Kornati Islands, CroatiaRisk management in medical laboratories

Ana Stavljenic-Rukavina 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

respiratory problemsinfectionsdermatitisdrug or medication reactions

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

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

LABORATORY HAZARDSNon-infectiousInfectiousdustsphysical agentschemical agentsmutagenic and teratogenic agentsskin irritantsstress (!)

hepatitisAIDS

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

Infectious occupational health hazardsHepatitis 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:

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 Patient safety Environment safety

ELEMENTS OF EMPLOYEE SAFETYBlood and body fluid exposuresAllergiesCommunicable disease exposuresMusculoskeletal injuriesImmunization programSystematic review, follow-up, and reporting of employee incidents

Levels of BiosafetyBSL 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.

Risk AssessmentPathogenicity of material disease incidence and severityRoutes of Transmission parenteral, airborne or ingestionAgent Stability ease of decontaminationInfectious Dose LD50Concentration infectious organisms/vol. & working volumeOrigin of material - Wild Type, primary cellsAvailability of effective prophylaxis Hep. B vaccineMedical surveillance exposure managementSkill level of staff

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

Primary ContainmentLab 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

Aerosol PrecautionsUse 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.

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

Needle and Sharps PrecautionsUsed 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.

Human Blood, Tissue and FluidOccupational 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.

ToxinsUse 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.

Select AgentsPossession, 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.

SecurityControl 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.

EmergenciesDevelop and practice plans for:Spills: large spills, spills inside BSCAccidental exposures: needlesticks, eye/mucous membrane splash, breathing aerosolsPower/Utility failures: BSC, freezers, ventilation, lights, waterFiresMedical emergencies

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

CRITICAL ELEMENTSCREATING A SAFETY CULTUREDemonstrate top leadership commitment to safetySwift and visible correction of unsafe conditionsEstablished procedures for reporting unsafe conditionsReward workers for following proceduresInvolve frontline healthcare workers in identifying problems and solutions

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

Development of Safety ProgramRecognition of hazardsDetermination (evaluation) of hazardsBaseline health and safety surveySampling strategyHealth and safety plan

Risk managementRISK ASSESSMENT (GENERIC)|TAKE THE DESIGN INTENTIONlCHANGE IT BY "GUIDE WORDS"lCREATE HYPOTHETICAL DEVIATIONSlCREATE IMAGESlSTIMULATE IMAGINATIONS OF THE TEAM TO SEARCH DATA FOR REAL DEVIATIONSlEXAMINE CAUSES AND CONSEQUENCEHARMLESSHARMFUL

IGNOREELIMINATE OR CONTROL

RegulationsOSHA Bloodborne Pathogenshttp://www.osha.gov/SLTC/bloodbornepathogens/index.htmlCDC Select Agentshttp://www.cdc.gov/od/ohs/lrsat.htmNIH Guidelines for Research Involving Recombinant DNA Molecules http://www4.od.nih.gov/oba/rac/guidelines/guidelines.htmlDOT/CDC Shippinghttp://www.cdc.gov/od/ohs/biosfty/shipregs.htmCDC Import Permitshttp://www.cdc.gov/od/ohs/biosfty/imprtper.htmUSDA/APHIS Permitshttp://www.aphis.usda.gov/vs/ncie/

ResourcesCDC Biosafety in Microbiological and Biomedical Laboratories http://www.cdc.gov/od/ohs/biosfty/bmbl4/bmbl4toc.htmABSA Risk Groupshttp://www.absa.org/riskgroups/index.htmCanadian MSDSshttp://www.hc-sc.gc.ca/pphb-dgspsp/msds-ftss/index.htmlEnvironmental Health & Safety Lab Safety http://www.ehs.sunysb.edu or 2-9672