Reference No.
: SJHLAB-QM-CC-001
VQR MEDICAL FOUNDATION FOR Revision No. : 1.0
MEDICAL & COMMUNITY Issue No. : 1.0
Effectivity Date January 1, 2018
DEVELOPMENT INC. Page No. : 1of 11
CLINICAL CHEMISTRY
STANDARD OPERATING PROCEDURES
This document is updated and controlled if it bears the red “CONTROLLED COPY” stamp. Otherwise, please refer to the Document Control Center (DCC) for your updated copy.
Prepared By: Reviewed By: Approved By:
JOHN VICKSEN M. DOMINGO, RMT ROGER P. VILLAREAL, RMT MODESTY A. LEAÑO, M.D., F.P.S.P.
Medical Technologist Chief Medical Technologist Anatomical & Clinical Pathologist
Reference No. : SJHLAB-QM-CC-001
CLINICAL CHEMISTRY Revision No. : 1.0
STANDARD OPERATING PROCEDURE
Issue No. : 1.0
“ GENERAL PROCEDURE FOR ALL CLINICAL Effectivity Date January 1, 2018
CHEMISTRY SPECIMEN” Page No. : 2 of 11
PURPOSE
This SOP defines the handling of a specimen from the time it is received until the time a report is released
from Clinical Chemistry Section. The specimen may be tracked for efficiency in reporting results in a timely
fashion, as well as for identifying those individuals responsible for processing the specimen and issuing a
final report of the result.
SCOPE
This procedure applies from the endorsement of specimen with requisition form to the clinical chemistry
section of the laboratory to issuance of final report of the result.
DEFINITION OF TERMS
Quality Control – process of monitoring results from control samples to verify accuracy of patient results.
Calibration – a process done to ensure accuracy of test results especially when new set of parameters are
installed
Controls – Samples that are chemically and physically similar to unknown specimen & is tested in exactly the
same manner
Delta Check – Comparison of patient data with previous results.
Levey Jennings Chart – a QC chart used to observe errors
Westgard Rules – rules used as a guide in pointing out the errors that occur in a given set of observation
Systematic Error – Error that influences all observations consistently in one direction
Random Error – Error that is present in all measurements; due to chance; no means of prediction
NEQAS – A method of QC that involves proficiency testing where in results are compared with those from
other laboratories involved in the program.
RELATED RECORD
Requisition Form
Result form
Specimen Collection and Transport
Criteria for Specimen Rejection
Levey Jennings QC Charts
Critical Values
This document is updated and controlled if it bears the red “CONTROLLED COPY” stamp. Otherwise, please refer to the Document Control Center (DCC) for your updated copy.
Prepared By: Reviewed By: Approved By:
JOHN VICKSEN M. DOMINGO, RMT ROGER P. VILLAREAL, RMT MODESTY A. LEAÑO, M.D., F.P.S.P.
Medical Technologist Chief Medical Technologist Anatomical & Clinical Pathologist
Reference No. : SJHLAB-QM-CC-001
CLINICAL CHEMISTRY Revision No. : 1.0
STANDARD OPERATING PROCEDURE
Issue No. : 1.0
“ GENERAL PROCEDURE FOR ALL CLINICAL Effectivity Date January 1, 2018
CHEMISTRY SPECIMEN” Page No. : 3 of 11
PROCESS FLOW
RESPONSIBLE
PROCESS FLOW DETAILS / REFRENCES
PERSON
Receive Specimen and Requisition Form. Medical
Medical Receive Specimen and Technologist on duty must ensure the laboratory
Technologist Requisition Form request form accompanying any sample received in
the laboratory has been properly “clocked in.”
Requisition form must contain the following minimum
information: patient’s complete name, age, and
gender; attending physician; ward or clinic; tests
requested; date and time specimen was collected;
Criteria for and pertinent clinical information.
Rejected Accepted
Specimen
Rejection
Criteria for Specimen Rejection. Medical
Technologist on duty must evaluate the received
specimen and requisition using a strict guidelines for
Repeat specimen specimen rejection for each analyte to be tested.
collection procedure Patient/Ward/Nurse Station must be informed of
the rejected specimen and a repeat collection of
specimen must be performed. For a complete
guideline for specimen rejection refer to the Criteria
for Specimen Rejection and Collection. After
Assign Worksheet accepting that the specimen is suitable for testing, A
Number / Code specimen code/number is assigned to the specimen.
Check Quality Control. Before performing
Check QC requested tests, Normal and Abnormal Controls of
each of the analyte to be tested must be checked
and validated that they are within acceptable range
to ensure quality assurance of the procedure. Out of
range controls must be troubleshooted. Refer to
Perform Requested Tests Quality Control for a detailed guideline for
on the Specimen troubleshooting out of range QC results.
Perform Requested Tests on the Specimen. After
ensuring QC, Perform analysis of assays on the
NO
Normal YES appropriate analyzer. Normal result must be
Result conferred with previous result of the same analyte
performed before being validated by the medical
technologist on duty. If the assay yields an abnormal
Delta Check Delta Check result, delta check/history of previous test must also
be checked. If the previous result and the generated
result does not correlate, Medical Technologist must
Check Reagent, Validate Result check the volume/level/expiration of the reagent,
Sample, QC and sample, QC and calibration before repeating the
Calibration assay of the abnormal test.
Generate/Issue a
Rerun Abnormal
final report
Result
This document is updated and controlled if it bears the red “CONTROLLED COPY” stamp. Otherwise, please refer to the Document Control Center (DCC) for your updated copy.
Prepared By: Reviewed By: Approved By:
JOHN VICKSEN M. DOMINGO, RMT ROGER P. VILLAREAL, RMT MODESTY A. LEAÑO, M.D., F.P.S.P.
Medical Technologist Chief Medical Technologist Anatomical & Clinical Pathologist
Reference No. : SJHLAB-QM-CC-001
CLINICAL CHEMISTRY Revision No. : 1.0
STANDARD OPERATING PROCEDURE
Issue No. : 1.0
“ GENERAL PROCEDURE FOR ALL CLINICAL Effectivity Date January 1, 2018
CHEMISTRY SPECIMEN” Page No. : 4 of 11
QUALITY CONTROL
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
Specimen collection, containers, labelling 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/deionized water
Calibration of measuring and testing instruments including balances, thermometers, incubators, waterbaths,
autoclaves, centrifuges and semiautomatic 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 through the use of 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 andcorrective actions implemented.
USE OF CALIBRATION GRAPHS
A fresh standard curve should be carried out for the analysis described in this manual whenever:
the calibrator is changed
new reagents are introduced
problems with QC are encountered
This document is updated and controlled if it bears the red “CONTROLLED COPY” stamp. Otherwise, please refer to the Document Control Center (DCC) for your updated copy.
Prepared By: Reviewed By: Approved By:
JOHN VICKSEN M. DOMINGO, RMT ROGER P. VILLAREAL, RMT MODESTY A. LEAÑO, M.D., F.P.S.P.
Medical Technologist Chief Medical Technologist Anatomical & Clinical Pathologist
Reference No. : SJHLAB-QM-CC-001
CLINICAL CHEMISTRY Revision No. : 1.0
STANDARD OPERATING PROCEDURE
Issue No. : 1.0
“ GENERAL PROCEDURE FOR ALL CLINICAL Effectivity Date January 1, 2018
CHEMISTRY SPECIMEN” Page No. : 5 of 11
POST-ANALYTICAL
In order to avoid transcriptional errors in the results of the test, the reporting/signatory technicians shall verify
the results entered manually or through on-line instrument interfaces before the results are reported or despatched.
RECTIFICATION OF LABORATORY ERRORS
To correct 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, construction of Levey-Jennings chart and daily analysis of
QC along with every batch of patients’samples
PREPARATION OF QC MATERIAL
CONTROL
Reconstitution
Using a volumetric pipette , reconstitute each vials of normal (Level 1) and abnormal (Level 2) controls
with ml of water. Replace the stopper and allow control to stand for 20 minutes, swirling occasionally.
Before sampling, gently swirl the vial several times to ensure homogenity
Storage and Stability
Controls are stable until expiratio date when stored unopened at 2-80C. Once the control is
reconstituted, all analytes will be stable for 7 days when stored tightly capped at 2-80C
Procedure
The Controls should be treated the same as patient specimens run in accordance with the instructions
accompanying the instrument, kit or reagent being used.
CALIBRATOR
Calibrators are QC materials that are provided by the manufacturer of the reagent or test kit being used
CONSTRUCTION OF LEVEY JENNINGS CHART
On each day before analysis are performed, the controls are is thawed, thoroughly mixed and analyzed. The
control is analysed for a period of one month. 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 definitely < 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.
[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]
This document is updated and controlled if it bears the red “CONTROLLED COPY” stamp. Otherwise, please refer to the Document Control Center (DCC) for your updated copy.
Prepared By: Reviewed By: Approved By:
JOHN VICKSEN M. DOMINGO, RMT ROGER P. VILLAREAL, RMT MODESTY A. LEAÑO, M.D., F.P.S.P.
Medical Technologist Chief Medical Technologist Anatomical & Clinical Pathologist
Reference No. : SJHLAB-QM-CC-001
CLINICAL CHEMISTRY Revision No. : 1.0
STANDARD OPERATING PROCEDURE
Issue No. : 1.0
“ GENERAL PROCEDURE FOR ALL CLINICAL Effectivity Date January 1, 2018
CHEMISTRY SPECIMEN” Page No. : 6 of 11
INTERPRETATION OF QC DATA
A. 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
- 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.
WESTGARD’S RULES FOR INTERPRETING QC DATA
Quality Control Rule Diagram
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)
This document is updated and controlled if it bears the red “CONTROLLED COPY” stamp. Otherwise, please refer to the Document Control Center (DCC) for your updated copy.
Prepared By: Reviewed By: Approved By:
JOHN VICKSEN M. DOMINGO, RMT ROGER P. VILLAREAL, RMT MODESTY A. LEAÑO, M.D., F.P.S.P.
Medical Technologist Chief Medical Technologist Anatomical & Clinical Pathologist
Reference No. : SJHLAB-QM-CC-001
CLINICAL CHEMISTRY Revision No. : 1.0
STANDARD OPERATING PROCEDURE
Issue No. : 1.0
“ GENERAL PROCEDURE FOR ALL CLINICAL Effectivity Date January 1, 2018
CHEMISTRY SPECIMEN” Page No. : 7 of 11
Remedial action
A well-run internal QC system makes possible immediate intervention in the release of patient’s results. In the event
of a control system alert, it is advisable to proceed through the following steps in that order.
(a) Decision: Immediate decision whether action is necessary.
(b) Investigation: Check to locate the error.
(c) Repair: Action to eliminate the error.
If the decision is taken that the method is out of control, the first action is to withhold patient’s results in that
batch. Then the analyst should start by checking for the simplest and most 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
photometer, flame photometer, etc.
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, and 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.
NOTE: While it is easy to identify systematic errors, it is quite difficult to pinpoint random errors. In order to minimize
this possibility, it is important to educate the staff about the most common causes of random errors.
This document is updated and controlled if it bears the red “CONTROLLED COPY” stamp. Otherwise, please refer to the Document Control Center (DCC) for your updated copy.
Prepared By: Reviewed By: Approved By:
JOHN VICKSEN M. DOMINGO, RMT ROGER P. VILLAREAL, RMT MODESTY A. LEAÑO, M.D., F.P.S.P.
Medical Technologist Chief Medical Technologist Anatomical & Clinical Pathologist
Reference No. : SJHLAB-QM-CC-001
CLINICAL CHEMISTRY Revision No. : 1.0
STANDARD OPERATING PROCEDURE
Issue No. : 1.0
“ GENERAL PROCEDURE FOR ALL CLINICAL Effectivity Date January 1, 2018
CHEMISTRY SPECIMEN” Page No. : 8 of 11
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.
St. James Laboratory participates in NEQAS and is performed before the end of the month. Results are reviewed and
compared to other laboratories participating in the NEQAS program. Results received are further reviewed by the medical
technologist and chief medical technologist and apply corrective actions if required.
This document is updated and controlled if it bears the red “CONTROLLED COPY” stamp. Otherwise, please refer to the Document Control Center (DCC) for your updated copy.
Prepared By: Reviewed By: Approved By:
JOHN VICKSEN M. DOMINGO, RMT ROGER P. VILLAREAL, RMT MODESTY A. LEAÑO, M.D., F.P.S.P.
Medical Technologist Chief Medical Technologist Anatomical & Clinical Pathologist
Reference No. : SJHLAB-QM-CC-001
CLINICAL CHEMISTRY Revision No. : 1.0
STANDARD OPERATING PROCEDURE
Issue No. : 1.0
“ GENERAL PROCEDURE FOR ALL CLINICAL Effectivity Date January 1, 2018
CHEMISTRY SPECIMEN” Page No. : 9 of 11
“STAT” EXAMINATIONS and CRITICAL VALUES
No STAT blood chemistry examination except for the following tests:
Serum electrolytes (sodium, potassium, chloride and calcium)
Creatinine
Urea Nitrogen
Trop-T
Bilirubin (for exchange transfusion only
Critical values/Panic Values
These are test results that could indicate a life threatening situation. Patient care personnel must be notified
immediately.
Glucose > 500 mg/dl or < 40 mg/dl
Bilirubin > 20 mg/dl
Sodium > 160 mmol/L or < 125 mmol/L
Potassium > 6.0 mmol/L or < 3.0 mmol/L
Chloride > 120 mmol/L or < 80mmol/L
Magnesium > 3.5 mg/dl or < 1.0 mg/dl
Troponin T > 50 ng/L
ISSUING / RELEASING A REPORT
Chemistry results which show normal results should be duplicated or rechecked before they are released.
Performing Delta Check is recommended before issuing a final report.
Chemistry results which show abnormally high or low results should be duplicated or rechecked before they are
released. Observe the following:
1. Perform Delta check
2. Check that the machine is calibrated and control results within the accepted range.
3. Reagent levels are must not be below the amount needed.
4. Water supply is enough and waste is not full
5. No clogs or dirt on the probe or sample wells
6. The patient’s specimen is correct and properly collected.
7. Transcription of result is correct
8. When there is no error is found, a duplicate test is done.
9. If the result is repeatedly high or low, the result is deemed correct and released.
If errors are noted in any of the above, the problem shall be referred to the medical technologist or the
pathologist.
This document is updated and controlled if it bears the red “CONTROLLED COPY” stamp. Otherwise, please refer to the Document Control Center (DCC) for your updated copy.
Prepared By: Reviewed By: Approved By:
JOHN VICKSEN M. DOMINGO, RMT ROGER P. VILLAREAL, RMT MODESTY A. LEAÑO, M.D., F.P.S.P.
Medical Technologist Chief Medical Technologist Anatomical & Clinical Pathologist
