 30% 40% 50% 60%

Howanitz, P. Hemolysis: The Last Frontier in Specimen Quality. Industry Workshop

AACC 2013
 Hemolysis Results for Fingerstick Samples
Are Variable Under Best Conditions

Study # 2
(N=59)
0% hemolyzed
Study # 1
(N=42) Study # 3
(N= 40)
7% hemolyzed
43% hemolyzed

Data from BD unpublished studies

 Effect of Hemolysis On POC Tests
Can Be Equal To the Core Lab
POC Instrument

Core Instrument
Na

POC Instrument
Na (Plasma)
 However, Effect of Hemolysis on
POC
Can
POC Differ From Core Lab Testing
Instrument

Core Instrument
BUN (plasma)

POC Instrument
NPT/POCT ?
 Cost Impact of Eliminating Quality Issues
in POCT
Scenario A: Scenario B:
Syringe draw causes higher error rates Syringe draw with an evacuated
(~15%) tube, lowers error rates (~5%)

Disposable Disposable
Redraws, re- 1.60 0.55
wastage ($) wastage ($)
tests and
confirmatory
tests
Labor costs Labor costs
1.80 0.60
($) ($)

Cost of current Cost of current

0.15 1.25
solution ($) solution ($)

Total value ($) $3.55 Total value ($) $2.40

 How To Reduce Preanalytical Errors in
NP/POC Testing?

Understand sources of preanalytical variability

Improve collection practices
Define

Create indicators

Me
Con

asu
trol

re
SIX SIGM Breakthrough

Monitor Breakthrough
Methodology
Y=f(X)
ze

Report data
Im
pr aly
o An
ve

Incorporate detection systems into current

instruments
 Conclusions

 Preanalytical variables can

cause NPT/POCT errors

 More data are needed to

better understand the true
impact of preanalytical errors
in NPT/POCT, particularly as it
relates to impact on patient
safety and healthcare cost