5.

ENSURING QUALITY OF
EXAMINATION RESULTS
• 5.6.1 General
• 5.6.2 Quality Control
• 5.6.2.1 General
• 5.6.2.2 Quality control materials
• 5.6.2.3 Quality control data
• 5.6.3 Interlaboratory Comparisons
• 5.6.3.1 Participation
• 5.6.3.2 Alternative approaches
• 5.6.3.3 Analysis of interlaboratory comparison samples
• 5.6.3.4 Evaluation of laboratory performance
• 5.6.4 Comparability of examination results
5.6 Ensuring quality of examination results Significant editorial
There has been major rewording of the clause, with
subclauses created to separate quality control (5.6.2)
and interlaboratory comparisons (5.6.3).
5.6.1 General New
The laboratory shall ensure the quality of
examinations by performing them under defined
conditions. Appropriate pre and post-examination
processes shall be implemented (see 4.14.7, 5.4, 5.7
and 5.8). The laboratory shall not fabricate any
results.
5.6.2 Quality Control
5.6.2.1 General
The laboratory shall design quality control
procedures that verify the attainment of the intended
quality of results.
NOTE In several countries, quality control, as referred to
in this subclause, is also named “internal quality control.”
5.6.2.2 Quality control materials New
The laboratory shall use quality control materials
that react to the examining system in a manner as
close as possible to patient samples.

Quality control materials shall be periodically

examined with a frequency that is based on the
stability of the procedure and the risk of harm to the
patient from an erroneous result.
5.6.2.2 Quality control materials New

NOTE 1 The laboratory should choose concentrations of

control materials, wherever possible, especially at or
near clinical decision values, which ensure the validity of
decisions made.

NOTE 2 Use of independent third party control materials

should be considered, either instead of, or in addition to,
any control materials supplied by the reagent or
instrument manufacturer.
5.6.2.3 Quality control data
The laboratory shall have a procedure to prevent the
release of patient results in the event of quality
control failure New.
When the quality control rules are violated and
indicate that examination results are likely to contain
clinically significant errors, the results shall be rejected
and relevant patient samples re-examined after the
error condition has been corrected and within-
specification performance is verified. The laboratory
shall also evaluate the results from patient samples
that were examined after the last successful quality
control event New.
5.6.2.3 Quality control data

Quality control data shall be reviewed at regular

intervals to detect trends in examination performance
that may indicate problems in the examination system.
When such trends are noted, preventive actions shall be
taken and recorded New.

NOTE Statistical and non-statistical techniques for

process control should be used wherever possible to
continuously monitor examination system performance.
5.6.3 Interlaboratory Comparisons
5.6.3.1 Participation
The laboratory shall participate in an interlaboratory
comparison programme(s) (such as an external quality
assessment programme or proficiency testing
programme) appropriate to the examination and
interpretations of examination results. The laboratory
shall monitor the results of the interlaboratory
comparison programme(s) and participate in the
implementation of corrective actions when
predetermined performance criteria are not fulfilled.
5.6.3.1 Participation
NOTE The laboratory should participate in
interlaboratory comparison programmes that
substantially fulfil the relevant requirements of ISO/IEC
17043.
The laboratory shall establish a documented
procedure for interlaboratory comparison participation
that includes defined responsibilities and instructions for
participation, and any performance criteria that differ
from the criteria used in the interlaboratory comparison
programme New.
5.6.3.1 Participation
• Interlaboratory comparison programme(s) chosen by
the laboratory shall, as far as possible, provide
clinically relevant challenges that mimic patient
samples and have the effect of checking the entire
examination process, including pre-examination
procedures, and post-examination procedures, where
possible.
5.6.3.2 Alternative approaches
Whenever an interlaboratory comparison is not
available, the laboratory shall develop other approaches
and provide objective evidence for determining the
acceptability of examination results.

Whenever possible, this mechanism shall utilize

appropriate materials.
5.6.3.2 Alternative approaches

NOTE
Examples of such materials may include:
— certified reference materials;
— samples previously examined;
— material from cell or tissue repositories;
— exchange of samples with other laboratories;
— control materials that are tested daily in
interlaboratory comparison programmes.
5.6.3.3 Analysis of interlaboratory comparison
samples
The laboratory shall integrate interlaboratory comparison
samples into the routine workflow in a manner that
follows, as much as possible, the handling of patient
samples New.

Interlaboratory comparison samples shall be examined

by personnel who routinely examine patient samples
using the same procedures as those used for patient
samples New.
5.6.3.3 Analysis of interlaboratory comparison
samples

The laboratory shall not communicate with other

participants in the interlaboratory comparison
programme about sample data until after the date for
submission of the data New.

The laboratory shall not refer interlaboratory

comparison samples for confirmatory examinations
before submission of the data, although this would
routinely be done with patient samples New.
5.6.3.4 Evaluation of laboratory performance

The performance in interlaboratory comparisons shall be

reviewed and discussed with relevant staff New.
When predetermined performance criteria are not
fulfilled (i.e., nonconformities are present), staff shall
participate in the implementation and recording of
corrective action. The effectiveness of corrective action
shall be monitored. The returned results shall be
evaluated for trends that indicate potential
nonconformities and preventive action shall be taken,
documented, and monitored.
5.6.4 Comparability of examination results
• There shall be a defined means of comparing
procedures, equipment and methods used and
establishing the comparability of a results for patient
samples throughout the clinically appropriate
intervals. This is applicable to the same or different
procedures, equipment, different sites or all of these.
Note: in particular case of measurement results that are
metrologically traceable to the same reference, the
results are described as having metrological
comparability providing that calibrators are
commutable.
5.6.4 Comparability of examination results
• The laboratory shall notify users of any difference in
comparability of results and discuss any implications
for clinical practice when measuring systems provide
different measurement intervals for same measurand
(e.g. glucose) and when examination methods are
changes.
• The laboratory shall document, record and, as
appropriate, expeditiously act upon results from the
comparisons performed. Problem or deficiencies
identified shall be acted upon and records of actions
retained.
• Points addressed in NABL 112 Draft Document
 EQAS file
• Registration detail, program detail,analysis
detail,coordinator detail
• Plan for EQAS- run date, received
• Master –method,reagent,unit
• Log in and password
• Entry in system-lab software
RAW data, signed and dated
entry in PT provider print out
evaluation report-signed and dated
CA and PA log
• 5.6. Ensuring quality of examination results
• The laboratory shall design the internal quality control procedure
appropriate to its size & scope. The results will be plotted on LJ
charts.
• Controls for some analytes such as CBC and blood gases have a
short shelf life. Therefore, the laboratory mean cannot be
calculated. In such situations the laboratory can use the
manufacturer’s assigned mean and SDs to detect out of control
values. The laboratory shall, however, calculate their imprecision as
CV% from the data obtained and shall ensure that the CV%
continuously remains in the acceptable range. The laboratory shall
perform root cause analysis and take corrective actions as when out
of control situations are detected.
• Inter-laboratory comparisons
• External Quality Assessment (EQA) / Proficiency
Testing (PT):
• The laboratory shall:
• 1. participate in EQA / PT in each discipline prior to
gaining accreditation
• 2. have a plan to cover critical tests
• 3. participate in an EQA program in case of change in
test methodology, equipment change and extension
of scope
• The laboratory shall document corrective actions
taken based on the EQA evaluation report.
• Testing of EQA / PT samples must be integrated
within the routine laboratory workload and analyzed
in rotation by personnel who routinely test patient
samples. In case of slides received as EQA samples,
they are to be reported by appropriate levels of staff
involved in the department without sharing of data.
They should then collectively discuss the results
before they are dispatched.
• For some tests, participation in PT program is not a
feasible option for one or more of the following reasons:
• 1. Non-availability of a formal national PT programme for
analytes of interest
• 2. Only few laboratories performing the test
• 3. The analyte to be measured is unstable e.g. blood
gases, ammonia, G6PD
• 4. Control material of the same matrix is not available
• 5. The sample is completely consumed during
performance of the test (e.g. ESR)
• Alternative approaches
• For those tests where a formal EQA is not available, the laboratory shall adopt
alternative approaches to validate performance. Such alternative approaches are:
• Replicate testing
• Examination of split samples (within the laboratory)
• Use of reference methods & materials, where available
• Exchange of samples with other accredited laboratories

• When the laboratory exchanges samples with other laboratories as an alternative

approach to EQA participation, following needs to be addressed:
• In the case of comparison between 2 laboratories, one will function as the
“reference laboratory” against which the other will be compared. This is to be
documented as an MoU
• When there are several laboratories, compare the result against the “reference
laboratory”-
• Other quality assurance procedures which are useful
in addition to IQC but do not replace split sample
analysis are:
• Review of daily mean
• Delta check
• Clinical correlation
• Correlation with other laboratory results
• Comparability of results
• If the laboratory uses more than one measuring system
where the measurements are not traceable to the same
reference material / reference method, or the biological
reference interval are different, it is essential to perform
a comparability study between the systems and prove
that there is agreement in performance throughout
appropriate clinical intervals at least twice in a year using
suitable statistical procedures such as Bland - Altman plot
and / or regression analysis. A written procedure and
complete record of all such data shall be retained till the
next assessment.
• A. Pre-analytical:
• 1. Try to perform the tests as early as possible from the date of receipt of EQA
samples. The lyophilized / stabilized samples should be stored in a refrigerator (2-
8 C) until testing. Do not freeze the lyophilized samples.
• 2. All EQAS samples must be treated in the same manner as a routine patient
specimen.
• 3. Most programs provide lyophilized / stabilized samples. Follow instructions
carefully about the reconstitution and preparation of sample. If exact volume of
water is not used for reconstitution, the resulting sample may be more dilute or
concentrated. Use of a calibrated volumetric pipette is recommended.
• 4. Mix gently to avoid frothing. After reconstitution, the sample should be kept at
room temperature for the prescribed period of time.
• 5. The testing should be performed within the recommended period of time after
reconstitution. If samples have been reconstituted and left for long periods of time
at room temperature, refrigerated or frozen and thawed, the results will become
unreliable.
• B. Analytical:
• 1. The procedure for testing must be identical to that for all the patient samples.
No additional precautions should be performed prior to testing EQA materials
except at the preparatory stage. This is because the test is being done to
determine the quality of routine procedures being followed in the laboratory (as
being followed for any random patient sample). For instance if the laboratory
repeats the test on the EQA sample

• whereas routine patients are tested only once then the purpose of participation in
EQAS is defeated.
• 2. The laboratory using any form of automation should not perform non-routine
quality / maintenance procedures on the analyzer prior to testing the EQA
material.
• 3. For laboratory that performs manual testing, it is preferable that the same
analyst who carries out the routine testing also performs the proficiency test. If
this is not done, then the laboratory will fail to get a true reflection of its practices
related to patient specimens.
• C. Post-analytical:
• 1. The reporting of EQA results should be in the same manner as
used for reporting patient results. Some of the routine laboratory
methods of reporting such as reviewing patient’s prior results may
not apply in these situations.
• 2. Precautions must be taken to ensure that there are no
transcription errors.
• 3. Reconstituted EQA samples should not be stored for future
testing as they tend to deteriorate and will not provide accurate
results.
• 4. Lyophilized samples if available may be stored in a refrigerator for
up to one year. Prior to use check for the presence of liquid in the
vial or discoloration of the pellet. These are indicators of
deterioration. Do not freeze lyophilized specimens.
• Handling unsatisfactory scores:
• The laboratory will at some time receive unsatisfactory scores. A single poor score should not
cause for excessive concern. That being stated, each unsatisfactory results should be
investigated carefully. This should not be a reason to precipitate procedural change until a
careful analysis has been performed. As a part of analysis the laboratory can use the
following protocol:
• 1. Perform a root cause analysis as to why the unsatisfactory result was obtained.
• 2. Begin from sample handling and address all aspects mentioned in pre-analytical factors.
• 3. Some errors may result from the non-standard sample preparation process required for
EQA samples. However, all other sources of error should be ruled out before labeling the
error as being such.
• 4. EQA results can be used to suggest preventable measures. Careful assessment of
acceptable results and comparison with unsatisfactory ones will be helpful in this regard.
• 5. Besides individual results, trends should be examined as they could signal potential
problems. Even if current results are satisfactory, timely action will help prevent future poor
results. Example: when several of the results lie on one side of the mean.

• 6. Accreditation processes require root cause analysis, corrective measures, preventive

measure reports & follow up audits be performed and documented.
• i. Clerical error
• 1. Transcription error (may be pre- or post-analytical factors).
• 2. Situations where wrong method has been registered for analysis or method change not updated.

• ii. Methodological problem

• 1. Instrument function checks (e.g., temperatures, blank readings, pressures) not performed as
necessary, or results not within acceptable range.
• 2. Scheduled instrument maintenance not performed appropriately.
• 3. Incorrect instrument calibration.
• 4. Standards or reagents improperly reconstituted and stored, or inadvertently used beyond
expiration date.
• 5. Instrument probes misaligned.
• 6. Problem with instrument data processing functions. The laboratory may need to contact the
manufacturer to evaluate such problems.
• 7. Problem in manufacture of reagents / standards, or with instrument settings specified by
manufacturer
• Carry-over from previous specimen.
• 9. Automatic pipettor not calibrated to acceptable precision and
accuracy.
• 10. Imprecision from result being close to detection limit of
method.
• 11. Instrument problem not detected by quality control:
• a) QC material not run within expiration date, or improperly stored
• b) QC material not run at relevant analyte concentration

• 12. Result not within reportable range (linearity) for instrument /

reagent system.
• 13. Obstruction of instrument tubing / orifice by clot or protein.
• 14. Incorrect incubation times.
• Technical problem
• 1. EQA material improperly reconstituted.
• 2. Testing delayed after reconstitution of EQA material (with problem from evaporation or deterioration).
• 3. Sample not placed in proper order on instrument.
• 4. Result released despite unacceptable QC data.
• 5. QC data within acceptable limits but showed trend suggestive of problem with the assay.
• 6. Inappropriate quality control limits / rules. If the acceptable QC range is too wide, the probability increases that a result
will fall within the acceptable QC range yet exceed acceptable limits for EQA.
• 7. Manual pipetting / diluting performed inaccurately, at an incorrect temperature or with incorrect diluent.
• 8. Calculation error or result reported using too few significant digits.
• 9. Secondary specimen tubes incorrectly labeled.
• 10. In addition to above discipline specific errors may also occur.

• iv. Problem with proficiency testing materials

• 1. Matrix effects: The performance of some instrument / method combinations may be affected by the matrix of the PT
sample. This can be overcome to some extent by assessing participants in peer groups – to be done by the PT provider.
• 2. Non-homogenous test material due to variability infill volumes, inadequate mixing, or inconsistent heating of lyophilized
specimens.
• 3. Non-viable samples for microbiology PT program.
• 4. Haemolysis on an immune-haemtology program samples.
• v.
• Problem with evaluation of results by the PT provider
• 1. Peer group not appropriate.
• 2. Inappropriate target value: Target values developed from participant
consensus can be inappropriate from non-homogeneous testing material
or lingering ("masked") outliers. However, occasional inappropriate target
values occur in every PT program.
• Inappropriate evaluation interval: An evaluation interval may be
inappropriately narrow e.g. if ± 2 standard deviation units are used with
an extremely precise method, much the acceptable range may be much
narrower than needed for clinical usefulness.

• Incorrect data entry by PT provider.

• No explanation after investigation

 Indian Red Cross Society
Gujarat State Branch
5.6.4 Comparability of examination results
There shall be a defined means of comparing procedures, equipment and methods
used and establishing the comparability of results for patient samples throughout
the clinically appropriate intervals. This is applicable to the same or different
procedures, equipment, different sites, or all of these.

NOTE In the particular case of measurement results that are metrologically traceable to the same reference, the results are
described as having metrological comparability providing that calibrators are commutable.

The laboratory shall notify users of any differences in comparability of results and
discuss any implications for clinical practice when measuring systems provide
different measurement intervals for the same measurand (e.g. glucose) and when
examination methods are changed.

The laboratory shall document, record and, as appropriate, expeditiously act upon
results from the comparisons performed. Problems or deficiencies identified shall
be acted upon and records of actions retained.