Kornati Islands, Croatia

Risk management in Risk management in medical laboratoriesmedical laboratories

Ana Stavljenic-RukavinaAna Stavljenic-Rukavina Zagreb, CroatiaZagreb, Croatia

The annual rate of illness and injury reported for hospital workers is 10% - about the same as for sheet metal workers, auto mechanics and paper mill workers

(Am J of Nursing, 1992)

The annual rate of illness and injury reported for hospital workers is 10% - about the same as for sheet metal workers, auto mechanics and paper mill workers

(Am J of Nursing, 1992)

The most frequent occupation-related illnesses among hc

personel

The most frequent occupation-related illnesses among hc

personel

respiratory problemsrespiratory problems infectionsinfectionsdermatitisdermatitisdrug or medication drug or medication

reactionsreactions

Reasons for the lack of emphasis on employer’s health:

Reasons for the lack of emphasis on employer’s health:

common notion that health common notion that health professionals are capable of professionals are capable of maintaining their health without maintaining their health without assistanceassistance

availability of informal consultation availability of informal consultation with hospital physicianwith hospital physician

hospitals are oriented toward hospitals are oriented toward treating disease rather than treating disease rather than maintaining healthmaintaining health

Accidents do not happen, they are caused

Accidents do not happen, they are caused

Safety should be taught and Safety should be taught and implemented on every level in the implemented on every level in the health care sectorhealth care sector

Within health care environment, both Within health care environment, both workers and patients are daily workers and patients are daily confronted with various health and confronted with various health and safety hazardssafety hazards

Therefore, implementation of general Therefore, implementation of general safety and risk reduction system is safety and risk reduction system is mandatorymandatory

LABORATORY HAZARDSNon-infectious InfectiousLABORATORY HAZARDSNon-infectious Infectious

dustsdusts physical agentsphysical agents chemical agentschemical agents mutagenic and mutagenic and

teratogenic teratogenic agentsagents

skin irritantsskin irritants stress (!)stress (!)

hepatitishepatitis AIDSAIDS

Material Safety Data Sheets (MSDS)

Material Safety Data Sheets (MSDS)

It is obligatory that the vendors supply It is obligatory that the vendors supply MSDS for the chemicalsMSDS for the chemicals

Vendor should make sure that the Vendor should make sure that the facility receives the MSDS before or facility receives the MSDS before or along the shipment of chemical productalong the shipment of chemical product

MSDS must be available for each MSDS must be available for each chemical used in an operationchemical used in an operation

Emergency and first aid procedures and Emergency and first aid procedures and handling precautions should be given in handling precautions should be given in writen form to professionalswriten form to professionals

Infectious occupational health hazards

Infectious occupational health hazards

Hepatitis B: a model for Hepatitis B: a model for transmission of blood-borne transmission of blood-borne patogens (10-40% of health care patogens (10-40% of health care workers have serologic evidence of workers have serologic evidence of past or present infection)past or present infection)

Infection risk after needle puncture:Infection risk after needle puncture:

HBV: 5-40%HBV: 5-40% HCV: 1-10%HCV: 1-10% HIV: <0.5%HIV: <0.5%

An individual is at risk for HBV or HIV infection in proportion to the extent at which he/she is exposed to blood and body fluids

An individual is at risk for HBV or HIV infection in proportion to the extent at which he/she is exposed to blood and body fluids

Therefore, effective protection against blood-borne diseases requires universal observation of common barrier precautions

Therefore, effective protection against blood-borne diseases requires universal observation of common barrier precautions

....which simply means: within healthcare environment, all body fluids and tissues should be treated as infectious. Equally important: waste disposal!

....which simply means: within healthcare environment, all body fluids and tissues should be treated as infectious. Equally important: waste disposal!

COMPONENTS OF MEDICAL SAFETY COMPONENTS OF MEDICAL SAFETY

Employee safetyEmployee safety Patient safetyPatient safety Environment safetyEnvironment safety

ELEMENTS OF EMPLOYEE SAFETYELEMENTS OF EMPLOYEE SAFETY

Blood and body fluid exposuresBlood and body fluid exposures AAllergiesllergies Communicable disease exposuresCommunicable disease exposures Musculoskeletal injuriesMusculoskeletal injuries Immunization programImmunization program Systematic review, follow-up, and Systematic review, follow-up, and

reporting of employee incidentsreporting of employee incidents

Levels of Biosafety Levels of Biosafety

BSL 1: Material not known to consistently BSL 1: Material not known to consistently cause disease in healthy adults.cause disease in healthy adults.

BSL 2: Associated with human disease. BSL 2: Associated with human disease. Hazard is from percutaneous injury, Hazard is from percutaneous injury, ingestion, or mucous membrane exposure.ingestion, or mucous membrane exposure.

BSL 3: Indigenous or exotic agents with BSL 3: Indigenous or exotic agents with potential for aerosol transmission; disease potential for aerosol transmission; disease may have serious or lethal consequences.may have serious or lethal consequences.

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

Risk AssessmentRisk Assessment

Pathogenicity of material – disease incidence Pathogenicity of material – disease incidence and severityand severity

Routes of Transmission – parenteral, airborne Routes of Transmission – parenteral, airborne or ingestionor ingestion

Agent Stability – ease of decontaminationAgent Stability – ease of decontamination Infectious Dose – LD50Infectious Dose – LD50 Concentration – infectious organisms/vol. & Concentration – infectious organisms/vol. &

working volumeworking volume Origin of material - Wild Type, primary cellsOrigin of material - Wild Type, primary cells Availability of effective prophylaxis – Hep. B Availability of effective prophylaxis – Hep. B

vaccinevaccine Medical surveillance – exposure managementMedical surveillance – exposure management Skill level of staffSkill level of staff

Risk AssessmentRisk Assessment

Risk of Activity – same agent can have Risk of Activity – same agent can have different containment levels at different different containment levels at different stages of protocol:stages of protocol: Procedures that produce aerosols Procedures that produce aerosols

have higher riskhave higher risk Procedures using needles or other Procedures using needles or other

sharps have higher risksharps have higher risk Handling blood, serum or tissue Handling blood, serum or tissue

samples may have lower risksamples may have lower risk Purified cultures or cell concentrates Purified cultures or cell concentrates

may have higher riskmay have higher risk Larger volumes (10 L) have higher riskLarger volumes (10 L) have higher risk

Primary ContainmentPrimary Containment

Lab practices – Lab practices – SOP regulatingSOP regulating access, access, biohazard warning sign, sharps/needle biohazard warning sign, sharps/needle precautions, SOPs for deconprecautions, SOPs for decontamination tamination andand waste. waste.

Safety equipment – biosafety cabinets Safety equipment – biosafety cabinets (BSC), sharps containers, sealed rotors.(BSC), sharps containers, sealed rotors.

Personal protective equipment (PPE) Personal protective equipment (PPE) : : coat, gloves, goggles.coat, gloves, goggles.

Host-vector for rDNAHost-vector for rDNA

Aerosol PrecautionsAerosol Precautions

Use BSC for all procedures that may Use BSC for all procedures that may generate aerosols.generate aerosols.

Use centrifuges with biosafety covers.Use centrifuges with biosafety covers. Do not use a syringe for mixing Do not use a syringe for mixing

infectious fluids. infectious fluids. Cultures, tissues, specimens of body Cultures, tissues, specimens of body

fluids, etc., are placed in a container fluids, etc., are placed in a container with a cover that prevents leakage with a cover that prevents leakage during collection, handling, processing, during collection, handling, processing, storage, transport or shipping.storage, transport or shipping.

Needle and Sharps PrecautionsNeedle and Sharps Precautions

Precautions are for any Precautions are for any contaminated sharp item, contaminated sharp item, including needles and syringes, including needles and syringes, slides, pipettes, capillary tubes, slides, pipettes, capillary tubes, and scalpels.and scalpels.

Plasticware should be substituted Plasticware should be substituted for glassware whenever possible.for glassware whenever possible.

Needle and Sharps PrecautionsNeedle and Sharps Precautions

Used disposable needles must not be bent, Used disposable needles must not be bent, sheared, broken, recapped, removed from sheared, broken, recapped, removed from disposable syringes, or otherwise disposable syringes, or otherwise manipulated by hand before disposal. manipulated by hand before disposal. Dispose in puncture-resistant containers Dispose in puncture-resistant containers which must be located near work. which must be located near work.

Non-disposable sharps must be placed in a Non-disposable sharps must be placed in a hard-walled container for transport to a hard-walled container for transport to a processing area for decontamination, processing area for decontamination, preferably by autoclaving.preferably by autoclaving.

Broken glassware must not be handled Broken glassware must not be handled directly by hand.Pick up by mechanical directly by hand.Pick up by mechanical means such as a brush and dustpan, tongs, means such as a brush and dustpan, tongs, or forceps. or forceps.

Human Blood, Tissue and Fluid

Human Blood, Tissue and Fluid

Occupational Exposure to Bloodborne PathogensOccupational Exposure to Bloodborne Pathogens

Use BSL 2 work practices and procedures.Use BSL 2 work practices and procedures. Additional requirements for HIV work.Additional requirements for HIV work. Everyone needs to be offered the Hepatitis Everyone needs to be offered the Hepatitis

B vaccine.B vaccine. Develop specific exposure plan SOPs. Develop specific exposure plan SOPs. Specific training is required.Specific training is required. Review needle/syringe use and replace with Review needle/syringe use and replace with

“safe” devices.“safe” devices. Exposure incidents must be followed up.Exposure incidents must be followed up.

ToxinsToxins

Use BSL 2 work practices and Use BSL 2 work practices and procedures. procedures.

Develop a Chemical Hygiene Develop a Chemical Hygiene Plan specific to the toxin used. Plan specific to the toxin used. Include containment (hoods, Include containment (hoods, biosafety cabinets).biosafety cabinets).

Some toxins are “Select Some toxins are “Select Agents” and require Agents” and require registration.registration.

Select AgentsSelect Agents

Possession, use and transfer of Possession, use and transfer of specific biological agents requires specific biological agents requires registrationregistration..

““Restricted Persons” are not Restricted Persons” are not allowed to have access to these allowed to have access to these agents.agents.

High security and containment High security and containment must be maintained.must be maintained.

SecuritySecurity

Control access to areas where biological Control access to areas where biological agents or toxins are used and stored.agents or toxins are used and stored.

Keep biological agents and toxins in Keep biological agents and toxins in locked containers.locked containers.

Know who is in the labKnow who is in the laboratory, oratory, what what materials are being brought materials are being brought andand what what materials are being removed from the materials are being removed from the lablaboratoryoratory..

Have a protocol for reporting incidents.Have a protocol for reporting incidents. Have an emergency plan.Have an emergency plan.

EmergenciesEmergencies

Develop and practice plans for:Develop and practice plans for: Spills: large spills, spills inside BSCSpills: large spills, spills inside BSC Accidental exposures: needlesticks, Accidental exposures: needlesticks,

eye/mucous membrane splash, eye/mucous membrane splash, breathing aerosolsbreathing aerosols

Power/Utility failures: BSC, freezers, Power/Utility failures: BSC, freezers, ventilation, lights, waterventilation, lights, water

FiresFires Medical emergenciesMedical emergencies

Waste DisposalWaste Disposal

““Red bag” or “Regulated Medical Waste”:Red bag” or “Regulated Medical Waste”: All mammalian cells or anything that All mammalian cells or anything that

came in contact with mammalian cellscame in contact with mammalian cells All BSL 2 material or anything that All BSL 2 material or anything that

came in contact with BSL 2 materialcame in contact with BSL 2 material All needles/syringes regardless of useAll needles/syringes regardless of use

No need to autoclave this waste prior No need to autoclave this waste prior to disposal in EH&S red bag/box to disposal in EH&S red bag/box (material is incinerated).(material is incinerated).

CRITICAL ELEMENTSCREATING A SAFETY CULTURECRITICAL ELEMENTSCREATING A SAFETY CULTURE

Demonstrate top leadership Demonstrate top leadership commitment to safetycommitment to safety

Swift and visible correction of unsafe Swift and visible correction of unsafe conditionsconditions

Established procedures for reporting Established procedures for reporting unsafe conditionsunsafe conditions

Reward workers for following Reward workers for following proceduresprocedures

Involve frontline healthcare workers in Involve frontline healthcare workers in identifying problems and solutionsidentifying problems and solutions

Role of managementRole of management

The scope: identifying The scope: identifying problem areas and exerting problem areas and exerting specific actions to correct specific actions to correct themthem

Development of Safety Program

Development of Safety Program

Recognition of hazardsRecognition of hazards Determination (evaluation) of Determination (evaluation) of

hazardshazards Baseline health and safety Baseline health and safety

surveysurvey Sampling strategySampling strategy Health and safety planHealth and safety plan

Risk managementRisk management

RISK ASSESSMENT (GENERIC)RISK ASSESSMENT (GENERIC)||

TAKE THE DESIGN INTENTIONTAKE THE DESIGN INTENTIONll

CHANGE IT BY "GUIDE WORDS"CHANGE IT BY "GUIDE WORDS"ll

CREATE HYPOTHETICAL DEVIATIONSCREATE HYPOTHETICAL DEVIATIONSll

CREATE IMAGESCREATE IMAGESll

STIMULATE IMAGINATIONS OF THE TEAM TO SEARCH DATA FOR REAL STIMULATE IMAGINATIONS OF THE TEAM TO SEARCH DATA FOR REAL DEVIATIONSDEVIATIONS

llEXAMINE CAUSES AND CONSEQUENCEEXAMINE CAUSES AND CONSEQUENCE

HARMLESSHARMLESS HARMFULHARMFUL

IGNOREIGNORE ELIMINATE OR CONTROLELIMINATE OR CONTROL

RegulationsRegulations

OSHA Bloodborne PathogensOSHA Bloodborne Pathogens http://www.osha.gov/SLTC/bloodbornepathogens/index.htmlhttp://www.osha.gov/SLTC/bloodbornepathogens/index.html CDC Select AgentsCDC Select Agents http://www.cdc.gov/od/ohs/lrsat.htmhttp://www.cdc.gov/od/ohs/lrsat.htm NIH Guidelines for Research Involving Recombinant DNA NIH Guidelines for Research Involving Recombinant DNA

Molecules Molecules http://www4.od.nih.gov/oba/rac/guidelines/guidelines.htmlhttp://www4.od.nih.gov/oba/rac/guidelines/guidelines.html DOT/CDC ShippingDOT/CDC Shipping http://www.cdc.gov/od/ohs/biosfty/shipregs.htmhttp://www.cdc.gov/od/ohs/biosfty/shipregs.htm CDC Import PermitsCDC Import Permits http://www.cdc.gov/od/ohs/biosfty/imprtper.htmhttp://www.cdc.gov/od/ohs/biosfty/imprtper.htm USDA/APHIS PermitsUSDA/APHIS Permits http://www.aphis.usda.gov/vs/ncie/http://www.aphis.usda.gov/vs/ncie/

ResourcesResources

CDC Biosafety in Microbiological and CDC Biosafety in Microbiological and Biomedical Laboratories Biomedical Laboratories

http://www.cdc.gov/od/ohs/biosfty/bmbl4/bmbl4toc.htm ABSA Risk GroupsABSA Risk Groupshttp://www.absa.org/riskgroups/index.htm Canadian MSDSsCanadian MSDSshttp://www.hc-sc.gc.ca/pphb-dgspsp/msds-ftss/index.html Environmental Health & Safety – Lab Environmental Health & Safety – Lab

Safety Safety http://www.ehs.sunysb.edu or 2-9672 or 2-9672