Kornati Islands, Croatia Risk management in medical laboratories Ana Stavljenic-Rukavina Zagreb, Croatia Zagreb, 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 most frequent occupation- related illnesses among hc personel ä respiratory problems ä infections ä dermatitis ä drug or medication reactions

Reasons for the lack of emphasis on employers health: common notion that health professionals are capable of maintaining their health without assistance common notion that health professionals are capable of maintaining their health without assistance availability of informal consultation with hospital physician availability of informal consultation with hospital physician hospitals are oriented toward treating disease rather than maintaining health hospitals are oriented toward treating disease rather than maintaining health

Accidents do not happen, they are caused Safety should be taught and implemented on every level in the health care sector Safety should be taught and implemented on every level in the health care sector Within health care environment, both workers and patients are daily confronted with various health and safety hazards Within health care environment, both workers and patients are daily confronted with various health and safety hazards Therefore, implementation of general safety and risk reduction system is mandatory Therefore, implementation of general safety and risk reduction system is mandatory

LABORATORY HAZARDS Non-infectiousInfectious dusts dusts physical agents physical agents chemical agents chemical agents mutagenic and teratogenic agents mutagenic and teratogenic agents skin irritants skin irritants stress (!) stress (!) hepatitis hepatitis AIDS AIDS

Material Safety Data Sheets (MSDS) It is obligatory that the vendors supply MSDS for the chemicals It is obligatory that the vendors supply MSDS for the chemicals Vendor should make sure that the facility receives the MSDS before or along the shipment of chemical product Vendor should make sure that the facility receives the MSDS before or along the shipment of chemical product MSDS must be available for each chemical used in an operation MSDS must be available for each chemical used in an operation Emergency and first aid procedures and handling precautions should be given in writen form to professionals Emergency and first aid procedures and handling precautions should be given in writen form to professionals

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

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!

COMPONENTS OF MEDICAL SAFETY Employee safety Employee safety Patient safety Patient safety Environment safety Environment safety

ELEMENTS OF EMPLOYEE SAFETY Blood and body fluid exposures Blood and body fluid exposures Allergies Allergies Communicable disease exposures Communicable disease exposures Musculoskeletal injuries Musculoskeletal injuries Immunization program Immunization program Systematic review, follow-up, and reporting of employee incidents Systematic review, follow-up, and reporting of employee incidents

Levels of Biosafety BSL 1: Material not known to consistently cause disease in healthy adults. BSL 1: Material not known to consistently cause disease in healthy adults. BSL 2: Associated with human disease. Hazard is from percutaneous injury, ingestion, or mucous membrane exposure. BSL 2: Associated with human disease. Hazard is from percutaneous injury, ingestion, or mucous membrane exposure. BSL 3: Indigenous or exotic agents with potential for aerosol transmission; disease may have serious or lethal consequences. BSL 3: Indigenous or exotic agents with potential for aerosol transmission; disease may have serious or lethal consequences. BSL 4: Dangerous/exotic agents which pose a high risk of life-threatening disease, aerosol- transmitted lab infections or related agents with unknown risk of transmission. BSL 4: Dangerous/exotic agents which pose a high risk of life-threatening disease, aerosol- transmitted lab infections or related agents with unknown risk of transmission.

Risk Assessment Pathogenicity of material – disease incidence and severity Pathogenicity of material – disease incidence and severity Routes of Transmission – parenteral, airborne or ingestion Routes of Transmission – parenteral, airborne or ingestion Agent Stability – ease of decontamination Agent Stability – ease of decontamination Infectious Dose – LD50 Infectious Dose – LD50 Concentration – infectious organisms/vol. & working volume Concentration – infectious organisms/vol. & working volume Origin of material - Wild Type, primary cells Origin of material - Wild Type, primary cells Availability of effective prophylaxis – Hep. B vaccine Availability of effective prophylaxis – Hep. B vaccine Medical surveillance – exposure management Medical surveillance – exposure management Skill level of staff Skill level of staff

Risk Assessment Risk of Activity – same agent can have different containment levels at different stages of protocol: Risk of Activity – same agent can have different containment levels at different stages of protocol: Procedures that produce aerosols have higher risk Procedures that produce aerosols have higher risk Procedures using needles or other sharps have higher risk Procedures using needles or other sharps have higher risk Handling blood, serum or tissue samples may have lower risk Handling blood, serum or tissue samples may have lower risk Purified cultures or cell concentrates may have higher risk Purified cultures or cell concentrates may have higher risk Larger volumes (10 L) have higher risk Larger volumes (10 L) have higher risk

Primary Containment Lab practices – SOP regulating access, biohazard warning sign, sharps/needle precautions, SOPs for decontamination and waste. Lab practices – SOP regulating access, biohazard warning sign, sharps/needle precautions, SOPs for decontamination and waste. Safety equipment – biosafety cabinets (BSC), sharps containers, sealed rotors. Safety equipment – biosafety cabinets (BSC), sharps containers, sealed rotors. Personal protective equipment (PPE) : coat, gloves, goggles. Personal protective equipment (PPE) : coat, gloves, goggles. Host-vector for rDNA Host-vector for rDNA

Aerosol Precautions Use BSC for all procedures that may generate aerosols. Use BSC for all procedures that may generate aerosols. Use centrifuges with biosafety covers. Use centrifuges with biosafety covers. Do not use a syringe for mixing infectious fluids. Do not use a syringe for mixing infectious fluids. Cultures, tissues, specimens of body fluids, etc., are placed in a container with a cover that prevents leakage during collection, handling, processing, storage, transport or shipping. Cultures, tissues, specimens of body fluids, etc., are placed in a container with a cover that prevents leakage during collection, handling, processing, storage, transport or shipping.

Needle and Sharps Precautions Precautions are for any contaminated sharp item, including needles and syringes, slides, pipettes, capillary tubes, and scalpels. Precautions are for any contaminated sharp item, including needles and syringes, slides, pipettes, capillary tubes, and scalpels. Plasticware should be substituted for glassware whenever possible. Plasticware should be substituted for glassware whenever possible.

Needle and Sharps Precautions Used disposable needles must not be bent, sheared, broken, recapped, removed from disposable syringes, or otherwise manipulated by hand before disposal. Dispose in puncture- resistant containers which must be located near work. Used disposable needles must not be bent, sheared, broken, recapped, removed from disposable syringes, or otherwise manipulated by hand before disposal. Dispose in puncture- resistant containers which must be located near work. Non-disposable sharps must be placed in a hard-walled container for transport to a processing area for decontamination, preferably by autoclaving. Non-disposable sharps must be placed in a hard-walled container for transport to a processing area for decontamination, preferably by autoclaving. Broken glassware must not be handled directly by hand.Pick up by mechanical means such as a brush and dustpan, tongs, or forceps. Broken glassware must not be handled directly by hand.Pick up by mechanical means such as a brush and dustpan, tongs, or forceps.

Human Blood, Tissue and Fluid Occupational 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 B vaccine. Everyone needs to be offered the Hepatitis 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 safe devices. Review needle/syringe use and replace with safe devices. Exposure incidents must be followed up. Exposure incidents must be followed up.

Toxins Use BSL 2 work practices and procedures. Use BSL 2 work practices and procedures. Develop a Chemical Hygiene Plan specific to the toxin used. Include containment (hoods, biosafety cabinets). Develop a Chemical Hygiene Plan specific to the toxin used. Include containment (hoods, biosafety cabinets). Some toxins are Select Agents and require registration. Some toxins are Select Agents and require registration.

Select Agents Possession, use and transfer of specific biological agents requires registration. Possession, use and transfer of specific biological agents requires registration. Restricted Persons are not allowed to have access to these agents. Restricted Persons are not allowed to have access to these agents. High security and containment must be maintained. High security and containment must be maintained.

Security Control access to areas where biological agents or toxins are used and stored. Control access to areas where biological agents or toxins are used and stored. Keep biological agents and toxins in locked containers. Keep biological agents and toxins in locked containers. Know who is in the laboratory, what materials are being brought and what materials are being removed from the laboratory. Know who is in the laboratory, what materials are being brought and what materials are being removed from the laboratory. Have a protocol for reporting incidents. Have a protocol for reporting incidents. Have an emergency plan. Have an emergency plan.

Emergencies Develop and practice plans for: Spills: large spills, spills inside BSC Spills: large spills, spills inside BSC Accidental exposures: needlesticks, eye/mucous membrane splash, breathing aerosols Accidental exposures: needlesticks, eye/mucous membrane splash, breathing aerosols Power/Utility failures: BSC, freezers, ventilation, lights, water Power/Utility failures: BSC, freezers, ventilation, lights, water Fires Fires Medical emergencies Medical emergencies

Waste Disposal Red bag or Regulated Medical Waste: Red bag or Regulated Medical Waste: All mammalian cells or anything that came in contact with mammalian cells All mammalian cells or anything that came in contact with mammalian cells All BSL 2 material or anything that came in contact with BSL 2 material All BSL 2 material or anything that came in contact with BSL 2 material All needles/syringes regardless of use All needles/syringes regardless of use No need to autoclave this waste prior to disposal in EH&S red bag/box (material is incinerated). No need to autoclave this waste prior to disposal in EH&S red bag/box (material is incinerated).

CRITICAL ELEMENTS CREATING A SAFETY CULTURE Demonstrate top leadership commitment to safety Demonstrate top leadership commitment to safety Swift and visible correction of unsafe conditions Swift and visible correction of unsafe conditions Established procedures for reporting unsafe conditions Established procedures for reporting unsafe conditions Reward workers for following procedures Reward workers for following procedures Involve frontline healthcare workers in identifying problems and solutions Involve frontline healthcare workers in identifying problems and solutions

Role of management The scope: identifying problem areas and exerting specific actions to correct them

Development of Safety Program Recognition of hazards Recognition of hazards Determination (evaluation) of hazards Determination (evaluation) of hazards Baseline health and safety survey Baseline health and safety survey Sampling strategy Sampling strategy Health and safety plan Health and safety plan

Risk management RISK ASSESSMENT (GENERIC) | TAKE THE DESIGN INTENTION l CHANGE IT BY "GUIDE WORDS" l CREATE HYPOTHETICAL DEVIATIONS l CREATE IMAGES l STIMULATE IMAGINATIONS OF THE TEAM TO SEARCH DATA FOR REAL DEVIATIONS l EXAMINE CAUSES AND CONSEQUENCE HARMLESSHARMFUL IGNOREELIMINATE OR CONTROL

Regulations OSHA Bloodborne Pathogens OSHA Bloodborne Pathogens CDC Select Agents CDC Select Agents NIH Guidelines for Research Involving Recombinant DNA Molecules NIH Guidelines for Research Involving Recombinant DNA Molecules DOT/CDC Shipping DOT/CDC Shipping CDC Import Permits CDC Import Permits USDA/APHIS Permits USDA/APHIS Permits

Resources CDC Biosafety in Microbiological and Biomedical Laboratories CDC Biosafety in Microbiological and Biomedical Laboratories ABSA Risk Groups ABSA Risk Groups Canadian MSDSs Canadian MSDSs Environmental Health & Safety – Lab Safety Environmental Health & Safety – Lab Safety or