ST.

ANDREW HOSPITAL

SAH-LAB CLINICAL LABORATORY

Tumaway, Talisay, Batangas

Section: Revision Code: 002 Page 1 of 8

Clinical Chemistry Effectivity Date: May 2022
Document Title:
Standard Operating Procedures

I. Introduction
The Chem-7 is referred as an analyzer is a compact , high performance, 16-bit micro controller-
based biochemistry analyzer for routine Chemistries, Electrolytes, Immunoassays, Hormones, Coagulation,
and drug tests. There are 10 modes of operation, including the coagulation mode. Programming, reading,
and reporting operations are user friendly. Operation is through a soft-touch keyboard with quick shift from
one function to another without going through complex sequential operations.
The analyzer is provided with 320x240 dots backlit display with alphanumeric ang graphic
capabilities. A patient-wise collated report is obtained upon request. Exhaustive quality control data at 2
levels, for any of the tests can also be stored in the memory of the analyzer. The software is complete with
the device diagnostics self-test function capable of providing timely flag/ error messages related to test
results or analyzer malfunctioning.
The State of Art features advanced optics, versatile analytical capabilities, and economy of 18 ul
flowcell makes it the analyzer of choice for St. Andrew Hospital. This analyzer is intended to be used for in
vitro quantitative and qualitative determination of wide range of analytes in the body fluids as mentioned
above and by the trained personnel of the laboratory.

II. Safety Requirements

The Medical Technologist must read the safety precaution and directions of the User Manual before
operating to be familiarized with the machine.
o Only qualified personnel should use the analyzer. While operating maintaining servicing or
repairing the analyzer, follow all the procedures described this manual.
o Use only with the analyzer manufacturer supplied power adapter.
o Always ensure that main switch is off while connecting or removing or servicing the analyzer.
o Observe all warnings and cautions posted on the system or described in the manual.
o Avoid contact with all electrical circuits of analyzer observe caution posted on the analyzer.
o Never use substitute parts on the analyzer or modify it in any way.
o Keep the analyzer out of the rain and any water splash. Pay attention inclination, vibration,
shock etc..
o During the operation photometric lamp becomes extremely hot. Do not look directly into the
light path of the lamp when it is ON . Do not touch the lamp when it is ON.
o If the lamp needs to be changed, always switch off the lamp by switching OFF the analyzer
and then wait for minimum 30-minutes / until lamp has cooled down.

Prepared by: Recommended by: Approved by:

Monalyn Marabi, M.D. Zenaida S. Mendoza, M.D. Mark Anthony S. Mendoza, M.D.
Laboratory Head Hospital Administrator Hospital Director
 ST. ANDREW HOSPITAL

SAH-LAB CLINICAL LABORATORY

Tumaway, Talisay, Batangas

Section: Revision Code: 002 Page 2 of 8

Clinical Chemistry Effectivity Date: May 2022
Document Title:
Standard Operating Procedures

o Avoid using dangerous flammable material around the analyzer. Fire or explosion may be
caused by ignition. Avoid areas that are adversely affected by atmospheric pressure,
temperature, humidity, ventilation, sunlight, dust and air containing salt, sulfur, etc.
o Operator is responsible for taking all necessary precautions against hazard associated with
the use of clinical laboratory chemicals. Specific recommendations for each reagent used
with the analyzer are normally found on the manufacturer’s package inserts or product
information sheets for each chemical. Wipe up any reagent spillage on the analyzer
immediately.
o Pay attention not to exceed time and volume necessary for diagnosis. Keep monitoring the
behavior of whole system to detect any malfunction.
o Take immediate corrective measures including shutdown of operation when any malfunction
is detected in the analyzer.
o In the event of trouble, do not play with the analyzer and leave any repair work to an
authorized expert.

IV. Definition

 Accuracy is the degree of agreement between a measured value and its ‘true/consensus’ value. On
the contrary, inaccuracy, which is represented by analytical bias, is defined as the % of the
difference between the measured value and the ‘true’ value over the true value. Therefore, good
accuracy means least analytical error.

 Precision refers to reproducibility. It refers to the agreement between replicate measurements. It is

quantitatively expressed as the standard deviation (SD) or more precisely as percent coefficient of
variation (CV), which is defined as SD times 100 divided by the mean value of the results in a set of
replicate measurements. Therefore, good precision means least CV.

 Pre-analytical
the pre-analytical system shall take care of the following aspects , as each can have a major effect
on the accuracy of the result:

• Patient preparation
• Request forms

Prepared by: Recommended by: Approved by:

Monalyn Marabi, M.D. Zenaida S. Mendoza, M.D. Mark Anthony S. Mendoza, M.D.
Laboratory Head Hospital Administrator Hospital Director
 ST. ANDREW HOSPITAL

SAH-LAB CLINICAL LABORATORY

Tumaway, Talisay, Batangas

Section: Revision Code: 002 Page 3 of 8

Clinical Chemistry Effectivity Date: May 2022
Document Title:
Standard Operating Procedures

• Specimen collection, containers, labeling and phlebotomy equipment and procedure

• Specimen transport
• Specimen preparation
• Specimen storage

 Analytical
The following aspects shall be monitored, evaluated, implemented, and maintained to ensure the
accuracy and precision of the test carried out:
• Quality of distilled water
• Calibration of measuring and testing instruments including balances, thermometers,
incubators, autoclaves, centrifuges and semi-automatic pipettes, and regular servicing and
maintenance of equipment.
It is essential to use a standard calibrator which is traceable to national/international reference
material. The laboratory shall obtain evidence of traceability to the reference material from the
supplier. Precision can be maintained using suitable QC material, either commercial or prepared in-
house. The QC material should be analyzed at predetermined intervals along with patient samples to
monitor systematic and random errors. Such QC material shall also be traceable to a
national/international certified reference material so that the accuracy of measurements can be
monitored. All data relating to the laboratory’s internal QC practices and performance in external
quality assessment schemes (scoring, ranks, etc.) shall be recorded, reviewed and corrective
actions implemented.

 Stability of reagents
Laboratory personnel should be aware that the stability of all reagents kept at room temperature will
go down from the stated values if the temperature exceeds 35ºC.

 Use of calibration graphs

A fresh standard curve should be carried out for the analyses described in this manual whenever:
 the calibrator is changed
 new reagents are introduced
 problems with QC are encountered

 Post-analytical

Prepared by: Recommended by: Approved by:

Monalyn Marabi, M.D. Zenaida S. Mendoza, M.D. Mark Anthony S. Mendoza, M.D.
Laboratory Head Hospital Administrator Hospital Director
 ST. ANDREW HOSPITAL

SAH-LAB CLINICAL LABORATORY

Tumaway, Talisay, Batangas

Section: Revision Code: 002 Page 4 of 8

Clinical Chemistry Effectivity Date: May 2022
Document Title:
Standard Operating Procedures

To avoid transcriptional errors in the results of the test, the reporting/signatory medical technologist
shall verify the results entered manually or through on-line instrument interfaces before the results
are reported or dispatched.

 Rectification of laboratory errors

 It is therefore essential to continually ask the following questions.

1. Is there an analytical error?

2. If so, what type of error is this?
3. What could have been the causes for this error?
4. How to rectify this error?

It is important to identify analytical errors and classify them as either random or systematic
errors. Towards this end, the laboratory should implement internal QC procedures. This
involves preparation of a QC pool, either human or bovine, quantification of unavoidable
laboratory errors, and construction of Levey-Jennings chart and daily analysis of QC along
with every batch of patients’ samples.

V. Construction of Levey Jennings Chart

On each day when analyses are performed a fresh sample is thawed, thoroughly mixed, and
analyzed. The QC serum is analyzed for a period of 20 days or so. [Important to note: Analysis
should not be carried out by only one person; all staff should participate in this exercise to determine
the true unavoidable error in the laboratory]. From these data, mean and SD are calculated. Levey
Jennings chart is then constructed with x + 2SD as warning limits and x + 3 SD as control limits.

Calculate the %CV for each analyte to ascertain whether this is within the acceptable limit
Ideal = < 5%. Must be < 8%). If % CV is found to be high, this will indicate that between-day
laboratory precision (variation) is high, and the data cannot be used to construct a Levey Jennings
chart. It is then essential to identify the causes for this, correct these and then repeat the whole
exercise and confirm that the %CV is well within the acceptable limit.

VI. Guidelines in Interpretation of QC data

A. According to WHO an analytical system is ‘out of control’ if one of the four criteria is met. That is:

• a value lies entirely outside the control limits

• seven consecutive values show a rising tendency

Prepared by: Recommended by: Approved by:

Monalyn Marabi, M.D. Zenaida S. Mendoza, M.D. Mark Anthony S. Mendoza, M.D.
Laboratory Head Hospital Administrator Hospital Director
 ST. ANDREW HOSPITAL

SAH-LAB CLINICAL LABORATORY

Tumaway, Talisay, Batangas

Section: Revision Code: 002 Page 5 of 8

Clinical Chemistry Effectivity Date: May 2022
Document Title:
Standard Operating Procedures

• seven consecutive values show a falling tendency

• seven consecutive values lie on the same side of the mean
If one of these situations arises, the patients’ results must be discarded, the cause of the error
sought and removed, and then the batch repeated with a QC serum.

B. Use of two different levels of QC simultaneously in every batch of analysis provided valuable
information on the type of errors – whether these are random (precision) errors or systematic
(accuracy) errors.

Warning Rule

12S One observation > x + 2 SD Rejection Rules (used if warning rule is exceeded; run rejected
if any of the following rules are violated) R= Random error; S = Systematic error

 R 13S One observation > x + 3 SD

 S 22S Two observations > same limit, that is x + 2 SD or x - 2SD (same control- two
consecutive runs, or two different controls – same run)
 R R4S Difference between two observations within run > 4SD (two different controls –
one > x + 2SD and the other > x – 2SD)
 S 41S Four consecutive observations>same limit, that is x + 1SD or x - 1SD (same
control four consecutive runs )
 S 10X Ten consecutive observations on same side of mean (same control, ten
consecutive runs, or two different controls, five consecutive runs)

Remedial action

A well-run internal QC system makes possible immediate intervention in the release of

patients’ results.
In the event of a control system alert, it is advisable to proceed through the following steps in
that order.
• Decision: Immediate decision whether action is necessary.
• Investigation: Check to locate the error.
• Repair: Action to eliminate the error.

If the decision is taken that the method is out of control, the first action is to withhold patients’
results in that batch. Then the analyst should start by checking for the simplest and most

Prepared by: Recommended by: Approved by:

Monalyn Marabi, M.D. Zenaida S. Mendoza, M.D. Mark Anthony S. Mendoza, M.D.
Laboratory Head Hospital Administrator Hospital Director
 ST. ANDREW HOSPITAL

SAH-LAB CLINICAL LABORATORY

Tumaway, Talisay, Batangas

Section: Revision Code: 002 Page 6 of 8

Clinical Chemistry Effectivity Date: May 2022
Document Title:
Standard Operating Procedures

frequent faults, and then continue as necessary in a logical order depending on the method
and equipment involved.
It is good practice to start by excluding gross errors such as mix-up of control materials,
reagents or pipettes, misuse of measuring instruments [wrong filter or aged lamp in the
photometer], or failure to follow instructions for a step in the method.

The results obtained on a control specimen may be in error for several reasons, including
deterioration due to age, incorrect storage or contamination, wrong identification and mistake
in preparation or constitution.
Further action will depend on whether the alert is due to a change in accuracy or in precision.
If accuracy has deteriorated, attention should be focused on the possibility of systematic
sources of error such as incorrect reaction temperature, calibration errors and faulty devices.
If precision has deteriorated, steps in the analytical procedure should be checked, for
instance, deproteinization, composition of reagents and reaction mixtures, measuring
systems .

To easily differentiate between systematic and random errors, laboratories are encouraged to
construct Youden charts. These are constructed by having x + 2SD & x + 3SD of one level
QC in the x axis and that of another level QC in the y axis. If an analyst analyses both levels
of QC and plots the data in the Youden chart, a single plot will be obtained. If this falls within
the inner square, it means that the value obtained for both QC are well within the acceptable
limit, i.e., x + 2SD. On the other hand, if a plot appears outside this limit, it could mean that
the data are outside the acceptable limit and the error could be either systematic or random.

Prevention of systematic errors

To prevent or minimize systematic errors, the laboratory should adhere to the following
points:
1. Use of proper calibration technique. Use of pure chemicals, precision balance, quality
distilled water. Proper preservative and storage
2. Regular checking of photometric filter, bulb, tubing, etc.
3. Use of recommended analytical methods
4. Calibration of pipettes at regular intervals
5. Instrument calibration – photometric check
6. Use of calibrated cuvette
7. Regular preventive maintenance of equipment – daily, weekly, and monthly. While it is
easy to identify systematic errors, it is quite difficult to pinpoint random errors. To minimize
this possibility, it is important to educate the staff on various aspects that could lead to
random errors.
Prepared by: Recommended by: Approved by:
Monalyn Marabi, M.D. Zenaida S. Mendoza, M.D. Mark Anthony S. Mendoza, M.D.
Laboratory Head Hospital Administrator Hospital Director
 ST. ANDREW HOSPITAL

SAH-LAB CLINICAL LABORATORY

Tumaway, Talisay, Batangas

Section: Revision Code: 002 Page 7 of 8

Clinical Chemistry Effectivity Date: May 2022
Document Title:
Standard Operating Procedures

VII. External quality assessment

Participation in External Quality Assessment Schemes is important for interlaboratory comparison

and the maintenance of long-term accuracy and precision of the analytical systems in the laboratory.
This gives the laboratory an opportunity to have an appraisal of the methods employed and switch
over to better methods.

VIII. Calibration

1. Frequency of calibration varies between tests and depends on the workflow.

2. Calibration is required when an existing calibration expires, when reagents are replaced and when
control results fall outside specified acceptable ranges refer to (Interpretation of QC data).

IX. Sample Collection and Storage

1. Collect blood samples according to the blood sample collection and handling SOPs.
2.Stability during storage varies between serum parameters. If analyses are not performed on the
day of collection, store serum samples at minus 20°C.
4. Volume required: 3ml
5. Exclusion criteria: severe hemolysis, icteric sample.

X. Sample Preparation

1. Prepare the serum samples collected on the same day of the measurement by centrifuge them at
~5000 x g for 3 -5 minutes.
2. If necessary, remove fibrinogen clots using a wooden applicator.
3. Load the racks according to the work lists.

XI. Quality Control

1. Each morning, all parameters are tested with control sera. Some parameters are tested with
control 1 and control serum 2, which consists of lyophilized human plasma with a normal and a
pathological concentration. Other parameters are tested with specific controls from other
suppliers.
2. . Controls are thawed and mixed before utilization and loaded according to the analyzer’s
display. Control values must lie within the acceptable range indicated by the manufacturer,

Prepared by: Recommended by: Approved by:

Monalyn Marabi, M.D. Zenaida S. Mendoza, M.D. Mark Anthony S. Mendoza, M.D.
Laboratory Head Hospital Administrator Hospital Director
 ST. ANDREW HOSPITAL

SAH-LAB CLINICAL LABORATORY

Tumaway, Talisay, Batangas

Section: Revision Code: 002 Page 8 of 8

Clinical Chemistry Effectivity Date: May 2022
Document Title:
Standard Operating Procedures

otherwise the specific tests must be recalibrated, and specific measurements repeated. Controls
can be stored in 200µl aliquots at -20°C for up to 1 week.

X. Analysing results
1. Samples that produce results that lie outside the linear range for a specific assay must be re-
tested.
2. Validate the data. (Refer to Validation of Result SOP)
3. Transfer the data to the data logbook.

XI. Instrumentation

Instrument used : Chem-7 ERBA Clinical Chemistry Analyzer

Prepared by: Recommended by: Approved by:

Monalyn Marabi, M.D. Zenaida S. Mendoza, M.D. Mark Anthony S. Mendoza, M.D.
Laboratory Head Hospital Administrator Hospital Director