Clinical Laboratory Safety Guidelines PDF

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UAGM-Gurabo Campus

Maria de los A. Oliveras

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clinical laboratory safety biosafety patient safety safety procedures

Summary

This document provides guidelines for safety in a clinical laboratory setting, covering facility safety, patient safety, and different hazards. It includes information on biological and chemical risks. Also, specific procedures and regulations are mentioned. Important considerations like safety management tools are included in detail.

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Safety Clinical Laboratory Maria de los A. Oliveras, MHSA, MLS(ASCP) Professor of Medical Technology UAGM-Gurabo Enclosure Safety ◦Facility Safety ◦ The laboratory work environment is dangerous. ◦Patient Safety ◦ Freedom from accidental injury: avoidance, prevention, and a...

Safety Clinical Laboratory Maria de los A. Oliveras, MHSA, MLS(ASCP) Professor of Medical Technology UAGM-Gurabo Enclosure Safety ◦Facility Safety ◦ The laboratory work environment is dangerous. ◦Patient Safety ◦ Freedom from accidental injury: avoidance, prevention, and amelioration of adverse outcomes or injuries stemming from the process of care. ◦ Adverse outcomes that may result from the laboratory testing process include false-positive and false-negative test results; missed and delayed diagnoses; or missed, delayed, or inappropriate treatment. Facility Safety Biological Hazards Chemical Risks Physical Hazards Safety in Clinical Laboratories Objectives 1. Identify the occupational hazards that exist in the Clinical Laboratory. 2. Define Standard Precautions 3. Describe the safe practices required by OSHA’s: "Occupational Expose to Bloodborne Pathogen Standard 4. Name the most important practices to prevent the spread of infections. 5. Identify the requirements of the "Occupational Exposure to Hazardous Chemicals in Laboratory Standard". 6. Describe the Principles of the Fire Prevention Program. 7. Define: "Safety Data Sheets", list the information it contains and when to use it. Facility Safety - Security Risks Fall into Three Categories: Biohazard Chemical Risks Physical Risks Electricity, OSHA OSHA Fire ✓Bloodborne Pathogen ✓ Hazardous Chemicals Ergonomic ✓Standard Precautions ▪ Chemical Hygiene plan Hearing loss ✓PPE Repetitive motion disorders ✓ Hazard Communication Standard Skeletomuscular disorders ✓ PPE Slip, trips, falls Safety Management A formal Safety Program ◦ Policies & Procedures ◦ Staff training ◦ Audit of safe work practices ◦ Reporting system for laboratories accidents ◦ Emergency preparedness ◦ Evacuation Types of safety controls ◦ Engineering controls - physical setups or devices that reduce exposure. ◦ Administrative controls – management strategies to reduce exposure (policies, procedures, audits, etc.) ◦ Work practice controls - work technique that minimize exposure to hazards Safety Management Tools Safety Management Leaders develop safety guidelines to protect workers and the public from infectious agents: OSHA – Occupational Safety and Health Administration ◦ Regulatory agency with legal jurisdiction over laboratories. ◦ Sets minimums standards for performing hazards jobs ◦ Inspects compliance. ◦ Issues citations for failures to comply standards. ◦ Requires employers to have a complete safety policy, provide appropriate safety equipment and conduct safety training. ◦ 29 CRF 1910.1030 - Bloodborne Pathogens ◦ 29 CRF 1910.1200 - Hazard Communication Standard (right to know) ◦ 29 CRF 1910.1450 - Hazards Chemicals in Laboratories: Chemical Hygiene Plan (CHP) ◦ Environmental hazards chemicals labeling Safety Management Leaders develop safety guidelines to protect workers and the public from infectious agents: ◦ Government Agencies: Regulatory Agencies ◦ Center for Medicare & Medicaid Services (CMS) (CLIA’88) ◦ US Department of Transportation (DOT) ◦ International Air Transport Association (IATA) ◦ Environmental Protection Agency (EPA) ◦ US Department of Homeland Security (DHS) Safety Management Leaders develop safety guidelines: Professional/ Research Bodies for Voluntary Compliance ◦ CDC- Centers for Disease Control and Prevention ◦ Do not regulate laboratories but define minimal accepted practice for handling biohazardous materials. ◦ Clinical Laboratory Standard Institute (CLSI) ◦ A private organization that produces Peer-reviewed Consensus guideline. ◦ National Fire Protection Association (NFPA) ◦ College Of American Pathologists (CAP) ◦ Commission On Accreditation Of Laboratories (COLA) ◦ The Joint Commission (TJC)--- JCAHO ◦ National Institutes for Health (NIH) Biological Hazards Biosafety Basic Clinical Laboratory Techniques Chain of the Infection ◦ Portal of Exit ◦ Means of Transmission ◦ Portal of Entry In the clinical laboratory, the most direct contact with an infection source is through the contact with a Patient Specimens. Hand Sanitizing and adhering to Standard Precautions are methods to break the chain of infection. Chain of the Infection ◦ Portal of Exit Mucous Membranes ◦ The chain of infection is broken when contaminated materials(tube/ specimens) are placed in biohazard containers are sealed. ◦ Means of Transmission ◦ Direct contact: touches the patient, specimen/contaminated object (reservoir) ◦ Airborne: inhales dried aerosol particles circulating on air currents ◦ Droplet: inhales infected aerosol droplets from the reservoir (e.g., aerosol droplets from a pat or an uncapped centrifuge tube, or when specimens are aliquoted or spilled) ◦ Vehicle: ingests a contaminated substance (e.g., food, water, specimen) ◦ Vector: an animal or insect bite ◦ Portal of Entry ◦ Susceptible Host : another patient during invasive procedures, visitors, and health-care personnel ◦ To break the chain of infection, health-care personnel must sanitize hands often, wear gloves, stay current with the required immunizations and tests, and maintain a healthy lifestyle. Biosafety Symbol: ◦ There is a risk or danger to health or the environment ◦ He warns that biomedical danger may be present. ◦ Workers must use exposure prevention measures. Biosafety Evolving Safety Regulations and Guidelines Year entity Law/Guide 1970 CDC Isolation techniques for use in hospitals 1975 CDC Review isolation techniques by specific category and prohibition Re-capping 1983 CDC Precautions Hospital isolation (seven categories)) 1985 CDC Universal Precautions (UP) (HIV epidemic) 1987 CDC Guides Isolation Body Substance 1988 US Congress CLIA’88 (Clinical Laboratory Improvement Amendments of 1988) 1991 OSHA Bloodborn Pathogens Standard (BBP)– mandatory UP 1996 CDC Synthesized UP and Substance Body Isolation– Standard Precautions Biosafety Evolving Safety Regulations and Guidelines Year entity Law/Guide 2000 US Congress Enactment Law on Prevention and Safety Needle Stick 2001 OSHA BBP Standard Revision in Response to Needlestick Safety and Prevention Act 2002 CDC Guide to Hand Hygiene in Healthcare Settings 2009 WHO Guides for hand hygiene in Health Facilities Biosafety Evolving Safety Regulations and Guidelines 1960 ---Tuberculosis / Infectious Diseases --- Exclusive Hospitals Insulation Techniques- Isolation Room in Regular Hospitals Universal Precautions– designed to protect the health care worker from exposure to blood/fluids containing these visibly. All Patient/Personal Protective Equipment (PPE) “Body Substance Isolation” BSI– Precautions for all body fluids and all moisture “Blood Pathogens Standard” BBP- Occupational Exposure HIV, HBV, HCV Blood and other potentially infectious materials: body fluids, open wound, cultures microbiology Workers in health facilities and other workers who may be at risk of exposure. Emphasis on Prevention of Punctures. Standard Precautions– Comprehensive Guide UP, BSI y BBP Protects Patient, Workers, Health Care and Prevention Associated Infections Caregivers. Includes transmission-based precautions: measles virus, tuberculosis, meningitis, multidrug-resistant organisms Biosafety Standard Precautions 29 CRF 1910.1030 - Bloodborne Pathogens It assumes that anyone can potentially be infected or colonized with an organism that can be transmitted in health facilities. ◦ Hand Hygiene ◦ Personal Protective Equipment (PPE) ◦ Respiratory Hygiene ◦ Patient Care Instruments / Equipment ◦ Environmental Care Safety and Quality Management Standard Precautions ◦ Proper hand hygiene, ◦ Correct disposal of contaminated materials, ◦ Wearing personal protective equipment (PPE) ◦ Mouth, nose, and eye protection: Face Shield ◦ Gown: ◦ Select a gown that is appropriate for the activity and the amount of fluid likely to be encountered. ◦ Remove a soiled gown as promptly as possible and sanitize hands to avoid transferring microorganisms to other patients or environments. Biosafety Safe Practices Required by OSHA Standard 1. Hand washing– Most important safety practice– Prevents the Spread of Pathogens 2. Eating, drinking, smoking, applying cosmetics in the work area of the Clinical Laboratory is prohibited. 3. Hands, pens, pencils, and other fomites keep away from the mouth and/or mucous membranes. 4. Food, meals, medicines keep in refrigerator separate from samples (specimens) 5. Never pipet with mouth. 6. Never handle needles or sharp objects– “Puncture with Needles” ◦ The most frequent cause of puncture is improper disposal. ◦ “Recapping” ------ One-handed Operation (Technique) 7. Sharp objects to be deposited in puncture-resistant container “Sharps Containers” ◦ Needles, lancets, slide glass, pipettes, syringes, Hand Washing Soap and water Alcohol not less than 70% Appropriate technique When to wash? Visible contamination Complete work Remove gloves Before leaving Laboratorio Before and after eating Before and after any activity that had contact with mucous membranes. Biosafety Safe Practices Required by OSHA Standard 8. Prevent splashing during procedures. ◦ Removing specimen caps, filling hemocytometer, making blood smear, discarding specimens, making dilutions. 9. Constant use of Personal Protective Equipment (PPE) ◦ Liquid-resistant gowns, wash Lab/Hospital DO NOT take home. ◦ Gowns for use only in Lab; Do not use in public places (dining room, bathroom, cafeteria, office, conference room) ◦ Gloves: size, Latex allergy, change between patients, Do not wash ◦ "Face shield" – potential aerosol. 10. Phlebotomy ◦ Trays labeled with biohazard symbol ◦ Sample to be transported in a second container – plastic bags. Biosafety Safe Practices Required by OSHA Standard 11. Pneumatic Tubes. ◦ Specimens (tubes) placed in secondary containers that are shatter-proof and labeled with the biomedical symbol. 12. Equipment Cleaning---- Routine cleaning 13. General Cleaning “Housekeeping” 14. Laundry – No disposable gowns 15. Hep B Vaccination 16. Training and documentation. 17. Regulated Medical Waste Management. Biosafety Standard Precautions Exposure Control Plan. ◦ Identifies employee (positions) to occupational exposure. ◦ Accessible to all employees ◦ Training – annually ◦ Specimen Handling Guides, Containers, Sharp Container. ◦ Exposure Control Methods ◦ Employer Provides PPE and HBV Immunization. ◦ Signs: identify risks. Biosafety Standard Precautions Exposure Control Plan: Exposure Control Methods ◦ Standard Precautions. ◦ PPE: Specialized clothing or equipment protect from direct exposure to blood and other substances. Gloves, fluid-resistant gowns, full-face shield, safety goggles ◦ Engineering Controls: devices that eliminate or minimize exposure. ◦ Acrylic wall on worktable, appropriate disinfectants, Sharp containers, needle-free devices. ◦ Biological Safety Cabinets ◦ Practice Safe Work: way to perform the task to reduce exposure. ◦ Do not eat/drink in work areas, do not store food in the refrigerator with samples/reagents, cosmetics ◦ Use disinfectant regularly on the surface (10% Clorox) Biosafety Standard Precautions Exposure Control Plan: Incidents at Exposure ◦ Punctures, cuts, "Splashes" mucous membranes, exposure to aerosols ◦ Immediately flood with water and clean any wounds with antiseptic and water. ◦ Report incident to supervisor ◦ Seek medical attention immediately. Biosafety- Other Biological Hazards In addition to Blood Pathogens in the Laboratory there is also a risk to a variety of microorganisms: bacteria, viruses, fungi or parasites. Decontamination Methods: Sterilization – kill or inactivate all organisms and viruses. ◦ Autoclaves- waste, glassware, instruments, culture media, reagents. Disinfection – chemicals on objects or surfaces to kill or inactivate microorganisms. ◦ Clorox 10% , alcohol 70-90%, iodophors 75ppm, phenol, quaternary ammonia compound. Antisepsis – chemicals used on skin or tissue to inhibit microbial growth. ◦ Alcohol, Hydrogen peroxide, iodine, chlorhexidine (Hibiclens), triclosan Decontamination ◦ Use of a 1:10 dilution of sodium hypochlorite for routinely disinfecting countertops and accidental spills. ◦ Because this solution is not stable, it must be made fresh daily. ◦ The container of 1:10 solution of bleach should be labeled properly with the name of the solution, the date and time prepared, the date and time of expiration (24 hours), and the initials of the preparer. ◦ The solution should be allowed to air-dry on the contaminated area. ◦ Bleach is not recommended for aluminum surfaces. Other solutions used to decontaminate include but are not limited to phenol-based disinfectants such as AMPHYL, tuberculocidal disinfectants, and 70% ethanol. ◦ Absorbent materials used for cleaning countertops and removing spills must be discarded in biohazard containers. ◦ Other products are commercially available. - Must be confirmed that the product is effective enough to eliminate most bacteria, including mycobacterium tuberculosis, fungi, and viruses. ◦ It is also important to know the contact time needed for disinfectant chemical products to work effectively on laboratory surfaces as prescribed by the manufacturer. ◦ When spills occur, do not mop or wipe the fluid; instead, use an absorbent powder (e.G., Zorbitrol) or paper towels to remove as much as possible before disinfecting. Sharp Hazards ◦ Including needles, lancets, and broken glassware, present a serious biological hazard, particularly for the transmission of bloodborne pathogens. ◦ All sharp objects must be disposed in puncture-resistant, leakproof container. ◦ With the biohazard symbol. ◦ Puncture-resistant containers should be conveniently located within the work area. Biosafety– Laboratory Environment Control Laboratory must control its environment for the safety of workers and optimal operation of various instruments and/or methods. Airflow– Air quality– CDC, NIOSH, OSHA, Joint Commission ◦ Ventilation, air conditioning, ◦ Negative pressure--- Air in polluted area Do not recycle Humidity Air Exchange Salon Ambient Temperature Chemical, Fire, Electrical Safety Basic Clinical Laboratory Techniques Safety and Quality Management Physical Hazards Electrical Hazards ◦ A Lab contains many electrical equipment. ◦ The danger of water or fluids encountering equipment is greater in the Lab setting. ◦ Equipment should not be operated with wet hands. ◦ Lab personnel should continually observe for any danger's conditions, such a frayed cords and overloaded circuits and report them to the supervisors. ◦ Equipment that has become wet should be unplugged and allowed to dry completely before reusing. ◦ Equipment should be unplugged before cleaning. ◦ All electrical equipment must be grounded with three-pronged plugs. Chemical, Fire, Electrical Safety Electrical Safety Good safe practices include: 1. Grounding all electrical equipment, according to manufacturer's instructions. 2. Disconnect the instrument from Electrical supply before repairing it. Ex. Microscope bulb change 3. Electrical cords and plugs in good condition – not stripped 4. Avoid overloading electrical circuits. 5. Avoid extensions Safety and Quality Management Physical Hazards Electrical Hazards When an electrical shock accident occurs, the electrical source must be removed immediately. ◦ This must be done without touching the person or the equipment. ◦ Turning off the circuit breaker. ◦ Unplugging the equipment. ◦ Or moving the equipment using a nonconductive glass or wood object. ◦ The victim should receive immediate medical assistance after discontinuation of the electricity. ◦ CPR may be necessary. Fire Safety Fire Triangle or Quadrahedron Oxygen Heat Fuel Chemical Chain Reaction Chemical, Fire, Electrical Safety Fire Safety Good practices for Fire Prevention: 1. Do not use flames – hot places, microwaves, electric incinerations, "warmer"” 2. Flammable chemicals to be stored in safety cabinets, away from heat sources and with ventilation. ◦ “Safety Can” 3. Fire extinguishers well located and accessible/ Fire Blanket ◦ Every 75 feet and checked monthly and maintained annually. ◦ Training on use: PAS (Pull, Aim, Squeeze) / Fire extinguisher fence ◦ Periodic inspections by Firefighters and certification. 4. Set appropriate alarms– Be tested every three (3) months (four times a year) 5. Fire Drills-- Eviction Plan and Procedure/ Output Plans Safety and Quality Management Physical Hazards Fire/Explosive Hazards ◦ The NFPS(National Fire Protection System) classified fires regarding the type of burning material. ◦ Assess the risk potential when a fire occurs. ◦ It also classifies the type of fire extinguisher that is used to control them. Types of fire extinguishes Safety and Quality Management Physical Hazards Fire/Explosive Hazards ◦ The multipurpose ABC fire extinguishers are the most common. ◦ The fire extinguishers will be able to operate. ◦ Acronym: PASS Safety and Quality Management Fire/Explosive Hazards The Lab workers often use potentially volatile or explosive chemicals that require special procedure for handling and storage: ◦ Flammable chemicals should be stored in safety cabinets. ◦ The cylinders of compressed gas should be located away from heat and securely fastened to a stationary device to prevent accidental capsizing. ◦ Fire blanket may be present in the Lab. Safety and Quality Management Fire/Explosive Hazards ◦ The Joint Commission (TJC) requires that all health-care facilities post Evacuations Routes and Detailed Plans to follow in the event of a fire. ◦ All employees are expected to take the actions to protect themselves and other. ◦ Acronym: RACE Chemical, Fire, Electrical Safety Equipment Security Centrifuges ◦ Follow instructions dictated by the manufacturer. ◦ Protection that prevents opening when you are operating. ◦ Open when rotor is stopped. ◦ Autoclaves ◦ Wear Insulation Gloves--- Removing hot objects. ◦ Glassware Chemistry Safety OSHA 29 CRF 1910.1450 Laboratory Standard 29CFR 1910.1200 Risk Communication Chemical, Fire, Electrical Safety Chemical Safety Chemicals can present a variety of risks: flammable, toxic, caustic (burns tissue), corrosive (destroys), carcinogenic, teratogenic, or mutagenic. Chemical Hygiene Plan SDS “Safety Data Sheet” Chemical Labels– Chemical Risk Communication “Right To Know” Chemical Storage Chemical, Fire, Electrical Safety Chemical Safety Chemical Hygiene Plan OSHA 29 CRF 1910.1450 Laboratory Standard OSHA – Mandatory to have a Written Safety Plan for Chemical Use ◦ Standard Operating Procedure (SOP) and Specific Work Practices ◦ Measures to Reduce Exposure to Hazardous Chemicals ◦ PPE / Hand hygiene practices ◦ Specifications for Safe Function of Protective Equipment and Fume Hoods ◦ Safety shower, Eyewash station ◦ Specific risk information for each of the hazardous chemicals. ◦ Provision of education and training to employees. ◦ Chemical Hygiene Officer / Chemical Hygiene Committee Chemical, Fire, Electrical Safety Chemical Safety--- Risk Communication OSHA- 29CFR 1910.1200 “Safety Data Sheets” (SDS) ◦ Required by law to manufacturers, distributors and importers for each chemical. ◦ It describes the risk of the chemical, required PPE, organs of the body that can be adversely affected by exposure to the chemical. ◦ It consists of 16 sections ◦ Additional information is included describing the techniques of first aid and medical treatment required if exposure occurs. ◦ It should be kept on file and accessible to employees. ◦ Each employee should read SDS and understand the risks associated with the chemical, measures to prevent harm from exposure, and first aid procedures. Chemical, Fire, Electrical Safety Chemical Safety “Safety Data Sheets” (SDS)- information (e.g.) SDS (Standardized)) ◦ Manufacturer Name, Address, Phone, Date Prepared ◦ Hazardous Ingredient / Product Identification ◦ Physical and chemical characteristics ◦ Documentation if the reagent (component) is considered a carcinogen, teratogen (congenital malformations), or mutagenic ◦ Risk Fire or Explosion / Reactivity ◦ Health Risks – Signs and Symptoms of Exposure ◦ Effusion or Liquefaction Procedure ◦ Data Transportation (DOT Rating) ◦ Precautions for Safe Handling and Use/Control Measures ◦ Special Precautions Chemical, Fire, Electrical Safety Chemical Safety : Chemical Tags. Risk information detailed: ◦ Symptoms of exposure ◦ First Aid Procedure ◦ Spill response procedure ◦ National Fire Protection Association (NFPA) ◦ Globally Harmonized System---- 2015 Chemical, Fire, Electrical Safety Chemical Safety--Chemical Tags National Fire Protection Association (NFPA)--- Diamond Figure ◦ It presents the type or category of risk by four colors: ◦ Blue– toxicity or health risk ◦ Red – Fire or flammability ◦ Yellow – Reactive chemical or unstable as oxides ◦ White - reactivity with water or risk of contact. (Use letter or code PPE) ◦ Number System : 0 – 4 indicated the risk for each category. ◦ 0 ---- minimal 4 –-- High level of risk NFPA Figure: Diamond Colors : Risk Category Number 0 – 4 : Relative Risk Chemical, Fire, Electrical Safety Chemical Safety--Chemical Tags Globally Harmonized System Comprehensive risk communication system of international scope. 1. Identification of the manufacturer/supplier/distributor. 2. Characterization of the chemical product. 3. Pictograms. 4. Warning words such as hazard warning and precautionary statements, among others. ◦ Classification criteria are based on the physicochemical, toxicological or ecotoxicological properties of the product and its effects on health and the environment. Globally Harmonized System GHS Standard Hazard Symbols White background Red border Globally Harmonized System (GHS) GHA Chemicals in original containers shipped from manufacturer ◦ Labeled with chemical name & appropriate Hazard warning. ◦ May use National Fire Protection Association to convey chemical hazards. GHA ◦ Transfer of a hazardous chemical for immediate use from either Secondary primary or secondary container by the individual performing the Container labels transfer, does not require labeling. Chemical, Fire, Electrical Safety Chemical Safety Chemical Storage ◦ Specialty Cabinets: flammable liquids, concentrated acids, concentrated bases ◦ Store according to the classification provided by the manufacturer. ◦ Some chemicals are incompatible to be stored together: chemical Do not store nearby ◦ Acetic acid ----- hydroxides: NaOH, KOH, Nitric Acid ◦ Acetone --------- Concentrated Sulfuric Acid, Nitric Acid ◦ Flammable liquids ----- Chromic Acid, Hydrogen Peroxide, Nitric Acid ◦ Sodium Azide ------ Copper (drainage tubes)) Chemical, Fire, Electrical Safety Chemical Safety Chemical Disposal Specific Regulations--- SDS ◦ Most can be discarded down the sink after diluting it with large amounts of water. ◦ Some are extremely dangerous and require special provision. ◦ Employer must provide specific instructions and appropriate containers for disposal of chemicals and reagents. Reference ◦ Denise M. Harmening -Clinical Hematology and Fundamentals of Hemostasis (5th ed.) F.A. Davis Company ◦ Strasinger, Susan King; Di Lorenzo, Marjorie Schaub. Urinalysis and Body Fluids F.A. Davis company. Kindle edition. ◦ Quick Compendium of Medical Laboratory Sciences Companion Self Study Text for BOC Study Guide for MLS/MLT Certification Examinations

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