ࡱ>  dbjbjWW 55 K!@@4hd  #%"%%%7'f'$'$HX!8+'"7'8+8+!%%M---8+^8%%-8+--[s%@85>+^ 0 + sst'(-w)*5'''!!,''' 8+8+8+8+'''''''''@ `:  UNIVERSITY OF MONTANA BLOODBORNE PATHOGENS EXPOSURE CONTROL PLAN  Institutional Biosafety Committee Last updated 1/3/14 Table of Contents I. PROGRAM ADMINISTRATION 4 A. The ϻ Bloodborne Pathogens Exposure Control Plan 4 B. Responsibilities 4 1. Supervisory personnel 4 2. Training instructors 5 C. Availability of the Exposure Control Plan to Employees and Students 5 D. Review and Update the Exposure Control Plan 5 II. DEFINITIONS 6 III. EXPOSURE DETERMINATION 7 IV. COMPLIANCE METHODS 7 A. Universal Precautions 7 B. Engineering Controls 8 Biological safety cabinets (BSC) 8 Sharps containers 8 Needles 8 Pipetting 8 Splash hazards 9 C. Administrative Controls 9 Hand washing 9 2. Work area restrictions 9 3. Specimen handling and transport 9 D. Personal Protective Equipment 10 E. Housekeeping 11 F. Regulated Waste Disposal (Infectious Waste) 11 1. Sharps 11 2. Liquid blood or other body fluids 12 3. Solid biohazardous waste 12 4. Laundry procedures 12 G. Hepatitis B Vaccination 12 H. Post-Exposure Evaluation and Follow-Up 13 I. Communication of Hazards 14 1. Warning labels 14 2. Biohazard signs 14 3. Other signs 14 J. HIV and HBV Research Laboratories 14 K. Training 16 V. RECORD KEEPING 17 A. Training Records 17 B. Medical Records 17 C. OSHA Record Keeping 17 D. Sharps Injury Log 17 Appendix A: Exposure Determination 18 Appendix B: Hepatitis B Vaccination Request/Waiver Form 20 Appendix C: Policy for Food and Drink in Laboratories 22 Appendix D: Human Cell Cultures 23 Appendix E: Biohazardous Spill Response 24 Appendix F: Disinfection 26 Appendix G: HIV and HBV Research Laboratories 29 THE UNIVERSITY OF MONTANA BLOODBORNE PATHOGENS EXPOSURE CONTROL PLAN I. PROGRAM ADMINISTRATION A. The ϻ Bloodborne Pathogens Exposure Control Plan The ϻ (ϻ) Bloodborne Pathogens Exposure Control Plan (ECP) is provided to eliminate or minimize the exposure of all ϻ employees and students to human blood or human blood products that might contain Bloodborne Pathogens (BBP). This plan is in compliance with the Occupational Safety and Health Administrations (OSHA) Bloodborne Pathogen standard 29 CFR 1910.1030. This Bloodborne Pathogens ECP includes: Definitions Exposure determinations Compliance methods, including: Universal precautions Engineering controls Administrative controls Personal protective equipment Housekeeping Regulated waste disposal Hepatitis B vaccination and follow-up titer Post-exposure evaluation and follow-up Communication of hazards HIV and HBV research Recordkeeping B. Responsibilities The President of ϻ has the ultimate responsibility for this ECP and all safety and health policies and procedures at the ϻ. The Institutional Biosafety Committee (IBC),  HYPERLINK "http://umt.edu/research/compliance/IBC/default.php" umt.edu/research/compliance/IBC/default.php, and Biosafety Officer (BSO) acting on behalf of the President are responsible for the Bloodborne Pathogens Program and have the responsibility to revise, amend and update these instructions as necessary. The Biosafety Officer is responsible for the administration and implementation of this program and has full authority to make any decisions to ensure its success. This includes the authorization to halt any operation that is not in compliance with requirements outlined in this procedure. The Biosafety Officer may be reached at (406) 243-6395. Each Principal Investigator or supervisor (PI/supervisor) will customize their own Exposure Control Plan based on the nature of the work being carried out in their facility. Their specific plan will remain on file in a central location within the laboratory/workplace together with the ϻ Biosafety Safety Manual ( HYPERLINK "http://umt.edu/research/compliance/IBC/safetymanual.php" umt.edu/research/compliance/IBC/safetymanual.php) for all personnel to access. 1. Supervisory personnel include Department Chairpersons, Directors, Principal Investigators, Managers and Supervisors. Supervisory personnel are responsible for compliance in their areas and will interact with the Biosafety Officer. Supervisory personnel will: Evaluate the bloodborne pathogen risk associated with an employee's job classification. Be certain that all employees and students in their area who are or may be at risk of exposure to bloodborne pathogens receive initial training and annual retraining in bloodborne pathogens as outlined in the "Training" section of this document (Section IV-K); Provide on-site and/or online instruction regarding universal precautions, engineering controls, administrative controls, personal protective equipment, regulated waste disposal, and proper procedures to follow after an exposure incident to employees and students in their area who are or may be at risk of exposure to bloodborne pathogens. Keep the Biosafety Officer informed of changes related to bloodborne pathogens in the work area so that IBC records can be updated. Assure that proper exposure control procedures are followed as outlined in the "Compliance Methods" (Section IV). Provide personal protective equipment that is specific to the task and in good working condition for all employees and students at risk of exposure to bloodborne pathogens. Provide post-exposure medical services to employees or students who experience an occupational exposure incident to blood or other potentially infectious materials. Care will be provided at Curry Health Center or other health facility of choice. 2. Training instructors Bloodborne pathogens training for employees and students will be offered through the IBC. The Biosafety Officer (or designee) will provide information and training to all employees and students who have an anticipated risk of exposure to bloodborne pathogens. The Biosafety Officer will: Maintain a list of trainers and the materials included in the BBP course. Review the training program to include appropriate new information. Designated trainers may perform training in their departments. Departmental trainers must observe the following: The training must include all mandatory training topics (as outlined in "Training" Section IV-K) in all initial training sessions and in annual training sessions; The trainer must generate records of training and maintain this information in their IBC lab binder as outlined in "Training" (Section IV-K). C. Availability of the Exposure Control Plan to Employees and Students The ϻ Bloodborne Pathogens Exposure Control Plan will be readily accessible to all employees and students through their Principal Investigator/supervisor. Employees and students will be advised of the availability of the plan during their education/training sessions. Copies of the ECP will be provided by each supervisor in areas where exposure to bloodborne pathogens can be anticipated. The ECP can also be accessed on-line at HYPERLINK "http://www.umt.edu/research/complianceinfo/IBC/BBP.aspx"http://www.umt.edu/research/complianceinfo/IBC/BBP.aspx . D. Review and Update the Exposure Control Plan The ECP will be reviewed and updated: Annually. When new or modified tasks and procedures are implemented which affect occupational exposure of employees and students. II. DEFINITIONS The following common terms and definitions are used in the Bloodborne Pathogens Exposure Control Plan. Blood: Human blood, human blood components and products made from human blood. Human blood components include plasma, platelets and wound exudates. Bloodborne pathogens (BBPs): Pathogenic microorganisms that may be present in human blood and can cause disease in persons who are exposed to blood containing the pathogen. These pathogens include but are not limited to human immunodeficiency virus (HIV) and agents of hepatitis A, B and C. Contaminated: The presence, or reasonably anticipated presence, of blood or other potentially infectious materials on any item or surface. Decontamination: The use of physical or chemical means to remove, inactivate or destroy bloodborne pathogens on a surface or item to the point where they are no longer capable of transmitting infectious particles and the surface or item is rendered safe for handling, use or disposal. Engineering controls: Equipment that is designed to isolate or remove the bloodborne pathogen hazard from the workplace (e.g. sharps disposal containers, biosafety cabinets, autoclaves and safer medical devices such as sharps with engineered sharps injury protection and needleless systems. Exposure incident: A specific eye, mouth, other mucous membrane, non-intact skin or parenteral contact with blood or other potentially infectious materials that results from the performance of an employees duties. Non-intact skin includes skin with dermatitis, hangnails, abrasions, chafing, etc. HBV: Hepatitis B virus; causes inflammation of the liver and may lead to long term liver damage including cirrhosis and cancer. HCV: Hepatitis C virus; causes inflammation of the liver and may lead to long term liver damage including cirrhosis and cancer. HIV: Human immunodeficiency virus; attacks critical cells of the immune system which leads to acquired immunodeficiency syndrome (AIDS), a life-threatening condition. Needleless systems: A device that does not use needles for: (A) the collection of bodily fluids or withdrawal of body fluids after initial venous or arterial access is established; (B) the administration of medication or fluids; or (C) any other procedure involving the potential for occupational exposure to bloodborne pathogens due to percutaneous injuries from contaminated sharps (e.g. intravenous medication delivery systems that administer medication or fluids through a catheter port or connector site using a blunt cannula or other non-needle connection, jet injection systems that deliver subcutaneous or intramuscular injections of liquid medication through the skin without the use of a needle). Occupational exposure: Reasonably anticipated skin, eye, mucous membrane, or parenteral contact with blood or other potentially infectious materials that may result from the performance of an employees duties. Other potentially infectious materials (OPIM): Human body fluids, any unfixed tissue or organ (other than intact skin) from a human (living or dead), and HIV-containing cell or tissue cultures (see Appendix D), organ cultures and HIV- or HBV (Hepatitis B) -containing culture medium or other solutions; and blood, organs or other tissues from experimental animals infected with HIV or HBV. Parenteral exposure: Piercing mucous membranes or the skin barrier through needle sticks, human bites, cuts, abrasions, or other mechanical means. Personal protective equipment (PPE): Specialized clothing or equipment worn by an employee for protection against a hazard. Post-exposure follow-up: In the case of an exposure incident, the mandatory course of action taken by the employer to provide medical services (i.e. medical assessment, vaccination, testing, and counseling) to the exposed worker in order to reduce the risk of infection. Regulated waste: Liquid or semi-liquid blood or other potentially infectious materials; contaminated items that would release blood or other potentially infectious materials in a liquid or semi-liquid state if compressed; items that are caked with dried blood or other potentially infectious materials and are capable of releasing these materials during handling; contaminated sharps; and pathological and microbiological wastes containing blood or other potentially infectious materials. Sharps: Needles, syringes, scalpels, and any contaminated object that can penetrate the skin such as razor blades, capillary tubes, scissors, etc. Sharps with engineered sharps injury protections: A non-needle sharp or a needle device used for withdrawing body fluids, accessing a vein or artery, or administering medications or other fluids, with a built-in safety feature or mechanism that effectively reduces the risk of an exposure incident. Source individual: Any individual, living or dead, whose blood or other potentially infectious materials may be a source of occupational exposure to the employee. Sterilize: The use of a physical or chemical procedure to destroy all microbial life including highly resistant bacterial endospores. Universal precautions: Treat all human blood and certain human body fluids as if they are infected with HIV, HBV and other bloodborne pathogens. III. EXPOSURE DETERMINATION An occupational exposure is one that may result from contact with blood or other potentially infectious material (OPIM) during the performance of duties by employees and students. Such an exposure would involve skin, eye, mucous membrane, or parenteral contact with blood or OPIM. Employers must determine which employees and students may incur occupational exposure to blood or other potentially infectious materials. The exposure determination is made without regard to the use of personal protective equipment (employees and students) that wear PPE still have the potential for exposure). Examples of job classifications that have a reasonably anticipated risk of exposure, or may incur risk, to bloodborne pathogens, either by the nature of the job or by specific tasks they are required to perform, are listed in Appendix A. Note: The Curry Health Center has a separate plan. IV. COMPLIANCE METHODS A. Universal Precautions Universal precautions will be observed by all employees and students at the ϻ. All human blood, tissue and fluids and other potentially infectious materials (OPIM) will be treated as if they are known to be infectious for HBV, HCV, HIV and other bloodborne pathogens. B. Engineering Controls Engineering controls such as hand washing facilities, eye wash stations, sharps disposal containers, biological safety cabinets, ventilating laboratory hoods, autoclaves, and safer sharps devices will be used to prevent or minimize exposure to bloodborne pathogens. The PI or Supervisor will ensure that employees and students are trained regarding the use of the engineering controls for the tasks/procedures they perform. These engineering controls will be examined and maintained on a regular schedule by the Principal Investigator or Supervisor. Contaminated equipment (biosafety cabinets, mechanical pipetting devices, splash guards, etc.) must be decontaminated after a spill and at the end of the workday. Biological safety cabinets (BSC): May contain infectious aerosols; isolate the operator from the agent; protect other personnel in the room. BSCs must be certified when they are installed, whenever moved and at least annually. Notify the Biosafety Officer if you are installing or moving a BSC or if you need the name of a certification company. Consult the Biosafety Officer for type of cabinet required for your needs. Sharps containers: Sharps are needles, syringes (with or without needles attached), scalpel blades and other such devices. Sharps must be contained within a sharps container. Sharps containers must be non-breakable, puncture resistant, leak proof, sealable and labeled with the biohazard symbol.  Sharps containers must be used for disposal of all sharps. Seal and replace sharps containers when two-thirds full. Filled sharps containers will be disposed of by calling Environmental Health and Risk Management (EHRM) ( HYPERLINK "http://www.umt.edu/research/EHRM/default.php" www.umt.edu/research/EHRM/default.php) at 243-4503 and scheduling a pick-up. Do not put broken glassware, empty vials or trash in sharps containers. Needles: Contaminated needles and other contaminated sharps shall not be bent or recapped unless a one-handed technique is utilized. Self-sheathing needles may be used. Shearing or breaking of needles is prohibited. Immediately after use contaminated needles shall be placed in sharps containers for disposal. Pipetting: Mouth pipetting is prohibited. Mechanical pipetting devices must be used.  Splash hazards: Splashguards and plastic backed absorbent pads shall be used to contain the spread of blood and potentially infectious material in the laboratory. C. Administrative Controls Work practice administrative controls are modifications of work procedures to reduce the likelihood of occupational exposure to blood or other potentially infectious materials. At the ϻ the following work practice controls will be utilized: Hand washing: Hand washing facilities must be readily accessible to all employees and students who incur exposure to blood or other potentially infectious materials. At the ϻ hand washing facilities are located in most laboratories and clinical areas. If hand washing facilities are not readily available, the Principal Investigator or Supervisor is required to provide either an antiseptic cleanser in conjunction with clean cloth/paper towels or antiseptic towelettes. If these alternatives are used then the hands are to be washed with soap and running water as soon as feasible. Note: All employees and students must wear gloves where potentially infectious agents are used. These may be surgical type gloves if chemicals are not used. After removal of gloves, employees and students shall wash hands and any other potentially contaminated skin areas immediately or as soon as feasible with soap and water. If employees or students incur exposure to their skin or mucous membranes, those areas shall be washed or flushed with water as appropriate as soon as feasible following contact. 2. Work area restrictions: In work areas or laboratories where there is a reasonable likelihood of exposure to blood or other potentially infectious materials, employees and students shall not eat, drink, apply cosmetics or lip balm, smoke, or handle contact lenses (Appendix C) except in specifically designated areas. Food and beverages are not to be kept in refrigerators, freezers, shelves, cabinets, or on counter tops or bench tops where blood or other potentially infectious materials or chemicals are present. Eating and drinking is prohibited in all but designated areas within laboratories at ϻ. Smoking is prohibited in all University buildings. Mouth pipetting/suctioning of blood or other potentially infectious materials is prohibited. All procedures will be conducted in a manner that will minimize splashing, spraying, splattering, and generation of potentially infectious aerosols. The Principal Investigator or Supervisor is responsible for identifying methods that will be employed in their areas. 4. Specimen handling and transport: Blood or other potentially infectious materials will be placed in a container which prevents leakage during the collection, handling, processing, storage, and transport of the specimen. The container used for this purpose will be labeled or color coded in accordance with the requirements of the OSHA standard and will be closed prior to handling. Any specimens, which could puncture a primary container, will be placed within a secondary container that is puncture resistant. The Principal Investigator or Supervisor shall specify how this will be carried out, i.e. which specimens, if any, could puncture a primary container, which containers may be used as secondary containers and where the secondary containers are located in their area. If outside contamination of the primary container occurs, the primary container shall be placed within a secondary container that prevents leakage during the handling, processing, storage, transport, or shipping of the specimen. Specimens for shipping must meet DOT/USPS requirements. For more detailed information, call the Biosafety Officer at 243-6395. All outgoing shipments of biohazardous materials must be coordinated through the Biosafety Officer ( HYPERLINK "http://umt.edu/research/compliance/IBC/shippingmanual.php" umt.edu/research/compliance/IBC/shippingmanual.php) D. Personal Protective Equipment 1. Personal protective equipment (PPE) will be provided by the employer at no cost to employees and students who have an occupational exposure to blood or potentially infectious material. This equipment may include: gloves, gowns, laboratory coats, face shield/masks, safety glasses, goggles, mouthpieces, resuscitation bags, and shoe covers. Each supervisor must determine what PPE is appropriate and required for their area. Consult with the BSO if you are unsure. The Principal Investigator or Supervisor will ensure that PPE is provided and worn by employees and students as needed and that training in the proper wearing and use of such equipment is provided. PPE is considered to be appropriate only if it does not permit blood or other potentially infectious material to pass through to or reach the employee's work clothes, street clothes, undergarments, skin, eyes, mouth, or other mucous membranes under normal conditions of use and for the duration of time that the protective equipment will be used. An employer shall ensure that PPE is available in appropriate sizes and accessible locations. All PPE will be cleaned, laundered, and disposed of by the employer at no cost to employees and students. Soiled personal protective equipment should not be taken home to launder. The PI/department will need to contract with a commercial laundry service. The department, at no cost to the employee, will make all repairs and replacements to personal protective equipment. All garments that are penetrated by blood shall be removed immediately or as soon as feasible. All PPE will be removed prior to leaving the work area. The Principal Investigator or Supervisor shall indicate where employees and students are expected to place the PPE upon leaving the work area. Gloves: Gloves shall be worn where it is reasonably anticipated that employees and students may have hand contact with blood, other potentially infectious materials, non-intact skin and mucous membranes, and when handling or touching contaminated items or surfaces. Disposable gloves are not to be washed or decontaminated for re-use and are to be replaced as soon as practical when they become contaminated or as soon as feasible if they are torn, punctured, or when their ability to function as a barrier is compromised. Utility gloves may be decontaminated for re-use provide that the integrity of the glove is not compromised. Utility gloves will be discarded if they are cracked, peeling, torn, punctured, or exhibit other signs of deterioration or when their ability to function as a barrier is compromised. Hypoallergenic gloves, glove liners, powerless gloves, or other similar alternatives shall be readily accessible to all employees and students who are allergic to the gloves normally provided. Gloves should be removed by grasping the outside wrist area of one glove using the other gloved hand. Take care not to touch skin or clothing with contaminated gloves. Pull the grasped glove inside out and hold onto it with the remaining gloved hand. Take the ungloved hand reach inside the wrist part of the remaining glove. Pull the remaining glove inside out. In this way the gloves should be one inside the other and the contaminated surfaces wrapped inside. Place contaminated gloves into a biohazard bag. Eye protection, face shields and masks: Masks in combination with eye protection devices, such as goggles or glasses with solid side shields, or chin length face shields, are required to be worn whenever splashes, spray, splatter, or droplets of blood or other potentially infectious materials may be generated and eye, nose, or mouth contamination can reasonably be anticipated. Protective clothing: Appropriate protective clothing shall be used, such as lab coats, gowns, aprons, or similar outer garments as appropriate. Disposable water-repellent overgowns should be worn when contamination with blood or other potentially infectious materials is anticipated. E. Housekeeping The Principal Investigator or Supervisor shall ensure that the laboratory is maintained in a clean and sanitary fashion at all times. Decontamination: Establishing decontamination procedures is the responsibility of the Principal Investigator or Supervisor. A 1:10 dilution of household bleach (prepared fresh daily) is recommended for use in most circumstances (Appendix F). For further assistance in selecting an appropriate disinfectant, call the Biosafety Officer at 243-6395. All contaminated work surfaces will be decontaminated After completion of procedures. Immediately or as soon as feasible after any spill of blood or other potentially infectious materials. Contaminated plastic backed absorbent pads shall be removed immediately or as soon as feasible after any spill of blood or other potentially infectious materials as well as at the end of the workday. All bins, pails, cans, and similar receptacles shall be inspected and decontaminated by using a 1:10 household solution. Any broken glassware that may be contaminated must not be picked up directly with bare or gloved hands. It must be removed by mechanical means such as tongs and/or dustpans and broom and placed in an appropriate infectious waste sharps container. Assistance from EH&RM is available by calling 243-4503. F. Regulated Waste Disposal (Infectious Waste) All biohazardous waste must be disposed of by one of the following means. There are no exceptions. Sharps All sharps must be collected in durable containers for offsite disposal with our biohazardous waste contractor. Special heavy wall red plastic sharps containers, coffee cans or other puncture-proof, stiff-walled containers may be used for sharps collection. You may NOT use plastic milk bottles, cardboard boxes or other containers that are likely to allow a needle to penetrate the container walls during handling. Under no circumstances may sharps be disposed of in the normal trash. Call Environmental Health and Risk Management ( HYPERLINK "http://www.umt.edu/research/EHRM/default.php" www.umt.edu/research/EHRM/default.php) at 243-4503 for free pick up of your sharps containers. Liquid blood or other body fluids Liquid blood or other body fluids may be disposed of down the drain. If you know these materials contain agents that are infectious, you should disinfect them with a bleach solution prior to drain disposal. Solid biohazardous waste Solid biohazardous waste such as used bandages, gloves, counter pads, disposable labware pipette tips etc. may be treated in several different ways. Small quantities may be chemically disinfected and disposed of in the normal trash as long as no appreciable free liquid is present. Dry waste may be placed into red biohazard bags and autoclaved and disposed of in the normal trash if the biohazard symbol is defaced on the bag prior to disposal. If biohazard bags are used that auto indicate that acceptable temperatures have been attained, then the bags and contents may be disposed of without manually defacing the biohazard symbol. Dry waste that cannot be autoclaved or otherwise decontaminated will be picked up by Environmental Health and Risk Management ( HYPERLINK "http://www.umt.edu/research/EHRM/default.php" www.umt.edu/research/EHRM/default.php) at 243-4503. NEVER put sharps in a biohazardous waste bag. You or someone else may experience a needle stick through the bag if all sharps are not contained as outlined above. Laundry procedures Recreation services (towels) Athletic dept (towels, uniforms, etc.) Public Safety uniforms Lab coats Apparel contaminated with blood or other potentially infectious materials will be handled as little as possible. Such apparel will not be sorted or rinsed in the area of use. All employees and students who handle contaminated apparel will utilize personal protective equipment to prevent contact with blood or other potentially infectious materials. Wash your hands immediately when you come into contact with surfaces that soiled laundry may touch. G. Hepatitis B Vaccination Employees and students at risk shall be offered vaccination within 10 days of assignment to a job with the risk of occupational exposure. Hepatitis B vaccination shall be made available at no cost to employees who have a potential risk of occupational exposure (see Appendix B) unless the employee has previously received the complete hepatitis B vaccination series (documented), antibody testing has revealed that the employee is immune (documented), or the vaccine is contraindicated for medical reasons. If the employee initially declines hepatitis B vaccination but at a later date while still covered under the standard decides to accept the vaccination, the employee shall have the hepatitis B vaccination at that time. STUDENTS: should have hepatitis vaccination and titer prior to beginning laboratory or clinical experience with potential exposure to bloodborne pathogens (vaccinations and titers can be obtained for a fee at Curry Health Center or other health provider). All employees and students who decline to accept hepatitis B vaccination must sign the OSHA approved waiver in Appendix B. H. Post-Exposure Evaluation and Follow-Up 1. Should an exposure incident occur, seek immediate attention with a healthcare provider. Give the name of the employee, department, supervisor, and supervisors phone number. 2. Following a report of an exposure incident, the employee shall have a confidential medical evaluation and follow-up with the healthcare professional, including: Documentation of the route(s) of exposure, and the circumstances under which the exposure incident occurred; Identification and documentation of the source of exposure. The source or the source individuals blood shall be tested as soon as feasible in order to determine HBV and HIV infectivity. Results of the testing shall be made available to the exposed employee, and the employee shall be informed of applicable laws and regulations concerning disclosure of the identity and infectious status of the source individual. Information provided to the healthcare professional: The healthcare professional evaluating an employee after an exposure incident will be provided the following information: A copy of this plan; A description of the exposed employees duties as they relate to the exposure incident; Documentation of the route(s) of exposure and circumstances under which exposure occurred; Results of the source or the source individuals blood testing, if available; and All medical records relevant to the appropriate treatment of the employee including vaccination status. Healthcare professionals written opinion: The employee shall be provided with a copy of the evaluating healthcare professionals written opinion within 15 days of the completion of the evaluation. The healthcare professionals written opinion for Hepatitis B vaccination shall be limited to whether Hepatitis B vaccination is indicated for an employee, and if the employee has received such vaccination. The healthcare professionals written opinion for post-exposure evaluation and follow-up shall be limited to the following information: results of the evaluation; and medical conditions resulting from exposure to blood or other potentially infectious materials which require further evaluation or treatment. all other findings or diagnoses shall remain confidential and shall not be included in the written report. I. Communication of Hazards Warning labels: Warning labels that include the international biohazard symbol shall be affixed to containers of regulated waste, refrigerators and freezers containing blood or other potentially infectious material, and other containers used to store, transport or ship blood or other potentially infectious materials.  Biohazard sign These signs that include the international biohazard symbol shall be fluorescent orange or orange-red or predominantly so, with lettering and symbols in a contrasting Individual containers of blood or other potentially infectious materials that are placed in a labeled container during storage, transport, shipment or disposal are exempted from the labeling requirement. Labels required for contaminated equipment shall be in accordance with this paragraph and shall also state which portions of the equipment remain contaminated. Regulated waste that has been decontaminated need not be labeled or color-coded. Other signs The employer shall post signs at the entrance to work areas which shall bear the international biohazard symbol and appropriate description of hazard. These signs shall be fluorescent orange-red or predominantly so, with lettering and symbols in a contrasting color. J. HIV and HBV Research Laboratories This section applies to research laboratories engaged in the culture, production, concentration experimentation, and manipulation of HIV and HBV. It does not apply to clinical or diagnostic laboratories engaged solely in the analysis of blood, tissues, or organs. These requirements apply in addition to the other requirements of the standard. See Appendix G. Research laboratories shall meet the following criteria: Standard microbiological practices All regulated waste shall be decontaminated by autoclaving. Special practices: Laboratory doors shall be kept closed and locked at all times when research involving HIV or HBV occurs. Access to the work area shall be limited to authorized persons. Written policies and procedures shall be established by the PI or Laboratory Supervisor whereby only persons who have been advised of the potential biohazard, who meet any specific entry requirements, and who comply with all entry and exit procedures shall be allowed to enter the work areas and animal rooms. When other potentially infectious materials are present in the work area or containment module, a hazard warning sign incorporating the universal biohazard symbol shall be posted on all access doors. All activities involving other potentially infectious materials shall be conducted in biological safety cabinets or other physical-containment devices within the containment module. No work with these or other potentially infectious materials shall be conducted on the open bench. Disposable laboratory coats or gowns or other appropriate protective clothing shall be used in the work area. Protective clothing shall not be worn outside of the work area and shall be decontaminated before being disposed of. Special care shall be taken to avoid skin contact with potentially infectious materials. Gloves shall be worn when handling infected materials. Before disposal all waste from work areas shall be decontaminated by autoclaving. Vacuum lines shall be protected with liquid disinfectant traps and high-efficiency particulate air (HEPA) filters or filters of equivalent or superior efficiency and which are checked routinely and maintained or replaced as necessary. Hypodermic needles and syringes shall be used only for aspiration of fluids from diaphragm bottles. Only needle-locking syringes or disposable syringe-needle units (i.e., the needle is integral to the syringe) shall be used for the aspiration of other potentially infectious materials. Extreme caution shall be used when handling needles and syringes. A needle shall not be bent, sheared, replaced in the sheath or guard, or removed from the syringe following use. The needle and syringe shall be promptly placed in a puncture-resistant container and autoclaved or decontaminated before disposal. All spills shall be immediately contained and cleaned up by appropriate professional staff or others properly trained and equipped to work with potentially concentrated infectious materials (Appendix E). A spill or accident that results in an exposure incident shall be immediately reported to the laboratory director and the Biosafety Officer at 243-6395 or EH&RM at 243-4503. Containment equipment: Certified biological safety cabinets (Class I, II, or III) or other appropriate combinations of personal protection or physical containment devices, such as special protective clothing, respirators, centrifuge safety cups, sealed centrifuge rotors, and containment caging for animals, shall be used for all activities with other potentially infectious materials that pose a threat of exposure to droplets, splashes, spills, or aerosols. Biological safety cabinets shall be certified when installed, whenever they are moved and at least annually. Please call the Biosafety Officer at 243-6395 when a new one is obtained or an existing one has been moved. HIV and HBV research facilities shall meet the following criteria: The work areas shall be separated from areas that are open to unrestricted traffic flow within the building. Passage through two sets of doors shall be basic requirement for entry into the work area from access corridors or other areas or activities may also be provided by a double-doored clothes-change room or other access facility that requires passing through two sets of doors before entering the work area. The surfaces of doors, walls, floors and ceilings in the work area shall be water resistant so that they can be easily cleaned. Penetrations in these surfaces shall be sealed or capable of being sealed to facilitate decontamination. Each work area shall contain a sink for washing hands and a readily available eye wash facility. The sink shall be foot, elbow, or automatically operated and shall be located near the exit door of the work area. Access doors to the work area or containment module shall be self-closing. An autoclave for decontamination of regulated waste shall be available within the work area. Ducted exhaust-air ventilation system shall be provided. This system shall create directional airflow that draws air into the work area through the entry area. The exhaust air shall not be recirculated to any other area of the building, shall be discharged to the outside, and shall be dispersed away from occupied areas and air intakes. The proper direction of the airflow shall be verified (i.e., into the work area). Additional training: The Principal Investigator or Supervisor shall consult with the Biosafety Officer for a description of applicable criteria and additional training required for employees and students who work in HIV/HBV research laboratories. K. Training All employees and students who have occupational exposure, or risk of exposure, to bloodborne pathogens will be provided bloodborne pathogen training. Annual refresher training for all employees and students shall be provided within one year of their previous training. Supervisors shall provide additional training, when changes such as modification of tasks or procedures or institution of new tasks or procedures affect the employees occupational exposure. Material appropriate in content and vocabulary to educational level, literacy, and language of employees and students shall be used. The training program shall contain at a minimum the following elements: An accessible copy of the regulatory text of this plan and an explanation of its contents. A general explanation of the epidemiology and symptoms of bloodborne diseases. An explanation of the modes of transmission of bloodborne pathogens. An explanation of the exposure control plan and the means by which the employee can obtain a copy of the written plan. An explanation of the appropriate methods for recognizing tasks and other activities that may involve exposure to blood and other potentially infectious materials. An explanation of the use and limitations of methods that will prevent or reduce exposure including appropriate engineering controls, work practices, and personal protective equipment. Information on the types, proper use, location, removal, handling, decontamination and disposal of personal protective equipment. An explanation of the basis for selection for personal protective equipment. Information on the hepatitis B vaccine, including information on its efficacy, safety, method of administration, the benefits of being vaccinated, and that the vaccine and vaccination will be offered free of charge. Information on the appropriate actions to take and persons to contact in an emergency involving blood or other potentially infectious materials. An explanation of the procedure to follow if an exposure incident occurs, including the method of reporting the incident and the medical follow-up that will be made available. Information on the post-exposure evaluation and the follow-up that the employer is required to provide for the employee following an exposure incident. An explanation of the signs and labels and/or color coding. The Principal Investigator/ Supervisor shall assure that employees and students demonstrate proficiency in standard microbiological practices and techniques and in the practices and operations specific to the facility before being allowed to work with HIV or HBV and have prior experience in the handling of human pathogens or tissue cultures before working with HIV or HBV. The PI/ Supervisor shall provide a training program to employees and students who have no prior experience in handling human pathogens. Initial work activities shall not include the handling of infectious agents. A progression of work activities shall be assigned as techniques are learned and proficiency is developed. The employer shall assure that employees and students participate in work activities involving infectious agents only after proficiency has been demonstrated. V. RECORD KEEPING A. Training Records Training records shall be maintained in the laboratory and shall include the following information: The dates of the training sessions. The contents or a summary of the training sessions. The names and qualifications of persons conducting the training. The names and job titles of all persons attending the training sessions. Training records shall be maintained for 3 years from the date on which the training occurred. B. Medical Records Medical records are maintained for each employee with occupational exposure in accordance with 29 CFR 1910.1020, Access to Employee Exposure and Medical Records. Bloodborne pathogen exposure records are kept at EHRM for 30 years. C. OSHA Record Keeping 1. An exposure incident is evaluated to determine if the case meets OSHAs Recordkeeping Requirements (29 CFR 1904). 2. This determination and the recording activities are done by the ϻ Workers Compensation Manager. D. Sharps Injury Log All sharps related injury records are maintained at Curry Health Center and EHRM. 1. All percutaneous injuries from contaminated sharps are also recorded in the Sharps Injury Log. All incidences must include at least: The date of the injury. The type and brand of the device involved. The department or work area where the incident occurred. An explanation of how the incident occurred. 2. This log is reviewed at least annually as part of the annual evaluation of the program, and is maintained for at least five years following the end of the calendar year that it covers. 3. If a copy is requested by anyone, the copy must have all personal identifiers removed from the report. APPENDIX A Exposure Determination These types of jobs may have occupational exposure to bloodborne pathogens based on the nature of their work or as a result of specific duties that may be required as part of their job. Some employees and students in other job classifications may have specific required routine or non-routine job tasks that result in occupational exposure. Type of JobRequired Duties (this column lists only examples of required duties that might result in occupational exposure)Assistant ProfessorProcess human blood and/or tissue samplesAssociate ProfessorProcess human blood and/or tissue samplesAthletic TrainerFirst aid and treatment of athletic injuryAthletic Trainer, studentFirst aid and treatment of athletic injuryBiosafety OfficerWorking in areas contaminated with human blood or OPMICustodianClean areas where blood may be presentEquipment ManagerHandling, maintaining and washing athletic wear and equipment that may be contaminated with human blood or OPIMEquipment Manager, studentHandling, maintaining and washing athletic wear and equipment that may be contaminated with human blood or OPIMGraduate AssistantProcess human blood and/or tissue samplesHousekeeperHandles linens soiled with human blood or OPIM; cleaning duties that involve contact with human blood or OPMIInstructorFirst aidLaboratory TechnicianProcess human blood and/or tissue samplesLaundry WorkerHandles soiled laundry from labs and dormsMaintenance WorkerHousekeeping (which may involve contact with human blood or OPIM)Maintenance Worker, studentHousekeeping (which may involve contact with human blood or OPIM)Medical staff, Curry HCDoctors, nurses, other medical staff with patient contactPhysical TherapistPatient contact with potential to encounter human blood or OPIMPostdoctoral FellowProcess human blood and/or tissue samples; maintain culture of bloodborne pathogensProfessorProcess human blood or OPIMPsychologistPatient contact with potential to encounter human blood or OPIMResearch AssociateProcess human blood and/or tissue samples; maintain culture of bloodborne pathogensResearch AssistantProcess and analyze human blood or OPIMResearch TechnicianProcess and analyze human blood or OPIMSpeech TherapistPatient contact with potential to encounter human blood or OPIMStudent TechnicianHandle/analyze human blood or tissuesWork Study StudentHandle/analyze human blood or tissues (Appendix A, continued) Division/DepartmentJob DutiesHazardAthletic DepartmentTrainersPhysical Training of AthletesHepatitis B Hepatitis C HIVEnvironmental Health and Risk ManagementAllCleaning up spills in laboratories disposing of contaminated waste productsHepatitis B Hepatitis C HIVϻ Department of Public SafetyAll Patrol and Detective PersonnelPotential for exposures to bloodHepatitis B Hepatitis C HIV Department Head, Principal Investigator or Laboratory Supervisory shall identify additional job classifications in their area in which employees and students maybe exposed if they are not already identified in the previous tables. Job Title Specific Duties Or Procedures That Could Lead To Exposure Hazard           APPENDIX B ϻ Hepatitis B Vaccination Faculty or Employee Faculty/Staff Member:  FORMTEXT       Griz Card #:  FORMTEXT       Department:  FORMTEXT       Work Phone:  FORMTEXT       Supervisor:  FORMTEXT       CHOOSE EITHER OPTION 1 OR OPTION 2: OPTION 1: If you are an employee with occupational exposure to human blood, fluids or tissues and you elect to receive hepatitis B vaccination at Curry Health Center (243-2790), sign the vaccine request and give to your immediate supervisor for a charge-back number. Once vaccinated, give confirmation of vaccination and subsequent titers to your supervisor. Vaccination Request I have read and understand the ϻ Bloodborne Pathogens Exposure Control Plan,  HYPERLINK "http://www.umt.edu/research/compliance/IBC/bbp.php" www.umt.edu/research/compliance/IBC/bbp.php, and have been trained about the hazards of bloodborne pathogens. I understand that due to my occupational exposure to human blood, fluids or tissues, I may be at risk of acquiring hepatitis B virus (HBV) infection. I elect to receive the hepatitis B vaccination series (3 injections over 6 months) at this time and at no cost to me. Signature of Employee Date:  FORMTEXT       OPTION 2: If you are faculty or an employee and (A) elect NOT to receive the hepatitis B vaccine, or (B) if you have been previously vaccinated, please sign below and give to your immediate supervisor. A. Hepatitis B Vaccine Declination I understand that due to my occupational exposure to blood or other potentially infectious materials I may be at risk of acquiring hepatitis B virus (HBV) infection. I have been given the opportunity to be vaccinated with hepatitis B vaccine, at no charge to myself. However, I decline hepatitis B vaccination at this time. I understand that by declining this vaccine, I continue to be at risk of acquiring hepatitis B, a serious disease. If in the future I continue to have occupational exposure to blood or other potentially infectious materials and I want to be vaccinated with hepatitis B vaccine, I can receive the vaccination series at no charge to me. Signature of Staff Member Date: B. If previously vaccinated, complete the following information (documentation required): Date of Vaccination Result/Titer Facility Signature of Faculty/Employee Date: ϻ Hepatitis B Surveillance Program Students Students Name:  FORMTEXT       Griz Card #:  FORMTEXT       Phone:  FORMTEXT       e-mail:  FORMTEXT       CHOOSE EITHER OPTION 1 OR OPTION 2: OPTION 1: If you are a student and elect to receive hepatitis B vaccination, fill out the vaccine request, sign and take to Curry Health Center or to a clinic or physician of your choice and return the form to your immediate supervisor with confirmation of your vaccination and subsequent titer. Vaccine Request I have read and understand the ϻ Bloodborne Pathogens Exposure Control Plan,  HYPERLINK "http://www.umt.edu/research/Compliance/IBC/BBP.php" www.umt.edu/research/Compliance/IBC/BBP.php, and have been trained about the hazards of bloodborne pathogens. I understand that due to potential exposure to human blood, fluids or tissues in my classes or training at ϻ, I may be at risk of acquiring hepatitis B virus (HBV) infection. I elect to receive the hepatitis B vaccine at this time and understand that as a student, I am responsible for the cost of the vaccination series and subsequent titer analysis. Signature of Student: Date:  FORMTEXT       OPTION 2: If you are a student and elect (A) NOT to receive the hepatitis B vaccination, or (B) if you have been previously vaccinated, please sign this form and give to your immediate supervisor. A. Hepatitis B Vaccine Declination I understand that due to potential exposure to blood or other potential infectious materials in my classes or training at ϻ, I may be at risk of acquiring hepatitis B virus (HBV) infection. I have been given the information about HBV and the HBV vaccination series. However, I decline hepatitis B vaccination at this time. I understand that by declining this vaccine, I continue to be at risk of acquiring hepatitis B, a serious disease. If I subsequently decide to be vaccinated, as a student, I am responsible for the cost of the vaccination series and titer analysis. Signature of Student Date: FORMTEXT       B. If previously vaccinated, complete the following information: Date of HBV Vaccination  FORMTEXT       Result/Titer  FORMTEXT       Facility  FORMTEXT       Signature of Student Date:  FORMTEXT       APPENDIX C Policy for Food and Drink in Laboratories There shall be no food, drink, smoking, or applying cosmetics in laboratories which have radioactive materials, biohazardous materials or hazardous chemicals present (certain desk areas within the laboratory may be marked as designated eating and drinking areas). There shall be no storage or disposal of these consumable items in laboratories (including refrigerators within laboratories). Rooms which are adjacent, but separated by floor to ceiling walls, and do not have any chemical, radioactive or biological agents present, may be used for food consumption, preparation, or applying cosmetics at the discretion of the principal investigator responsible for the areas. APPENDIX D Human Cell Cultures A. ESTABLISHED CELL LINES 1. Cell lines should be documented to be pure cells and shown to be free of bloodborne pathogens in order to be exempted from the ECP requirements. Human cell lines may be adulterated with laboratory pathogens introduced by cultivation with other cell cultures, or cells may be physically contaminated by other cultures handled in the same lab. Exclusion from compliance with the bloodborne pathogen standard, must include Screening the cell lines or strains for viruses characterized as bloodborne pathogens (e.g., HIV, HBV, EBV), and Determining that the cells are not capable of propagating such viruses. Most cell lines are screened only for human mycoplasma and are determined to be free of bacterial and mycotic contaminants. Testing to identify latent viruses capable of infecting humans such as Herpesviruses (e.g., EBV), or papilloma members of the Papovirus group, etc. may include: a) Antigenic screening for viral or agent markers; b) Co-cultivation with various indicator cells that allow contaminants to grow; c) Using molecular techniques (polymerase chain reaction or nucleic acid hybridization). Cell lines obtained from commercial vendors or other sources documented as free of human bloodborne pathogens and protected by the employer from environmental contamination may be excluded from the bloodborne pathogens standard. 2. The final judgment for making the determination if human or animal cell lines in culture are free of bloodborne pathogens will be made by the Biological Safety Officer at ϻ and/or the Institutional Biosafety Committee (IBC) in consultation with the Principal Investigator (PI), in accordance with the requirements of the bloodborne pathogen standard. Documentation that such cell lines are not OPIM should be on file with the PI. B. PRIMARY CELL LINES All primary human cell explants and in vitro passages of human tissue explant cultures (human cell strains must be regarded as containing bloodborne pathogens and are subject to Universal Precautions and the requirements of the ECP. Human cell strains are cells propagated in vitro from primary explants of human tissue or body fluids which have finite lifetime (non-transformed) in tissue cultures for 20-70 passages. Human cell strains must be handled as potential biohazards unless characterized by documented testing to be free of bloodborne pathogens. However, tissue explants or subsequent cultures derived from human subjects known to carry bloodborne pathogens (e.g., HIV, HBV), or deliberately infected with bloodborne pathogens, must be handled in accordance with the bloodborne pathogens standard and the ϻ ECP. The same applies for animal tissues and explants or cell lines contaminated by deliberate infection with bloodborne pathogens. Non-transformed, human cell strains characterized by documented, reasonable laboratory testing, to be free of HIV, hepatitis viruses, or other bloodborne pathogens may be exempted from the ECP requirements. APPENDIX E Biohazardous Spill Response A biohazardous spill is an unplanned release of potentially infectious material into the work environment. Proper response to such an incident can ensure personnel safety. For more information regarding biohazardous spill response procedures, or for assistance with developing a departmental procedure, please contact the ϻ Biosafety Officer at 243-6395. Biohazardous Spill Kit Each work group that has a potential for a biohazardous spill should have sufficient and appropriate spill cleanup materials available to respond to the largest anticipated spill for that area. The basic items to include in a kit are: Gloves: nitrile or latex (multiple pairs) Splash goggles Absorbent powder (i.e. Superfine) Absorbent towels Disinfectant (a registered tuberculocidal product or a product effective for destruction of HIV and hepatitis B virus, i.e. bleach) Remember that once diluted, bleach has a short shelf life. Mechanical tools (i.e. forceps, dustpan/broom, tongs, and plastic scrapers) Biohazard bags Antimicrobial towelettes Additional items might include: a fluid resistant smock to protect street clothes and a sharps container if contaminated sharps may be present Biohazardous Spill Response Procedure Biohazardous spills can happen in a number of different situations. When developing or adopting a spill procedure, assure that it is appropriate for your work areas specific needs. In addition, the following principles should be kept in mind: Minimize the spill responders risk of exposure to both biological and chemical hazards. Eliminate unnecessary handling of the disinfectants (particularly in concentrated form) and spilled material. Prior to using a disinfectant, review the manufacturers recommendations and material safety data sheet to assure safe and appropriate use of the product. Follow prescribed contact times and concentrations for disinfectants. These two parameters are critical to the effectiveness of these products. Be prepared. Supervisors must provide or arrange for training for all affected personnel regarding the spill protocol. Assure that spill clean-up materials are available and accessible. For more information on responding to spills in a biosafety containment lab, please refer to the ϻ HYPERLINK "http://www.umt.edu/research/complianceinfo/IBC/safetymanual.aspx"Biosafety Safety Manual. In some situations, it may not be appropriate for personnel to clean up a biohazardous spill An employee has not received training in biohazardous spill cleanup. Appropriate spill materials are not available. The spill is a combined hazard spill (i.e. radiation and biohazard). The spill is too large to be handled by your staff. In these situations, personnel should take the following primary response steps: Notify others in the work area of the spill; Close off the area where the spill is located; Call the designated spill responders (the biosafety officer, EH&RM, etc.); Keep others out of the spill area until responders arrive and spill hazard is removed. (APPENDIX E, continued) Sample Biohazardous Spill Procedure A. Treatment of contaminated spills on a nonporous surface such as a tile floor or concrete floor. 1. Notify others working in the area of the hazard present. 2. Get your biohazard spill kit and review spill procedure before proceeding with cleanup. 3. Remove spill supplies from kit and line bucket/container with a biohazard bag. (Retrieve a sharps container for disposal of sharps if necessary.) 4. At a minimum, wear two pairs of gloves and splash goggles. 5. If applicable, using mechanical means (i.e. dustpan/broom, tongs), pick up any contaminated sharp items (needles, broken glass, etc.) and place them in an approved sharps container for disposal. 6. Cover the spill with an absorbent material (i.e. Superfine, SSS Clean-up Powder). 7. Remove the absorbent material by using a mechanical means (i.e. dustpan and broom, plastic scrapers) and deposit it along with the mechanical tool into a biohazard bag. 8. Spray the spill area with disinfectant and allow the appropriate contact time as recommended by the disinfectant manufacturers instructions (i.e. 10 minute contact time for bleach) 9. Remove residual disinfectant with paper towels. Dispose of the towels in the biohazard bag. 10. Repeat steps 8 and 9 for sufficient disinfection of contaminated surfaces. 11. Remove outer pair of gloves only and dispose of them in the biohazard bag. 12. Remove splash goggles with inner gloves still on, and clean the goggles with an antimicrobial towelette (can also dispose of goggles if contaminated) 13. Remove inner pair of gloves and place them in the biohazard bag for disposal. 14. Close the bag and dispose of as biohazardous waste 15. Wash your hands with soap and water as soon as possible. 16. Return spill kit to designated location. Ensure that the spill kit is restocked for next use. B Treatment of contaminated items (solid, non porous items such as glassware): 1. Spray the item with disinfectant and allow a ten minute contact time (or as recommended by the disinfectant manufacturers instructions). 2. Remove the contamination by wiping down the item with a paper towel. 3. Reapply the disinfectant and allow a ten minute contact time (or as recommended by the disinfectant manufacturers instructions). 4. Remove excess disinfectant with a paper towel and allow to air dry. 5. Assure that ALL disinfectant is removed from the item. Most disinfectants are corrosive and can cause irritation if they come in contact with the skin. C. Treatment of contaminated items (porous surfaces such as fabric items): 1. If the item is university-owned (such as a lab coat, sheets, etc.), contain it in a biohazard bag. 2. If the item is a personal item and is heavily contaminated, contain it in a biohazard bag and send to a commercial laundry. APPENDIX F Disinfection Introduction Disinfection, sterilization, and antisepsis are all important aspects of infection control in the hospital and laboratory. It is important to understand the differences between the following, because disinfection and sterilization are not interchangeable terms. Sterilization is the use of physical or chemical processes to destroy all forms of microbial life. Disinfection is the act of or process of reducing the amount of microbial life with the goal of obtaining a safe level (destroying pathogenic microbes). Antisepsis is the disinfection of living tissue. The chemicals used for antisepsis are not the same as those used for disinfection. Disinfection is one type of infection control that is widely used. For practical reasons, chemical disinfection is used in the clean-up of spills and to decontaminate surfaces. Some of these chemicals will be discussed below. Factors Affecting Disinfection The following are six primary variables that influence the efficacy of disinfection: 1. Nature of the item to be disinfected The rougher the surface, the longer the contact time required for disinfection. 2. Number of microorganisms present The number of microorganisms present will lengthen the time for effective disinfection to take place. In general, higher numbers of organisms require more time for disinfection. 3. Resistance of microorganisms Some microorganisms are more resistant to disinfection than others. The generally accepted order from the most resistant to the least resistant is: bacterial spores, mycobacteria, hydrophilic viruses, fungi, vegetative bacteria, lipid viruses. Disinfecting a spill with a small concentration of bacterial spores will require longer disinfection time than a large concentration of lipid viruses. 4. Type and concentration of disinfectant used Resistance of microorganisms depends on the type of disinfectant used. A particular microorganism may be more resistant to one type of disinfectant than another. For instance, alcohol (isopropyl or ethyl) is effective against vegetative bacteria and most lipophilic viruses, but is not effective against bacterial spores or most hydrophilic viruses. Many disinfectants are broad spectrum; that is, effective against all or most forms of microbial life. Some broad spectrum disinfectants include glutaraldehyde, sodium hypochlorite (bleach), and hydrogen peroxide. Non-broad spectrum disinfectants include phenolics and quaternary ammonium compounds. Alcohols lie somewhere in between these two. The concentration of a particular disinfectant effects disinfection. In most cases, a higher concentration increases microbial killing power and decreases time necessary for disinfection. However, some disinfectants are not as effective in higher concentrations. Iodophors must be diluted according to the directions on the label; over-diluting or under-diluting may substantially (Appendix F, continued) lower the microbicidal potency. Alcohols used in concentrations above 90% are less effective because the water added to dilute the alcohol allows it to penetrate better and reach its target. Optimal concentration range is between 70 and 90%. 5. Presence of organic material The presence of organic soiling matter will compromise disinfection. Blood, blood products, bodily fluids, and feces contain significant amounts of proteins, and protein will bind and inactivate some disinfectants or slow their action. Therefore, in the presence of large amounts of protein, a higher concentration of disinfectant and longer contact time will be necessary to achieve maximal disinfection. 6. Duration of exposure and temperature Duration of exposure and temperature influences the disinfection process. The longer the duration of exposure, the higher the degree of disinfection achieved. Some disinfectants require a longer contact time to achieve killing, and some microorganisms need longer exposures to be killed. Higher temperatures increase the killing power of most disinfectants, whereas lower temperatures may slow the killing power of most disinfectants. Disinfectant Types Different disinfectants operate by different mechanisms, and some are more effective than others. Thus, it is not appropriate to use the various disinfectants interchangeably. The large numbers of chemical disinfectants that are available include alcohol, chlorine and chlorine compounds, formaldehyde, glutaraldehyde, hydrogen peroxide, iodophors, phenolics, and quaternary ammonium compounds. Effectiveness of a particular disinfectant will sometimes vary from organism to organism. For example, quaternary ammonium compounds are effective for destroying: fungi, bacteria, and lipophilic viruses (such as HIV and HBV); however, they are not effective for destroying spores. In addition, they are not generally effective for destroying Mycobacterium tuberculosis or hydrophilic viruses. Please call the Biosafety Officer for the practical use of a particular disinfectant for your facility. Bloodborne Pathogens and Tuberculosis Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), and Mycobacterium tuberculosis (M. tuberculosis) are of concern because of potential consequences associated with infection. HIV and HBV are bloodborne; M. tuberculosis is an airborne infectious agent and present in respiratory secretions. HIV and HBV are both lipophilic viruses and therefore susceptible to a variety of disinfectants. Bleach solution: A freshly made 1:10 dilution of 5.25% sodium hypochlorite (common household bleach) to water is recommended for disinfection of material potentially infected with HIV and HBV. Before disinfecting a surface after a blood spill with 1:10 solution of household bleach, one should clean the surface first because of the fact that hypochlorites and other germicides are substantially inactivated in the presence of blood. Other products: Glutaraldehyde, hydrogen peroxide (3-6%), and iodophors are also effective for destroying bloodborne pathogens. Although isopropyl alcohol and ethanol will inactivate HIV and HBV, these disinfectants evaporate rapidly so sufficient contact time may be difficult to achieve. In order to assure adequate disinfection time (for contact times refer to the manufacturers directions). Destruction of Mycobacterium tuberculosis presents a challenge, as many disinfectants are not effective for destroying this pathogen. Bleach is effective only in higher concentrations. Alcohols and hydrogen peroxide have varying results; quaternary ammoniums are not effective for destroying M. tuberculosis. Phenolics are the best tuberculocides, for they readily inactivate M. tuberculosis. However, when (Appendix F, continued) disinfecting for M. tuberculosis, it is very important to avoid generation of droplets or aerosols, which are the primary transmission routes. Choosing a Disinfectant Choosing a disinfectant should be based on the spectrum of antimicrobial activity, availability, and cost. Bleach is an effective broad spectrum disinfectant, readily available, inexpensive, and works well for spills. Although alcohols do not have the spectrum of activity that bleach has, they are readily available, economical, and excellent for everyday use. Other disinfectants have similar qualities. Conclusion Disinfection is a very important process in infection control. One must not only disinfect a surface after a spill, but develop a regular schedule for disinfection. Awareness of the proper technique can prevent infection and maintain a safe work environment. It is recommended that the level of disinfectant used is appropriate to the agent involved. Do not overkill. Appendix G HIV and HBV Research Laboratories HIV and HBV research laboratories present increased risk for occupational exposure to bloodborne pathogens. A research laboratory produces or uses research laboratory-scale amounts of HIV or HBV. A research laboratory may produce high concentrations of HIV or HBV, but not in the volume found in a production facility. These laboratories engaged in the culture, production, concentration, experimentation, and manipulation of HIV or HBV will reduce employee risk by providing additional administrative controls, protective equipment, information and training beyond that required for research laboratories not involved in such work. These requirements are in addition to the other requirements as outline in this Exposure Control Plan. Security: 1. Keep laboratory doors closed when work involving HIV or HBV is in progress. 2. A hazard warning sign incorporating the universal biohazard symbol shall be posted on all access doors when potentially infectious material or infected animals are present in the work area or containment module. 3. Access to work area shall be limited to authorized persons only. 4. Establish written procedures whereby only persons who have been advised of the biohazard, who meet any specific entry requirements, and who comply with all entry and exit procedures shall be allowed to enter the work area and animal rooms. Sharps: 1. Hypodermic needles, syringes, and other sharp instruments shall be used only when a safer alternate technique is not feasible. 2. Safety needles/syringes shall be used for the injection or aspiration of other potentially infectious material. (See section on Sharps Injury Protection Program) 3. Use extreme caution when handling needles and syringes to avoid autoinoculation and the generation of aerosols during use and disposal. 4. Do not bend, shear, or replace needles in the sheath or guard, or remove from the syringe after being used. 5. Promptly place the needle and syringe in a puncture-resistant container, and decontaminate, preferably by autoclaving, before being discarded or reused. Work Practice Controls: 1. Certified biological safety cabinets or other appropriate combinations of personal protective equipment or physical containment devices, such as any of the following, shall be used for all activities with other potentially infectious material that poses a threat of exposure to droplets, splashes, spills, or aerosols: a. Special protective clothing b. Centrifuge safety cups c. Sealed centrifuge rotors (Appendix G, continued) 2 Report all spills or accidents resulting in an exposure incident immediately to the principle investigator or other responsible person and to the Biosafety Officer at 243-6395 (Appendix E). 3 Spills must be contained and cleaned up immediately by employees and students that are trained and equipped to work with potentially concentrated infectious material (Appendix E). Engineering controls: 1. 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Do not conduct this work on the open bench. Note: Biological safety cabinets shall be certified when installed, at least annually, and when they are relocated. 2. Each laboratory shall contain a sink for washing hands and an eye wash station that are readily available in the work area. The eyewash must supply a sufficient quantity of water to completely flush the eyes. A 15-minute supply of continuous free-flowing water is acceptable. The hands must be free to hold the eyelids open to aid in the complete flushing of the eyes. 3. HEPA (high-efficiency particulate air) filters, or equivalent filters, and disinfectant traps must be used to protect vacuum lines. Check filters and traps routinely, and maintain or replace as necessary. 4. When transporting contaminated material, use containers that are durable, leak-proof, labeled or color-coded, and closed before leaving the work area. 5. An autoclave for the decontamination of regulated wastes shall be available. All infectious liquid, solid waste, and all waste from work areas, shall be decontaminated before disposal by autoclaving. Personal Protective Equipment: 1. Disposable laboratory coats, gowns, smocks, or other appropriate protective clothing shall be used in the work area. 2. Do not wear protective clothing outside of work area. 3. Protective clothing must be autoclaved before disposal. 4. Gloves shall be worn when making contact with potentially infectious materials. Administrative: 1. Personnel must be advised of potential hazards and are required to read and follow instructions on practices and procedures. This will be documented with a bloodborne pathogens site-specific checklist. 2. Personnel must read the ϻ Biosafety Manual.     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