3. A set of written instructions that document
a routine or repetitive activity followed by an
organization.
SOPs should be followed the exact same way every
time to guarantee that the organization remains
consistent and in compliance with industry
regulations and business standards.
5. SOPs : are documents contain written step-by-step
instructions that laboratory staff should
meticulously follow when performing a procedure.
SOPs: are written instructions that detail the steps
to be performed during a given experimental
procedure and include information about potential
hazards and how these hazards will be mitigated.
6. These SOPs are complied to laboratory management
system to help lab staff to carryout complex routine
operations .
Labs must have written SOPs when work involves
the use of hazardous materials (chemical,
(
radioactive, biological and physical hazards
7. 1. SOPs are a set of written instructions that
describes in detail, how to perform a laboratory
process or experiment safely and effectively.
2. carry out the operations correctly and always
in the same manner.
8. SOPs are help to ensure:
Consistency
Accuracy
Quality
Consistency : everyone should perform the tests
exactly the same way so that the same result can be
expected from all staff.
9. Consistency enables people who use
laboratory results to observe changes
in a particular patient’s results over time
If different laboratories use the same SOPs,
comparisons of their results can be made; it
should be emphasized that all laboratory staff
must follow the SOPs exactly.
10. Accuracy: following written procedures helps
laboratory staff produce more accurate results than
relying on memory alone because they will not
forget steps in the process.
Quality: consistent (reliable) and accurate results
are primary goals of the laboratory, and could be
considered as the definition of quality in the
laboratory
11. SOPs are required for the following
reasons :
To improve and maintain the quality of
laboratory service to patients and identify problem
associated with poor work performance .
To provide laboratory staff with written
instructions on how to perform tests consistently
to an acceptable standard in their laboratory.
1
2
12. To prevent changes in the performance of
tests which may occur when new members of staff are
appointed.
SOPs also help to avoid short –cuts being taken
when performing tests.
3
s.
4
5 To facilitate the preparation of a list and
inventory of essential reagents, chemicals
and equipment.
13. To make clinical and epidemiological
interpretations of test results easier by standardizing
specimen collecting techniques , test methods, and test
reporting.
To provide written standardized techniques for use
in the training of laboratory personnel
To promote safe laboratory practice.
6
7
8
14. 1- detailed, clear and concise
so that staff not normally performing
the procedure will be able to do so by
following the SOP—all necessary details
(e.g. ambient temperature
requirements and precise timing
instructions) should be included.
2-easily understood by new personnel
or students in training
A good
SOP
should
be
15. . 3-reviewed and approved by the laboratory
management
-approval is indicated by a signature and
a date (this is important to ensure that the
procedures being used for testing in the
laboratory are those that are up to date and
appropriate.
4. Updated on regular basis .
16. SOPs must be:
Applicable and achievable in the laboratory
in which they will be used.
Clearly written and easy to understand and
follow.
Kept up to date using appropriate valid
technologies
important features of SOPS
17. Requirements
of a standard
operating
procedure
- Header
- Purpose
- Scope
- References and related
documents
- Definitions
- Roles and responsibilities
- Procedure
- Appendices
Revision history, and
approval signatures
18.
19.
20. * SOPs must be written and implemented by qualified
experienced laboratory officer, and followed exactly
by all members of staff.
*For each SOP it is best to follow a similar format with
the information presented under separate headings.
*Each SOP must be given a title and identification
number, and be dated and signed by an authorized
person.
Preparing and writing SOPs
22. SOPs
should
include the
following
information
Header
purpose
include information about the test (why it is
important,, and whether it is intended for
screening, to diagnose, or to follow treatment and
if it is to be used for public health surveillance)
instructions
detailed information for the entire testing
process, including pre examination,
examination and post-examination phases
name of the person preparing the SOP
signatures of approving officials and dates of
approval
Name & address of the lab
SOP number , Date when SOP prepared
l reviewed
23. address
should
:
examination instructions
-
Pre
sample collection and transport to the laboratory,
and conditions needed for proper sample handling.
example, instructions should indicate whether the
sample needs a preservative, and whether it should
be refrigerated, frozen or kept at room temperature.
24. Instructions should also reflect laboratory policies
for sample labeling, such as requirements to verify
more than one type of patient identification, to write
the collection date on the sample label, and to make
sure all information needed is included on the test
request form.
should address the actual
Examination instructions
step-by-step laboratory procedures to follow and the
quality control procedures needed to ensure
accuracy and reliability.
25. should provide
examination instructions
-
Post
information on reporting the results, including the
unit of measurement to be used, the normal
(reference) range, ranges that are life-threatening
(sometimes called “panic values”) and instructions
for how to deal with an urgent report. They should
also include references to the published sources of
the procedures, including published evidence that
the procedures are scientifically valid.
26.
27. What to write under headings
VALUE OF TEST
State the main reason(s) for performing the test, i.e.
clinical and/or public health reasons (consult with
medical officer(s). Example: To detect, identify, and
quantify malaria parasites in a person with suspected
malaria?
PRINCIPLE OF TEST
State briefly the technology used.
.
28. chemical reagent strip test to detect glucose in urine
based on glucose oxidase reaction (urine glucose
test).
SPECIMEN
State the specimen required and how to collect it,
including:
– volume required
– container and its preparation,
- use of any anticoagulant or stabilizer/ preservative.
29. – collection procedures (for adult and child)
with health and safety notes
– how container should be labeled
– stability of specimen and requirements for
storage and transport
– time within which the specimen should reach
the laboratory.
30. EQUIPMENT
List the items of equipment needed to perform the
test.
Main items of equipment such as a microscope,
centrifuge, colorimeter, incubator, water bath ,etc.
REAGENTS/STAINS List reagents, stains, reagent
strips, etc. needed to perform the test.
31. CONTROLS List controls that used in the test
METHOD OF TEST Describe in a numbered
sequence how to perform the test.
For quantitative tests include details of
calibration, use of graph or factor, and
calculations.
32. Describe how to control the procedure and also
the health and safety measures which apply.
REPORTING RESULTS/INTERPRETATION
:
should be reported, including
State how the test
* units to be used and format of reporting
(explain any abbreviations).
* accepted reference range for a quantitative test.
33. * action to take if a result is seriously abnormal
or unexpected, e.g. need for verification,
additional testing, and, or immediate
notification of the result.
* interpretation comments that should
accompany the test result.
34. SOURCES OF ERROR Summarize the important
and commonest causes of an incorrect test result.
Examples: Sample not well mixed, smear too thick for
staining, inaccurate measurement (pipetting) of
a blood or serum sample, clots in anti-coagulated
blood sample , air bubbles in the solution when using
a colorimeter or the sides of the cuvette not being
clean and dry, etc.
35. REFERENCES List the main source(s) of the
information contained in the SOP, e.g. book,
journal, published paper, manufacturer’s leaflet,
WHO guidelines or document, etc.
APPENDEX
36. – method of preparation and performance testing/QC
– any associated hazard, e.g. chemical that is
flammable, toxic, harmful, irritant or corrosive
What should be included in the appendices ?
APPENDIX A STAINS/REAGENTS
For each stain and reagent, the following information
is required:
– labeling specifications
– storage requirements and stability (‘shelf-life’).
37. .
– source(s) of chemicals and stains, ordering
information (correct name/chemical formula and
where possible, catalogue number), and amount
of each chemical/stain, etc. to be kept in stock.
APPENDIX B EQUIPMENT
For each item of equipment the following
information is required:
– name (including model number) and supplier.
38. – details of how to replace components such as
a lamp, fuse, etc.
– maintenance schedule. – replacement parts to be
kept in stock with part numbers and details of
supplier(s).
– trouble-shooting and action to take if the
equipment fails.
– daily QC, e.g. cleaning, performance checks
– instructions for use, including any safety
precautions.
39. APPENDIX C HEALTH AND SAFETY
This appendix should include:
– the safe handling and disposal of specimens.
– decontamination procedures, e.g. use of chemical
agents (disinfectants), autoclaving, etc.
– safe use of chemicals.
– personal safety measures.
– action to take in the event of a fire.
– First Aid procedures.
40. review and approval of SOPs:
SOP review process: is a systematic way of
evaluating, revising, and approving your SOPs on a
regular basis.
It involves checking for accuracy, clarity,
completeness, and alignment with your goals and
standards
The review process should also involve people
outside of the writing process, to ensure
41. CLSI* recommends several rounds of reviews by
different laboratory staff, focusing on different
aspects per review round. CLSI also recommends
document verification to ensure that byfollowing
the procedure the correct end result is obtained.
*CLSI :clinical and laboratory standard institute
that the SOP can be used by persons that are not
familiar with the topic.
42. This can be done, for example, by asking the
laboratory staff who were not involved in writing
and reviewing to perform the procedure exactly as
is written in the SOP .
Apart from the review process during the SOP
development, revisions are required on a regular
basis (e.g., annual or biannual review),
43. while updates may occur at any time ,when needed.
SOP is approved : by the laboratory management,
e.g., by circulating a signature page together with
the SOP or by an electronic sign-off.
SOP approval ensures that the content of the SOP
is known to the managers and that they approve
the use of the SOP by the staff.
44. SOP approval also allows coordinated and timely
implementation of the SOP on-site.
An approval procedure should be established,
specifying the individuals involved (by their
positions or functions) and the order in which
approvals are given.
45. Verbal instructions
* Advantages :
- Clarity
-effective for complex information
Disadvantage :
*
- Misunderstand
-Not heard
-difficulty in technical information
-forgotten
46. Written instructions
* Advantages :
- Clarity and understanding
- Easy to preserve
- permanent record
- Ease in verification
- Fewer chances of distortion
48. References :
District laboratory practice in tropic countries
Part 1 second edition Monica cheesbrough
Laboratory Quality Management System WHO CLSI CDC
COAST PROVINCIAL GENERAL HOSPITAL
ANTIRETROVIRAL THERAPY (ART)
PROGRAMME Standard Operating
Procedures for Laboratory Services
