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Standard Operating Procedure (SOP)
Standard Operating Procedure (SOP)
Title
AUTHORS:
GADIAZA, SANDARA
GARCIA, GENESIS
EFFECTIVE DATE:
APRIL 17 , 2024
II. Purpose
III. Scope
IV. Responsibilities
V. Materials
* A. Equipment
* B. Reagents
* C. Supplies
VI. Procedures
VIII. Reporting
X. Safety Precautions
XI. References
III. Purpose
IV. Scope
V.Responsibilities
VI. Materials
● List all necessary materials, equipment, and reagents required for the
procedure.
● Include specific details like brand names, catalog numbers, and preparation
VII. Procedure
patterns.
IX. Reporting
● Specify the format for reporting, such as laboratory information system (LIS)
or paper forms.
X. Quality Control
● Outline the quality control procedures to ensure the accuracy and reliability of
● List potential hazards associated with the procedure and how to minimize
risks.
XII. References
III. Purpose
the proportion of red blood cells in whole blood. Hct testing is essential for
IV. Scope
protocols.
V.Responsibilities
to healthcare providers.
● Pathologists: Oversee Hct testing procedures, provide guidance on result
VI. Materials
A. Equipment:
● Hematocrit centrifuge
● Hematocrit reader
● -Hematocrit sealant
● Hematocrit rotor
B. Reagents:
● Calibration controls
● Cleaning solutions
C. Supplies:
● Gloves
● Lancets
● Alcohol swabs
● Labelling materials
● Disposal containers
VII. Procedure
Preparation:
lab coat.
4. Blood Collection:
6. Fill a capillary tube with blood to the mark indicated, taking care to avoid air
bubbles.
7. Seal one end of the capillary tube with clay or sealing compound.
9. Centrifugation:
10. Place the sealed capillary tubes in a hematocrit centrifuge, ensuring they are
balanced.
11. Centrifuge the tubes at [specified rpm] for [specified time] to separate the
blood components.
12. Carefully remove the capillary tubes from the centrifuge without disturbing the
sedimented blood.
13. Measure the length of the packed red blood cells (RBCs) column and the total
reader.
14. Calculate the hematocrit as the ratio of the length of the packed RBCs column
Recording Results:
15. Record the hematocrit value in the patient's medical record, along with
● Normal Results:
● In a normal sample, red blood cells (RBCs) will settle to the bottom of
the capillary tube, forming a distinct red layer with a clear plasma layer
above.
● The hematocrit value obtained from the packed RBCs column should
Abnormal Results:
handling.
anemia or polycythemia.
interpretation Guidelines:
Normal Hematocrit:
normal limits.
Abnormal Hematocrit:
● Repeat the test using a new blood sample to confirm the result and rule
IX. Reporting
● Patient Identification:
● Ensure proper patient identification by matching the test sample with the
● Record the hematocrit value obtained from the test in the designated area of
test interpretation.
Reporting Format:
● If reporting on paper forms, ensure the format includes fields for patient
Verification:
● Verify the accuracy of the recorded test results and quality control data before
● Follow the designated fields and format for entering patient information and
test values.
Paper Forms:
● Include sections for patient demographics, test results, quality control data,
X. Quality Control
a. Outline:
Daily Calibration:
samples.
Control Samples:
control samples.
Negative Controls:
Operator Training:
Daily Calibration:
Control Samples:
● Analyze control samples at the beginning of each testing session and
program.
Negative Controls:
interference.
hematocrit value.
Bloodborne Pathogens:
Chemical Hazards:
for sealing capillary tubes and cleaning agents for equipment maintenance.
● Centrifuge Hazards:
● Potential risks associated with the operation of the centrifuge, including
mechanical hazards from rotating parts and the potential for sample spillage
or breakage.
Sharp Objects:
● Risk of needlestick injuries or cuts from handling sharp objects like capillary
● Electrical Hazards:
● Wear appropriate PPE including gloves, lab coat, and safety goggles or face
● Handle all blood samples and chemical reagents with care to prevent spills
and contamination.
Centrifuge Safety:
● Ensure proper loading and balancing of the centrifuge rotor to prevent
● Do not open the centrifuge lid until the rotor has come to a complete stop to
● Use caution when handling capillary tubes and lancets to avoid accidental
Electrical Safety:
● Inspect electrical cords and plugs for any damage before use and do not use
XII. References
II. Purpose
The objective of this Standard Operating Procedure (SOP) for Total Hemoglobin
III. Scope
This SOP applies to all laboratory personnel involved in performing Total Hgb testing,
entire Total Hgb testing process, from specimen collection to result interpretation,
IV. Responsibilities
results accurately.
troubleshoot technical issues, interpret Total Hgb results, and communicate findings
to healthcare providers.
interpretation, verify critical results, and ensure quality assurance and compliance
A. Equipment:
● Hemoglobinometer or spectrophotometer
● Microcentrifuge
● Hemolysis tubes
● Timer
B. Reagents:
C. Supplies:
● Microcentrifuge tubes
● Pipette tips
● Absorbent paper
● Labels
instructions.
4. Centrifuge the sample at [specified rpm] for [specified time] to separate the
6. Add the hemoglobin reagent to the test tube or cuvette as per the
manufacturer's instructions.
7. Mix the contents thoroughly and allow them to stand for the specified
incubation period.
standard solutions.
10. Calculate the concentration of hemoglobin in the sample using the standard
curve.
● Adult Male: [Specify range, e.g., 13.8-17.2 grams per deciliter (g/dL)]
● Child: [Specify range for relevant age group, e.g., 11-16 g/dL]
VIII. Reporting
● Identification: Clearly label the test results with patient information, including
name, identification number, date and time of sample collection, and any other
relevant identifiers.
g/dL, g/L).
taken during the testing process, including calibration checks, control sample
b. Reporting Format:
● If your laboratory utilizes a Laboratory Information System (LIS), enter the test
● Input patient information and test results according to the LIS interface
requirements.
● Ensure that the LIS generates a report with all necessary information for
Paper Forms:
● If paper forms are used for reporting, fill out the designated sections
● Include patient demographics, test results, date and time of testing, and any
● Ensure that the paper forms are securely stored and archived according to
institutional policies.
c. Distribution:
● Medical Records: Ensure that the test results are accurately recorded in the
a. Outline:
accuracy of results.
they are within specified expiry dates and maintain their integrity.
control sample values, calibration results, and any deviations from expected
ranges.
● Daily Calibration:
samples.
● Acceptable Range: Ensure that the calibration curve aligns with expected
● Control Samples:
● Frequency: Run control samples at the beginning of each testing session and
program.
● Reagent Checks:
● Frequency: Check reagent integrity before each testing session and verify the
expiry date.
● Operator Training:
Documentation:
● Frequency: Maintain up-to-date records of quality control data for each testing
session.
X. Safety Precautions
1. Handle all biological samples and reagents with care to avoid contamination.
Smith, J., & Johnson, K. (Year). "Standard Operating Procedure for Total
IMMUNOSEROLOGY SECTION:
II. Purpose
Blood typing is a common test when blood transfusions and tissue transplants
are required, as well as during pregnancy. A blood type lab test identifies certain
inherited substances (antigens) that may be present on the surface of red blood cells
and classifies them into four common groups: A, B, AB, or O, and is known as the
ABO system.
In addition, a second system, the Rh system, determines if the red blood cells
are Rh-positive or Rh-negative. You are Rh-positive when you have the Rh factor. It
is important to know both the ABO and Rh types in that a mismatch is capable of
III. Scope
This procedure applies to all those activities that are performed to determine
the correct ABO group and Rh D type of a donor and ensure the reliability of the
absence of A, B & D antigens on red cells by using Anti-A, Anti-B and anti D antisera
(antibodies) against the corresponding antigens. Anti A & Anti B are monoclonal IgM
antibodies specific against A & B red cell antigen. Anti D is also monoclonal which
may be purely IgM or a blend of IgG and IgM (preferably). Reverse blood grouping
should always be run in parallel with forward ABO typing for group confirmation
Mismatch transfusion of ABO/D blood group can cause fatal transfusion reactions
especially in child bearing age females where it may cause haemolytic disease on
the newborn.
IV. Responsibilities
procedure:
donors
❖ Medical Officer is responsible to supervise the procedure and to rule out any
❖ It is the responsibility of all staff performing the ABO grouping and D typing to
ensure that quality controlled reagents and proper cell concentrations are
used.
V. Materials
A. Equipment
❖ Refrigerator to store samples and reagents at 2- 6 oC
to a row of wells
reader interprets the reactions and prints the blood testing results
❖ Incubator
B. Reagents
❖ Use only Anti-D reagents approved for use in microtest plate tests2
C. Specimen
❖ Automated methods may require the use of samples drawn from donor into a
❖ Permanent Markers
❖ Timer
❖ Disposal box
❖ 2 plastic beakers
VI. Procedures
2. Add 1 drop of 2-3% saline suspension of red cells to each well containing
3. Mix the contents of the wells by gently rotating the plate on the microtest plate
rotator.
centrifuge.
5. Resuspend the red cell buttons by gently manually tapping the plate or with
red cell test results with those obtained in testing serum or plasma.
2. Add 1 drop of 2-3% suspension of A1, B and O reagent red cells to separate
3. Mix the contents of the wells by gently tapping the slides of the plate or on a
centrifuge.
5. Re-suspend the red cell buttons by manually tapping the plate or with the aid
Rh D GROUP TESTING
1. Place 1 drop of anti-D reagent into a clean well of the microtest plate. If the
well.
3. Mix the contents of the wells by gently tapping the slides of the plate or on a
centrifuge.
5. Re-suspend the red cell buttons by manually tapping the plate or with the aid
the results.
There is a discrepancy between the forward and reverse ABO blood grouping
There is a discrepancy between the results of the two wells for Rh D grouping
❖ Any discrepancy between results on cell and serum or plasma tests should be
group
VIII. Reporting
Confirm the ABO cell grouping results with those obtained in serum/reverse grouping
All Rh-D-negative results must be retested with a weak D test (cf. BTS/SOP/TP/24a)
RhD-Positive
IX. Quality Control
Positive and negative controls must be run and documented each day of
testing. Before running controls, reagents and controls should be checked for
expiration date, lot number, and turbidity. Expired or contaminated controls and
reagents should not be used since they could give inaccurate or weak reactions.
or the lab may choose to use the ABO reagents used to type the blood. The reagent
Controls for Anti-D can be purchased from the manufacturer or verified known
patients can be used. When performing Weak D (Du) testing, always confirm that the
check cells
X. Safety Precautions
❖ Discard the alcohol swabs, lancet, cotton balls and toothpick after their use.
❖ Drop all the materials, including the glass slide into the biohazard disposal
XI. References
https://www.labflorida.com/internal/COLA/guides/elf27.pdf
https://www.vedantu.com/biology/blood-group-test
CROSS MATCH (SALINE/BOVINE-ALBUMIN/IAT)
II. Purpose
recipient against the red blood cells of the donor. These antibodies attach to the red
blood cells of the donor after transfusion. An incompatible transfusion can result in a
III. Scope
transfusion. There are two types of cross match, i.e. Major and Minor. Routinely
major cross match is done in which donor red cells are cross matched with patient
IAT phase). Minor crossmatch is done when a transfusion reaction is observed and
is done by taking patient red cells which cross match with the donor plasma to detect
antibodies in the donor plasma. Incompatible blood units should never be used for
transfusion.
IV. Responsibilities
V. Materials
A. Equipment
❖ Tabletop centrifuge
❖ 0.9% saline
C. Specimen
❖ Patient‘s serum or plasma. Patient sample should not be older than 3 days
❖ Donor red cells acquired from the blood packs intended to be transfused
D. Miscellaneous
❖ Disposal box
❖ 2 glass beakers
VI. Procedures
situations).
2. Prepare 3% red cell suspension of donor red cells (60 microliters of washed
red cells and 2 ml 0.9% normal saline) OR Prepare 5% red cell suspension of
donor red cells (100 microliters of washed red cells in 2 ml 0.9% normal
saline).
3. Centrifuge patient blood at 3400 rpm for 5 minutes to get clear serum.
5. Add one drop of 3% or 5% donor red cell suspension to the tube containing
patient serum.
8. Observe for haemolysis and then for agglutination by gently shaking the tube.
10. Always continue with the AHG phase, even in emergency situations, but in
AHG/COOMBS PHASE
(IgG) antibodies in patients blood which can cause destruction of the transfused
donor red cells. Coombs' phase should always be included in the cross match.
Continue with the tubes used in 5.1 saline room temperature immediate spin.
enhancement media.
3. Take out the tube and centrifuge at 3400 rpm for 15 seconds, then observe
5. After the 3rd wash discard all saline/supernatant by gently tapping on tissue
paper.
8. Take out the tube gently, observe macroscopically for haemolysis and
10. To all negative results add one drop of ―Coombs Control Cells‖ to validate
the results. (Dispense one drop of check cells to the negative result tube and
centrifuge immediately at 3400 rpm. Take out the tube and gently disperse the
cell button, this time agglutination should be present at least 1+ or 2+. (The
free AHG/Coombs reagent in the test tube causes agglutination of the check
cells/sensitised cells). This validates that the Coombs reagent was working
incompatible crossmatch.
crossmatch.
NOTE:
❖ Never use plastic tubes for cross match as it adsorbed IgG antibody which
going on in the patient then monitor the size of cell button after incubation at
matched with the original blood sample. If the colour of the supernatant
becomes darker then the original sample it means haemolysis had occurred
Limitations
The saline/enzyme cross match will not:
VIII. Reporting
X. Safety Precautions
care professionals take several precautions. Before starting the transfusion, usually
a few hours or even a few days beforehand, the person is cross-matched with the
donor blood (not done for transfusions of plasma or platelets). In cross-matching,
blood bank personnel mix a small amount of blood from the donor and the recipient
After double-checking labels on the bags of blood that are about to be given
to ensure the units are intended for that recipient, the health care professional gives
the blood to the recipient slowly, generally over 1 to 4 hours for each unit of blood.
Because most adverse reactions occur during the first 15 minutes of the transfusion,
the recipient is closely observed at first. After that, a nurse checks on the recipient
XI. References
https://pbta.punjab.gov.pk/system/files/SOP%20for%20Blood%20bank.pdf
HEMATOLOGY SECTION:
CLINICAL CHEMISTRY SECTION:
The Basic Metabolic Panel (BMP) is a group of blood tests used to assess general
health and screen for potential medical conditions. This SOP outlines the procedures
for performing a BMP analysis in the Clinical Chemistry section of the laboratory.
III. Scope
This SOP applies to all laboratory personnel involved in analyzing BMPs, including
phlebotomists collecting blood samples, laboratory technicians performing the
analysis, and technologists interpreting and reporting results.
IV. Responsibilities
V. Materials
A. Equipment
● Laboratory centrifuge
● Automated chemistry analyzer
● Pipettes (calibrated)
● Refrigerated centrifuge
● Refrigerator for specimen storage
B. Reagents
● Commercially prepared test kits or reagents for electrolytes (Na, K, Cl), BUN,
Creatinine, Total Protein, Albumin, ALP, and Glucose (specific to the
chemistry analyzer)
● Quality control materials (controls with known values for each analyte)
● Disposable cuvettes or reaction cartridges (compatible with the analyzer)
C. Supplies
● Tourniquet
● Blood collection tubes (serum or plasma separator)
● Aliquot tubes
● Waste disposal containers
● Personal Protective Equipment (PPE) like gloves, lab coat, safety glasses
VI. Procedures
X. Safety Precautions
XI. References
II. Purpose
This document outlines the standard operating procedure (SOP) for performing liver
function tests (LFTs). The purpose of this SOP is to ensure the consistent and
accurate performance of LFTs in a clinical laboratory setting. Standardized
procedures promote reliable results that aid in the diagnosis and monitoring of liver
disease.
III. Scope
IV. Responsibilities
● Phlebotomist: Responsible for proper patient identification, blood collection,
and specimen labeling.
● Laboratory Technician: Performs the LFT assays according to the outlined
procedures, ensuring proper handling and analysis of specimens.
● Pathologist: Reviews and interprets LFT results, integrating them with clinical
findings for diagnosis and patient management.
V. Materials
A. Equipment
● Centrifuge
● Spectrophotometer
● Automatic pipettes
● Incubator (if required for specific assays)
● Quality control materials
B. Reagents
● Reagents for each LFT test (e.g., alanine aminotransferase (ALT), aspartate
aminotransferase (AST), alkaline phosphatase (ALP), bilirubin, albumin)
C. Supplies
VI. Procedures
1. Patient Preparation
● Instruct the patient to fast for a specific timeframe before the test, if
required by the specific LFTs being performed.
● Document any medications or supplements the patient is taking, as
some can affect LFT results.
2. Blood Collection
● The phlebotomist will identify the patient using two identifiers (e.g.,
name and date of birth).
● Apply a tourniquet and locate a suitable vein for blood collection.
● Disinfect the venipuncture site with an alcohol swab.
● Perform venipuncture and collect blood into the appropriate tubes
according to the tests ordered.
● Properly label the blood collection tubes with patient identification
information and test name(s).
● Release the tourniquet and dispose of sharps in a designated sharps
container.
3. Specimen Processing
● Centrifuge the blood collection tubes as per the manufacturer's
instructions to separate serum from red blood cells.
● Transfer the serum to appropriately labeled test tubes for analysis.
4. LFT Assays
● Laboratory technicians will perform the specific LFT assays according
to the manufacturer's instructions and established laboratory protocols.
● This may involve using automated analyzers or performing manual
assays.
● Proper controls should be run concurrently to ensure the accuracy of
the tests.
5. Data Analysis
● The instrument will generate readouts for each LFT test.
● The laboratory technician will record the results in the laboratory
information system (LIS).
● The pathologist will review the LFT results in conjunction with the patient's
clinical history and other laboratory findings.
● Elevated or abnormal LFT values may indicate liver damage or disease. The
specific pattern of abnormalities can help narrow down the cause.
● The pathologist will interpret the results and provide a report for the ordering
physician.
VIII. Reporting
● LFT results are reported to the ordering physician electronically or through the
LIS.
● The report should include the individual LFT values, reference ranges, and
any interpretive comments by the pathologist.
● Regular quality control procedures are essential to ensure the accuracy and
consistency of LFT results.
● This includes running control materials with each batch of tests to monitor for
errors or variations.
● Routine calibration and maintenance of equipment should also be performed
according to the manufacturer's recommendations.
X. Safety Precautions
XI. References
II. Purpose
This SOP outlines the procedure for performing a Gram stain, a rapid and differential
staining technique used to classify bacteria into two broad categories: gram-positive
and gram-negative.
III. Scope
This SOP applies to all personnel in the microbiology laboratory responsible for
IV. Responsibilities
clinical information.
V. Materials
● Microscope slides
● Staining reagents:
instructions)
● Inoculating loop
● Bibulous paper
● Disinfectant wipes
VI. Procedure
1. Specimen Preparation:
○ Heat fixation: Carefully pass the slide through the flame of a Bunsen
4. Decolorization:
○ Tilt the slide and slowly add decolorizing agent drop-by-drop until the
○ DO NOT over-decolorize.
5. Counterstaining:
6. Air-drying:
7. Microscopic Examination:
● Gram-negative bacteria: Stain pink due to the loss of the crystal violet-iodine
safranin.
IX. Reporting
● Document the Gram stain results in the laboratory information system (LIS) or
X. Quality Control
containers.
biological materials.
XII. References
● Reference for Gram stain technique: e.g., Baron S, et al. Baron’s Medical
III. Purpose
This Standard Operating Procedure (SOP) outlines the proper techniques for
IV. Scope
various clinical specimens, including skin scrapings, nail clippings, sputum, vaginal
VI. Materials
● Cover slips
● 10% KOH solution (prepared with KOH flakes and distilled water)
● Disposable gloves
● Safety glasses
VII. Procedure
1. Preparation:
information.
2. Specimen Processing:
○ Mix the specimen container thoroughly to ensure even distribution.
3. KOH application:
4. Mounting:
○ Gently tilt the slide to bring the two droplets together and mix them
slightly.
○ Carefully place a coverslip over the mixed droplet, avoiding air bubbles.
5. Microscopic Examination:
○ Observe the preparation under a microscope using the low power (10x)
7. Negative Control:
○ Include a blank slide with a drop of 10% KOH solution and a coverslip
reagents.
8. Documentation:
not necessarily rule out fungal infection. Negative results may require further
IX. Reporting
● Report the KOH examination results in the laboratory information system (LIS)
elements.
X. Quality Control
● Perform positive and negative controls with each batch of KOH examinations.
● Regularly monitor the expiration date of the 10% KOH solution and prepare
program.
● KOH is a caustic substance and can cause skin and eye irritation. Wear
gloves and safety glasses at all times while handling KOH solution.
container.
materials.
XII. References
https://main.icmr.nic.in/sites/default/files/guidelines/Standard_Operating_Proc
https://www.cdc.gov/labtraining/docs/job_aids/routine_microscopy_procedure
PURPOSE:
SCOPE
The applicability of a Standard Operating Procedure (SOP) for clinical microscopy and
parasitology can be defined as its relevance and necessity in the clinical laboratory
setting for specific tasks, processes, or activities related to the diagnosis and
identification of parasites in clinical samples. The SOP should provide clear
instructions and guidelines for the preparation, staining, and examination of blood
films, as well as quality assurance measures for ensuring accurate and reproducible
results.
RESPONSIBILITIES
MATERIALS
The necessary materials, equipment, and reagents required for the procedure in the
standard operating procedure for clinical microscopy and parasitology include:
Preparation of Microscope:
INTERPRETATION OF RESULTS
In the case of the Direct Agglutination Test (DAT) for Leishmania parasites, a serum
can be considered positive if at a dilution ≥ 1:3,200, agglutinated promastigote cells
are visible by naked eye as a blue mat in the microtiter plate wells; absence of
agglutination is visible as a neat blue spot in the bottom of the microtiter plate wells.
The diagnostic performance of DAT is high in all VL-endemic regions with overall
sensitivity and specificity of 95% (93-97%) respectively, irrespective of the Leishmania
species causing VL ( L. donovani or Leishmania [ L.] infantum).
In microscopy examination of red blood and yeast cell agglutination, the sample
volume, concentration of CV-IIL, and incubation time play a significant role in the
observation of agglutination patterns. High concentrations of CV-IIL give large
agglutinates clearly visible even with the naked eye on the microscope glass slide,
but high concentrations of CV-IIL in combination with a low amount of the yeast cells
give less stable agglutinates.
In urine microscopy, there is no set normal range for cells in urine, as it is not
possible to account for all patient types or conditions. The interpretation of urine
microscopy results should be based on the clinical context and the presence or
absence of abnormal cells or casts.
REPORTING
1.
2. Documentation Process:
○ Record Keeping: Maintain detailed records of all tests performed,
including patient information, specimen details, test procedures, and
results.
○ Verification: Ensure that all results are verified for accuracy before
documentation.
○ Date and Time: Document the date and time when the test was
conducted and when the results were obtained.
○ Quality Control: Include information on quality control measures
undertaken during the testing process.
3. Reporting Process:
○ Format: The format for reporting test results can vary based on the
laboratory's practices. Common formats include electronic reporting
through Laboratory Information Systems (LIS) or paper forms.
○ Laboratory Information System (LIS):
■ Electronic Reporting: Enter test results directly into the LIS for
automated reporting and storage.
■ Patient Identification: Ensure accurate patient identification
details are entered to match the results with the correct
individual.
■ Result Interpretation: Provide clear and concise interpretations of
the test results.
○ Paper Forms:
■ Manual Entry: Write down the test results on designated paper
forms.
■ Legibility: Ensure that the results are legible and clearly written
to avoid misinterpretation.
■ Signature: Sign and date the paper form to authenticate the
results.
4. Content of the Report:
○ Test Results: Clearly state the results of the test, including any
observed agglutination patterns or other relevant findings.
○ Reference Ranges: Compare the results to established reference ranges
or expected values to determine normalcy.
○ Interpretation: Provide an interpretation of the results based on the
observed agglutination patterns and reference ranges.
○ Quality Control: Include information on the quality control measures
followed and any positive or negative controls used during the testing
process.
QUALITY CONTROL
1.
2. Positive and Negative Controls:
○ Frequency: Positive and negative controls should be included with each
test run.
○ Purpose: Positive controls help validate the test's ability to detect weak
positive reactions, while negative controls ensure the absence of false
positives.
○ Acceptable Ranges: Positive controls should be close to the cut-off
value of the test, and negative controls should consistently show no
reaction.
3. Live Control Organisms:
○ Frequency: Live control organisms with predictable reactions should be
used to verify stains, reagents, and media regularly.
○ Purpose: These controls help ensure that the laboratory equipment and
materials are functioning correctly.
○ Acceptable Ranges: The reactions of live control organisms should
align with expected outcomes based on established standards.
4. Regular Assessment of Equipment and Supplies:
○ Frequency: Regularly assess the quality and functionality of equipment,
reagents, and supplies.
○ Purpose: Ensures that high-quality work is maintained by using reliable
equipment and consumables.
○ Acceptable Ranges: Equipment should meet minimum standards, and
supplies should be of the specified quality to produce accurate results.
5. Documentation and Record-Keeping:
○ Frequency: Continuous documentation of quality control measures and
corrective actions.
○ Purpose: Provides a record of quality control processes and facilitates
continual improvement of the laboratory quality system.
○ Acceptable Ranges: Records should be maintained according to
regulatory requirements and best practices.
6. Incubator and Equipment Maintenance:
○ Frequency: Regular maintenance and monitoring of incubators,
microscopes, refrigerators, and other equipment.
○ Purpose: Ensures that equipment is functioning correctly and maintains
the integrity of test results.
○ Acceptable Ranges: Equipment should be calibrated and maintained
according to manufacturer guidelines.
SAFETY PRECAUTIONS
REFERENCES