Laboratory Biosafety and Biosecurity Current Situation in Lebanon

Laboratory Biosafety and Biosecurity Current Situation in Lebanon Laboratory Biosafety and Biosecurity Current Situation in Lebanon

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<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


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