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Galore International Journal of Health Sciences and Research

Vol.4; Issue: 1; Jan.-March 2019


Website: www.gijhsr.com
Original Research Article P-ISSN: 2456-9321

Study of Pre-Analytical Errors in a Clinical Biochemistry Laboratory: The


Hidden Flaws in Total Testing
Dr. Sushma Bhopalam Jagannatha, Dr. Shrikant Chandrakar

Assistant Professor, Dept. of Biochemistry, Chandulal Chandrakar Medical College & Hospital, Kachandur,
Durg, Chhattisgarh

Corresponding Author: Dr. Shrikant Chandrakar

ABSTRACT contributes significantly in making the right


diagnosis to the right patient at right time
Aim of the study: The aim and objective of the and hence the right treatment, which affects
present study was, to enumerate and evaluate the duration of hospital stay, early treatment
different types of pre-analytical errors in the response and the well-being of the patient.
clinical biochemistry laboratory and to compare
Modern day medicine practice is purely
the frequency of errors in the pre-analytical
phase of testing before and after training, the evidence based which focuses on the valid
technical staff posted in the clinical laboratory reports for the effective and
biochemistry laboratory. timely management of patients. [1]
Materials and Methods: A prospective Study Advancement in the automation along with
was conducted at Dept. of Biochemistry, CIMS, point of care testing, in the laboratory
Bilaspur. Chhattisgarh Institute of Medical testing has occupied utmost position in the
Sciences, a tertiary care hospital cum medical modern health care, which has led to the
college in Bilaspur for the period of 4 months drastic improvements in the performance
from August 2016 to December 2016. During and speed up of laboratory reports. Despite
this period, different types of pre-analytical of advanced automation considerable error
errors were monitored.
rates are at clinical diagnostic labs. [1]
Results: Of the 19,411 samples received during
the study period, 670 samples were found to be Laboratory testing involves mainly
unsuitable for testing, accounting for 3.45% of three phases: 1) Pre-analytical phase 2)
the rejection. All these samples were rejected Analytical Phase and 3) Post-analytical
due to different types of pre-analytical errors phase. The pre-analytical phase
that are due to wrong identification (0.26%), encompasses all the processes from the time
missing samples (0.05%), draw from IV site of a laboratory request made by the
(0.07%), inadequate samples (1.02%), wrong physician until the specimen is analyzed in
timing of sample collection (0.06%), hemolysed the lab (e.g. patient preparation, blood
samples (1.83%) and lipemic samples (0.28%). drawing, sample transportation,
Conclusion: Of all the samples received in the centrifugation, dilutions etc). The analytical
clinical biochemistry laboratory, the overall
stage involves the analysis of the analytes
percentage of rejection is 3.45%. We also found
that, there was reduction in the frequency of using automation especially in clinical
errors before and after training the staff. biochemistry laboratory and validation of
the test results. The post-analytical stage
Key words: Pre-analytical errors, Hemolysis, refers to the interpretation of the results by
Rejection, Frequency of Errors and Clinical laboratory consultants and reporting to the
Biochemistry Laboratory. clinicians via printed reports. [2]
Laboratory errors might occur at any
INTRODUCTION of these three phases, depending upon their
Central Clinical Laboratory is the source and time of presentation respectively.
backbone to the hospital set up, as it

Galore International Journal of Health Sciences and Research (www.gijhsr.com) 24


Vol.4; Issue: 1; January-March 2019
Sushma Bhopalam Jagannatha et. al. Study of Pre-Analytical Errors in a Clinical Biochemistry Laboratory:
The Hidden Flaws in Total Testing

The pre-and post-analytical phases of the considering the high volume of quantitative
process account for 93% of the errors. [3] testing performed in clinical laboratories.
Laboratory errors in healthcare are However, recent studies have shown that up
of concern when they lead to actual or to 70% of the errors are related to
potential adverse outcomes for patients. preanalytical phase of laboratory testing.
Given the complex nature of healthcare and The most common pre-analytical errors
the difficulty in assessing the effect of a include inappropriateness of test order,
specific laboratory error on patient patient identification error, timing errors in
management, the prevalence of proven sampling and preparation, hemolytic
patient harm, is difficult to assess. Obvious samples, lipemic samples, inappropriate
extreme errors in qualitative test results as transport and inappropriate sample
we see in histopathology, blood transfusion, collection tubes. [4]
microbiology, virology, genetic testing are The purpose of our study was to evaluate
easiest to measure but assessing the effect of different types of pre-analytical errors in the
quantitative errors in clinical biochemistry clinical biochemistry laboratory and to
and hematology results is much more compare the frequency of errors before and
difficult. Such difficulties mean that; present after training the technical staff posted in
measurements probably significantly the clinical biochemistry laboratory.
underestimate the size of the problem

Table 1: Shows Laboratory Total Testing Process and Their Potential Errors
Testing Phase Errors related to testing phase
1) Missed Test Requisition Form (TRF)
Pre-Analytical Phase 2) Incorrect sample identification
3) Incorrect sample tube
4) Sample from IV running area
5) Delay in sample transportation
6) Insufficient samples
7) Sample mix-ups
8) Tube broken in centrifuge
9) Wrong timing for Collection
10) Invalid Specimen: Haemolysed Sample, Lipemic Sample & Icteric Sample
1. Instrument not calibrated properly
2. Specimen mix-up
3. Inadequate specimen
Analytical Phase 4. Presence of interfering substances
5. Wrong analytical method
6. Lack of precision
1. Wrong patient identification
2. Report not legible
Post-analytical phase 3. Report delayed
4. Transcriptional error
5. Specificity of the test not understood
6. Previous values are not available for comparison

Aim and objectives of the Study MATERIALS AND METHODS


The aim and objective of the present study Source of Data
was A prospective Study On “Pre-
a. To enumerate and evaluate different Analytical Errors in a Clinical Biochemistry
types of pre-analytical errors in the Laboratory” was conducted at Dept. of
clinical biochemistry laboratory. Biochemistry, CIMS, Bilaspur. Chhattisgarh
b. To compare the frequency of errors in Institute of Medical Sciences, a tertiary care
the pre-analytical phase of testing before hospital cum medical college in Bilaspur
and after training the technical staff specializing in Medicine, Dermatology,
posted in the clinical biochemistry Surgery, Pediatrics, Obstetrics and
laboratory. Gynecology, Psychiatry and Neurosurgery.
The clinical biochemistry department is
equipped with Automated Biochemistry

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Vol.4; Issue: 1; January-March 2019
Sushma Bhopalam Jagannatha et. al. Study of Pre-Analytical Errors in a Clinical Biochemistry Laboratory:
The Hidden Flaws in Total Testing

Analyzer EM-360, Electrolyte Analyzers of sample. Sample collection procedure at


and Automated Immunoassay Analyzer OPD centralized collection center is as
(Beckman Coulter Access 2) and other follows: Patients came along with the test
ancillaries for sample processing and requisition forms (TRF), after ensuring
testing. information on TRF, patients are asked to sit
Study Protocol on regular chair for phlebotomy. Required
A total of 19,411 samples were amount of blood sample was collected using
analyzed in the clinical biochemistry disposable syringes into the appropriate
laboratory for the period of 4 months from manually labelled (OPD number, name, age,
August 2016 to December 2016. All the gender) vacutainers. The sample collection
technical staff and the ward nursing staff timings were 10 AM - 12 PM, all the filled
were trained in the month of October. vacutainers for Biochemistry tests were
Weekly 3 classes were held to educate the placed in a separate rack and were sent to
staff regarding sample collection, order of Clinical Biochemistry Unit in the central
draw, pre-analytical variables and their laboratory for the sample processing and
influence on various parameters, Quality analysis. Once samples are reached to lab,
control checks & Quality control charts (LJ they were centrifuged to obtain
charts & westgard rules). A comparative serum/plasma for test analysis. All the lab
study was done to know the frequency of personal were instructed about the of
pre-analytical errors before and after staff monitoring and documentation pre-
training. analytical errors on daily basis.
During the study period, Individual Pre-analytical, Analytical and Post-
sample was followed from the start of order analytical phases of testing were monitored.
of blood test to the final reporting of the test Analytical phase and post-analytical errors
results. Each step of laboratory processing were monitored to ensure that these errors
was recorded, which include patient did not occur significantly in the present
preparation, test requisition form, specimen study. Analytical phase was also ensured
collection, specimen transportation, with the calibrations & quality control runs
specimen preparation, specimen processing, (internal quality control and external quality
instrument handling and maintenance, controls). Fully Automated machines were
quality control check, reports interpretation, used to analyze the samples. These
critical values and release of reports. All the equipments had inbuilt calibration
lab personnel were instructed about the pre- traceability, these equipments were
analytical errors monitoring and validated and verified, when they were
documentation on daily basis. These errors installed. These equipments were
were reviewed on weekly basis. maintained weekly or monthly as per the
Sample Collection maintenance schedule provided by the
Inpatient blood samples were vendor.
collected by the nursing staff in the
respective wards and the outpatient blood Pre-analytical errors were monitored in
samples were collected on site at centralized this study are
collection center by the lab personal. The 1. Incorrect sample identification:
samples were delivered to the lab by mismatch between the name on sample
paramedical staff from wards and laboratory and test requisition form (TRF)
supportive staff from OPD respectively. 2. Missed Sample
OPD samples were collected by the lab 3. Sample from IV running area
personal, the samples were followed from 4. Inadequate Sample: sample received is
the moment of sample draw to vacutainer not sufficient for testing
transportation, centrifugation of vacutainers, 5. Wrong timing for Collection - lipid
separation of serum/plasma and the analysis profile

Galore International Journal of Health Sciences and Research (www.gijhsr.com) 26


Vol.4; Issue: 1; January-March 2019
Sushma Bhopalam Jagannatha et. al. Study of Pre-Analytical Errors in a Clinical Biochemistry Laboratory:
The Hidden Flaws in Total Testing

6. Haemolysed Sample: Presence of pink vacutainer tubes for various biochemical


to red tinge in serum or plasma. tests, method of blood draw, recapping of
7. Lipemic Sample: Presence of turbidity needles/destroying needle after usage.
in serum or plasma caused by the Training classes were conducted to all the
accumulation of lipoprotein particles. technical staff in the month of October
Pre-Assessment, Training of Technicians thrice a week, each session lasting for 2
and Post-Assessment of Technical Staff hours duration. This training included hands
All the study participants were given on, series of lectures, MCQ discussions,
10 MCQs to assess the knowledge and project works and chart preparations. After,
skills. Time given for each question was 45 the training similar assessments were
seconds. These MCQ questionnaire conducted as it was in pre-assessments.
consisted of the questions which focused
pre-analytical variables like Patient RESULTS
Preparation (fasting and post- prandial), A total of 19,411 samples were
Sample collection, Color coded tubes used analyzed in the clinical biochemistry
for sample collection, Various laboratory for the period of 4 months, which
anticoagulants used in various analysis, included both IPD and OPD samples,
Dietary influence on certain parameters, received from various clinical departments
Normal ranges of certain parameters. We of our hospital. Out of 19,411 samples, pre-
had conducted several training classes analytical errors were observed in 670
weekly thrice various crucial topics like samples, which is approximately 3.45% of
patient preparation, sample collection, order the total number of samples received. The
of draw, sample transportation, critical distributions of different types of pre-
values, biomedical waste management, analytical errors were calculated. Out of
interfering factors in various biochemical 19,411 samples, 51 samples were wrongly
assays, anticoagulants, arterial blood gas identified (0.26%), 10 samples were missing
analysis, urine preservatives and syringe (0.05%), 14 samples were drawn from IV
collection versus vacuum tube collection. running area (0.07%), 198 samples were
After the training classes, again the inadequate (1.02%), 12 samples were
knowledge and skills were assessed by collected in the wrong time (0.06%), 356
questionnaire on these topics. Skills were samples were hemolysed (1.83%) and 55
assessed by Direct Observation: skills that samples were lipemic (0.28%) as mentioned
were included under direct observation in the table 2. All these samples were
include; method of cleaning of the rejected for the testing and all these patients
phlebotomy site by using 70% of Isopropyl were advised for repeat fresh sample with
alcohol in circular motion from inwards to proper TRF.
outwards, usage of properly colour coded

Table 2: Shows the distribution and frequency of pre-analytical errors observed in a


total of 19,411 patients during 4 months
SL/No Type of Pre-Analytical variable Frequency Percentage (%)
1 Incorrect sample identification 51 0.26
2 Missed sample 10 0.05
3 Sample from IV running area 14 0.07
4 Inadequate sample 198 1.02
5 Wrong timing of sample collection 12 0.06
6 Haemolysed Sample 356 1.83
7 Lipemic Sample 55 0.28

A total of 9970 samples were samples were missing (0.06%), 9 samples


received for the analysis in 2 months from were drawn from IV running area (0.09%),
August to September, out of which 35 168 samples were inadequate (1.68%), 8
samples were wrongly identified (0.35%), 6 samples were collected in the wrong time

Galore International Journal of Health Sciences and Research (www.gijhsr.com) 27


Vol.4; Issue: 1; January-March 2019
Sushma Bhopalam Jagannatha et. al. Study of Pre-Analytical Errors in a Clinical Biochemistry Laboratory:
The Hidden Flaws in Total Testing

(0.08%), 228 samples were hemolysed (2.28 mentioned in the table 3.


%) and 15 samples were lipemic (0.15%) as

Table 3: Shows the distribution and frequency of pre-analytical errors observed in a total of
patients 9970 during 2 months (August & September)
SL/No Type of Pre-Analytical variable Frequency Percentage (%)
1 Incorrect sample identification 35 0.35
2 Missed sample 6 0.06
3 Sample from IV running area 9 0.09
4 Inadequate sample 168 1.68
5 Wrong timing of sample collection 8 0.08
6 Haemolysed Sample 228 2.28
7 Lipemic Sample 15 0.15

A training the staff in the month of October, from IV running area (0.05%), 30 samples
a total of 9441 samples were received for were inadequate (0.37%), 4 samples were
the analysis in 2 months from November to collected in the wrong time (0.04%), 128
December, out of which 16 samples were samples were hemolysed (1.35%) and 40
wrongly identified (0.17%), 4 samples were samples were lipemic (0.42%) as mentioned
missing (0.04%), 5 samples were drawn in the table 4.

Table 4: Shows the distribution and frequency of pre-analytical errors observed in a


total of patients 9441 during 2 months (November & December)
SL/No Type of Pre-Analytical variable Frequency Percentage (%)
1 Incorrect sample identification 16 0.17
2 Missed sample 4 0.04
3 Sample from IV running area 5 0.05
4 Inadequate sample 30 0.37
5 Wrong timing of sample collection 4 0.04
6 Haemolysed Sample 128 1.35
7 Lipemic Sample 40 0.42

It is quite evident from Table 3 & 4 & sigma value translates in lower defects and a
Figure 1, that there was reduction in the lower sigma value means a higher number
frequency of errors before and after training of defects. A process is cited to be
the staff, with respect to Incorrect sample performing at ‘world class’ levels when it is
identification from 0.35% to 0.17%, missed functioning at levels of six sigma. [5] In
samples from 0.06% to 0.04%, Sample from other words, a process performing at six
IV running area from 0.09% to 0.05%, sigma level translates into a phenomenal 3.4
Inadequate sample from 1.68% to 0.37%, Defects per Million (DPM) opportunities,
Wrong timing of sample collection from the practical limit to perfection. [6]
0.08% to 0.04% & Haemolysed Sample The analytical phase of laboratory
from 2.28% to 1.35%. In case of lipemic medicine is arguably the best performing
samples it varied from 0.15% to 0.42%. sector in healthcare with close to 5 sigma
performance (0.002%). [7] This is more than
DISCUSSION 3,000 times lower than the rates of infection
Error rates are often described using and medication errors and reflects the
the sigma concept, which refers to the standardized quantitative nature of much of
number of standard deviations that lie laboratory medicine testing, which is well
between the process mean and the suited to statistical quality control measures.
[8]
specification limit. Sigma (σ) is a Greek However, the accomplishments of
alphabet letter, used to describe variability laboratory medicine drop, when errors in all
in a process. In the six sigma methodology, phases of the total testing process are
the unit used is defects per unit. A sigma considered. [9,10] The proportion of errors
value indicates the frequency of defects associated with the two extra-analytical
occurring in a process. Therefore, a higher phases is 4-5 times that seen in the

Galore International Journal of Health Sciences and Research (www.gijhsr.com) 28


Vol.4; Issue: 1; January-March 2019
Sushma Bhopalam Jagannatha et. al. Study of Pre-Analytical Errors in a Clinical Biochemistry Laboratory:
The Hidden Flaws in Total Testing

analytical phase, with the pre-analytical rejection which is similar to many other
phase consistently representing over half of studies. [18] Hemolysis has a profound
all errors in published studies. [11-15] influence on various parameters like
Advances in science and technology Potassium, Acid Phosphatase (ACP),
have led to many path-breaking advances in Lactate Dehydrogenase (LDH), Aspartate
the field of medical diagnostics that have Transaminase (AST), Alanine Transaminase
transformed laborious, manual & (ALT), Creatinine, Creatine Kinase (CK),
cumbersome testing methods into fully albumin, alkaline phosphatase (ALP),
automated tests, which yields reliable, rapid, chloride, gamma-glutamyl transferase
accurate and précised results. However, (GGT), glucose and sodium. Parameters like
despite advances in analytical phase and Potassium, Alanine Transaminase (ALT),
post-analytical phase of testing (Laboratory Creatinine, Creatine Kinase (CK) are
Information System), still notable errors are overestimated when hemolysed sample are
happening particularly in the pre-analytical used for analysis, whereas parameters like
phase, due to which the results are affected, albumin, alkaline phosphatase (ALP),
no matter how best is the performance of the chloride, gamma-glutamyl transferase
automation. If the pre-analytical errors are (GGT), glucose, bilirubin and sodium are
not eliminated in the system, report underestimated when hemolysed sample are
reliability will be questionable. used for analysis. The various causes for
Pre-analytical phase errors have hemolysis found to be Cleansing the
been the focus of research in past decades. venipuncture site with alcohol and not
Previous studies have focused on the allowing the site to dry appropriately (at
analytical phase of diagnostic tests, and least 30 sec), syringe draws, vigorous
many quality control programmes were mixing of the samples, transferring the
initiated at diagnostic labs to monitor sample into a tube by pushing down on the
analytical phase errors. However post-and syringe plunger to force blood into a tube &
pre-analytical errors were neglected not allowing the serum specimen to clot for
worldwide, and currently many studies are the recommended amount of time can result
focusing on the importance of pre-analytical in fibrin formation in the serum. [19]
phase to obtain accurate lab results. An The next common error that we
American Pathologist program conducted a come across in our study was inadequate
study enrolling 660 laboratories and showed sample, accounting for 1.02% sample
that order error rate from outpatient’s center rejection. Every analytical process requires
was 4.8%. [16] The College of American specified amount of serum/plasma for
Pathologists, including 120 labs, concluded analysis. The main reason behind this error
that misidentification is a common was the phlebotomist were lacking the
laboratory error. Another study conducted in knowledge about the testing volume,
the past by Danish on laboratory errors difficulty in sampling in pediatric cases,
showed that 81% of the lab errors were pre- debilitating diseases, not reading the test
analytical, while only 10% of lab errors requisition form properly by the laboratory
were analytical. Moreover, 82.6% human personnel (number of tests requested in test
errors and 4.3% technical errors observed. requisition form), large number of patient’s
[17]
samples need to be collection in the
In our study, we observed 3.45% of specified timings & shortage of manpower.
different types and frequencies of pre- Lipemic samples accounted for
analytical errors in clinical biochemistry 0.15% of rejection. Lipemic samples arise
laboratory at our institute. Among all the due to wrong timing of sample collection
types of pre-analytical errors, the most (post-meals) and if a patient is diagnosed
common error was found to be hemolysis, have hyperlipoproteinemias. This can be
which accounted for 1.83% of total sample avoided by advising for overnight fasting

Galore International Journal of Health Sciences and Research (www.gijhsr.com) 29


Vol.4; Issue: 1; January-March 2019
Sushma Bhopalam Jagannatha et. al. Study of Pre-Analytical Errors in a Clinical Biochemistry Laboratory:
The Hidden Flaws in Total Testing

along with post one week treatment state and speak his or her name. If a patient
overnight sample if it was not emergency cannot provide this information, he or she
and for emergency samples sample dilution must provide some form of identification or
method and interference testing assay was be identified by a family member or
performed. In case of patient diagnosed to caregiver. Check the identification band that
have hyperlipoproteinemias, we requested is physically attached to the patient.
the clinicians mention it on TRF. The Wristbands with unique barcoded patient
direction and magnitude of lipemia identifiers will have a great potential for
interference in spectrophotometric assays reducing patient misidentification.
depends on wavelength of the reaction and The other errors which accounted for
blanking of the method. Especially like rejection are, missing samples (0.05%),
AST, ALT, glucose which uses NADPH at samples drawn from IV area 0.07% and
340 nm is affected. Lipemia results in wrong timing of sample collection 0.08%.
falsely decreased levels of serum All the technical staff and the ward
electrolytes due to high proportion of lipid nursing staff were trained in the month of
in plasma (25%) which is normally around October. Weekly 3 classes were held to
8% in plasma, hence water portion is only educate the staff regarding sample
about 75% compared to 92% water in collection, order of draw, pre-analytical
normal plasma. [20] variables and their influence on various
Patient identification is the critical parameters, Quality control checks &
first step in blood collection. In the 2007 Quality control charts (LJ charts & westgard
Laboratory Services, National Patient Safety rules). A comparative study was done to
Goals from The Joint Commission, goal # 1 know the frequency of pre-analytical errors
is accuracy in patient identification. Patient before and after staff training. We found
misidentification errors are potentially that after training the staff, there was
associated with the worst clinical outcomes reduction in the frequency of errors before
because of the possibility of misdiagnosis and after training the staff, with respect to
and mishandled therapy. In our study, we Incorrect sample identification from 0.35%
found 0.26% incorrectly identified samples to 0.17%, missed samples from 0.06% to
which accounted for of the rejection. This 0.04%, Sample from IV running area from
may be probably, due to heavy work load 0.09% to 0.05%, Inadequate sample from
and it is important to identify a patient 1.68% to 0.37%, Wrong timing of sample
accurately so that blood is collected from collection from 0.08% to 0.04% &
the correct person. Drawing blood from the Haemolysed Sample from 2.28% to 1.35%.
wrong person or labelling the correct Icterus or hyperbilirubinemia is the
patient’s sample with a different patient’s presence of elevated bilirubin levels, occurs
label can certainly contribute to laboratory due to increased bilirubin production or
error. When identifying the patient, have inappropriate excretion as we see in
them provide their full name, address, hemolytic anemia, liver diseases or biliary
identification number and/or date of birth. tract obstruction. Icteric serum or plasma
Hospital inpatients should be wearing an ranges in color from dark yellow to bright
identification band with the above yellow, rather than normal straw color. The
information, which the phlebotomist should abnormal colour of the serum can interfere
confirm before the venipuncture. with photometric measurements because of
Phlebotomists should pleasantly introduce its ability to react chemicals in other
themselves to the patient and clearly explain reagents resulting in decreased analyte
the procedure to be performed. It is always a values or spectral interferences during color
courtesy to speak a few words in a patient’s measurement. Concentrations of bilirubin
native language if English is not their first greater than 2.5 mg/dL can lead to clinically
language. It is necessary to have the patient relevant changes of anti-thrombin. Higher

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Vol.4; Issue: 1; January-March 2019
Sushma Bhopalam Jagannatha et. al. Study of Pre-Analytical Errors in a Clinical Biochemistry Laboratory:
The Hidden Flaws in Total Testing

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Vol.4; Issue: 1; January-March 2019
Sushma Bhopalam Jagannatha et. al. Study of Pre-Analytical Errors in a Clinical Biochemistry Laboratory:
The Hidden Flaws in Total Testing

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