Beruflich Dokumente
Kultur Dokumente
Assistant Professor, Dept. of Biochemistry, Chandulal Chandrakar Medical College & Hospital, Kachandur,
Durg, Chhattisgarh
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
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.
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
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
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
concentrations can interfere with situation. Ann Clin Biochem. 2012; 53:279-
coagulation tests. In our study, were found 284
1.37% of icteric samples. 3. Bone DJ. Governmental perspectives on
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