Safety, Security & PAPR - PowerPoint Presentation

Slide1

Safety, Security & PAPR Annual Training 2016

North Carolina State Laboratory of Public HealthBioterrorism and Emerging Pathogens Unit*Required for new employees, annual refresher and as needed when changes occurSlide2

Biosafety

Biosafety is the application of combinations of laboratory practice and procedure, laboratory facilities, and safety equipment when working with potentially infectious microorganisms. Biosafety guidelines are put into place to protect laboratorians and prevent exposures in biological laboratories.

Everyone working in the laboratory is responsible for employing proper biosafety practices at all times and in all situations.Slide3

Principles of Biosafety

Good biosafety practices prevent occupationally acquired infections by intercepting microorganisms. Blocking the routes of transmission by intercepting microorganisms before they can infect through proper work practices, protective equipment, immunization, treatment and surveillance

Reservoir

of pathogen

Portal

of escape

Transmission Route of entry/infectious dose Susceptible host Incubation period InfectionSlide4

Biosafety Plan Key Elements

Biosafety manual and SOPsResponsibilitiesIdentification of biohazardsEntry requirements and signageRisk assessments and control of biohazardsPackaging and shipping p

rotocols

General laboratory safety practices

Waste management

Decontamination/Disinf-ection

Emergency proceduresTraining programMedical surveillance

Evaluation/Drills/Auditing program and DocumentationSlide5

Containment

Containment (barrier) describes safe methods, facilities and equipment for managing infectious materials in the laboratory environment where they are being handled or maintained. Purpose:Manage infectious materialsReduce or eliminate exposure Elements:Safety Equipment (Primary Containment)Facility Design and Construction (Secondary Containment)Slide6

Laboratory Practice and Technique

The most important element of containment is strict adherence to standard microbiological practices and techniques. Standard practices and proceduresCommon to all

laboratories, handling sharps, decontamination

Special practices and procedures

Entry and Exit procedures, Address

the risk of handling agents requiring increasing levels of

containmentAdministrative- Immunizations, security clearance, training and supervisionSlide7

Standard Microbiological Practices and Techniques

Limited or restricted access to the laboratoryHand washing protocolsNo eating, drinking, smoking, handling contact lenses or applying cosmetics in the laboratoryUse of mechanical pipetting devices – No mouth pipetting!

Waste decontamination and disposal program

Insect and rodent control program

Minimization of splashes and aerosolsSlide8

Procedures That Emit Aerosols

CatalaseInoculating biochemicals or blood culture bottlesPipettingMixing

Centrifugation

Grinding

Vortexing

Pouring

Loading syringesLasers, cell sortersSplashes

Opening lyophilized culturesFlaming loops

Entering or opening vessels at non-ambient pressures, fermenters, freezer vialsSlide9

Ways to Minimize Aerosols

Pour liquids carefullyWork over absorbent bench padsUse centrifuge safety cupsUse sealed centrifuge rotorsUse capped tubes when mixing or vortexing

Use pipette aids with filters

Work in BSCSlide10

Primary Containment (Barriers)Primary containment is provided by the use of appropriate safety equipment. It provides protection of personnel and the immediate laboratory environment from exposure to infectious agents.

Biosafety Cabinet

Safety Centrifuge Cup

Eye/Face Protection

Respiratory Protection

Shoe covers

Lab Coat/Gown

GlovesSlide11

Biosafety Cabinet

The Biosafety Cabinet is the principal device used to provide containment of infectious splashes or aerosols generated by many microbiological procedures.Slide12

Secondary Containment -

Facility Design and ConstructionThe design and construction of the facility contributes to the laboratory workers’ protection, provides a barrier to protect persons outside the laboratory, and protects persons or animals in the community from infectious agents which may be accidentally released from the laboratory.Slide13

Facility Design and Construction

Separation of the laboratory work area from public accessAvailability of a decontamination facility (autoclave)Hand washing facilitiesSpecialized ventilation systems to ensure directional airflow

Air treatment systems to decontaminate or remove agents from exhaust air

Controlled access zones

Airlocks at laboratory entrances

Separate buildings or modules to isolate the laboratorySlide14

Biosafety LevelsSlide15

Biosafety Levels

Laboratories are divided into four different safety levels that basically determine the type of work that can be performed in that laboratory. Provide increasing levels of personnel and environmental protectionConsist of combinations of laboratory practices and techniques, safety equipment and laboratory

facilities

The performance of risk assessments is necessary and mandatory. Generally, work with known agents should be conducted at the biosafety level recommended in the BMBL Section

VII

When

specific information is available to suggest that virulence, pathogenicity, antibiotic resistance patterns, vaccine and treatment availability, or other factors are significantly altered, stringent practices may be specifiedSlide16

BSL 1

Very Basic – Used when handling agents not known to cause disease in

healthy

humans

BSL 1

No primary barriers required

Open bench topHand washing sinkLab coats and gloves

Sharps policySlide17

BSL 2

Lab activities involving clinical specimens, blood, other body fluids and tissues from humans or animals potentially infected with human pathogens.

Lab coats and gloves at minimum

Hand washing sinks

Waste

d

econtamination facilities

Risk of percutaneous injury,

ingestion

, mucous membrane exposure

Medical surveillance policyBSC or safety centrifuge cupsSlide18

BSL 3

BSL 3

Used for lab activities involving work with indigenous or exotic agents which may cause serious or potentially lethal disease as a result of exposure by the inhalation

route

More

emphasis

placed on primary and secondary barriers to protect personnel, the community and the environment from exposure to potentially infectious aerosolsSlide19

BSL-3

Primary BarriersClass I or Class II BSCs or other physical containment devices used for all open manipulations of agentsPPE - protective lab clothing, gloves,

goggles, respiratory

protection as required by risk assessment (PAPRs)

Secondary Barriers – Engineering controls

Physical separation from access corridors

Self-closing , double-door access doorsHEPA filtration systemExhausted air not recirculatedNegative airflow into laboratoryDecontamination of ALL

wasteEyewash availableSlide20

Raleigh BSL-3 Facility

BSL-3 Entry and Exit ProcedureVisitor’s LogPPE RequirementsDonning and Doffing of PPE

Transfer of Biohazardous Agents into the Laboratory

Precautions for Sharps

Gross Decontamination

HVAC, Alarms, BSC, Local and Air Pressure Differential Alarms

HEPA FilterElectrical SystemSlide21

BSL-4Dangerous/exotic agents which pose high risk of life threatening disease, aerosol-transmitted lab infections; or related agents with unknown risk of transmission

Primary hazards to personnel are respiratory exposure to infectious aerosols, mucous membrane or broken skin exposure to infectious droplets or auto inoculationsTwo types of BSL-4 laboratories:Cabinet = all procedures conducted in Class III BSCSuit = all procedures conducted in Class I or II BSC in combination with full-body, air supplied pressure personnel suitSlide22

Laboratory Risk AssessmentsSlide23

Risk Assessments

Risk assessment is a process used to identify:the hazardous characteristics of a known infectious or potentially infectious agent or materialthe activities that can result in a person’s exposure to an agent

t

he likelihood that such exposure will cause a lab acquired infection

t

he probable consequences of such infection

A risk assessment involves trying to predict what might go wrong, how likely it is to go wrong and how severe the consequences would be. Risk

= the chance of injury, damage, or loss

Chance =

the probability of something happening

Hazard = something that is

dangerous

A risk assessment must be completed for each organism that is used in the laboratory. Slide24

When to Perform Laboratory Risk Assessments

At regular intervals - at least annuallyLaboratory move or renovationNew employeeNew infectious agent or new reagentNew piece of equipmentChanges in protocols/proceduresSlide25

Components considered in developing a risk assessment

MenQualificationExperience and TrainingAttitude

Immune status

Physical handicaps

Materials

Pathogens and toxins

PathogenicityMode of transmissionReagentsContainers and closures

MethodsProcedures

SOPsDocumentation

MachineryBuildingLaboratory design

FacilitiesAir flow (air handling)

EquipmentBSC, Fume hoodsCentrifuge cups/carriers

Four M’sSlide26

According to the BMBL…

There are things to be considered after an organism or method has been chosen. These items should be included in a biological risk assessment:Pathogenicity – disease incidence and severity, LAIsRoute of transmission – inhalation, ingestion, cutaneous

Agent Stability – survival over time in the environment

Infectious dose – how much? Immune status?

Concentration – working volume, # of infectious organisms per unit

Origin – domestic or foreign in origin. Host

?Availability of prophylaxis/therapeutic treatment – vaccines, antibiotics and anti-viral meds

Medical Surveillance – Serum banking, monitoring employee health status, post-exposure management

Experience and skill level of personnel – laboratorians, maintenance, housekeepingSlide27

Useful Tools for Performing Risk Assessments

Review laboratory recordsInjury, illness and surveillance reportsEquipment maintenance records (is the equipment well maintained/inspected/certified)Inspect the laboratory

Daily monitoring by employees, periodic walk-throughs and formal inspections

Review published materials

Equipment manuals, manufacturers’ bulletins, package inserts, scientific journals, safety manuals and guidelines

Observe laboratory operations

New procedures, new employees, new equipment, workflow Slide28

Controls to Reduce Risk

Avoid the hazardDo not perform the assay or handle the agentUse alternates/surrogate organismsProcedural Controls

Perform assay when less people are around

Separate areas

Engineering/Mechanical controls

BSC

Mechanical pipetting devicesPPEDetermine specific types(s) of PPE required (i.e. respirators)Emergency Procedures

Incident/Accident response proceduresHealth SurveillanceSlide29

Benefits of Completing a Risk Assessment

Effective use of resourcesIdentification of training needs and supervisionAdvance planning for renovationEvaluation of procedural changes

Prevention of biohazard transmission to family members of employees

Ensure compliance with governmental regulations

Justification for space and equipment needs

Cost effective laboratory operation

Evaluation of emergency plansSlide30

Entry and Exit ProcedureSlide31

BSL-3 Entry and Exit Procedures are posted

at the

main entrance and

to

each

individual BSL-3 suite.Slide32

Laboratory Entry

Notify team mate that you will be working in the BSL-3 laboratory.Access using security measures – access key card, biometricsWhen scanning for entry, all employees wishing to enter the lab must scan their card key/fingerprint.Observe any signage on anteroom door – maintenance, do not enter, etc.

Document entry in log book – all visitors must read the precautions document and sign the Visitor’s log

.

Document that the visual airflow device or indicator was checked and that air is flowing properly

.

Don PPE located in anteroomObserve and post proper sign on individual BSL-3 suite door – includes occupancy, types of PPE in use, maintenance, etc.Slide33

Potential Risks and Hazards for VisitorsSlide34

Minimum PPE Requirements while infectious agents are not in use:

i.e. Taking Temperatures, Inventory, Restocking, Maintenance Personnel, Tours, etc.Donning order while in Sign-in Room:

Bootie/shoe

covers

Gown – unless you are re-using a gown stored in the common area

Gloves

, single layer - Required for entry; this layer of gloves should be considered “hands” and must be worn at all times when in the BSL-3

Protective eyewearSlide35

Minimum PPE Requirements for work with infectious agents:

Donning order while in Sign-in room:Bootie/shoe covers Jumpsuit, if required by risk assessmentGown - unless you are re-using a gown stored in the common areaGloves, single layer - Required for entry; this layer of gloves should be considered “hands” and must be worn at all times when in the BSL-3Protective eyewear 

Donning order while in the BSL-3 Common Area:

For all testing requiring the use of PAPRs,

the PAPR will be donned in the common area before entering the BSL-3 corridor

Donning order while in the BSL-3 Corridor:

Second pair of gloves - Required when working with agentsSlide36

Personal Protective EquipmentSlide37

Doffing PPE

Doffing order in isolation room:Discard sleeves, if worn, and outer layer of gloves

while

in

BSC

Remove gown if jumpsuit is also worn

 Doffing order in BSL-3 Corridor:

Doff jumpsuit, if worn, and discard into biohazard bag

If no jumpsuit is worn,

Doff gown and discard into biohazard bag Remove

and discard booties into biohazard bag

Doff the inner layer of gloves

Doffing

order in common

area:

Don clean gloves to doff PAPR unit

Doff PAPR unit. Place hood in biohazard bag and place PAPR unit in a holding bin. If re-entry is required, use a new hood.

If

sample is negative, store one hood per laboratorian and recharge PAPR unit for reuse

.

If sample is positive,

decontaminate

PAPR unit(s

) and recharge

for reuse.

If breach is suspected, discard hood and change filter.

Remove gloves and discard into a biohazard bag.

Wash hands.Slide38

Doffing PPE

NOTE:In accordance with the NCSLPH Exposure Control Plan:all personal protective equipment is removed immediately, or as soon as possible, if overtly contaminated and placed in an appropriately designated area or container for storage, washing, decontamination, or disposal.

This includes disposal or decontamination of face and eye protection prior to reuse.

 Slide39

Laboratory ExitProperly dispose of PPE

Change signWash handsExit to anteroom Complete logbook Exit Slide40

Powered Air Purifying Respirator (PAPR)Slide41

PAPR

Motor blower draws contaminated air through a HEPA filter and blows filtered air up into the head covering. The PAPR provides respiratory protection again airborne contaminants:Dust, fumes, mists, smokePAPRs DO NOT reduce exposure to gases or vapors

Note the difference between fumes and vapors

fumes - heated solid particles temporarily suspended in air

vapors - gaseous

The PAPR with the head cover reduces exposure by a factor of 25, PAPR with hood reduces exposure by a factor of 1000.Slide42

PAPR

Prior to wearing a PAPR, staff must undergo medical evaluation. The facility’s Respiratory Protection Program Director reviews the medical clearance questionnaire and decides if employee needs to be referred to a personal physician for clearance to wear a PAPR.Physiological stresses

Pulmonary

Cardiac

Signs and symptoms limiting

use

Claustrophobia, latex allergySlide43

PAPR components

Hood

Breathing Tube

Blower /

Filtration Unit (w/Airflow Indicator)

Battery ChargerSlide44

Preparing to Wear the PAPR

Inspect PAPR unit. Replace if cracked or warped. Check breathing tube for any cracks or tears. The tube should be flexible. Pay particular attention to the rubber O-ring gasket – replace if it is worn, cracked or no longer flexible.Attach the breathing tube to the blower/filter/battery unit by inserting the male end of the hose and turning it clockwise until it stops.

Turn the power on.

Check the airflow with the airflow indicator.Slide45

Check Airflow with the Airflow Indicator

Turn the PAPR power on.Place the indicator in end of the hose. The indicator should float on the air coming out of the tube.Two lines on the indicator should be visible.If the test fails, do not use the unit. Perform troubleshooting.

Problem

Possible

Causes

Corrective Action

Low airflowBattery needs changingFilter is loaded

PAPR blower malfunctionBreathing tube restricted

Switch to fully charged batteryReplace filterSwitch to a different blower

Remove restrictionSlide46

Changing a PAPR Filter

The PAPR filter and gasket should be replaced when:PAPR doesn’t pass airflow checkFilter is physically damaged

Water has entered the filter

To comply with administrative procedures

Gasket is torn or damaged

A breach is suspectedSlide47

Changing a PAPR Filter

Release back cover locking tabs and remove the back cover.Remove the filter and filter gasket. Autoclave and dispose of the filter and gasket.Remove the battery pack. Inspect the battery and the housing. Replace if

damaged, cracked or no longer holds a charge.

Insert new filter and filter gasket.

Replace back cover.

Test PAPR using airflow indicator.Slide48

PAPR Donning

After all other appropriate PPE has been donned:Obtain PAPR components and hood.Attach PAPR to the waist, latching in the front.Insert breathing tube into the PAPR unit. Twist breathing tube/air hose to secure into the unit.

Turn on PAPR unit.

Attach PAPR breathing tube to the hood.

Place hood over head and shoulders.

Tuck inner skirt into the jumpsuit.

Put the gown on last.Slide49

PAPR Doffing

After all appropriate levels of PPE have been doffed:Remove hood from head.Turn off PAPR unit.

Remove breathing tube from PAPR unit.

Remove PAPR unit from waist.

Place tube and PAPR unit in designated area for re-processing. Slide50

LimitationsImpaired lung function

Communication and vision problemsFatigueReduced work efficiencyClaustrophobiaBattery failureOnly in atmospheres with sufficient O2“Over breathing”Latex allergiesSlide51

RisksImproper use – training must be provided and documented annually for each user.

“Breakthrough” – Contaminants pass through the filtering material when organic vapors and gases cause the filter to reach capacity.“Penetration” – improper seal is created allowing aerosols or other harmful air contaminants to enter.Degradation of effectiveness – occurs when parts of the PAPR begin to deteriorate.Contamination of wearers when doffing – may occur if the PAPR is doffed improperly.Slide52

PAPR Cleaning/Disinfection/Storage

CleaningWipe the outside surfaces with a mild solution of warm water and mild detergent. Do not clean with organic solvents.If necessary, wipe with a 10% bleach solution.PAPR hoods are disposable, but may be reused by a single user and must be cleaned between each use.

Disinfection/Storage

Disinfect the PAPR after each use – 10% bleach solution

Battery pack should be stored fully charged

Store PAPR so that it is protected from damage, contamination, dust, sunlight, extreme temperatures, excessive moisture, and damaging chemicals.

Store PAPR in a cool, dry place.Slide53

GeneralSlide54

Transfer of Biohazardous Agents into a High-Security Laboratory

No infectious agents should be transported via the public elevator. Use the freight or specimen elevator for the transport of samples.Specimens of a suspected bioterrorism event should remain un-opened until they are inside the biological safety cabinet dedicated for this task.

Infectious agents should be placed into an unbreakable, secondary container or double-bagged in a

leak

proof container, both of which are sealed

tightly with O-ring seal.All containers of size 250 ml or greater should be transported on a cart or in a bottle carrier.Slide55

Precautions for SharpsDisposable sharps are placed in sharps containers that are autoclaved when the container is two thirds full. Disposable sharps are not to placed in the reusable waste containers with bag inserts.

Non-disposable sharps are placed in a hard walled container such as a metal tray for transport to the autoclave and sterilized before re-use.Sharps involved in molecular testing should not be re-used due to possible nucleic acid contamination.Slide56

Gross Decontamination

The appropriate method of decontamination will be based on the organisms and quantities in use.Ports in the walls of individual rooms to facilitate gross decontamination using Vaporized Hydrogen Peroxide (VHP). If

gross decontamination were to occur in a BSC or BSL-3

room,

perform VHP decontamination of those spaces. Refer to the risk

assessment

to determine the proper decontamination method. During decontamination, the laboratory or designated spaces may be restricted to all investigators. Slide57

BSCs and Local AlarmsTo ensure that local alarms sound in each isolation room in the BSL-3 when there are either airflow disruptions or exhaust system failures,

BSCs will remain ON at all times.Slide58

Responding to HVAC alarmsIn the case of airflow disruption or exhaust system failure:

Audible alarms on actively operating Biosafety Cabinets will soundAir pressure differential alarms, both audible and visual, in individual rooms will alarm if the pressure differential becomes positive.Upon hearing the alarms, the laboratorians should assume that negative pressure has been compromised and immediately secure any biological agent being worked uponLeave the BSL-3 following proper procedures and post the “DO NOT ENTER” signage on the anteroom door. The Responsible Official, BTEP supervisor, Laboratory Director, and appropriate maintenance personnel should be notified of the situation as soon as possible. After hours, the state capital police should be notified 919-733-3333 and they will contact the after-hours DOA maintenance administrator. Slide59

Air Pressure Differential Alarms

The BSL-3 laboratory is designed for 100% single passage, uni-directional flow-through air. The exhaust air system is electronically connected to the supply air system.The fans of these systems are programmed to maintain a predetermined cfm (cubic feet per minute) flow differential to maintain the negative pressure in the BSL-3 suite in relation to the adjacent lab areas. Visual and audible alarms will indicate if the differential nears neutral or reaches positive pressure.

If activities occur that will knowingly sound the alarm (e.g. opening the door,

etc

.), staff will alert other team members working in the area of the impending alarm. Otherwise, all work should safely cease and alarm investigated/assessed/documented/reported.Slide60

HEPA Filters

SuiteFansFilter Bank

Modules

Unknowns

EF 3-1. 3-2

F-3*, **

1

BT/VirologyEF5-1. EF5-2

F-2

9

Each BSL3 lab suite has two exhaust bag-in/bag-out HEPA filter housings and two exhaust fans which are located in the mechanical penthouses and roof. Each filter bank has pre-filters and HEPA filters. Some filters also include HEGA

(carbon filtration for chemicals) filters (this varies with each suite).

The supply is not HEPA filtered. *This suite does not have redundant filter banks.

**

This suite also has HEGA filters inline with the HEPA filters.Slide61

Electrical System

Emergency Generator – restores power within 10 secondsAll BSCs have UPS unit to bridge gap of timeROOM

NUMBERS

3916

is panel # OL3A5 and circuit # 29

3921 is panel # OL3A5 and circuit # 41

3922 is panel # OL3A5 and circuit # 17 & 3 (2 cabinets in the room)3923 is panel # OL3A5 and circuit #  9 & 11(2 cabinets in the room) 3903 is panel # OL3A6 and circuit # 27

3904 is panel # OL3A6 and circuit # 383905 is panel # OL3A6 and circuit # 33

3906 is panel # OL3A6 and circuit # 193907 is panel # OL3A6 and circuit # 1

 The cabinets are being fed from circuits OL3A5 and OL3A6. These 2 panels are themselves being fed from the distribution panel # ODL3A1 in the electrical room #3136. ODL3A1 in turn is fed from transformer #T7 in room #3136 and the transformer is fed off of switchboard A.Slide62

Emergencies in the BSL-3Slide63

Emergencies in the BSL-3

Personal safety comes first! Personnel shall not expose themselves to any unnecessary risks in order to comply with select agent or BSL-3 policies.Fire

Natural Disaster

Hurricane

Tornado

Equipment failure

PAPRBSCLoss of power

Interruption of air flowSlide64

Emergencies in the BSL-3

Upon hearing any emergency alarm:Use common sense!Secure any organisms to the best of the investigator’s ability prior to leaving the BSL-3.

R

emove as much PPE as possible without self-contamination or self-endangerment and wash your hands.

*During

a fire alarm, the interlock will be engaged. This will not allow both doors to be open. If bypass is needed, press the green ‘over-ride’ button next to the door. Alternative exit emergency methods include doors in equipment room (3902 & 3919).Slide65

BSL-3 Laboratory Emergencies

Emergency ResponseEvacuation RouteDial 8-911Pull fire alarm located in hallwayBuilding operator:

3-7834

Other numbers: 919-733-3333 (State Capitol Police – 24-hour Law Enforcement presence

on-site

)

Exit BSL-3 lab suite via exterior door.Turn right and exit building via closest stairwell.Upon exiting building, assemble in the third row of the front parking lot.Check in with supervisor.Slide66

BiosecuritySlide67

Security Measures

Entry/exit reportsAccess proximity cardBiometricsVideo surveillance

Motion detectors

Locked incubators, freezers, and refrigerators

Knox box

24-hour law enforcement presenceSlide68

Other security measures

Security risk assessmentsInspection of all packages to reduce the risk of an unauthorized removal of agents or information from the laboratory.Security plan – describes how the institution will handle unacceptable risks. A chain-of-command and roles and responsibilities must be clearly defined. Ensure that the plans are created, exercised and revised as needed.Slide69

Notify your Responsible Official

Security related incidents may occur that will warrant the notification of the Responsible Official:Loss of keys

Termination of employment

Loss, theft, or release of Select Agent

Alteration of inventory records

Unauthorized entry to the laboratory

Symptoms consistent with lab-acquired infectionsMost common – Brucellosis and TularemiaSlide70

Responsible Parties

Controller

Lou Turner

Responsible Official

Dee Pettit

Alternate Responsible Official/Safety Officer

Kristy OsterhoutSlide71

Incident Response FormNature of threat

Breach discovery i.e. potential exposureDetails of occupational releaseAgent or toxin missingActions taken to resolve the incidentDetermination of causePreventive actionsEvaluation of new measuresSlide72

References

http://www.cdc.gov/biosafety/publications/bmbl5/http://www.selectagents.gov/resources.html

http://

multimedia.3m.com/mws/media/735385O/3m-air-mate-high-efficiency-powered-air-purifying-respirator-papr-user-instructions.pdf