Kornati Islands, Croatia

1. Risk management in medical laboratories Ana Stavljenic-Rukavina Zagreb, Croatia Kornati Islands, Croatia

2. 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)

3. The most frequent occupation-related illnesses among hcpersonel • respiratory problems • infections • dermatitis • drug or medication reactions

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

5. Accidents do not happen, they are caused • 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 • Therefore, implementation of general safety and risk reduction system is mandatory

6. dusts physical agents chemical agents mutagenic and teratogenic agents skin irritants stress (!) hepatitis AIDS LABORATORY HAZARDSNon-infectious Infectious

7. Material Safety Data Sheets (MSDS) • 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 • 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

8. 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) • Infection risk after needle puncture: • HBV: 5-40% • HCV: 1-10% • HIV: <0.5%

9. 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

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

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

12. COMPONENTS OF MEDICAL SAFETY • Employee safety • Patient safety • Environment safety

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

14. Levels of Biosafety • 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 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.

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

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

17. Primary Containment • 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. • Personal protective equipment (PPE) : coat, gloves, goggles. • Host-vector for rDNA

18. Aerosol Precautions • Use BSC for all procedures that may generate aerosols. • Use centrifuges with biosafety covers. • 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.

19. Needle and Sharps Precautions • 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.

20. 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. • 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.

21. Human Blood, Tissue and Fluid Occupational Exposure to Bloodborne Pathogens • Use BSL 2 work practices and procedures. • Additional requirements for HIV work. • Everyone needs to be offered the Hepatitis B vaccine. • Develop specific exposure plan SOPs. • Specific training is required. • Review needle/syringe use and replace with “safe” devices. • Exposure incidents must be followed up.

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

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

24. Security • Control access to areas where biological agents or toxins are used and stored. • 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. • Have a protocol for reporting incidents. • Have an emergency plan.

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

26. Waste Disposal “Red bag” or “Regulated Medical Waste”: • 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 needles/syringes regardless of use • No need to autoclave this waste prior to disposal in EH&S red bag/box (material is incinerated).

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

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

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

30. 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 HARMLESS HARMFUL IGNORE ELIMINATE OR CONTROL

31. Regulations • OSHA Bloodborne Pathogens • http://www.osha.gov/SLTC/bloodbornepathogens/index.html • CDC Select Agents • http://www.cdc.gov/od/ohs/lrsat.htm • NIH Guidelines for Research Involving Recombinant DNA Molecules • http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html • DOT/CDC Shipping • http://www.cdc.gov/od/ohs/biosfty/shipregs.htm • CDC Import Permits • http://www.cdc.gov/od/ohs/biosfty/imprtper.htm • USDA/APHIS Permits • http://www.aphis.usda.gov/vs/ncie/

32. Resources • CDC Biosafety in Microbiological and Biomedical Laboratories http://www.cdc.gov/od/ohs/biosfty/bmbl4/bmbl4toc.htm • ABSA Risk Groups http://www.absa.org/riskgroups/index.htm • Canadian MSDSs http://www.hc-sc.gc.ca/pphb-dgspsp/msds-ftss/index.html • Environmental Health & Safety – Lab Safety http://www.ehs.sunysb.edu or 2-9672