Laboratory Biosafety and Biosecurity Current Situation in Lebanon
Laboratory Biosafety and Biosecurity Current Situation in Lebanon Laboratory Biosafety and Biosecurity Current Situation in Lebanon
Laboratory Biosafety and Biosecurity Current Situation in Lebanon By Zuhayr Tabbarah, MD MENA Biosecurity Workshop Alexandria, Egypt-February 23-24,2009 24,2009
- Page 3 and 4: Safety and Technical Standards for
- Page 5 and 6: Safety and Technical Standards for
- Page 7 and 8: Health and safety of staff Licensin
- Page 9 and 10: Required Equipments for Licensing M
- Page 11 and 12: Clinical Laboratory American Univer
- Page 13 and 14: Rafik Hariri University Hospital (R
- Page 15 and 16: Checklist according to BSL 1 Standa
- Page 17 and 18: Checklist according to BSL 2 Standa
- Page 19 and 20: Checklist according to BSL 3 Standa
- Page 21 and 22: Gap analysis according to Biosecuri
- Page 23 and 24: Gap analysis according to Biosecuri
<strong>Laboratory</strong> <strong>Biosafety</strong> <strong>and</strong> <strong>Biosecurity</strong><br />
<strong>Current</strong> <strong>Situation</strong> <strong>in</strong> <strong>Lebanon</strong><br />
By<br />
Zuhayr Tabbarah, MD<br />
MENA <strong>Biosecurity</strong> Workshop<br />
Alex<strong>and</strong>ria, Egypt-February 23-24,2009<br />
24,2009
Safety <strong>and</strong> Technical St<strong>and</strong>ards for Licens<strong>in</strong>g a<br />
Medical laboratory<br />
Lebanese M<strong>in</strong>istry of Public Health<br />
• Work areas is 7.5 m² m per worker<br />
• Average area ≥100 m² m<br />
• Sections <strong>and</strong> services:<br />
- Biochemistry<br />
- Serology<br />
- Hematology<br />
• Sections must be distributed <strong>in</strong> a separate or connected<br />
pattern where the average area is not less than 60 m 2<br />
• Work benches ≥ 30 m<br />
-Distance between benches is ≥ 3 m<br />
-Height not exceed<strong>in</strong>g 78 cm sitt<strong>in</strong>g <strong>and</strong> 90 cm<br />
st<strong>and</strong><strong>in</strong>g
Safety <strong>and</strong> Technical St<strong>and</strong>ards for Licens<strong>in</strong>g a<br />
Medical laboratory<br />
Lebanese M<strong>in</strong>istry of Public Health<br />
• Work benches: resistant to bacteria, acids, <strong>and</strong> alkali, with a<br />
width ≥ 70 cm <strong>and</strong> adequate illum<strong>in</strong>ations<br />
• Two UPS sockets must be available for every 2 meters <strong>and</strong><br />
two water outlets, one hot <strong>and</strong> one cold <strong>and</strong> one natural gas<br />
outlet for every section of the<br />
• Walls <strong>and</strong> ceil<strong>in</strong>g: coated with washable <strong>and</strong> humidity<br />
resistant<br />
• Floors: : Acids, salts, alkali <strong>and</strong> slippery resistant..<br />
• Heat<strong>in</strong>g <strong>and</strong> ventilation: adequate ventilation must be<br />
available at least 12 changes of air per hour .Work<strong>in</strong>g<br />
temperature must be between 22 <strong>and</strong> 24 degree Celsius.
Safety <strong>and</strong> Technical St<strong>and</strong>ards for Licens<strong>in</strong>g a<br />
Medical laboratory<br />
Lebanese M<strong>in</strong>istry of Public Health<br />
• Electrical network: : Outlets earthed/grounded. Sufficient<br />
number of outlets<br />
• Dra<strong>in</strong>age: resistant to acids with chemical treatment<br />
<strong>in</strong>struments.<br />
• Distance between the ceil<strong>in</strong>g <strong>and</strong> the floor ≥ 2.8 m<br />
• Width of the external doors ≥ 1.2 <strong>and</strong> the <strong>in</strong>ternal doors ≥<br />
90 cm<br />
• Easily accessible by h<strong>and</strong>icapped<br />
• UPS system enough for all equipment emergency lightn<strong>in</strong>g<br />
stations<br />
• Gas l<strong>in</strong>es with<strong>in</strong> work benches <strong>and</strong> the cyl<strong>in</strong>ders are<br />
secured<br />
• Lighten<strong>in</strong>g: the general illum<strong>in</strong>ation must be<br />
(800-1000 LUX) <strong>in</strong> work areas
Health <strong>and</strong> Safety of Staff<br />
Licens<strong>in</strong>g Medical <strong>Laboratory</strong><br />
Lebanese M<strong>in</strong>istry of Public Health<br />
• Appropriate equipment, measures <strong>and</strong> <strong>in</strong>structions should<br />
be available to protect from the hazards result<strong>in</strong>g from<br />
chemicals, <strong>in</strong>fections <strong>and</strong> radiation<br />
• Prevent leakage of biologic wastes to the municipal sewage<br />
system<br />
• Specify evacuation areas <strong>in</strong> case of fire <strong>in</strong> all units of the<br />
laboratory<br />
• Exit sign must automatically illum<strong>in</strong>ate accord<strong>in</strong>g to ISO<br />
st<strong>and</strong>ards<br />
• Signs to control unauthorized access to the laboratory must<br />
be present
Health <strong>and</strong> safety of staff<br />
Licens<strong>in</strong>g Medical laboratory<br />
Lebanese M<strong>in</strong>istry of Public Health<br />
Personal protective<br />
equipment<br />
Fire ext<strong>in</strong>guishers<br />
Chemical storage<br />
Emergency showers with<strong>in</strong> a distance not<br />
exceed<strong>in</strong>g 30 meters<br />
Eye-wash stations<br />
Safety glasses or goggles<br />
Water sprays<br />
Fire –fight<strong>in</strong>g equipment:<br />
Dry powder ext<strong>in</strong>guishers<br />
Carbon dioxide fire ext<strong>in</strong>guishers<br />
Place the ext<strong>in</strong>guisher near the exit<br />
Storage facilities must be available <strong>and</strong><br />
located <strong>in</strong> specific areas to assure the<br />
safety of laboratory workers
Safety <strong>and</strong> Technical St<strong>and</strong>ards for Licens<strong>in</strong>g a<br />
Medical <strong>Laboratory</strong>-Microbiology<br />
Lebanese M<strong>in</strong>istry of Public Health<br />
• Separate, <strong>and</strong> near wash<strong>in</strong>g <strong>and</strong> sterilization rooms<br />
• Area ≥ 18 m² m<br />
• Work<strong>in</strong>g benches ≥ 4 m with specialized exhaust fan<br />
• Adequate illum<strong>in</strong>ation <strong>and</strong> ventilation<br />
• Sterilization <strong>and</strong> tube wash<strong>in</strong>g room equipped with a s<strong>in</strong>k<br />
not less than 3 m <strong>in</strong> length<br />
• Physician office<br />
• Rest room<br />
• Storage room<br />
• Reception <strong>and</strong> wait<strong>in</strong>g room<br />
• One toilet for employees & Two toilets for visitors.<br />
• Technical room to store the gas cyl<strong>in</strong>ders or others.
Required Equipments for<br />
Licens<strong>in</strong>g Microbiology <strong>Laboratory</strong><br />
Lebanese M<strong>in</strong>istry of Public Health<br />
• Incubator 37 ˚C 54 ˚C<br />
• Microscope Objectives 10 – 20 - 40/50 - 100 immersion<br />
• Fume Hood<br />
• Refrigerator<br />
• Freezer -30<br />
˚- 300 L<br />
• Centrifuge<br />
• Water distiller 41/h<br />
• Biologic safety cab<strong>in</strong>et<br />
• Water bath<br />
• Slide warmer<br />
• Vortex<br />
• Shaker<br />
• Inc<strong>in</strong>erator (electric or gas)<br />
• Autoclave<br />
• Incubation jars
Work Organiz<strong>in</strong>g St<strong>and</strong>ards<br />
Licens<strong>in</strong>g Medical laboratory<br />
Lebanese M<strong>in</strong>istry of Public Health<br />
• Services delivered as per certification<br />
• Def<strong>in</strong>e work<strong>in</strong>g hours<br />
• Def<strong>in</strong>e procedures <strong>and</strong> protocols<br />
• Estimate work load <strong>in</strong> every unit.Identify type of work<br />
conducted <strong>in</strong> every unit: manual, mechanical or automatic<br />
• List all the equipments <strong>in</strong> the Lab<br />
• Ma<strong>in</strong>ta<strong>in</strong> a paper logbook <strong>in</strong>dicat<strong>in</strong>g (other modern means<br />
of record<strong>in</strong>g are acceptable): Name of patient name of<br />
physician <strong>and</strong> required tests with full <strong>in</strong>formation <strong>and</strong><br />
results. <strong>Laboratory</strong> owner is responsible for safekeep<strong>in</strong>g of<br />
the record <strong>and</strong> patient confidentiality.<br />
• Human staff should be qualified to use the equipment.
Cl<strong>in</strong>ical <strong>Laboratory</strong><br />
American University of Beirut Medical Center<br />
• H<strong>and</strong>l<strong>in</strong>g Human specimen only<br />
• Biologic safety cab<strong>in</strong>et for h<strong>and</strong>l<strong>in</strong>g brucella isolates<br />
• Personnel Safety: gloves, masks <strong>and</strong> gowns<br />
• Dis<strong>in</strong>fectant jars, autoclavable bags<br />
• Lockable freezer (-21(<br />
˚C)<br />
• Only authorized personnel have access to the Freezer
Cl<strong>in</strong>ical <strong>Laboratory</strong><br />
Islamic Hospital Tripoli-<strong>Lebanon</strong><br />
• All personnel work<strong>in</strong>g <strong>in</strong> the <strong>Laboratory</strong> wear gloves<br />
• Class B safe cab<strong>in</strong>et <strong>in</strong> Bacteriology section<br />
• Soap / Antiseptic gel<br />
• Predef<strong>in</strong>ed protocol for accidents
Rafik Hariri University Hospital (RHUH)<br />
Laboratories<br />
• Cl<strong>in</strong>ical <strong>Laboratory</strong> (>500 m²) m<br />
Chemistry<br />
Serology<br />
Endocr<strong>in</strong>ology<br />
Bacteriology & Parasitology<br />
Mycobacteriology<br />
Hematology & Coagulation<br />
Blood Bank<br />
Molecular Biology (open<strong>in</strong>g soon)<br />
• Research <strong>Laboratory</strong> (300m²)<br />
PCR Technique
Gap Analysis at RHUH<br />
Laboratories<br />
By<br />
Ms Maya Ze<strong>in</strong><br />
Biomedical Eng<strong>in</strong>eer
Checklist accord<strong>in</strong>g to<br />
BSL 1 St<strong>and</strong>ards<br />
• <strong>Laboratory</strong> Manuals<br />
• <strong>Laboratory</strong> Design<br />
• Gas cyl<strong>in</strong>ders storage<br />
• Chemicals storage<br />
• Refrigerators/freezers<br />
• Status electrical equipment<br />
• Personal protective equipment<br />
• Waste management<br />
• General practices<br />
• General laboratory housekeep<strong>in</strong>g<br />
• Fire protection
Gap analysis accord<strong>in</strong>g to<br />
BSL 1 St<strong>and</strong>ards<br />
• Some equipment are not properly labeled<br />
• Some shelves are not secured<br />
• Insufficient storage space<br />
• Unavailable refrigerator for human consumption<br />
• Some freezers <strong>and</strong> refrigerators are not locked<br />
• Few miss<strong>in</strong>g personnel protection items<br />
• Improper control on waste segregation<br />
• Waste disposal procedures are not posted<br />
• Inappropriate storage of decontam<strong>in</strong>ated glass conta<strong>in</strong>ers
Checklist accord<strong>in</strong>g to<br />
BSL 2 St<strong>and</strong>ards<br />
• Biological Safety Cab<strong>in</strong>et (BSC)<br />
• <strong>Laboratory</strong> regulations<br />
• Decontam<strong>in</strong>ation procedures<br />
• H<strong>and</strong>l<strong>in</strong>g of contam<strong>in</strong>ated waste<br />
• Personal protection<br />
• Work practices<br />
• Facility design
Gap analysis accord<strong>in</strong>g to<br />
BSL 2 St<strong>and</strong>ards<br />
• Biological Safety Cab<strong>in</strong>et not well ma<strong>in</strong>ta<strong>in</strong>ed<br />
• Restricted Access to laboratory is verbally implemented<br />
• Miss<strong>in</strong>g biohazard signs<br />
• Accidents are reported but not documented<br />
• One type of dis<strong>in</strong>fectant is available<br />
• Management of <strong>in</strong>fectious <strong>and</strong> chemical wastes need<br />
improvement<br />
• Culture stocks are h<strong>and</strong>led improperly<br />
• Additional personnel self protection tra<strong>in</strong><strong>in</strong>g is required<br />
• Transportation of <strong>in</strong>fectious specimen to be regulated<br />
• Washbas<strong>in</strong> is unavailable at the laboratory exit
Checklist accord<strong>in</strong>g to<br />
BSL 3 St<strong>and</strong>ards<br />
• Facility Design<br />
• Personnel protection<br />
• H<strong>and</strong> protection<br />
• Respiratory protection<br />
• Work practices
Gap analysis accord<strong>in</strong>g to<br />
BSL 3 St<strong>and</strong>ards<br />
• Facility is not designed accord<strong>in</strong>g to BSL 3 St<strong>and</strong>ards<br />
• Automatic/H<strong>and</strong>/foot/elbow controlled s<strong>in</strong>ks are not<br />
available<br />
• Waste is not autoclaved prior to disposal<br />
• Annual updates/tra<strong>in</strong><strong>in</strong>g for procedural changes are<br />
<strong>in</strong>adequate<br />
• Additional personnel self protection tra<strong>in</strong><strong>in</strong>g is required
Gap analysis accord<strong>in</strong>g to <strong>Biosecurity</strong> St<strong>and</strong>ards<br />
Physical security<br />
Limited <strong>and</strong> exclusion area access control:<br />
• Escort policies are available:<br />
- not universally implemented<br />
- no visitor records are ma<strong>in</strong>ta<strong>in</strong>ed<br />
• Personnel is tra<strong>in</strong>ed to <strong>in</strong>form supervisor on <strong>in</strong>truders<br />
but no written policy for subsequent action<br />
Performance test<strong>in</strong>g <strong>and</strong> ma<strong>in</strong>tenance:<br />
• Security procedures <strong>and</strong> performance test plan are not<br />
available<br />
• No policy for periodic test<strong>in</strong>g of equipment
Gap analysis accord<strong>in</strong>g to <strong>Biosecurity</strong> St<strong>and</strong>ards<br />
Physical security<br />
• Need to implement tra<strong>in</strong><strong>in</strong>g policies <strong>and</strong> take corrective<br />
actions<br />
• Pathogens are stored <strong>and</strong> used with<strong>in</strong> specified area but<br />
unlocked<br />
• The laboratories are not equipped with Electronic Intrusion<br />
Detection System<br />
• Inappropriate tra<strong>in</strong><strong>in</strong>g <strong>and</strong> exercises for security guards
Gap analysis accord<strong>in</strong>g to <strong>Biosecurity</strong> St<strong>and</strong>ards<br />
• Transport Security<br />
Policies are available but not rigorously applied<br />
• Information Security<br />
Cl<strong>in</strong>ical laboratory: L<strong>in</strong>ked to central servers<br />
Research laboratory: Independent IT system
Thank you for your Attention