الجزء الأول

Standard Operating Procedure- SOP
Name of institution
Meetings Management ID Code:

Ap 1
Topic & Purpose: Review Period:

Explains how the management of meetings is 1 year
achieved
Location: Distribution:
Version number: Annex:

V 1.0 None
Written by:
Name(s), Date(s) and Signature(s) of the Author(s)
Reviewed by:
Name(s), Date(s) and Signature(s)
Authorized by:
Name, Date and Signature
Replaces the version:

Not applicable (1st version)
Changes to the last authorized version:

Institution: Version: 1.0 Date: Number of pages: Name of ID Code: Ap 1
3 procedure:
Meetings QM chapter: 3
Management
Procedure
Meetings Management Procedure

Application ....................................................................................................... 2
Objective .......................................................................................................... 2
Definitions ........................................................................................................ 2
References....................................................................................................... 2
Responsibilities ................................................................................................ 2
Operating mode ............................................................................................... 2
Preparing for the meeting ............................................................................. 2
Conducting the meeting................................................................................ 2
Finalizing the meeting minutes ..................................................................... 3
Related documents .......................................................................................... 3
Application
This procedure applies to all official meetings of the organization to ensure
optimal communication among staff.
Objective
This procedure describes how meetings should be planned and recorded.
Definitions
To be filled in if necessary
References
Responsibilities
The Laboratory Director or the Quality Manager is responsible for scheduling
the meetings.
Operating mode
Preparing for the meeting

Any member of the staff can request a meeting to be scheduled, subject to the
approval of the Laboratory Director or the Quality Manager.
Meeting objectives and agenda, which must be defined and approved prior to
the meeting, will be posted and/or distributed to all staff.
Conducting the meeting

At the beginning of the meeting, a staff member will be designated to be the
Recorder and take minutes of the meeting.
An attendance sheet will be available at the beginning of the meeting for staff
to sign, which will provide a list of all staff who attended the meeting.
2
3 procedure:
Meetings QM chapter: 3
Management
Procedure
Finalizing the meeting minutes

The meeting minutes will be circulated for two days among staff for comments
or proposed edits. After this time, the minutes will be modified as appropriate
and the final version saved.
Related documents
List of attendants to the meetings will be filed with records Ref XXX
Minutes of the meeting will be filed with records Ref XXX
3
Name of institution
Safe Manipulation ID Code:

Ap 2

Explains the “rules" for laboratory safe 1 year
operation

V 1.0 None
Written by:
Reviewed by:
Authorized by:


5 procedure:
Safe Manipulation QM chapter: 4
Procedure
Safe Manipulation Procedure

Application ....................................................................................................... 2
Objective .......................................................................................................... 2
Definitions ........................................................................................................ 2
References....................................................................................................... 2
Operating mode ............................................................................................... 2
Application
This procedure ensures safety of laboratory staff.
Objective
This procedure summarizes laboratory safety practices that help ensure the
safe operation of the laboratory.
Definitions
References
WHO. Laboratory Biosafety Manual. Third edition. Geneva, World Health
Organization, 2004
(http://www.who.int/csr/resources/publications/biosafety/WHO_CDS_CSR_LY
O_2004_11/en/, accessed 28 August 2013).
OSHA. Occupational Safety and Health Administration (OSHA) standards for

bloodborne pathogens. Washington, Occupational Safety and Health
Administration, 2001
(https://www.osha.gov/SLTC/bloodbornepathogens/standards.html, accessed
28 August 2013).
Responsibilities
Safe laboratory practices are the responsibility of all laboratory personnel.
The Biosafety Officer supervises laboratory safety procedures.
Operating mode
Safe laboratory practices require that laboratory personnel:
 Do not work alone without prior approval.
 Develop safe work practices and avoid careless actions.
 Be alert to unsafe conditions and immediately notify the Biosafety
Officer of unsafe conditions.
 Become familiar with the laboratory’s emergency equipment (e.g.
eyewash, safety shower, and fire extinguisher).
 Follow the standard operating procedures (SOPs) for the laboratory.
 Never pipette by mouth.
2
5 procedure:
Procedure
 Perform all technical procedures in a way that minimizes the formation

of aerosols and droplets.
 Do not eat, drink, smoke, store food, or apply cosmetics in laboratory
work areas (refer to SOP Restricted Area, Signs and Labels).
 Do not lick labels or place any materials (e.g. pencils or pens) into the
mouth when in laboratory work areas.
 Keep the laboratory neat, clean and free of materials that are not
pertinent to the work (refer to SOP Laboratory Washing Benches and
Floors).
 Do not wear open-toed footwear.
 Store protective laboratory clothing (e.g. laboratory coats) in a separate
location from street clothing.
 Do not permit any animals not involved in the work of the laboratory in
or near the laboratory.
 Do not use broken or damaged glassware.
 Display the international biohazard sign (refer to SOP Restricted Area,
Signs and Labels) on the doors of rooms where Risk Group 2 or higher
risk groups microorganisms are handled.
 Decontaminate all work surfaces after any spill of potentially dangerous
material as well as at the end of the working day (refer to SOP
Laboratory Washing Benches and Floors).
 Decontaminate all used laboratory materials, specimens and cultures
prior to either disposal or cleaning for reuse.
a. Place items to be decontaminated in leak-proof, color-coded
plastic biohazard bags for autoclaving or incineration on the
premises.
b. The bags should be supported in rigid containers while being
filled.
c. If it is necessary to move the biohazard bags to another site for
decontamination, place the bags in leak-proof (i.e. solid-
bottomed) containers, which can be closed before they are
removed from the laboratory (refer to SOP Sterilization by Dry
Heat, SOP Sterilization by Wet Heat, SOP Disinfection and
Chemical Cold Sterilization, and SOP Waste Disposal).
 Always wash hands after handling animals or potentially infectious
materials and before leaving the laboratory (refer to SOP Hand
Washing).
 Wear appropriate personal protective equipment (PPE), refer to SOP
Personal Protective Clothing and Equipment.
a. Wear laboratory coveralls, gowns or uniforms for work in the
laboratory and do NOT wear these in non-laboratory areas such
as offices, libraries, staff rooms and canteens. Decontaminate
used laboratory clothing by appropriate methods (refer to SOP
Washing of Tissue, Laboratory Coat).
b. Wear safety glasses, face shields (visors) or other protective
devices when it is necessary to protect the eyes and face from
splashes and/or projectiles.
3
5 procedure:
Procedure
c. Use appropriate gloves for all procedures that may involve

accidental direct contact with blood, infectious materials or
infected animals.
i. Remove disposable gloves aseptically and autoclave
them with other laboratory wastes before disposal (refer
to SOP Waste Disposal).
ii. Wash reusable gloves prior to and after removal from the
hands; after removal these gloves must be cleaned and
disinfected before reuse.
iii. Wash hands after laboratory glove removal (refer to SOP
Hand Washing).
 Limit the use of hypodermic needles and syringes to primarily
parenteral injection and aspiration of fluids from laboratory animals.
a. Avoid using hypodermic needles and syringes to extract fluid
from diaphragm bottles (opening devices are available, which
permit the use of pipettes).
b. Do not use hypodermic needles and syringes as substitutes for
pipetting devices in the manipulation of infectious fluids.
c. Use cannulas instead of needles whenever possible.
 Immediately report all spills, accidents and overt or potential exposures
to infectious materials to the laboratory supervisor and maintain a
written record of such accidents and incidents (refer to SOP
Occurrence Report).
 Inform the Biosafety Officer of any biosafety problem or concern.
The laboratory Biosafety Officer should ensure that:

 Sufficient training in laboratory safety is provided; for example,
personnel should be advised of special hazards and required to read,
understand and follow standard practices and procedures (refer to SOP
Biosafety Management).
 Only those persons who have been advised of the potential hazards
and who meet specific entry requirements (e.g. immunization) are
allowed to enter the laboratory working areas (refer to SOP Vaccination
for Laboratory Staff and SOP Restricted Area, Signs and Labels).
a. Restrict laboratory and animal areas access to authorized
personnel.
b. Keep laboratory doors closed when work is in progress.
c. Exclude children from laboratory working areas.
 An appropriate medical evaluation, surveillance and treatment program
is available to laboratory personnel (refer to SOP Medical Surveillance
of Personnel Exposed to Biohazards).
a. Baseline serum samples may be collected from laboratory staff
and other persons at risk. These should be stored as
appropriate.
b. Additional specimens should be collected periodically depending
on the organisms handled and the function of the laboratory.
4
5 procedure:
Procedure
 SOP Minor Occurrence or SOP Major Occurrence is referenced for any

reported biosafety problem and then, if needed, the problem is reported
to the Biosafety Committee to find a solution.
Related documents
SOP Biosafety Management Ref XXX
SOP Disinfection and Chemical Cold Sterilization Ref XXX
SOP Hand Washing Ref XXX
SOP Laboratory Washing Benches and Floors Ref XXX
SOP Major Occurrence Ref XXX
SOP Medical Surveillance of Personnel Exposed to Biohazards Ref XXX
SOP Minor Occurrence Ref XXX
SOP Occurrence Report Ref XXX
SOP Personal Protective Clothing and Equipment Ref XXX
SOP Restricted Area, Signs and Labels Ref XXX
SOP Sterilization by Dry Heat Ref XXX
SOP Sterilization by Wet Heat Ref XXX
SOP Vaccination for Laboratory Staff Ref XXX
SOP Washing of Tissue, Laboratory Coat Ref XXX
SOP Waste Disposal Ref XXX
5
Process- PR
Name of institution
Equipment Installation ID Code:

Ap 3

Describes the equipment installation process 1 year
in the laboratory

V 1.0 None
Written by:
Reviewed by:
Authorized by:


Institution: Version: 1.0 Date: Number of pages: Name of process: ID Code: Ap 3
2 Equipment
Installation QM chapter: 5
Process
Equipment Installation Process
2
Process- PR
Name of institution
Equipment Repair ID Code:

Ap 4

Describes the equipment repair process in 1 year
the laboratory

V 1.0 None
Written by:
Reviewed by:
Authorized by:


Institution: Version: 1.0 Date: Number of pages: Name of process: ID Code: Ap 4
2 Equipment Repair
Process QM chapter: 5
Equipment Repair Process
2
Name of institution
Decontamination of Laboratory Equipment ID Code:

Ap 5

Explains how to decontaminate equipment in 1 year
the laboratory

V 1.0 1. Checklist for “OK to Service”
Certification of Equipment Containing
Hazardous Chemicals and Biological
Agents
2. Certification tag
Written by:
Reviewed by:
Authorized by:


8 procedure:
Decontamination QM chapter: 5
of Laboratory
Equipment
Procedure
Decontamination of Laboratory Equipment Procedure

Application ....................................................................................................... 2
Objective .......................................................................................................... 2
Definitions ........................................................................................................ 2
References....................................................................................................... 2
Operating mode ............................................................................................... 2
Material removal ........................................................................................... 3
Radiological residues ................................................................................ 3
Chemical residues .................................................................................... 3
Bio-hazardous contaminants .................................................................... 3
Certification and labelling ............................................................................. 4
Equipment service ........................................................................................ 4
Biosafety consideration ................................................................................ 4
Annex 1 ............................................................................................................ 6
Annex 2 ............................................................................................................ 8
Application
This procedure ensures decontamination of laboratory equipment.
Objective
This procedure explains the measures to be followed to safely and properly
decontaminate laboratory equipment prior to service or repair by Facilities
Operations or commercial service vendors. Adherence to this procedure will
ensure that service employees are not needlessly exposed to potentially
hazardous materials and that no materials are inappropriately released to the
environment.
Definitions
References
Responsibilities
To be defined
Operating mode
Any unusual problems must be referred to the Biosafety Officer, who will
assist in managing unusual or special problems, and will authorize any
necessary deviations from this procedure.
The Biosafety Officer will not authorize equipment repair or other service until
the equipment has been cleared as outlined in this procedure.
22
8 procedure:
of Laboratory
Equipment
Procedure
A copy of this procedure will be provided to commercial service vendors and

Facilities Operations staff prior to any service or repair of equipment.
Staff and students will follow this procedure, and will refer any problems or
questions to their supervisor.
Material removal
Before servicing or repair of equipment, laboratory personnel will completely
remove all hazardous chemical, radiological, or bio-hazardous materials from
the equipment, then either store or dispose the materials, as appropriate.
In some instances, it may be appropriate to decontaminate only part of the

equipment, in consideration of the nature of the service to be performed and
the equipment surfaces with which workers are expected to come into contact.
In this case, materials may remain within the equipment if there will be no
direct contact with the materials in the course of servicing the equipment.
It is strongly recommended that service workers and laboratory personnel

discuss in advance the proposed service in order to mutually determine the
required level of decontamination.
Radiological residues
If radiological substances are used in the laboratory, potential radiological
residues should be addressed.
Chemical residues
Chemical residues will be removed, neutralized, or otherwise rendered non-
hazardous using an appropriate method determined by the chemical and
physical characteristics of the contaminant(s), and the physical nature of the
equipment (refer to SOP Use of Hazardous Chemicals or Physical Hazards).
Hazard labels shall be removed, defaced, or temporarily covered as

appropriate.
The decontamination method shall be documented, and records shall be

available for inspection by the Biosafety Officer.
Any incidental wastes shall be disposed of properly according to the SOP

Waste Disposal.
Bio-hazardous contaminants
Bio-hazardous contaminants shall be removed or rendered nonpathological.
This will typically be accomplished using a bleach solution or other chemical
means (refer to SOP Disinfection and Chemical Cold Sterilization) or by steam
sterilization (refer to SOP Sterilization by Wet Heat).
33
8 procedure:
of Laboratory
Equipment
Procedure
Hazard labels shall be removed, defaced or temporarily covered as

appropriate. The decontamination method shall be documented and records
made available for inspection by the Biosafety Officer.
Any incidental wastes shall be disposed of properly according to SOP Waste

Disposal.
The “Checklist for ‘OK to Service’ Certification of Equipment Containing

Hazardous Chemicals and Biological Agents” (Annex 1) shall be implemented.
If decontamination cannot be achieved, it may be appropriate instead to cover

the contaminated surfaces with impermeable materials such as polyethylene
sheets. Any contamination, which has been temporarily covered over, must be
clearly labelled and explained to service personnel before work begins. After
servicing is completed, the covering material shall be disposed of as
appropriate for the contaminant hazard.
No decontamination is required for equipment within laboratories that has no

potential for contamination, such as computers, office equipment, audio-visual
equipment, cameras, optical equipment, refrigerators, etc.
Certification and labelling

Once material removal and decontamination have been completed, the
Biosafety Officer (or other authorized individual as designated in writing) shall
affix an “OK to Service” certification tag to the equipment (see Annex 2). All
sections of the tag shall be completed with the relevant information or “NA”
(non applicable) as appropriate. A copy of the tag will be retained, and shall
be available for inspection. The original should be kept for the laboratory’s
records and a second copy should be sent to the Biosafety Committee.
For equipment with no potential for contamination, the “No Potential for
Contamination” box shall be checked on the “OK to Service” tag. In addition,
the name and date section should be completed, while the other sections may
be left blank.
Equipment service
Once the “OK to Service” tag has been affixed to the equipment, it may be
serviced. Facilities Operations will not service any equipment that has not
been tagged. Laboratory personnel should be readily available to answer
questions, and should explain any special considerations to service
personnel.
Biosafety consideration
If a biosafety problem occurs, laboratory personnel will inform the Biosafety
Officer, who will refer to SOP Minor Occurrence or SOP Major Occurrence
44
8 procedure:
of Laboratory
Equipment
Procedure
and SOP Occurrence Report, and then, if needed, report the problem to the
Biosafety Committee and find a solution. This will be recorded in the
corresponding logbook XXX.
Related documents
SOP Disinfection and Chemical Cold Sterilization Ref XXX
SOP Sterilization by Wet Heat Ref XXX
SOP Use of Hazardous Chemicals or Physical Hazards Ref XXX
SOP Waste Disposal Ref XXX
55
8 procedure:
of Laboratory
Equipment
Procedure
Annex 1
Checklist for “OK to Service” Certification of Equipment Containing
Hazardous Chemicals and Biological Agents
All laboratory equipment to be serviced must be decontaminated prior to

servicing. Please implement the checklist below to ensure the equipment is
“OK to Service” safely.
Plan enough time to perform all necessary decontamination procedures.
a) Specify the service requested on the Equipment “OK to Service”

Certification Form.
b) Determine what area of the equipment needs to be accessed for servicing

and which area(s) are restricted due to potential chemical, biological, or
radiological contamination.
c) If the service area(s) contain(s) hazardous chemicals or biological

materials, determine what can be disposed of (check for items that might have
significant chemical degradation).
Process disposal paperwork and have wastes removed. Follow SOP Waste
Disposal for biohazardous material.
Remove and properly store any containers of hazardous materials that are to
be saved.
d) Decontaminate all area surfaces that the equipment repair worker may
contact with appropriate chemical or physical methods that are known to
remove, neutralize, or otherwise render non-hazardous to human health or the
environment any hazardous chemicals (chemical residues, stains, deposits,
etc.). Refer to SOP Use of Hazardous Chemicals or Physical Hazards.
e) Decontaminate all area surfaces that the equipment repair worker may
contact with appropriate solutions that are known to kill the organisms that
may be present as well as inactivate any hazardous substances of biological
origin. Refer to SOP Disinfection and Chemical Cold Sterilization.
f) If decontaminating agents may leave a corrosive or otherwise harmful

residue, the surfaces must be rinsed clean of hazardous deposits.
g) Before certifying the equipment as “OK to Service”, do a thorough survey of

the area(s) (internal and external surfaces, void spaces, etc.) to verify proper
decontamination was performed.
66
8 procedure:
of Laboratory
Equipment
Procedure
h) Fill in the Equipment "OK to Service" Certification tag (see Annex 2).
SPECIFY ON THE TAG THE DURATION FOR WHICH THE
CERTIFICATION WILL REMAIN IN EFFECT (start and finish dates).
i) Affix the Equipment “OK to Service” Certification tag, with area(s) that are
“OK to Service” clearly stated, to the exterior of the equipment in a prominent
location. This will certify that the equipment poses no hazard to human health
or the environment.
77
8 procedure:
of Laboratory
Equipment
Procedure
Annex 2
Equipment "OK to Service" Certification
Service requested: ______________________________________________
Dates certification is in effect: ____________ to ___________
[ ] This equipment has no potential for chemical, radiological, or bio-hazardous

contamination because it has never been used for or in contact with such
materials and is therefore "OK to Service" for unrestricted use.
[ ] This equipment has been decontaminated in accordance with the "OK to

Service" Checklist and is safe to service with the following restrictions or
special conditions:
______________________________________________________________
______________________________________________________________
______________________________________________________________
[ ] This equipment has been decontaminated in accordance with the "OK to

Service" Checklist and is safe to service.
Item’s Description: Make / Model / Serial Number

______________________________________
Identification Number
_______________________________________
Item's Current Location: Room / Building / Department

_______________________________________
Item Responsible Person Name: ____________________________________

Phone: ____________________________________
Certification Statement
I certify that the above named equipment is free to the limits specified above
of any hazardous chemical, biological and radioactive materials and I attest
that this equipment does not pose a hazard to human health or the
environment to the limits specified above.
Certified By:
_________________________ _______________________ ____________

Print name Signature Date
88
Name of institution
Equipment Decommission ID Code:

Ap 6

Explains how to dispose of equipment in the 1 year
laboratory

V 1.0 1. Laboratory Equipment Disposal Form
Written by:
Reviewed by:
Authorized by:


5 procedure:
Equipment QM chapter: 5
Decommission
Procedure
Equipment Decommission Procedure

Application ....................................................................................................... 2
Objective .......................................................................................................... 2
Definitions ........................................................................................................ 2
References....................................................................................................... 2
Operating mode ............................................................................................... 2
Annex 1 ............................................................................................................ 4
Application
This procedure ensures proper decommission of equipment.
Objective
Laboratory equipment may be contaminated with dangerous materials that
can become a safety hazard for anyone handling or using the equipment.
This procedure explains how to safely decommission equipment. Items of
concern include, but are not limited to: refrigerators, freezers, incubators,
storage cabinets, glassware, water baths, shakers, and analytical instruments.
Definitions
References
Responsibilities
To be defined
Operating mode
1. Laboratory equipment to be disposed must first be decontaminated and
cleaned as indicated in SOP Decontamination of Laboratory Equipment.
2. The Laboratory Equipment Disposal Form (Annex 1) must be filled in, and
then reviewed by XXX (equivalent to Environmental Health and Safety
Committee).
3. Laboratory employees are prohibited from:

 discarding laboratory equipment or appliances in the trash without prior
approval of XXX;
 abandoning equipment or appliances on docks, in storage areas, in
exterior spaces, or any other areas where the equipment would create
a hazard or nuisance.
Note: Material is considered abandoned if it is no longer suitable for its

intended purpose, poses an immediate hazard, or is not expected to be used
2
5 procedure:
Decommission
Procedure
within a reasonable amount of time. The Biosafety Officer (or other authorized
individual as designated in writing) will remove abandoned materials.
4. If a biosafety problem occurs, laboratory personnel will inform the Biosafety

Related documents
SOP Decontamination of Laboratory Equipment Ref XXX, provided in this QM
template as Ap 5
3
5 procedure:
Decommission
Procedure
Annex 1
Laboratory Equipment Disposal Form
Mail, Fax or Email form to: XXX (equivalent to Environmental Health and Safety
Committee)
Attn: XXX Date: _______________

Email: XXX
Phone: XXX Fax: XXX
Equipment to be disposed (Item Description):

_____________________________________
Item Location (Room / Building):
_____________________________________
Releasing Department:
_____________________________________
Item Responsible Person Name: ____________________________________
Phone: ____________________________________
Location: ___________________________________
1) Identification of risks (check where applicable)
[ ] Equipment has never been used with or contained radioactive materials,

chemicals (especially perchloric acid), or biological agents.
Note: Equipment must still be cleaned with detergent. Date cleaned: _____________
Equipment has been in contact with (please check where applicable):

[ ] Electrical Equipment (X-ray units, transformers, or other items containing oil, capacitors,
ballasts, etc.)
Comments / List: _____________________________________________________
[ ] Chemicals (list high risk chemicals, perchlorates)
Comments / List: _____________________________________________________
[ ] Biological Agents
Comments / List: _____________________________________________________
[ ] Radioactive Materials (list radioisotopes)
Comments / List: _____________________________________________________
Inspected by: XXX (equivalent to Radiation Safety Committee):
Signature: ___________________________________ Date: __________________
2) Verification of cleaning
[ ] Appropriate cleaning procedure(s) used

List procedure used:
_________________________________________________________
4
5 procedure:
Decommission
Procedure
Cleaning performed by (print name): _______________________________

Date: __________________ Phone: ________________________
3) Validation
[ ] No known hazard now exists

Name/Signature of Dept. Rep.: ____________________________Date: __________
Review (by equivalent to Environmental Health and Safety Committee)
Name (print name): ______________________________Phone: _______________

Comments: __________________________________________________________
_________________________________________________________
[ ] Item approved for disposal
Signature: ___________________________________ Date: __________________
5
Name of institution
General Sampling Conditions ID Code:

Ap 7

Explains optimal conditions for sampling 1 year

V 1.0 None
Written by:
Reviewed by:
Authorized by:


5 procedure:
General Sampling QM chapter: 7
Conditions
Procedure
General Sampling Conditions Procedure

Application ....................................................................................................... 2
Objective .......................................................................................................... 2
Definitions ........................................................................................................ 2
References....................................................................................................... 2
Operating mode ............................................................................................... 2
Methodology ................................................................................................. 2
Conditions relating to the patient .................................................................. 2
Special conditions relating to certain tests.................................................... 3
Conditions relating to the specimen collector ............................................... 3
Potential adverse outcomes relating to the patient’s condition ..................... 4
Potential adverse outcomes relating to the specimen collector .................... 4
Application
This procedure ensures optimal conditions for specimen collection.
Objective
This operating mode explains the conditions that the patient and the specimen
collector must fulfil to ensure smooth operation and good quality sample.
Definitions
References
Responsibilities
To be defined
Operating mode
Methodology
To obtain a good sample:
 The collector must be qualified and aware of his/her role.
 The patient must be rested and sometimes be fasting or on a specific
diet.
Conditions relating to the patient

1. The patient must be:
 situated in a suitable room that is quiet, aired and clean;
 seated in a chair with arm rests that is accessible from both sides and
will recline to allow the patient to lie in a prone position, if necessary; or
lying in a hospital bed;
 in comfortable clothes with no tightness round the collar, arms or waist.
2
5 procedure:
Conditions
Procedure
2. The patient should not be stressed before or during the sampling

procedure.
Special conditions relating to certain tests

1. The patient must be rested before certain tests are taken. For example (to
be checked in the Laboratory Clinical Manual):
 for prolactine, ACTH, growth hormone measurements (at least 20
minutes rest);
 for renin or angiotensin measurements (1hour’s rest lying down).
2. The patient may need to be fasting or have followed a diet prior to sample
collection. For example (to be checked in the Laboratory Clinical Manual):
 for studying the dynamic metabolism of glucides, lipids and
phospholipids: strictly fasting, i.e. having not consumed either liquids
or solids for 12 hours;
 for haemostasis: not have consumed any fatty substances for 12
hours, not have smoked for 1 hour and (for women) not be
menstruating;
 for determining postprandial glycaemia (using the test associated with
glycaemia when fasting): have had a meal 1h30 before;
 for other examinations: partial fasting with recommendation to drink
water to avoid risks of haemo-concentration due to dehydration, which
may cause result interpretation errors.
3. The patient must have taken physical exercise:

 for urine sampling to test for urinary schistosomiasis.
Conditions relating to the specimen collector

1. The collector must be qualified, specifically:
 have a certificate of capacity to carry out blood sampling
 have been trained in the prevention of biological risks
 know how to take a sample for the prescribed test.
2. The collector must be aware of the impression he/she gives and:

 have a correct presentation: tunic should be buttoned and clean,
hands and nails clean and cared for, hair clean and, if necessary,
restrained;
 properly wash his/her hands before taking each sample;
 show a professional attitude: calm and reassuring, but reserved.
3. The collector should be aware of his/her job requirements:

 he/she should be organised, quick and efficient;
 permanent equipment (tourniquets, tube holders, chair) must be
decontaminated after each patient;
3
5 procedure:
Conditions
Procedure
 equipment must be prepared before the beginning of each sample

collection, because once begun, collection cannot be interrupted
except in the event of the patient’s indisposition.
4. The collector must be aware of the patient’s perception of the collector’s

role. For example, the patient may perceive a benign, but invasive gesture,
with concern and this can cause uneasiness.
5. Other steps that the collector must perform include:

 verifying the patient‘s identity and that of the prescribing doctor;
 checking the patient’s fasting state (if needed);
 inquiring which (if any) potentially interfering medications have been
taken by the patient because of their possible interference with the
results of the prescribed test: for example, acetylsalicylic acid may
interfere with bleeding time tests and insulin may interfere with
glycaemia tests;
 appropriately labelling the receptacles to contain the biological
specimens in the presence of the patient (SOP Sample Labelling).
Potential adverse outcomes relating to the patient’s condition

1. Clothing that is too tight can act like a tourniquet and cause an
indisposition in the patient.
2. Physical exercise by the patient can lead to a change in the serum

concentration of certain compositions by displacing liquids between
compartments, loss of sweat and hormonal synthesis (e.g. increasing
catecholamines, ACTH, cortisol, glucagon, hGH and reduction of insulin).
3. Patient stress during the specimen collection procedure increases:

 the probability of the patient fainting through vasovagal reaction;
 plasma concentration of hormones, proteins, lactate, cholesterol and
leucocytes.
4. Certain drinks or foods can alter the result of some tests:

 caffeine increases glycogenolysis, modifies the acid-base balance and
the calcium metabolism;
 saccharine modifies glycaemia and insulin counts;
 fats modify the result of lipid doses, cellular counts and perturb any
spectrophotometer doses.
Potential adverse outcomes relating to the specimen collector

1. If the collector does not respect the basic rules of hygiene (e.g. properly
washing hands before and after taking the specimen), he/she becomes a
source of potential infection for patients, for him/herself and for all his/her
colleagues.
4
5 procedure:
Conditions
Procedure
2. If the collector does not properly identify the patient and label the specimen
receptacles, the samples will be rejected. This will result in either the test not
being performed or the patient having to undergo another collection
procedure.
If any occurrence happens, laboratory personnel will inform the Biosafety

Related documents
Laboratory Clinical Manual
SOP Sample Labelling Ref XXX, provided in this QM template as Ap 8
5
Name of institution
Sample Labelling ID Code:

Ap 8

Explains how to label samples arriving in the 1 year
laboratory

V 1.0 1. Test Request Form
Written by:
Reviewed by:
Authorized by:


4 procedure:
Sample Labelling QM chapter: 7
Procedure
Sample Labelling Procedure

Application .................................................................................................................... 2
Objective ....................................................................................................................... 2
Definitions ..................................................................................................................... 2
References.................................................................................................................... 2
Responsibilities ............................................................................................................. 2
Operating Mode ............................................................................................................ 2
Methodology .............................................................................................................. 2
Problems and solutions ............................................................................................. 3
Related documents ....................................................................................................... 3
Annex 1 ......................................................................................................................... 4
Application
Sampling
Objective
This operating procedure explains how to label a sample correctly before it is sent to
the laboratory for testing.
Definitions
References
Responsibilities
To be defined
Operating Mode
Methodology
1. Obtain labelling information and verify this information as correct with the patient
before collecting the patient’s specimen:
 Verify the patient’s identity in a positive manner: this means the collector should
ask the patient for his/her correct name and date of birth, and NOT ask the
patient “Are you Mr. X, born the XX/XX /XX?”
For women, also identify the patient’s maiden name, if applicable.
 Compare the information supplied by the patient with:
o information indicated on the prescription (Test Request Form, Annex 1),
o hospital records (if the patient is admitted to the hospital) or with the
social security card or other legal identification (if the patient is not
admitted).
 If there is concordance of the patient identifying information, the collector can
proceed to specimen collection.
2. Before starting specimen collection, in the presence of the patient, label all
specimen containers with indelible ink with the following information:
2
4 procedure:
Sample Labelling QM chapter: 7
Procedure
 Patient’s first and last names (including maiden name if applicable);

 Personalized identification number (e.g. social security or hospital accession
number);
 Date of birth;
 Sex;
 Date and hour of specimen collection;
 Type of specimen;
 Specimen collector’s name.
3. The specimens will be accepted if they meet the acceptability criteria established
and detailed in the SOP Sample Rejection or Acceptance.
Problems and solutions

1. If the hospitalized patient has no identity number: ask the patient's nurse or
responsible party to confirm the patient’s identity. Never trust the information found at
the end of the bed. Resolve any discordance before proceeding to specimen
collection.
2. If the patient cannot give his/her name: ask the person accompanying the patient.
Resolve any discordance before proceeding to specimen collection.
3. If the patient’s information does not correspond to information written down on the
Test Request Form: communicate with the person accompanying the patient and
resolve any discordance before proceeding to specimen collection.
Related documents
SOP Sample Rejection or Acceptance Ref XXX, provided in this QM template as Ap 9
3
Institution: Version: 1.0 Date: Number of pages: Name of Reference: Ap 8
4 procedure:
Sample Labelling QM Chapter: 7
Procedure
Annex 1
Test Request Form
Patient information
Last name: __________________________ First name: ____________________
(maiden name, if applicable): _______________
Sex (circle one): M F Date of birth: ______________
Identification number: ____________
Address: ______________________ City: ____________________
Zip code: ____________
Collection information
Specimen type: ________________
Date of prescription (request): ____________________

Date of specimen collection: __________________ Hour: ________________
Name of specimen collector: __________________________
Date sample sent to the laboratory: ________________ Hour: ________________
Clinical details: _______________________________________
Tests requested
_______________________________________
Prescriber's name: _______________________________

Address: _______________________________________
Telephone: ________________ Fax: ________________
For the reception of sample at the laboratory

Date sample received at the laboratory: _______________ Hour: ____________
Name of the person receiving the sample: ______________________________
Acceptable sample (circle one): Yes No

An acceptable sample indicates that for the requested tests the following criteria are met:
 specimen was collected by appropriate means in the correct container
 adequate volume
 absence of leaks
 no obvious deterioration
 sample was received by the laboratory:
o within an appropriate time frame after collection
o under appropriate temperature conditions (e.g. on ice).
Comments: __________________________________________________________
4
Name of institution
Sample Rejection or Acceptance ID Code:

Ap 9

Explains when to accept or reject a sample 1 year

V 1.0 None
Written by:
Reviewed by:
Authorized by:


5 procedure:
Sample Rejection QM chapter: 7
or Acceptance
Procedure
Sample Rejection or Acceptance Procedure

Application ....................................................................................................... 2
Objective .......................................................................................................... 2
Definitions ........................................................................................................ 2
References....................................................................................................... 2
Operating mode ............................................................................................... 2
Initial tasks upon receipt of patient sample ................................................... 2
Test request or order form required information ........................................... 3
Examples of sample rejection criteria ........................................................... 3
1. Unlabelled or mislabelled samples........................................................ 3
2. Duplicate samples................................................................................. 3
3. Leaky containers ................................................................................... 3
4. Contaminated samples ......................................................................... 4
5. Inappropriate sample sources ............................................................... 4
6. Delayed transport time and sample processing .................................... 4
Actions for when samples are rejected ......................................................... 4
Application
This ensures the proper receipt and processing of patient samples.
Objective
This procedure explains the criteria for whether to reject or accept a sample.
Definitions
References
Responsibilities
The Quality Manager is responsible for developing sample rejection and
acceptance criteria policies, which are then authorized by the Laboratory
Director.
Laboratory staff is responsible for adhering to sample rejection and
acceptance policies.
Operating mode
Initial tasks upon receipt of patient sample

 Document the date and time the sample was received.
 Assign an accession number to be used as sample identification in the
laboratory.
 Verify that the patient identification on the laboratory test request form
matches the identification on the sample.
2
5 procedure:
or Acceptance
Procedure
 Examine the sample visually to evaluate for acceptability.

 Review and evaluate the test request for suitability of the type of
sample collected for the test.
 Determine the suitability, with respect to the test(s) ordered, of the
transport conditions, including the following:
o Transport medium or preservative for the sample
o Temperature of sample upon receipt
o Length of time between sample collection and receipt
o Transport container intact, i.e. no leaks or cracks.
Note: A reception room is ONLY for administrative tasks. Samples cannot be

opened in the reception room.
Test request or order form required information

The test request form must include the following:
 Complete patient identification;
 Complete and specific description of sample type;
 Date and, where relevant, time of collection;
 Tests requested;
 Putative diagnosis or description of clinical investigation;
 Name and contact information (e.g. telephone number and address) of
requesting physician or other medical provider.
Examples of sample rejection criteria

1. Unlabelled or mislabelled samples
Refer to SOP Sample Labelling.
2. Duplicate samples
Most duplicate samples received on the same day are unacceptable and
should not be processed. Exceptions include blood culture samples, cerebral
spinal fluid (CSF), tissue, and sterile body fluids (excluding urine).
 If it has been verified by the person collecting the sample that two
samples received at the same time are identical, for the purpose of
testing, these samples may be combined and processed as one.
 If duplicate samples are received at different times on the same day,
notify the patient’s physician or nurse, and document. If it is acceptable
not to process the sample, report “Duplicate sample: test not
performed”, and note the reference number of the sample that was
processed.
3. Leaky containers
 A sample is unacceptable when the outside of the container is grossly
contaminated with the sample. In this case, request a new sample.
 If the container is leaking, analyze the sample only if the sample is not
compromised and if the leakage will not contaminate any laboratory
equipment during the testing process.
3
5 procedure:
or Acceptance
Procedure
4. Contaminated samples
 Contaminated samples are unacceptable. Types of contamination
include when another type of sample is mixed with the desired sample.
For example, a urine sample should not contain stool, and vice versa.
 In the case of a contaminated sample, request a new sample.
5. Inappropriate sample sources

Samples that do not conform to the type of sample needed for the requested
test(s) are unacceptable.
 For example:
o Do not process saliva in place of sputum.
o 24–hour urine samples are unacceptable for routine bacterial
cultures.
o The type of anti-coagulant for a blood sample (or the absence of
an anti-coagulant) must be appropriate for the type of blood test.
 If an incorrect or inappropriate sample type is received, request a new
sample and specify the proper sample for the test requested.
6. Delayed transport time and sample processing

 Ideally, all samples should be less than 2 hours old when received.
 Appropriate transport media and detailed instructions should be
available for samples transported to laboratories (refer to SOP Sample
Transport).
 If the time between sample collection and receipt is too long for a valid
test to be performed, with respect to sample requirements for the
requested test(s), request a new sample.
 If a sample was received after prolonged delay but is not rejected by
the laboratory, document it and indicate the length of time after
collection that the sample was received.
Actions for when samples are rejected

 If the unacceptable sample can be replaced, notify the requesting
healthcare provider.
 Document the reason for the sample unacceptability and request
another sample.
 Do not discard the sample until the patient’s healthcare provider has
confirmed that another can be collected.
 If the patient has already been started on antimicrobial therapy or if a
repeat sample cannot be collected, this must be documented.
 If a repeat sample is not available, document the problem and proceed
with the test if possible.
Related documents
SOP Sample Labelling Ref XXX, provided in this QM template as Ap 8
SOP Sample Transport Ref XXX, provided in this QM template as Ap 10

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Standard Operating Procedure- SOP

Meetings Management ID Code:

Topic & Purpose: Review Period:

Version number: Annex:

Name(s), Date(s) and Signature(s) of the Author(s)

Name(s), Date(s) and Signature(s)

Name, Date and Signature

Replaces the version:

Changes to the last authorized version:

Meetings Management Procedure

Preparing for the meeting

Conducting the meeting

Finalizing the meeting minutes

Safe Manipulation ID Code:

Topic & Purpose: Review Period:

Version number: Annex:

Name(s), Date(s) and Signature(s) of the Author(s)

Name(s), Date(s) and Signature(s)

Name, Date and Signature

Replaces the version:

Changes to the last authorized version:

Safe Manipulation Procedure

OSHA. Occupational Safety and Health Administration (OSHA) standards for

The Biosafety Officer supervises laboratory safety procedures.

 Perform all technical procedures in a way that minimizes the formation

c. Use appropriate gloves for all procedures that may involve

The laboratory Biosafety Officer should ensure that:

 SOP Minor Occurrence or SOP Major Occurrence is referenced for any

Equipment Installation ID Code:

Topic & Purpose: Review Period:

Version number: Annex:

Name(s), Date(s) and Signature(s) of the Author(s)

Name(s), Date(s) and Signature(s)

Name, Date and Signature

Replaces the version:

Changes to the last authorized version:

Equipment Installation Process

Equipment Repair ID Code:

Topic & Purpose: Review Period:

Version number: Annex:

Name(s), Date(s) and Signature(s) of the Author(s)

Name(s), Date(s) and Signature(s)

Name, Date and Signature

Replaces the version:

Changes to the last authorized version:

Equipment Repair Process

Decontamination of Laboratory Equipment ID Code:

Topic & Purpose: Review Period:

Version number: Annex:

Name(s), Date(s) and Signature(s) of the Author(s)

Name(s), Date(s) and Signature(s)

Name, Date and Signature

Replaces the version:

Changes to the last authorized version:

Decontamination of Laboratory Equipment Procedure

A copy of this procedure will be provided to commercial service vendors and

In some instances, it may be appropriate to decontaminate only part of the

It is strongly recommended that service workers and laboratory personnel

Hazard labels shall be removed, defaced, or temporarily covered as

The decontamination method shall be documented, and records shall be

Any incidental wastes shall be disposed of properly according to the SOP

Hazard labels shall be removed, defaced or temporarily covered as

Any incidental wastes shall be disposed of properly according to SOP Waste

The “Checklist for ‘OK to Service’ Certification of Equipment Containing

Dates certification is in effect: __ to _

_____________ _ __

Name (print name): ________________Phone: _

Signature: _________________ Date: