Principal Investigator by vBF2CN


									                                                                                              Table of Contents
                                                                                              Guidelines                            p. X
                                       Biosafety                                              Template                                X
                                                                                              Reference                               X
           Standard Operating Procedure
                               Biohazardous Materials

Purpose                                                                 Principles of Biosafety
This Standard Operating Procedure (SOP) is means to ensure              According to the Center for Disease Control and Prevention
that specific activities with biohazardous materials are                publication, Biosafety in Microbiological and Biomedical
conducted in a safe manner. SOPs are required as a part of              Laboratories (BMBL) 5 Edition, a fundamental objective of
the Biological Use Authorization (BUA) for all laboratories at          biological safety program is the effective management of
Biosafety Level 2 and above.                                            potentially harmful biological agents through the use of
                                                                        administrative and engineering controls such as containment.
                                                                        Administrative controls are management tools that provide staff
Responsibilities                                                        with a set of guidelines describing how to safely operate with
                                                                        biological hazard(s) in an environment designed for
                                                                        containment of the hazard. The term "containment" is used in
Principal Investigator                                                  describing safe methods, facilities, and equipment for
Principal Investigator (PI) has the primary responsibility for          managing biohazardous materials in the laboratory
ensuring that his/her laboratory is safe by conducting an initial       environment where they are being handled or maintained. The
risk assessment, developing administrative controls, and                purpose of containment is to reduce or eliminate exposure of
ensuring that all work is conducted with the appropriate                laboratory staff, other individuals, and the outside environment
engineering controls. PI’s should refer to the applicable               to potentially hazardous agent(s). The risk assessment of the
guidelines and regulations (e.g., National Institute of Health,         work to be done with a specific agent will determine the
Centers for Disease Control, Cal/OSHA, and USDA).                       appropriate combination of these elements. For more
                                                                        information,                         refer                    to
Laboratory Staff/Students                                     
Laboratory staff and students are responsible for knowing the
potential hazards of the biological material contained within
their respective work areas, and the appropriate procedures
                                                                        Risk Assessment
                                                                        Risk assessment is a process used to identify the hazardous
and practices to be used in the laboratory. Laboratory
                                                                        characteristics of a known infectious or potentially infectious
employees must follow approved laboratory procedures and
                                                                        agent or material, the activities that can result in a person’s
safety guidelines at all times.
                                                                        exposure to an agent, the likelihood that such exposure will
                                                                        cause a laboratory acquired infection, and the probable
Emergency Contact Information                                           consequences of such an infection. The information identified
The first page of the SOP should include the following                  by risk assessment will provide a guide for the selection of
information so that it is quickly and easily accessible:                appropriate biological safety level(s) and microbiological
                                                                        practice(s), safety equipment, and facility protections that could
1.   Emergency Contact Information for:                                 prevent laboratory acquired infection or environmental escape.
       Principal Investigator: Name and telephone number               The risk assessment will determine the biological safety
        (24 hour/7 days per week)                                       containment level (BSL) at which the work can be safely
       Lab Supervisor(s): Name and telephone number (24                conducted. A risk assessment should distinguish the following:
        hour/7 days per week)
       Biosafety Officer: (951) 827-2648 (during business                      Origin of material
        hours)                                                                  Pathogenicity of material: disease incidence and
       Environmental Health & Safety (EH&S): (951) 827-                         severity
        5528 (during business hours)                                            Route of transmission: airborne, ingestion, or
       Police (UCPD): 911 (after regular business hours)                        parenteral,
                                                                                Concentration of working quantities and infectious
2.   Locations of:                                                               organisms per ml of stock solution
       Fire Alarms                                                             Infectious Dose
       Fire extinguishers                                                      Agent stability; how easily the material could be
       Eyewashes (Note: eyewashes should be flushed                             decontaminated
         monthly)                                                               Availability of prophylaxis (vaccination)
       Emergency Showers (Note: showers should receive                         Medical surveillance programs and exposure
         maintenance every 6 months)                                             management (post-exposure prophylaxis)
                                                                                Staff knowledge and skill level including training

Standard Operating Procedure                                        1                                                  Version 07/24/2012
Biohazardous Materials
Additional risk assessment that may be needed include:
                                                                       Spills in the laboratory
        Procedures being used that may produce an aerosol
        Procedures being used that may use needles or                 Each Principal Investigator/laboratory supervisor must develop
         sharps                                                        specific spill cleanup methods tailored to the biological
                                                                       agent(s), quantities, and procedures being implemented in the
        If material has been concentrated or purified from cell
                                                                       lab, and ensure that the appropriate spill response material(s)
                                                                       is immediately accessible. The following recommended
        Use of larger volumes (>10Liters)
                                                                       procedures may be utilized as a basis for cleaning spills of
        If the research material has been altered, how does           biological materials.
         that affect the hazards associated with the material?
        Is the infectious material attenuated (to reduce the
         virulence/infectious nature of the material) ?                Minor (small) Biological Spill:
        How could an exposure event occur?                            Steps to cleaning-up a biological spill:

Biological Safety Containment                                          1.   Post the area where the spill occurred to avoid the
                                                                            potential for cross contamination and unnecessary
Levels                                                                 2.
                                                                            exposure to others in or near the work area.
                                                                            Since a spill has the potential to generate an aerosol, let
The following is a general understanding of the different
                                                                            the aerosol settle (minimum 30minutes)
biosafety levels and their relevant best practices is
                                                                       3.   Wear a laboratory coat and gloves and obtain or prepare
                                                                            fresh disinfectant solution for clean-up the spill (10 %
                                                                            bleach solution or EPA-Approved disinfectant).
Biosafety Level 1 (BSL-1)                                              4.   Place paper towels or other absorbent material on top of
    BSL-1 is suitable for work involving well-characterized                 the spill zone
    agents not known to consistently cause disease in                  5.   Starting from the outermost edge of the spill and working
    immunosuppressed adult humans, and present minimal                      in toward the center of the spill, pour disinfectant onto the
    potential hazard to laboratory personnel and the                        absorbent material and allow sufficient contact time to
    environment. BSL-1 laboratories are not necessarily                     destroy any biological contaminants. Contact time is range
    separated from the general traffic patterns in the building.            between 20 to 30 minutes refer to the instruction on the
    Work is typically conducted on open bench tops using                    bottle of disinfectant.
    standard microbiological practices. Special containment            6.   Properly dispose of waste (including your gloves) in
    equipment or facility design is not required, but may be                appropriate Biohazard waste containers lined with
    used as determined by appropriate risk assessment.                      biohazard bag for final disposal.
    Laboratory personnel must have specific training in the
    procedures conducted in the laboratory and must be                 Major Biological Spill:
    supervised by a scientist with training in microbiology or a
                                                                       Major Biological Spill is one that requires assistance of EH&S
    related science.
                                                                       and/or external emergency personnel. Major Biological Spills
                                                                       involve releases of BSL2 or higher materials outside of a
Biosafety Level 2 (BSL-2)                                              biological safety cabinet, or spills of such materials that involve
    BSL-2 builds upon BSL-1. BSL-2 is suitable for work                excessive splashing or aerosol formation. Alert personnel in
    involving agents that pose moderate hazards to personnel           the laboratory of the spill, and prevent entrance of additional
    and the environment. It differs from BSL-1 in that 1)              personnel by notification or posting of area. If any material has
    laboratory personnel have specific training in handling            been splashed on you, if you have been exposed to the agent,
    pathogenic agents and are supervised by scientists                 or if any of your personal protective equipment has been
    competent in handling infectious agents and associated             breached, please follow the procedure outlined in the
    procedures; 2) access to the laboratory is restricted when         Exposure Control Plan:
    work is being conducted; and 3) all procedures in which
    hazardous aerosols or splashes may be created are                       1.   Remove and disinfect any contaminated clothing.
    conducted in biological safety cabinets (BSCs) or other                 2.   Notify your supervisor and EH&S at 951-827-2648 of
    physical containment equipment.                                              the incident.
                                                                            3.   If the situation involves an imminent life-threatening
Biosafety Level 3 (BSL-3)                                                        injury or a release outside the building; or has other
                                                                                 catastrophic potential, call 911 to reach UCPD
    BSL-3 is applicable to facilities where work is performed               4.   Have persons knowledgeable of incident and
    with indigenous or exotic agents that may cause serious or                   laboratory available to assist EH&S and/or emergency
    potentially lethal disease through inhalation route                          personnel.
    exposure or serious damage to the environment if
    containment is breached. Laboratory personnel must
    receive specific training in handling pathogenic and               Training
    potentially lethal agents, and must be supervised by
    scientists competent in handling the agents and                    Laboratory staff should have both instructional and hands-on
    associated procedures.                                             training for all biological hazards present in the laboratory and
                                                                       should demonstrate proficiency in techniques before being
For more information, refer to Section IV of the Biosafety in          permitted to perform laboratory procedures independently.
Microbiological and Biomedical Laboratories (BMBL) 5

Standard Operating Procedure                                       2                                                   Version 07/24/2012
Biohazardous Materials
General training                                                        Waste Disposal
EH&S provides some online training courses, including the               Information on biological material disposal, including medical
following:                                                              waste and autoclaves, can be found online at
        Bloodborne Pathogens (8 CCR 5193 / 29 CFR              All   recombinant      material  is
         1910.1030)                                                     considered hazardous and must be disposed of as biological
        Biosafety (introduction)                                       waste.
        Laboratory Safety Orientation
         Chemical Hygiene
         Hazardous Waste Management
                                                                        Special practices include: decontaminating work surfaces after
For more information, refer to             completing the work with the infectious materials, keeping non-
                                                                        research animals out of the laboratory, and reporting all spills
                                                                        and accidents.
Specific training
Laboratory-specific training should be provided by the PI, or
senior scientist who has several years of experience working            Autoclaves
with the biological materials and can direct staff in safe              EH&S monitors autoclave effectiveness and performance on a
handling of the materials to avoid any accidental exposures. All        recurring basis with B.Stearothermophilus indicators. To
training sessions should be documented with the: training               participate in the autoclave monitoring program, contact the
session topic(s), instructor, date, and attendees. Depending on         EH&S Biosafety Officer (951) 827-2648. For more information
the significance of the hazards involved, curriculum training           about the effective use of autoclaves, refer to the Fast Facts
and proficiency testing may be warranted.                               available online at under “Resources” (Fast
                                                                        Facts for Effective Use of Autoclaves).
Medical Surveillance
Depending on the biological materials manipulated in the                Needles and Sharps Precautions
laboratory, vaccinations and/or other medical surveillance                 Substitute plastic ware, when possible
programs may be warranted for employees. For more                          DO NOT bend, shear, break, recap or remove needle from
information on work-related injuries, you may review the                    syringe
“Injuries and Medical Treatment” flipchart located in each                 Use sharps containers (don’t fill more than ¾ full), which
laboratory, which is also available online at           must be located as close to work area as possible.
                                                                           Non-disposable sharps should be placed in a rigid
Personal Protective Equipment                                               container for transport to appropriate area for
                                                                            decontamination, such as by autoclaving
(PPE)                                                                      Only needle-locking syringes or disposable syringe-needle
In addition to the required standard PPE in a BSL2 laboratory,              units (needle is integral to the syringe) should be used
other PPE may be required to safely manipulate the agent. In               Syringes that re-sheathe the needle, needleless systems,
particular, you should consider additional PPE if you are                   and other safety devices may also be used
manipulating animals and include this in your SOP.                         Do not handle broken glass directly by hand. Use a
The following is a list of common PPE found in the laboratory:              mechanical device such as forceps or protective gloves to
         Gloves                                                            pick up and dispose of glass in a glass box or sharps
         Safety Glasses/Goggles                                            container
         Gowns/Aprons                                                  For more information, refer to
         Laboratory Coat                                               Transportation of biological
         Respiratory protection (fit test and medical clearance
          required)                                                     materials outside of the laboratory
         Surgical Mask                                                 Transportation of biological material(s) from one location to
         Shoe Covers                                                   another (e.g. from one lab to another, between buildings,
         Bonnets                                                       through common hallways) should be done in a primary
         Face Shields                                                  container, with a secondary sealed and leak-proof container
                                                                        capable of containing the entire contents. Make sure to place

Warning Signs and Postings
                                                                        a label on the primary container to identify the contents in the
                                                                        event the container is misplaced or dropped and spills.
Each laboratory must clearly display a sign that provides safety
information to visitors and service personnel. For more
information, contact the EH&S Biosafety Officer (951) 827-

Bio-containment and Biological
Safety Cabinets (BSCs)
The selection and use of BSCs are the primary means of
containment developed for working safely with hazardous
microorganisms. For more information, refer to Appendix A of
the Biosafety in Microbiological and Biomedical Laboratories
(BMBL) 5 Edition.
Standard Operating Procedure                                        3                                                 Version 07/24/2012
Biohazardous Materials

Standard Operating Procedure
INSTRUCTIONS: Use this template to develop a Standard Operating Procedure for your laboratory to address biological
safety risks.

                                PRINCIPLE INVESTIGATOR (PI) NAME:                                        PHONE:


                                (Building, Room #)
                                PROJECT TITLE:                                                           BUA #:

                                AGENTS (ORGANISM(S) OR ANIMAL TISSUE(S), ETC.):

                                LOCATION OF NEAREST EMERGENCY EQUIPMENT:

                                      Item:                           Location
                                      Eyewash / Safety Shower
                                      First Aid Kit

                                      Fire Alarm
                                      Fire Extinguisher
                                      Fire Alarm
                                      Manual Pull Station

                                ACCIDENT RESPONSE PROCEDURES                      SPILL RESPONSE PROCEDURES
                                                                                  Describe emergency procedures. Describe disinfectant(s) and
                                                                                  environmental decontamination procedures.

                                EMERGENCY CONTACTS (PHONE NUMBERS)

                                      Principal Investigator (PI):
                                      Laboratory Supervisor:
                                      Biosafety Officer:              (951) 827-2648 (during business hours)
                                      EH&S:                           (951) 827-5528 (during business hours)
                                      Police (UCPD):                  9-1-1 (after regular business hours)

Standard Operating Procedure (SOP)                                                    4                                                         2012
                         (Describe the risk of the agent(s). Determine if immunization is needed.)

                         ROUTES OF EXPOSURE
                         (Prior to assigning containment requirements, it is essential to identify the routes of transmission, such as inhalation,
                         ingestion, skin, etc.)

                         EXPOSURE RISKS
                         (e.g., sharps, exposure, splash exposure, non-intact skin exposure, other exposure such as inanimate)

                         (e.g., All personnel that actively handle human cell culture or human specimens in the laboratory)
                         If individual declined the HBV, must sign the following HBV Declination form available online at


Standard Operating Procedure (SOP)                                                    5                                                              2012
                                PROCEDURE METHOD(S) AND MATERIAL(S):
                                (Incorporate each category as it pertains to your work)

                                SIGNAGE AND LABELING
                                (e.g., restriction, locks)

                                PERSONAL PROTECTIVE EQUIPMENT (PPE)
                                (e.g. Entry and exit procedures, use PPE during work, removal and proper disposal)

Standard Operating Procedure (SOP)                                                        6                          2012
                 (Work practices, use of conveniently located sharps containers, safer needles and sharps, absorbent material on counter)

                 (Equipment, Biological Safety Cabinet (BSC), covered centrifuge cup)

                 (e.g. transport carriers)

Standard Operating Procedure (SOP)                                         7                                                           2012
                            STANDARD MICROBIOLOGICAL METHODS
                            (e.g. handwashing, no mouth pipetting, no food or drink in refrigerator(s) where material is stored)

                            CLEANING AND DISINFECTION

                            (Describe surface decontamination, cleaning procedures, and types of disinfectant(s) used in cleaning process)

                            (Identify the types of waste generated and procedures for handling biological waste including contaminated, non-
                            contaminated waste and use of sharps containers)

Prepared by. By signing this form the                      PRINT NAME / SIGNATURE                                        DATE:
individual certifies that the
information provided is true and
correct to the best of their knowledge.

Standard Operating Procedure (SOP)                                                  8                                                          2012
             Laboratory workers conducting research under this protocol must complete the following training requirements:
                    Laboratory Safety Orientation
                    Biosafety
                    Bloodborne Pathogens
                    Hazardous Waste Management
                    Laboratory-Specific training

             Document any laboratory-specific training below. Attach additional sheets, if necessary.

               Course                       Name                       Date            Student Signature          Instructor
                                            (Last, First)                                                         Signature

Additional Resources for Information
Resources for information, consultation, and advice on biohazard control, decontamination procedures, and other aspects of laboratory and animal
safety management include:

Centers for Disease Control (CDC)                                             American Biological Safety Association
Biosafety in Microbiological and Biomedical Laboratories (BMBL)                  1200 Allanson Road
           Office of Health and Safety (Mailstop: F-05)                          Mundelein, IL 60060-3808
           1600 Clifton Road                                                     Telephone: (847) 949-1517
           Atlanta, Georgia 30333                                                Fax: (847) 566-4580
           Telephone: (404) 639-7233                                             Website:
           Fax: (404) 639-2294
           Website:                                                           CDC Etiologic Agent Import Permit Program
               Centers for Disease Control and Prevention
                                                                                 Etiologic Agent Import Permit Program (Mailstop: F-46)
AAALAC International                                                             Atlanta, Georgia 30333
   Association for Assessment and Accreditation of Laboratory                    Telephone: (404) 718-2077
   Animal Care International                                                     Fax: (404) 718-2093
   5283 Corporate Drive, Suite 203                                               Website:
   Fredrick, MD 21703-2879
   Telephone: (301) 696-9626                                                  Select Agents General Information
   Fax: (301) 696-9627                                                            Website:

Standard Operating Procedure (SOP)                                        9                                                               2012

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