Impact of Pre-analytical Quality Monitoring

on Clinical Outcomes

ENDANG HOYARANDA
IACC-BD SYMPOSIUM
THE PREANALYTICAL PHASE: PAST, PRESENT AND FUTURE
Our endless efforts in improving quality…..

Labs around the world have made great improvements

in analytical and post-analytical quality

Analytical Quality: Post-analytical Quality:

 In batch QC/ daily QC  Implementation of IT based features:
 Sigma measurements automatic reporting, critical value
reporting, online result delivery
 Calibration and maintenance of
instrument  Interpretation of results improvements

 Maintenance of reagent quality  Lean management

 Proficiency testing programs  Robotics/AI

 Certification programs – accreditation

programs
 Automation, robotics, AI
The Magnitude of Pre-analytical Errors
The 70% Claim :
Laboratory medicine data influences 70% of clinical decisions

Post-analytical
23%
Analytical 15%
Pre-analytical 62%

Pre-analytical Analytical

Post-anaytical

Çuhadar S. Preanalytical variables and factors that interfere with the biochemical parameters: A review. OA Biotechnology 2013 Jun 01;2(2):19.

Plebani M, Carraro P: Mistakes in a stat laboratory: Types and frequency. Clin Chem 1997;43:1348-1351

Carraro P, Plebani M. Errors in a stat laboratory: types and frequencies 10 years later. Clin Chem 2007 Jul;53(7):1338-42
Pre-analytical errors still a major problem

Despite improvements in analytical and post-

analytical quality, pre-analytical processes are often
underestimated as potential sources of error The
Overlooked
Potential for
Lack of awareness towards potential errors due to Errors
pre-analytical factors
in Pre-
analytical
Lack of trainings and QA programs for laboratory
practitioners processes
 Pre-analytical errors management in the clinical
laboratory:
A five year study

 The overall rate of critical pre-analytical errors: 0.047%

 The total rate of sampling errors in the study period was
13.54%.
 The highest rates were found for the indicators
 haemolysed sample (8.76%),
 urine sample not submitted (1.66%) and
 clotted sample (1.41%)

Biochem Med 2014;24(2):248-57.

Giménez-Marín A1, Rivas-Ruiz F, Pérez-Hidalgo Mdel M, Molina-Mendoza P
“It is clear that most current errors occur in the preanalytical phase of TTP, meaning
all procedures performed before the sample reaches the laboratory.
Issues such as proper patient and specimen identification, appropriateness of test
requests, accuracy in blood drawing, specimen handling, and transportation can
no longer be considered trivial because they strongly affect total quality.

Another important finding of the present study is the very high (73%) percentage of
errors classified as preventable. This aspect is even more important when we
consider that 24,6% of errors have resulted in unnecessary laboratory testing
repetition, further inappropriate investigations, and episodes of negative clinical
outcomes. “

Carraro, P, Plebani, M, ,Clinical Chemistry 53:7, 2007

A sample taken at the wrong time,
with the wrong devices, or with
wrong techniques, is worse than
taking no sample at all
A sample whose analytical results
arrive too late is a wasted sample
 Preanalytical Turnaround Time

question and request of patient Id

sample sample sample
selection of laboratory and test
transport preparation storage
test test sampling

% Time of Total Turnaround Time:

Preanalytical 39-60;
Analytical 20-30;
Postanalytical 5-25
Non-phlebotomy Pre-analytical Factors
Affecting Blood Constituents

 Food - urea, uric acid, TG, glucose, urine constituents

 Prolonged fasting - coagulation factors, cholinesterase, oral
glucose tolerance
 Circadian rhythm - K, Fe, cortisol, eosinophil
 Muscular activity - CK, Hb, LDH, glucose, coagulation factors,
leucocytes, Troponin I
 Body position - proteins, lipids, enzymes
 Exercise
 Alcohol - glucose, UA. lactate, amylase, gamma GT
 Smoking – lipase, amylase, cholesterol, glucose
 Coffee - glycerol (TG), cortisol
Variables during sampling

 Time of sampling
 Influence of diagnostic and
therapeutic procedures
 Supine or upright position
 Extended tourniquet application
 Increase (%)
of plasma concentration
of various analytes
when changing
from supine
to an upright position

Guder, W, Narayanan, S, Pre-examination Procedures in Laboratory Diagnostics2015

 Change (%)
In serum concentration
of various analytes
After a tourniquet
application time
of 6 minutes

Affecting proteins, enzymes,

cells

Guder, W, Narayanan, S, Pre-examination Procedures in Laboratory Diagnostics2015

 Interferences

Food, drinks, smoking

Drugs
Herbs
 Deviation (%)
In blood concentration
between nonsmokers
and current smokers

Guder, W, Narayanan, S, Pre-examination Procedures in Laboratory Diagnostics2015

Sample Transportation
 On site
 Human carriers or runners
 Pneumatic tubes delivery systems
 Mobile robots
 Conveyor and/or track systems
 Long distance
 Packaging
 Temperature
 Temperature monitoring
 Special
considerations: stability, safety, special
analytes
Analytical vs Pre-analytical Errors
Analytical Pre-analytical

√ √ √ √
Elimination of Standardisation Elimination of Standardisation
error factors By technology error factors By technology
√
√

x √ √ x
Error issues Error issues
beyond lab QA schemes beyond lab QA schemes
control control
√ X
 Errors within and beyond
laboratory control

Pre-pre analytical errors 46-68%

Pre analytical errors 3-5% Within

the
Laboratory’s
Post analytical errors 13-20%
Control

Post-post analytical errors 25-46%

Numbers adopted from Plebani M, Ann Clin Biochem 2010; 47: 101-110 (PubMed)
Pre-pre and post-post analytical error
high incidence patient safety hazards involving the clinical laboratory

 Pre-pre-analytical error:
 Errors beyond immediate control of the laboratory occurring before
sample is handled by laboratory
 Major ‘unquantifiable’ error: wrong test order
 Improvement effort: diagnostic algorithms , reflex testing
 Post-post-analytical error:
 Errors beyond immediate control of the laboratory occurring after
delivery of results
 Major error: wrong interpretation of result
 Improvement effort: expert-driven interpretation by laboratory
professionals to improve quality of diagnosis
Laposata, M, Clin Chem Lab Med 2007; 45 (6) : 712-9
Most frequent sources of errors
in the pre- and pre-pre-analytical steps

PRE-PRE-ANALYTICAL PRE-ANALYTICAL
ERRORS (46-68%) ERRORS (3-5%)

• Inappropriate test request

• Order entry mistake
• Patient/sample • Labeling (secondary
misidentification specimen) errors
• Sample collection problems • Sorting and routing errors
(hemolysis, clotting, • Pour-off errors
insufficient volume, etc) • Specimen-processing errors
• Sample collection from (centrifugation, decapping,
infusion route aliquoting, etc)
• Inappropriate container
• Sample handling, storage
and transportation problems

M Plebani, eJIFCC; 26 , 1 : 7-14

Most frequent sources of errors
in the post- and post-post analytical steps

POST-ANALYTICAL POST-POST-ANALYTICAL
ERRORS (13-20%) ERRORS (25-46%)

• Erroneous validation of
analytical data
• Failure in
• Delayed/missed reaction to
laboratory reporting
reporting/addressing the
• Incorrect interpretation
report
• Inappropriate/inadequate
• Excessive turn-around time
follow-up plans
• Improper data entry
• Manual transcription error
• Failure to order appropriate
consultation
• Failure/delay in reporting
critical values

M Plebani, eJIFCC; 26 , 1 : 7-14

Quality Assessment
in the Pre-analytical phase
 Registration systems
 Reporting systems
 Questionnaires
 Sample distribution (error simulated)
 Direct Assessment method
IACC – BD Collaboration for Pre-analytic Improvement
MAY I HELP YOU CAMPAIGN

Patient Safety Healthcare workers

safety
Patient identification
Needle recapping
Patient information
Incorrect device disposal

Infection Control
Specimen quality
Change of gloves
Centrifuge calibration
Correct disinfection
procedure Proper/underfilling of tubes
Single use tourniquet Fibrin strands/mass formation
Hemolysis, etc
Single use holder

Phlebotomy technique Facility

Closed system collection
Expired product
Appropriate tourniquet
release Lighting of phlebotomy
Mixing of tubes
counter
Order of draw Waste management

Assessment Parameters
May I HELP You Campaign
SCOPE OF SURVEY
based on location

1. Blood Collection Section

Blood Patient and

Infection
collection specimen Phlebotomy Healthcare
control
device identification technique worker safety
procedure
storage procedure
May I HELP You Campaign

SCOPE OF SURVEY
based on location

2. Laboratory Section

Workflow Analysis Sample Quality

Sample accessioning and tube labeling Tube fill volume

Transport time and temperature Clotting and fibrin

Centrifugation process Hemolysis

 Phlebotomy Technique
Order of Draw Error Order of Draw Error
Discard
Citrate EDTA

100% 100% 100%

82%
80% 80% 76% 80%

60% 52% 60% 60%

48%
40% 40% 40%
24%
20% 20% 20% 18%

0% 0% 0%
No Yes No Yes No Yes

Comments
• 48% of citrate tubes were not used in the right order of draw
• 24% of EDTA tubes were not used in the right order of draw
• 82% were not performing the right discard procedure
 Healthcare Worker Safety
Needle & Syringe Correct Device
Needle Recapping
Collections Disposal

100% 100% 100%

82%
80% 80% 80% 72%
60% 55% 60% 60%
45%
40% 40% 40%
28%
20% 20% 18%
20%
0% 0% 0%
No Yes No Yes Yes No
Comments
• 55% were still performing needle recapping
• 18% were using needle and syringe for blood collection
• 28% were not performing the correct device disposal procedure

2
8
 OVERALL PERFORMANCE
2016 – 2018

different institutions

2017-2018
Average Compliance 70% 0 10 20 30 40 50 60 70 80 90 100

2016
Average Compliance 66%
0 10 20 30 40 50 60 70 80 90 100

29
 AUDIT OUTCOMES - SUMMARY

 Blood collection device storage  Appropriate tourniquet release

100% 91%
 Blood collection device expired stock  Mixing by >3 inversions 69%
0%
 Order of draw error EDTA 24%
 Patient ID confirmation 92%
 Order of draw citrate 4 8%
 Minimum Patient ID obtained 84%
 Non-safety device in use 90%
 Specimen labelling before procedure
 Correct activation of safety mechanism
36%
38%
 New gloves worn during collection 94%
 Correct device disposal 72%
 Correct disinfection procedure
 Needle recapping 55%
84%
 Needle & syringe collections 18%
 New single use tourniquet 6%
 New single use holder 17%
 WHY DO AUDITS / SELF - ASSESSMENT?

1. Identify the strong vs weak points

2. Identify focus of training area – perhaps
fewer but more specific items
3. Results of audit may help initiate change
of mind
4. Results of audit may build a basis for
continuous improvement
“THE MAJORITY OF MEDICAL ERRORS WAS NOT
THE RESULT OF INDIVIDUAL RECKLESSNESS OR THE
ACTIONS OF A PARTICULAR GROUP BUT WAS
CAUSED BY FAULTY SYSTEMS, PROCESSES, AND
CONDITIONS THAT LED PEOPLE TO MAKE
MISTAKES OR FAIL TO PREVENT THEM”.

Hawkins R, Ann Lab Med 2012 Jan; 32(1): 5-16

Improving Pre-analytical Procedures
for Better Outcomes

1. Identify sources of Errors

2. Identify ways for improvement
3. Create procedures for improvement
4. Create monitoring tools
5. Train and inforce commitment
6. Implement
7. Monitor
8. Evaluate periodically
9. Improve method if necessary
Identifying sources of errors

Carraro, P, Plebani, M, ,Clinical Chemistry 53:7, 2007

Identifying ways for improvement-
creating tools
 Who does phlebotomy?
 Go manual or digital/automate?
 Create SOPs or operating manuals
 Create monitoring tools
 Establish performance and/or quality indicators
Automation in Pre-analytical procedures
Pre-analytical workstations: A tool for reducing laboratory errors
Automation in Pre-analytical procedures
 Monitor !

Improvement can only be

achieved
when you monitor
and evaluate
Periodic Evaluation

Carraro, P, Plebani, M, ,Clinical Chemistry 53:7, 2007

Ten Major Benefits of Diagnostic Pathways
1. Clinicians rapidly obtain the right result with the appropriate test(s) for
the clinical question based on the best available evidence
2. Based on diagnostic pathways, frequent routine processes follow a
fixed and uniform standard of quality across all medical disciplines and
professional groups
3. Weak points in the process are readily recognized, necessary changes
are triggered
4. Dispensable and redundant tests are avoided
5. Crucial tests, leading to the correct diagnosis, are requested
automatically and cannot be missed
6. Human errors are minimized and legal certainty is improved
7. Diagnostic decisions become transparent and accessible to all those
involved in patient care
8. The nature and extent of resource consumption can clearly be
identified. Departments receive valid data for process and finance
control.
9. Diagnostic pathways provide a platform for cross-section consensus
and improve the interaction between the clinicians and the laboratory
10. Diagnostic pathways are a valuable educational tool for clinicians,
nurses and students
Hoffmann, G, et al, Requesting Laboratory Tests: Benefits and Limitations of Laboratory Diagnostic Pathways,
in Guder, W, Nayaranan, S, Pre-examination Procedures in Laboratory Diagnostics, 2015
Key Takeaway Issues

Focus on
 Human issues:
 Competency

 Change management
 Education of Medical team outside the
laboratory
THANK YOU