University College Dublin

Transcription

1 University Cllege Dublin Labratry Bisafety Manual Rev 1. University Cllege Dublin Safety Office

2 Cntents 1.0 Intrductin Types Of Bilgical Agents Bacteria Viruses Prins Fungi Parasites Rutes Of Infectin Incidental Expsure T Bilgical Agents Intrductin Incidental Expsure T Bilgical Agents Legal Requirements Deliberate Use Of Bilgical Agents Intrductin Deliberate Use Of Bilgical Agents Legal Requirements Classificatin Cntainment Risk Assessment Ntificatin t the Health and Safety Authrity Training and Infrmatin Recrds Health Surveillance Gd Micrbilgical / Hygiene Practises Bilgical Agents Risk Assessment UCD Pr Frma Bilgical Agents Risk Assessment Template Bilgical Labratry Safety Key Aspects Emergency Planning Spillages Wrker Training / Supervisin Lne Wrking Recrd Keeping Selectin Of Persnal Prtective Equipment Rutes Of Expsure T Pathgenic Agents Persnal Hygiene In The Labratry Vaccinatins Waste Management Selectin And Use Of Disinfectants Micrbilgical Safety Cabinets Safe Use Of Autclaves Safe Use Of Centrifuges` Safe Use Of Sharps Cell Cultures Universal Precautins Fr The Handling Of Bld Prducts Wrking Safely With Research Animals Transprt Of Infectius Materials Accident Reprting Pregnant Emplyees Surces Of Bisafety Infrmatin Revisin Histry 63 Rev. 1 1

3 1.0 Intrductin The Safety Health and Welfare At Wrk (Bilgical Agents) Regulatins 1994 (SI 146) defines a bilgical agent as a micr-rganism including thse which have been genetically mdified, a cell culture and a human endparasite, which may be able t prvke any infectin, allergy r txicity The definitin f bilgical agent in the legislatin des nt extend t include nn micrbilgical bilgical entities therefre the specific prvisins f this legislatin d nt apply t their usage / interactin with wrkers. Fr example whilst a bull n a farm might pse a significant risk t farm wrkers it is nt cnsidered a bilgical agent under the legislatin and therefre the prvisins f the varius bilgical agents regulatins d nt apply t its handling. Hwever as it pses a risk t the safety f farm emplyees it s presence n the farm wuld be subject t the same requirements fr risk assessment as any ther wrkplace hazard. As a rule f thumb if a bilgical agent is capable f causing an infectin r a txic respnse in a wrker then it is cvered by the bilgical agents legislatin. In the wrkplace there are tw distinct types f wrker expsure t bilgical agents. The first is incidental expsure, which is where wrkers are expsed t bilgical agents which happen t be present in the wrkplace but which are nt deliberately handled r utilised, e.g. in diagnstic labratries. The secnd is where wrkers are expsed t bilgical agents which are deliberately utilised, e.g. in research labs using E. cli bacteria. This handbk is designed t prvide University staff and students with guidance n the safe handling and usage f bilgical agents (including thse which are genetically mdified) in a labratry r similar setting. Users f genetically mdified bilgical agents must als refer t the UCD Use Of Genetically Mdified Organisms Manual fr further infrmatin n the legal requirements fr their use. Rev. 1 2

4 2.0 Types Of Bilgical Agent There are a number f different types f bilgical agent that may be encuntered within the University. These include but are nt limited t: 2.1 Bacteria These are single celled rganisms that can cause a number f diseases in humans. Many types f bacteria pse n risk t healthy humans and live n and in the human bdy cntinuusly. In sme circumstances bacteria which are nrmally cnsidered t be nn pathgenic can cause disease. Cmmn diseases caused by bacterial infectin include Tuberculsis (Mycbacterium spp.); Tetanus (Clstridium tetani); and Chlera (Vibri chlerae). Mst bacterial infectins are susceptible t antibitics, whilst fr destrying bacteria in the envirnment there a range f effective disinfectant agents available. It is pssible t get vaccinatins against sme f the diseases caused by bacterial agents. 2.2 Viruses Viruses are simple entities that can infect individual human cells causing the infected cell t prduce mre virus particles. Large scale viral infectins in ppulatins can lead t wrld wide epidemics. Sme viruses have an ability t cnstantly change their characteristics leading t many strains f the same virus e.g. the influenza virus. Cmmn diseases caused by viruses include Influenza (Orthmyxviridae spp); Chicken Px (Varicella simplex); and Cld Sres (Herpes simplex). Viral infectins are nt treatable with antibitics althugh effective disinfectant agents are available fr destrying viruses in the envirnment. It is pssible t get vaccinated against sme viral agents. 2.3 Prins Prins are very simple bilgical agents made up f prteins. Prin infectins are very difficult t treat and the prin agent itself can als be very difficult t destry in the envirnment. There are n vaccinatins available t prevent prin infectin. Prins are the causative agents f Creutzfeldt-Jacb Disease and Bvine Spngifrm Encephalitis. A Pathgen is defined as any rganism capable f prducing disease Rev. 1 3

5 2.4 Fungi Fungi include yeasts, mulds and mushrms. Sme species f fungi have the ability t clnise and t grw n and in the bdy. These include Candida spp which can cause thrush infectins and Cryptcccus nefrmans which can cause lung infectins. Fungal infectins are usually treatable. There are n vaccinatins available t guard against fungal infectins. 2.5 Parasites Parasites are defined as rganisms that infect a hst and live n r in that hst t the detriment f the hst. Parasites can live inside the bdy (endparasites) r n the utside f the bdy (ectparasites). Parasites may cme frm a variety f bilgical families including nematdes (e.g. rundwrms); prtzans (single celled rganisms e.g. malaria); cestdes (tapewrms); insects (e.g. fleas); etc. Sme parasitic infectins are easily treatable whilst thers cam be extremely difficult t treat. In sme cases the parasite may have n nticeable negative effect in the bdy whilst in ther cases such infectins can be fatal. Rev. 1 4

6 3.0 Rutes Of Infectin Fr bilgical agents t give rise t a negative affect in a persn that persn must be infected by that agent. T infect a persn a bilgical agent must either get nt r int a persns bdy. There are a number rutes f infectin fr a bilgical agent. i. Ingestin Of The Agent: This may happen thrugh the cnsumptin f cntaminated water r fd r thrugh the insertin f cntaminated fingers, pens, etc. int the muth. ii. Inhalatin Of The Agent: Inhalatin f an infectius agent can ccur if an infectius aersl is present. iii. Entry Via Mucsal Membranes: Sme infectius agents can pass thrugh thin bdy membranes n simple cntact and can cause infectin e.g. thrugh the eyes, nse, ears r muth. This rute f entry can be further exacerbated if fingers r ther items are inserted int the eyes, muth, nse r ears whilst wrking with risk material. iv. Entry Via Damaged Skin: Cntact between infectius material and brken skin, e.g. skin abrasins, can allw an infectius agent t directly enter the bdy. v. Subcutaneus Entry: This ccurs when infectius agents are physically intrduced int the bdy thrugh the skin, e.g. thrugh a needle stick injury with a cntaminated syringe. vi. Physical Cntaminatin: A persn may als becme cntaminated with a bilgical agent fllwing a simple cntact with infectius material. In such cases the agent may cause a disease at the site f cntaminatin r may be spread abut the bdy. Once in r n a persns bdy a bilgical agent may give rise t a recgnisable disease. Hwever peples susceptibility t a bilgical agent varies greatly between individuals and depends n a range f factrs including age, sex, general state f health, etc. An aersl is defined in this instance as a suspensin f bilgical agents in the air. Rev. 1 5

7 In rder t prevent the infectin f persns with a bilgical agent the ptential rutes f transmissin between infectius materials and that persn must be identified and eliminated r minimised t as lw a level as is practicable. This is the ultimate aim f any Bisafety Risk Reductin measures implemented in the University. Rev. 1 6

8 4.0 Incidental Expsure T Bilgical Agents 4.1 Intrductin Incidental expsure t bilgical agents may take place when such agents are t be fund in the University but are nt directly r deliberately handled r utilised. In sme wrkplaces materials are rutinely handled r utilised that have the ptential t cntain r harbur bilgical agents whilst in ther settings bilgical agents may be naturally present in the wrking envirnment. Fr example persns wrking with human r animal waste r with bdily fluids (e.g. bld) are at risk f expsure t any bilgical agents that may be carried in thse materials. Similarly all wrk with animals has the ptential t place persns at risk f expsure t bilgical agents that may be carried by the animals (Znses is the term used t describe diseases that can be transmitted frm animals t man, e.g. Bvine Tuberculsis, Brucellsis, etc.). The ptential fr harmful bilgical agents t be present in the wrkplace must always be cnsidered, especially when persns are wrking with prducts f human r animal rigin. In mst cases it will be necessary t take specific steps t minimise the risk t wrkers frm incidental expsure t bilgical agents. 4.2 Incidental Expsure T Bilgical Agents Legal Requirements The Safety Health and Welfare At Wrk (Bilgical Agents) Regulatins 1994 (SI 146) are applicable t wrkplaces where there is a risk f incidental expsure f emplyees t bilgical agents. The regulatins require that emplyers cnduct a written risk assessment in rder t identify the ptential fr emplyee expsure t a bilgical agent where the presence f a bilgical agent in the wrkplace is suspected r can be reasnably assumed given the nature f the wrk undertaken. Risk reductin measures designed tprtectwrker safety must be identified and implemented. At a minimum the implementatin f gd micrbilgical and hygiene practices as utlined in Sectin 6 belw is legally required. Where deemed necessary by said risk assessment the legal requirements fr the deliberate use f a bilgical agents as utlined in Sectin 5.2 belw shuld als be implemented. Guidelines n risk assessment are utlined in Sectin 7. Rev. 1 7

9 5.0 Deliberate Use Of Bilgical Agents 5.1 Intrductin The deliberate use f named bilgical agents in the University may expsure persns t a risk f infectin by that agent. Cnsequently the requirements f the legislatin fr thse persns deliberately utilising named bilgical agents is much greater that that impsed n persns wh may be incidentally expsed t such agents in the curse f their wrk. 5.2 Deliberate Use Of Bilgical Agents Legal Requirements Classificatin Where a named bilgical agent is deliberately used in the wrkplace it must be classified int ne f fur bihazard classificatins. These are: Hazard Class I: a bilgical agent that is unlikely t cause human disease Hazard Class II: a bilgical agent which can cause human disease and might be a hazard t emplyees, althugh it is unlikely t spread t the cmmunity and in respect f which there is usually effective prphylaxis r treatment available Hazard Class III: a bilgical agent which can cause severe human disease and presents a serius hazard t emplyees and which may present a risk f spreading t the cmmunity, thugh there is usually effective prphylaxis r treatment available Hazard Class IV: a bilgical agent which causes severe human disease and is a serius hazard t emplyees and which may present a high risk f spreading t the cmmunity and in respect f which there is usually n effective prphylaxis r treatment available A cmprehensive list f bilgical agents and their classificatins is given in the Furth Schedule f the 1994 Bilgical Agents Regulatins. Hwever this list was updated by the Bilgical Agents (Amendment) Regulatins (SI N. 248 f 1998), and it is this updated list that shuld be referred t when assigning a bilgical agents it s hazard classificatin. The list as given in the 1994 regulatins is n lnger valid. Rev. 1 8

10 If the rganism in questin cannt be fund within the listings cntained within the relevant legislatin then reference shuld be made t the UK Health and Safety Executive s The Apprved Lists Of Bilgical Agents which can be dwnladed free f charge frm the internet. The latest editin was published in If an rganism cannt be fund in this listing then further enquiries shuld be made with ther researchers t establish the internatinally accepted classificatin fr that rganism. The classificatin system fr bilgical agents is based n Wrld Health Organisatin Guidelines and is standard wrldwide. In the eventuality that n classificatin fr a bilgical agent can be fund then the user must assign a classificatin themselves based n the prperties f the rganism and similar type rganisms Cntainment Within the 1994 regulatins the minimum legally binding cntainment measures necessary fr the safe use f each class f bilgical agent are laid dwn within the Seventh Schedule and Eight Schedule f the regulatins. The Seventh Schedule lays dwn minimum requirements fr health and veterinary care facilities, labratries, diagnstic labratries and rms in which deliberately infected animals r animals suspected f being infected are being kept. The Eight Schedule lays dwn minimum requirements fr industrial prcesses utilising bilgical agents (refer t Tables 1 and 2belw). When a bilgical agent is intentinally used in the wrkplace then the minimum cntainment measures applicable t its hazard classificatin as utlined in the relevant schedule must be implemented. Cntainment levels are classified as Levels 1-4 in accrdance with the hazard classificatin f the agents in questin. An animal carrying r suspected t be carrying a bilgical agent must be classified in accrdance with the hazard class f the agent it is carrying. In wrk settings which are labratries, diagnstic labratries and rms in which deliberately infected animals r animals suspected f being infected are being kept emplyers must: Determine the cntainment measures required in rder t minimise infectin Carry ut activities invlving the handling f a bilgical agent nly in wrking areas crrespnding t at least the minimum cntainment level required fr that agent Adpt at a minimum Cntainment Level 2 in labratries handling materials in respect f which there exists uncertainties abut the presence f a bilgical Rev. 1 9

11 agent which may cause human disease, but which d nt have as their aim wrking with a bilgical agent including cultivating r cncentrating a bilgical agent and cntainment levels 3 r 4 as and when apprpriate, where it is knwn r it is suspected that it is necessary Risk Assessment A written risk assessment is required where bilgical agents are deliberately used r handled in the wrkplace. Guidelines n risk assessment are utlined in Sectin 7. At a minimum the implementatin f gd micrbilgical and hygiene practices as utlined in Sectin 6 belw and the minimum cntainment measures applicable t the class f agent being handled are legally required. Where the deliberate use is f a Class 1 bilgical agent then the implementatin f gd micrbilgical and hygiene practices is sufficient there are n specific cntainment measures utlined fr the use f Class 1 agents in the legislatin Ntificatin T The Health and Safety Authrity Persns must infrm the Health and Safety Authrity (HSA) f the use f a bilgical agent: Thirty days prir t the cmmencement f wrk invlving the use fr the first time f a Grup 2 r 3 r 4 bilgical agent Thirty days prir t the cmmencement f wrk invlving the use fr the first time f each subsequent Grup 4 bilgical agent Thirty days prir t the cmmencement f wrk invlving the use fr the first time f any Grup 3 bilgical agent where the user prvisinally classifies that bilgical agent himself Fr the first time nly in the case f labratries prviding a purely diagnstic service in relatin t a Grup 4 bilgical agent In any case where there are substantial changes f imprtance t safety and health at wrk t prcesses r prcedures which render the ntificatins required abve ut f date A standard ntificatin frm is available frm: Persns must als infrm the HSA f any accident r incident which may have resulted in the release f a bilgical agent and which culd cause bth severe human infectin and human illness r bth. Rev. 1 10

12 Table 1. Extract Frm The Seventh Schedule Of The 1994 Bilgical Agents Regulatins Cntainment Measures At Different Cntainment Levels Fr Health And Veterinary Care Facilities, Labratries, Diagnstic Labratries And Rms In Which Deliberately Infected Animals Or Animals Suspected Of Being Infected Are Being Kept. Cntainment Measures Cntainment Cntainment Cntainment 1. The wrkplace is t be separated frm any ther activities in the same building 2. Input air and extract air t the wrkplace are t be filtered using HEPA r likewise 3. Access is t be restricted t nminated wrkers nly 4. The wrkplace is t be sealable t permit disinfectin 5. Specified disinfectin prcedures 6. The wrkplace is t be maintained at an air pressure negative t atmsphere 7. Effective vectr cntrl e.g. rdents and insects 8. Surfaces impervius t water and easy t clean 9. Surfaces resistant t acids, alkalis, slvents, disinfectants 10. Safe strage f a bilgical agent 11. An bservatin windw, r alternative, is t be present, s that ccupants can be seen 12. A labratry is t cntain wn equipment 13. Infected material including any animal is t be handled in a safety cabinet r islatr r ther suitable cntainment 14. Incineratr fr dispsal f animal carcases Level 2 Level 3 Level 4 N Recmmended Yes N Yes, n extract air Yes, n input and extract air Recmmended Yes Yes, via airlck N Recmmended Yes Yes Yes Yes N Recmmended Yes Recmmended Yes Yes Yes, fr bench Yes, fr bench and flr Recmmended Yes Yes Yes, fr bench, walls, flr and ceiling Yes Yes Yes, secure strage Recmmended Recmmended Yes N Recmmended Yes Where apprpriate Yes, where infectin is by airbrne rute Yes Recmmended Yes (available) Yes, n site Rev. 1 11

13 Table 2. Extract Frm The Eight Schedule Of The 1994 Bilgical Agents Regulatins Cntainment Measures At Different Cntainment Levels Fr Industrial Prcesses Utilising Bilgical Agents Cntainment Measures Cntainment Cntainme Cntainmen 1. Viable rganisms shuld be handled in a system which physically separates the prcess frm the envirnment 2. Exhaust gases frm the clsed system shuld be treated s as t: 3. Sample cllectin additin f materials t a clsed system and transfer f viable rganisms t anther clsed system, shuld be perfrmed s as t: 4. Bulk culture fluids shuld nt be remved frm the clsed system unless the viable rganisms have been: Level 2 nt Level 3 tlevel4 Yes Yes Yes Minimise release Minimise release Inactivated by validated means Prevent release Prevent release Inactivated by validated chemical r physical means Prevent Prevent release Prevent release Inactivated by validated chemical r physical means Prevent 5. Seals shuld be designed s as t: Minimise release release release 6. Clsed systems shuld be lcated within a Optinal Optinal Yes and cntrlled area purpse built (a) Bihazard signs shuld be psted Optinal Yes Yes (b) Access shuld be restricted t nminated Optinal Yes Yes, via an persnnel nly airlck (c) Persnnel shuld wear prtective clthing Yes, wrk Yes A cmplete clthing change (d) Decntaminatin and washing facilities Yes Yes Yes shuld be prvided fr persnnel (e) Persnnel shuld shwer befre leaving N Optinal Yes the cntrlled area (f) Effluent frm sinks and shwers shuld be N Optinal Yes cllected and inactivated befre release (g) The cntrlled area shuld be adequately Optinal Optinal Yes ventilated t minimise air cntaminatin (h) The cntrlled area shuld be maintained N Optinal Yes at an air pressure negative t atmsphere (i) Input air and extract air t the cntrlled N Optinal Yes area shuld be HEPA filtered (j) The cntrlled area shuld be designed t N Optinal Yes cntain spillage f the entire cntents f the clsed system (k) The cntrlled area shuld be sealable t permit fumigatin (l) Effluent treatment befre final discharge N Optinal Yes Inactivated by validated means Inactivated by validated chemical r physical means Inactivated by validated chemical r physical means Rev. 1 12

14 5.2.5 Training And Infrmatin Emplyers must prvide all emplyees with sufficient and apprpriate training and infrmatin cncerning: Any ptential risks t health The precautins t be taken t prevent expsure Any hygiene requirements Infrmatin n the wearing and use f persnal prtective equipment The steps t be taken by emplyees in the case f incidents and t prevent incidents Recrds Emplyers must keep recrds f all persns expsed t a Grup 3 r a Grup 4 bilgical agent (r bth), indicating the type f wrk dne by each emplyee, and, whenever pssible, the bilgical agent t which they have been expsed, as well as recrds f expsures accidents and incidents, as apprpriate. These recrds must be kept fr at least 10 years Health Surveillance Where necessary prvisins fr the Health Surveillance f emplyees shuld be made. Health Surveillance is defined as the peridic review, fr the purpse f prtecting health and preventing ccupatinally related disease, f the health f emplyees, s that any adverse variatins in their health which may be related t wrking cnditins are identified as early as pssible. Health surveillance may include at least ne f the fllwing measures: Keeping recrds f an emplyee's medical and ccupatinal histry A persnalised assessment f the emplyee's state f health Where apprpriate, bilgical mnitring as well as detectin f early and reversible effects Further tests may be decided upn fr each emplyee, when he is the subject f health surveillance, in the light f the mst recent knwledge available t ccupatinal medicine Rev. 1 13

15 6.0 Gd Micrbilgical / Hygiene Practices At a very minimum the fllwing bisafety precautins shuld be taken where relevant t avid expsure t bilgical agents when wrking in University labratries r similar: 1. The avidance f the use f a harmful bilgical agent r if the nature f the activity permits it s replacement with a less hazardus agent 2. The implementatin f gd hygiene practices, e.g. The prvisin f adequate welfare and washing facilities The cvering f all cuts and abrasins with a waterprf dressing The prhibitin f eating, drinking and smking in areas where bilgical agents may be present The washing f expsed skin fllwing cmpletin f wrk and befre eating, drinking r smking Nt inserting fingers int muth r biting fingernails 3. The keeping f the number f ptentially expsed persns t a minimum 4. The prvisin f adequate infrmatin and training t relevant persns particularly in the recgnitin f symptms f infectin 5. The prvisin f vaccinatins free f charge if deemed necessary t affected persns 6. The prvisin and use f suitable persnal prtective equipment which is prperly stred, cleaned as required, is replaced when defective and is separated frm nrmal clthing 7. The design f wrk practices s as t minimise ptential fr cntact with bilgical agents 8. Onging health screening fr affected persns if deemed necessary 9. The frmulatin and implementatin f lcal cdes f practice fr the safety f persnnel where required, especially fr the taking, handling and prcessing f samples f human r animal rigin 10. The display f warning ntices were necessary 11. The keeping f adequate recrds f persns ptentially expsed t infectius agents where deemed necessary 12. The drawing up f plans t deal with accidents invlving a bilgical agent. 13. The testing, where it is necessary and technically pssible, fr the presence, utside the primary physical cnfinement, f a bilgical agent used at wrk. 14. The use f means fr the safe cllectin, strage and dispsal f waste by emplyees, including the use f secure and identifiable cntainers, after suitable treatment where apprpriate. Rev. 1 14

16 15. The making f arrangements fr the safe handling and transprt f a bilgical agent within the wrkplace. In additin where bld prducts are being handled then the implementatin f a series f measures knwn as Universal Precautins shuld als be cnsidered. Universal Precautins are a set f safety guidelines which are based arund the Universal Precautins Fr The Handling Of Bld And Bld Based Prducts. The applicatin f Universal Precautins requires that all bld and bdy fluids be regarded as ptentially infectius and apprpriate prtective actin taken. Universal Precautins include: 1. The assumptin that all bld prducts are ptentially infectius 2. The implementatin f gd persnal hygiene practices and the avidance f hand r equipment t muth/eye/nse/ear cntact 3. The use f vaccinatins where necessary 4. The wearing f suitable persnal prtective equipment 5. The preventin f puncture wunds, cuts and abrasins in the presence f bld and bdy fluids 6. The prtectin f skin lesins and existing wunds n wrkers 7. The avidance f the use f sharps and sharp bjects when pssible but, where unavidable, taking particular care in their handling and dispsal 8. The develpment f suitable wrking area decntaminatin prcedures 9. The eliminatin r cntainment f any wrk practises that culd give rise t aersls r the uncntrlled release fmaterial 10. The develpment f emergency respnse plans 11. The dispsal f all cntaminated waste safely 12. The prvisin f training and infrmatin t all emplyees engaged in handling ptentially infectius material Rev. 1 15

17 7.0 Bilgical Agents Risk Assessment The ultimateaimfabilgical Agent Risk Assessment is t assess the risk frm the use / presence f the bilgical agent in the wrkplace t the health and safety f persns and t identify cntrl measures designed t reduce the risk t as lw a level as pssible. In the case f bilgical agents risk reductin can be achieved thrugh the use f prcedural, management and physical cntrls. Hazard is defined as the ptential / ability t cause harm, and in the case f bilgical agents the rganism / infectius material itself represents the hazard. Risk is defined as the ptential f the hazard, i.e. the bilgical agent cncerned, t cause harm under the actual circumstances f use. The assessment f risk is based n the linkage f the prbability f expsure / infectin f wrkers with the bilgical agent with the severity f injury resultant frm that expsure. The risk assessment matrix belw (Table 3) can be used t assess risk frm wrkplace hazards. Table 3. UniversityCllegeDublinStandard Risk Assessment Matrix Severity Of Outcme Of Expsure Prbability Of Slightly Harmful Very Harmful Expsure Harmful Unlikely Likely Very Likely trivial risk acceptable risk mderate risk acceptable risk mderate risk substantial risk mderate risk substantial risk intlerable risk Severity Of Outcme Of Expsure Slightly Harmful Outcmes: Superficial injuries Minr cuts and bruises Eye irritatin Nuisance and irritatin Temprary discmfrt Harmful Outcmes: Laceratins Burns Cncussin Sprains Minr fractures Rev. 1 16

18 Dermatitis Asthma Very Harmful Outcmes: Fatality Amputatin Majr fracture Pisning Cancer Life shrtening disease Deafness Head injuries Eye injuries Risk Rating Risk assessments are thus graded as trivial risk, acceptable risk, mderate risk, substantial risk r intlerable risk. Trivial Risk N actin needed Acceptable Risk N additinal risk cntrl measures required Mderate Risk Implement further risk cntrl measures if pssible Substantial Risk Further cntrl measures must beimplemented. If nt pssible then wrk must be strictly managed t ensure safety Intlerable Risk Wrk must be prhibited until further cntrl measures are implemented. Risk assessments must be cmpleted fr all bilgical agents in use prir t thse agents being used fr the first time and fr all wrkplace activities where there is a risk f expsure t bilgical agents. When carrying ut the risk assessment in the Rev. 1 17

19 case f activities invlving ptential expsure t several types f bilgical agent then the danger presented by all hazardus bilgical agents present must be cnsidered. Risk assessments must be cmpleted by a cmpetent persn. That persn must have sufficient knwledge and experience t identify and classify the hazards assciated with a bilgical agent and als hw t reduce the risks frm these hazards. When cmpleting any Bilgical Agents Risk Assessment the fllwing shuld always be brne in mind: The use f a less hazardus bilgical agent. The keeping as lw as pssible f the number f emplyees expsed r likely t be expsed t a bilgical agent. The design f wrk prcesses and engineering cntrl measures s as t avid r minimise the release f a bilgical agent int the place f wrk. The use f bth cllective prtectin measures, and individual prtectin measures where expsure cannt be avided by ther means. The use f hygiene measures cmpatible with the aim f preventing r reducing the accidental transfer r release f a bilgical agent frm the wrkplace. The use f the bihazard sign and ther relevant warning signs. The drawing up f plans t deal with accidents invlving a bilgical agent. The testing, where it is necessary and technically pssible, fr the presence, utside the primary physical cnfinement, f a bilgical agent used at wrk. The use f means fr the safe cllectin, strage and dispsal f waste by emplyees, including the use f secure and identifiable cntainers, after suitable treatment where apprpriate. The making f arrangements fr the safe handling and transprt f a bilgical agent within the wrkplace. Risk assessments must be reviewed n a regular basis (it is recmmended that Bilgical Agents Risk Assessments are reviewed at least annually) and when changes in wrk practices necessitate it. Written cpies f the mst up t date risk assessment must be maintained in the wrkplace and if deemed necessary extracts shuld be displayed prminently in r adjacent t the areas t which they refer. All risk assessments shuld be dated and have a sectin detailing their review histry. Rev. 1 18

20 The name f the persn wh wrte r last reviewed the assessment must be clearly indicated als. The University Safety Office recmmends the use f the UCD Pr Frma Bilgical Agents Risk Assessment Template when cnducting bilgical agents risk assessments. Rev. 1 19

21 8. UCD Pr Frma Bilgical Agents Risk Assessment Template The University Safety Officer has develped a pr frma template t aid persns in cmpleting a Bilgical Agents Risk Assessment. 1. Name & Status Of Persn Carrying Out Assessment Persns cmpleting the risk assessment shuld insert their name and status here, e.g. academic, pstgraduate students, etc. 2. Date Of Assessment Insert the date f assessment here. 3. Lcatin Of Wrk The physical lcatin f the wrk under review shuld be inserted here. 4. Detail The Prcess Invlving The Use Or Risk Of Expsure T Bilgical Agents A descriptin f the prcess invlving the risk f expsure t bilgical agents shuld be inserted here. Persns shuld indicate the frequency and duratin f the prcess, the materials t be handled and wh will be carrying ut the prcess. If necessary a written prcedure fr the prcess shuld be attached. 5. Des The Wrk Invlve The Deliberate Use Of A Named Bilgical Agent If the wrk invlves the use f a named bilgical agent persns shuld tick yes and mve t sectin 6. If nt they shuld tick n and mve t sectin Deliberate Use Of Named Bilgical Agent In this sectin persns shuld indicate the name and type f agent in use. They shuld als indicate its hazard classificatin and tick the relevant mandatry cntainment measures as utlined in Appendix 1 fr that class. If the agent in questin is a Class 1 rganism then they shuld prceed t Sectin 8. When this sectin is cmpleted persns shuld prceed t sectin Nn Deliberate Use Of Bilgical Agent The names f the agents that persns may be ptentially expsed t in their wrk shuld be indicated here. In wrk settings which are labratries, diagnstic labratries and rms in which deliberately infected animals r animals suspected f being infected are being kept Cntainment Level 2 measures must be implemented. See Appendix 1 fr details. Rev. 1 20

22 8. Is specialist training required befre this prcess cmmences Is specialist training is required the it must be rganised fr relevant persns befre the prcess can be undertaken. 9. List Persns Likely T Be Expsed T Bilgical Agents: The persns wh are likely t be expsed t the agent shuld be listed here. Apart frm the user themselves these may include ther persns in the labratry, cleaners, etc. 10 Ptential Likely Rutes Of Expsure The likely rute f expsure f persns t the bilgical agents in questin shuld be indicated here. 11. Ptential Health Effects Of Bilgical Agent(s) Detail the ptential health effects f the bilgical agents under cnsideratin here. 12. Cntrl Measures Designed T Allw Safe Use Of Agent In this sectin a range f infrmatin shuld be inserted. A. PPE Required: insert required PPE in this sectin B. Engineering cntrls required: state what engineering cntrls are required C. Insert emergency respnses fr spillages and accidental expsure and indicate a suitable disinfectant D. Indicate the gd hygiene practices required E Indicate if a vaccinatin is required and if s give details F Any further risk cntrl measures as deemed necessary shuld be indicated here. 13. Risk Rating Ariskrating fr the bilgical agent under review shuld be assigned in this sectin. If the final assessment is acceptable then the dcument shuld be signed and dated by the assessr. If the risk frm an agent cannt be reduced t an acceptable level then the wrk cannt be carried ut. This sectin shuld als be used t ascertain whether r nt the prcess is suitable fr lne wrking. Sectin 14. Ntificatin T The Health and Safety Authrity Required: Indicate if ntificatin is required t the HSA. Rev. 1 21

23 Sectin 15. Ntificatin T The University Bisafety Cmmittee All wrk with bilgical agents that may result in expsure t a bilgical agent must be ntified t the University Bisafety Cmmittee. Users shuld submit a cpy f their cmpleted risk assessment t bisafety@ucd.ie as ntificatin. Sectin 16. Revisin Histry The assessment s revisin histry shuld be detailed here. Rev. 1 22

24 University Cllege Dublin Pr Frma Bilgical Agents Risk Assessment Template Persns cmpleting this assessment shuld refer t the UCD Bisafety Manual 1. Name & Status Of Persn Carrying Out Assessment 2. Date Of Assessment 3. Lcatin Of Wrk 4. Detail The Prcess Invlving The Use Or Risk Of Expsure T Bilgical Agents indicate the frequency and duratin f the prcess, the materials t be handled and wh will be carrying it ut - if necessary attach a written prcedure fr the prcess. 5. Des The Wrk Invlve The Deliberate Use Of A Named Bilgical Agent Yes if yes prceed t sectin 6 N if n prceed t sectin 7 6. Deliberate Use Of Named Bilgical Agent Name Of Agent Type Of Agent (bacteria, virus, etc) Classificatin f Agent: (1-4) if Class 1 prceed t Sectin 8 Cntainment Required Cntainment Measures 1. The wrkplace is t be separated frm any ther activities in the same building 2. Input air and extract air t the wrkplace are t be filtered using HEPA r likewise 3. Access is t be restricted t nminated wrkers nly 4. The wrkplace is t be sealable t permit disinfectin 5. Specified disinfectin prcedures 6. The wrkplace is t be maintained at an air pressure negative t atmsphere 7. Effective vectr cntrl e.g. rdents and insects 8. Surfaces impervius t water and easy t clean 9. Surfaces resistant t acids, alkalis, slvents, disinfectants 10. Safe strage f a bilgical agent 11. An bservatin windw, r alternative, is t be present, s that ccupants can be seen 12. A labratry is t cntain wn equipment 13. Infected material including any animal is t be handled in a safety cabinet r islatr r ther suitable cntainment 14. Incineratr fr dispsal f animal carcases Ticking a cntainment measure indicates it s implementatin. Please see Appendix 1 fr mandatry cntainment measures. Prceed t Sectin 8 Implemented Rev. 1 23

25 7. Nn Deliberate Use Of Bilgical Agent Detail ptential infectius agents that persns may be expsed t: In wrk settings which are labratries, diagnstic labratries and rms in which deliberately infected animals r animals suspected f being infected are being kept Cntainment Level 2 measures must be implemented. See Appendix 1 fr details. Have these measures been implemented where necessary yes 8. Is specialist training required befre this prcess cmmences: yes n 9. List Persns Likely T Be Expsed T Bilgical Agents: 10. Indicate Ptential Rutes Of Expsure Ingestin Of The Agent Inhalatin Of The Agent Entry Via Mucsal Membranes Subcutaneus Entry Entry Via Damaged Skin Physical Cntaminatin 11. Ptential Health Effects Of Bilgical Agent(s) 12. Risk Cntrl Measures Designed T Allw Safe Use Of Agent A. PPE Required: Lab Cat: Safety Glasses: Safety Gggles: Face Shield: Glves: Other: (give details) B. Engineering Cntrls Required: Safety Cabinet Other: (give details) C. Emergency Respnse First Aid Respnses Spill Respnse Suitable Disinfectant D. Gd Hygiene Practises: N eating r drinking in wrk area Hand washing Facilities Available Mandatry washing f expsed skin after wrk cmpleted Cvering f cuts and abrasins N insertin f bjects int muth, etc Rev. 1 24

26 E. Vaccinatin Required n yes (give details) F. Further Risk Cntrl Measures Required T Eliminate / Minimise Identified Rutes Of Expsure (Sectin 10) Cnsider the fllwing: 1. The design f wrk practices s as t minimise ptential fr cntact with bilgical agents 2. Onging health screening fr affected persns if deemed necessary 3. The frmulatin and implementatin f lcal cdes f practice fr the safety f persnnel where required, especially fr the taking, handling and prcessing f samples f human r animal rigin 4. The display f warning ntices were necessary 5. The keeping f adequate recrds f persns ptentially expsed t infectius agents where deemed necessary 6. The drawing up f plans t deal with accidents invlving a bilgical agent. 7. The testing, where it is necessary and technically pssible, fr the presence, utside the primary physical cnfinement, f a bilgical agent used at wrk. 8. The use f means fr the safe cllectin, strage and dispsal f waste by emplyees, including the use f secure and identifiable cntainers, after suitable treatment where apprpriate. 9. The making f arrangements fr the safe handling and transprt f a bilgical agent within the wrkplace. 10. The remval f sharps frm the wrkplace 11. The implementatin f Universal Precautins fr handling bld prducts 12. The restrictin f access t the wrkplace 13. Pregnant emplyees 14. Equipment requirements 15. Sharps issues 16. Lab animal issues 17. Additinal hygiene cntrl measures Rev. 1 25

27 13. Risk Rating Assessment f Severity High (H ) = Very Harmful Medium (M) = Harmful Lw (L) = Slightly Harmful Assessment f Likelihd Of Expsure: High (H) = Very Likely Medium (M) = Likely Lw (L) = Unlikely Risk = Severity x Likelihd RISK RATING: Likelihd Severity L M H L M H Shaded Area = risk rating 1. Trivial Risk: N further actin needed 2. Acceptable Risk: N additinal risk cntrl measures required 3. Mderate Risk: Implement further risk cntrl measures if pssible 4. Substantial Risk: Further cntrl measures must be implemented. If this is nt pssible then wrk must be strictly managed t ensure safety. 5. Intlerable: Wrk must be prhibited until further cntrl measures are implemented. Is the risk rating acceptable: If yes sign and date belw and ensure all risk cntrl measures have been implemented. If n identify further cntrl measures and reassess risk. If the risk cannt be reduced t an acceptable level then prcess cannt be carried ut. yes n Signed: Date: Psitin: Is the prcess suitable fr lne wrking yes n Sectin 14. Ntificatin T The Health and Safety Authrity Required yes n Sectin 15. Ntificatin T The University Bisafety Cmmittee yes n Sectin 16. Revisin Histry Rev. 1 26

28 Appendix 1. Extract Frm The Seventh Schedule Of The 1994 Bilgical Agents Regulatins Cntainment Measures At Different Cntainment Levels Fr Health And Veterinary Care Facilities, Labratries, Diagnstic Labratries And Rms In Which Deliberately Infected Animals Or Animals Suspected Of Being Infected Are Being Kept. Cntainment Measures Cntainment Cntainment Cntainment 1. The wrkplace istbe separated frm any ther activities in the same building 2. Input air and extract air t the wrkplace are t be filtered using HEPA r likewise 3. Access is t be restricted t nminated wrkers nly 4. The wrkplace is t be sealable t permit disinfectin 5. Specified disinfectin prcedures 6. The wrkplace is t be maintained at an air pressure negative t atmsphere 7. Effective vectr cntrl e.g. rdents and insects 8. Surfaces impervius t water and easy t clean 9. Surfaces resistant t acids, alkalis, slvents, disinfectants 10. Safe strage f a bilgical agent 11. An bservatin windw, r alternative, is t be present, s that ccupants can be seen 12. A labratry is t cntain wn equipment 13. Infected material including any animal is t be handled in a safety cabinet r islatr r ther suitable cntainment 14. Incineratr fr dispsal f animal carcases Level 2 Level 3 Level 4 N Recmmended Yes N Yes, n extract air Yes, n input and extract air Recmmended Yes Yes, via airlck N Recmmended Yes Yes Yes Yes N Recmmended Yes Recmmended Yes Yes Yes, fr bench Yes, fr bench and flr Recmmended Yes Yes Yes, fr bench, walls, flr and ceiling Yes Yes Yes, secure strage Recmmended Recmmended Yes N Recmmended Yes Where apprpriate Yes, where infectin is by airbrne rute Yes Recmmended Yes (available) Yes, n site Rev. 1 27

29 9. Bilgical Labratry Safety Key Aspects 9.1 Emergency Planning All labratries / facilities where bilgical agents are handled must have in place at all times anemergency Respnse Plan which utlines the respnses t be taken in the event f an emergency. Emergencies may include such things as fire, gas leak, chemical leak, failure f critical equipment, pwer failure, wrker injury, expsure t a bilgical agent, unintentinal release r spillage f a bilgical agent, etc. The emergency respnse plan must detail the necessary steps t be taken t deal with such incidents. Key functinaries must be named and their respnsibilities utlined in the plan. If any emergency respnse equipment is identified by the plan as being required t deal with an incident then this material must be kept readily available n site and if necessary training in its crrect use must be given t the named functinaries. Emergency Respnse Plans shuld be reviewed n a regular basis and when changes in wrk practices necessitate it. Respnse plans must be tested n a regular basis. 9.2 Spillages AkeypartftheEmergency Respnse Plan is the prcedure t be fllwed in the event f a spillage r lss f bilgical material. Key t the safe management f spillages is the use f apprpriate disinfectants, persnal prtective equipment (PPE) and staff training. Fr spillages where aersls are nt likely t be prduced persns shuld dn the necessary PPE and treat the affected area with an apprpriate dry disinfectant r cver with tissue paper and apply a liquid disinfectant. The treated area shuld be allwed t remain lng enugh fr the disinfectant t take effect befre being cleaned and the waste material being dispsed ff accrdingly. The cntact time and the type f disinfectant t be used may vary depending n the bilgical agent in questin and this shuld be clearly indicted in the Emergency Respnse Plan. Where a spillage may give rise t aersls, e.g. during the rupture f a sample tube in a centrifuge, the area must be evacuated and the drplets allwed time t settle. Persns then wearing apprpriate PPE may enter the effected area treat the spillage. In sme cases extensive decntaminatin f the wrking area may be required. If Rev. 1 28

30 deemed necessary testing fr the presence f the bilgical agent can be dne fllwing the cmpletin f the disinfectant prcedure. Respiratry prtectin may be required when dealing with spillages that have generated aersls. 9.3 Wrker Training / Supervisin All persns wrking with bilgical agents must be adequately trained s that they can wrk with the material safely and withut undue risk t their wn r their cwrkers safety. The extent f a wrkers training will depend n the nature f the wrk in which they are engaged and the type f bilgical agent which they are handling. All wrkers will require sme frm f supervisin, especially undergraduate students and inexperienced pstgraduates. Academic supervisrs and facility managers must ensure that apprpriate supervisin is prvided t all staff under their cntrl. Emplyers must prvide all emplyees with sufficient and apprpriate training and infrmatin cncerning: Any ptential risks t health The precautins t be taken t prevent expsure Any hygiene requirements Infrmatin n the wearing and use f persnal prtective equipment The steps t be taken by emplyees in the case f incidents and t prevent incidents All relevant risk assessments and labratry prcedures Any labratry equipment that they are required r are likely t use (refer t Table 4 belw) Emplyers must als prvide written instructins and if apprpriate display ntices which must include the prcedures t be fllwed in the event f a serius accident r incident invlving the handling f a bilgical agent. All training and infrmatin must be prvided in a frm, manner and language likely t be understd by the persn receiving the training. Training shuld nt be limited t thse wrking at the bench; managers, administratrs, services staff, maintenance cntractrs and cleaners may require sme frm f training. Senirity f rank / grade is nt an indicatin f cmpetence. Similarly a lack f frmal qualificatins des nt indicate a lack f cmpetence. Cmpetency shuld be viewed as a cmbinatin f training, experience and Rev. 1 29

31 knwledge which enables the user t handle and wrk with the bilgical agent safely. A minimum training / cmpetency level fr all relevant emplyees must be laid dwn within the risk assessment. Cntainment Level 1and2 3and4 Table 4 Wrker Training Requirements Key Cmpetencies Awareness f the nature f the bilgical agents in use and its health effects Awareness and understanding f allprceduresandrisk assessments Technical cmpetency fr wrk in questin Knwledge and understanding f disinfectin and hygiene requirements Knwledge f waste management prvisins Knwledge f the emergency respnse plan Safe use f PPE As fr Class 1 and 2 Safe evacuatin, sealing and fumigatin prcedures 9.4 Lne Wrking All labratries r facilities must have in place a Lne Wrking Plicy. This plicy must utline the requirements fr thse persns wh wish t wrk with bilgical agents during ut f hurs perids when they are may be alne in the labratry. At a minimum persns wishing t engage in lne wrking shuld be required t prduce a Lne Wrking Risk Assessment in rder t identify any ptential hazards assciated with the wrk and t assign a risk rating t the lne wrk. This assessment must be reviewed and apprved by the facility manager / academic supervisr befre lne wrking can cmmence. Lne wrking must nt be allwed fr any High Risk activities, when wrking with Class 3 r 4 agents and when engaging in any activity the emergency respnse t which requires the presence f mre than ne persn. 9.5 Recrd Keeping The 1994 Bilgical Agents Regulatins requires that a range f recrds be kept when persns are wrking with ptentially hazardus bilgical agents. All risk assessments carried ut fr any wrk with a bilgical agent(s) must be kept in a written frmat in the wrkplace. All vaccinatin recrds and training recrds fr staff wrking with bilgical agents must be available within the wrkplace. Rev. 1 30

32 All recrds f any health surveillance undertake must be maintained by the university (these recrds must be made available t the individual emplyees cncerned if requested). Accident recrds must be available in the wrkplace Emplyers must als keep a list f the emplyees wh may have been expsed t a Class 3 r 4 bilgical agent (r bth), indicating the type f wrk dne by each emplyee, and, whenever pssible, the bilgical agent t which they have been expsed, as well as recrds f expsures accidents and incidents, as apprpriate. This list must be kept fr at least 10 years fllwing the end f expsure. Such recrds must be kept fr 40 years in situatins where: The wrk was with a bilgical agent knwn t be capable f establishing persistent r latent infectins That in the light f present knwledge, are indiagnseable until illness later develps That have particularly lng incubatin perids befre illness develps That result in an illness which recrudesce at times ver a lng perid despite treatment That result in illnesses that may have serius lng-term sequelae In additin t the abve recrds which must be kept t cmply with statutry requirements labratry managers / prject managers must als keep all recrds pertaining t equipment maintenance, waste dispsal and staff training. All users f genetically mdified material must keep a written recrd f the wrk carried ut n each cntained use and such recrds must be submitted t the Envirnmental Prtectin Agency within ne mnth f the end f each calendar year. Users f Class 1 material must keep a written recrd f each risk assessment and f the wrk carried ut n each cntained use, and such recrds must be submitted t the EPA within ne mnth f the end f each calendar year. 9.6 Selectin Of Persnal Prtective Equipment Health and safety legislatin requires that where the risk frm a hazard cannt be cntrlled by ther means then wrkers must be prvided with suitable Persnal Prtective Equipment (PPE) designed t prtect their safety. Whilst the use f PPE is generally cnsidered t be the ptin f last resrt when cntrlling wrkplace Rev. 1 31

33 hazards in the case f wrking with bilgical agents the selectin and crrect use f apprpriate PPE is key t cntrlling the risks presented by bilgical material. Emplyers must ensure that any necessary PPE supplied is prperly stred in a designated place, is checked and cleaned if pssible, befre, and in any case after each use, and is repaired, where defective, r replaced, befre further use. Prtective Clthing All persns wrking in a bilgical labratry must at a minimum wear a clsed labratry cat. Such cats must be remved when leaving the labratry and must be laundered n a regular basis. In s far as is practicable such cats shuld be laundered in-huse and nt brught t the users hme. Heavily siled labratry cats shuld be remved immediately and if necessary dispsed ff. Glves Persns invlved in the manipulatin f bilgical material must als wear prtective glves. Dispsable glves which prvide a mechanical barrier between the users skin and the material being handled are sufficient. Where pssible latex glves shuld be avided due t the allergic reactins that such material can generate in wearers. If certain prcedures are being undertaken then the use f specialist glves may be required, e.g. when handling cntaminated sharps, cleaning up brken glass, etc. In sme cases duble glving may be required. Eye / Face Prtectin Where there is a risk f material splashing r being ejected under pressure safety glasses must be wrn by wrkers. Cnsideratin shuld be given t the wearing f a full face shield when bld is being handled and there is a risk f splashing. Respiratry Prtectin Under nrmal cnditins respiratry prtectin shuld nt be required in labratries handling Class 1 and 2 bilgical agents, althugh it may be required in labratries handling Class 3 and 4 material. If a mask is required t prtect the wrker frm the material being handled then the risk cntrl measures have failed. Hwever, respiratry prtectin may be required during the clean up fllwing the spillage r unintentinal release f bilgical material. If specialist respiratry prtectin is required in such instances then apprpriate training must be given t the persns respnsible fr its use. Rev. 1 32