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Principal Investigator Training Safety Training.ppt

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					             2012
Principal Investigator Training

    Department of Veterans Affairs
           Medical Center

            Lexington, KY
                   2012
   Principal Investigator Training

• Purpose
  To address the safety and lab
  management responsibilities of
  Principal Investigators in Research
  Service.

• Annual Training
  This PI training is required every year.
The PI on a research project is
ultimately responsible for the
safety of personnel and their
compliance with training and
regulations.

Extensive resources are available
to assist the PI in meeting these
requirements.
 The PI must ensure that
  all personnel complete
required and appropriate
         training.
           Educational Requirements for VA Employees (FT, PT, WOC, IPA)
                                 Revised 5/24/10

Annual training (every fiscal year) unless otherwise noted for all employees:

•Traumatic Brain Injury (once for new employees who are likely to be in contact with a
  TBI veteran)
•New Employee Orientation (once for new employees only)
•EEO (once for new employees only)
•Government Ethics (once for new employees; annually for those required to file
  financial disclosures)
•Disruptive Behavior/Violence Prevention (once for new employees; every 2 years for
  designated staff)
•Compliance (CBI or Business Compliance)
•Suicide Prevention
•Customer Service
•Sexual Harassment (every 2 years)
•No FEAR (every 2 years)
•VHA Privacy Policy Training (VA10203, VA5331, or VA10204)
•VA Information Security Awareness Training
•Bloodborne Pathogen Training (all new employees; annually for employees with potential
  of exposure)
Additional annual training required for all research employees:

   Information Security for R&D Personnel 201 (once only)
   Role Specific Ethics Training
 
Additional training (every 12 months) for employees involved in human research:

   Collaborative IRB Training Initiatives (CITI)
   Human Subject Protection
   Good Clinical Practice
 
Additional training (every 12 months) for employees involved in animal research:

   American Association for Laboratory Animal Science (AALAS) courses as assigned by VMU supervisor
   Essentials for Institutional Animal Care and Use Committee (IACUC) Members
   Working with the IACUC:  VA Version
   Post-Procedure Care of Mice and Rats in Research:  Minimizing Pain and Distress
   Introduction to Research Animal Methodologies:  Introduction to Mice
   Introduction to Research Animal Methodologies:  Introduction to Rats
   Introduction to Research Animal Methodologies:  Introduction to Rabbits
   Aseptic Technique for Rodent Survival Surgery
   Avoiding Financial Conflict of Interest in Federal Research
   Introduction to VA Biosecurity Concepts (once)

 
Additional training (every 12 months) for employees involved in laboratory research:

   Laboratory Safety
  Additional protocol specific training as prescribed by Subcommittee on Research Safety (SRS)
     including:
         Hazardous Agents
         Chemical Hazards
         Biological Hazards
         Select Agents/Toxins
         Radiation Safety
         rDNA
         Introduction to VA Biosecurity Concepts (once)
 
Additional training (as required) for employees involved in hazardous materials
shipping:

    DOT/IATA 
 
Mandatory training (every fiscal year) for certain non-employees (including monitors,
contractors):

    VHA Privacy Policy Training as above (if user of VA sensitive information)
    VA Information Security Awareness Training (if user of VA information systems)
 
*Principal Investigators are responsible for conducting/documenting initial and annual training that is
protocol specific (including any procedures and/or hazards) for personnel involved in their research.
       Why all this Training?
• To keep researchers, others, patient privacy
  and the environment safe and secure!

• We have no choice – Training is mandatory.

• The most important safety factor is your
  personal attitude and individual actions! 
         Committee Approvals
• All approvals are required BEFORE work begins!

• All Projects: SRS – Subcommittee on Research
  Safety (reviews safety issues for every project).

• Human Studies: IRB - Institutional Review Board.

• Animal Studies: IACUC - Institutional Animal Care
  and Use committee.

• FINAL Approval by R & D Committee – Research
  and Development Committee.
           New Employees
• Must complete VA paper work before starting
  work. Tell the truth!!
• Lab & VMU personnel must receive safety
  training from Research Safety Manager before
  starting work.
• Must be supervised until safety is assured.
• All visitors must log in when entering the
  Research Facility.
         Local Inspections
• Monthly: Lab Safety Inspection

• Monthly: Service Safety Inspection-all areas

• Monthly: Veterinary Medical Unit inspection.

• Semi-Annual: Environment of Care (EOC)
  inspections by Associate Hospital Director.
         Annual Inspections
• VISN, Annual Workplace Evaluation.

• VISN, Continuous Readiness Review.

• Local, Hazard and Vulnerability Assessment by
  VA Police.

• Local, Research Vulnerability Assessment by a
  Research Committee.
          National Inspections
• The Office of Research Oversight (ORO) is actively
  enforcing compliance in Research Service.

• All serious and/or continuing non-compliance issues
  are reported immediately to the Hospital Director and
  to the ORO.

• The Inspector General (IG) may visit in response to
  specific compliance issues.

• Joint Commission, ORO, IG and SOARS (System wide
  Ongoing Assessment and Review Strategy) are on
  routine 2-3 year cycles.
        Compliance Officer
• Research Service has a full time
  compliance officer.

• The compliance officer audits Research
  Projects and reports directly to the
  Hospital Director.
    Principal Investigator Responsibilities
LABORATORY SPECIFIC SAFETY TRAINING

Every laboratory has unique safety issues that
require customized training for everyone
working in the laboratory.

Because……

Every laboratory uses unique chemicals,
biologicals and protocols.
 
Lab Specific Biosafety Manual
• This Manual presents the Safety issues
  present in your laboratory.
• Each lab must complete and customize its
  own Lab Specific Biosafety Manual.
• All those working in your lab must read,
  understand and sign the manual.
• Lab personnel should participate in
  developing your Lab Specific Manual. 
                                        Example !!!!

          Lab Specific Biosafety Manual Table of Contents

            SECTION 1…………………………………………………….…………Contents

                         SECTION 2……………….……………………………..…General Procedures
                        Signature and Acknowledgment Page……….……………………………………. 1
                        Disclaimer…………………………………………………………………………. 1
                        Director’s Certification… ……………………………………………………….…2
                        Purpose... ……………………………………………………………………….….3
                        Background…………………………………………………………………….…...3
                       Description of Laboratories………………………………..…………………….….3
                        General Lab Rules…………………………………………………….………..….. 4 
                        Emergency Phone Numbers and Procedures……………….……….………..…….5
                        Emergency Procedures………………………………………………..………...…..5
                        Proper Use of Biological Safety Cabinet………………..…………………...……..8
                        Decontamination Procedures……………………………………..………….….….9
                        Specimen Transport………………………………………………………….…... 10
                        Lab Floor Plan……………………………………………………..…… …….…..11

             SECTION 3……………………………………...... ……….……BSL-2 Guidelines
             SECTION 4…………………………………….......................... Internet Resources
             SECTION 5………………………………..…………………..Biological Inventory
             SECTION 6……………………………………………………..Chemical Inventory
             SECTION 7……………………….…………………………..VA Handbook 1200.6
             SECTION 8……………………………………………………….Lab Specific SOPs
         Inventories
• The VA requires semi-annual
  inventories of all
   Chemicals
            and
               Biologicals.
                 BMBL
     (Biosafety in Microbiological and
         Biomedical Laboratories)

• New 5th Edition now available online.
     -- Frequently Updated
     -- on CDC web Site
     -- also a link on ABSA web site
                 Laboratory Security
•   Laboratory management has changed with the
    passage of anti-terrorism laws such as the Patriot Act,
    and the rules regulating Select Agents.

•   The most active terrorist groups are the animal rights
    groups.

•   However, the most common problem involves a
    dishonest, disgruntled or mentally unstable employee
    or colleague. Most thefts from laboratories are due to
    individuals from inside the facility.

•   The VA will assist the PI in managing these issues as
    needed.
      Personnel Restrictions

• Some individuals may be restricted from
  working in VA laboratories and/or on
  VA projects.
       Background Checks
-- Everyone at VA Research will have a
   background check done.

-- This includes WOC employees.

-- Over 100 have been done. One problem
   was identified.
              Select Agents
• The possession of dangerous biological agents is
  highly regulated.

• These agents are termed “Select Agents” and
  they must be registered with the Federal
  government.

• Pre approval must be obtained prior to their
  possession and use in your laboratory.  
            Select Agents
• Select Agents are not allowed in this VA!

• Current Regulations and Select Agents
  list:
        Access the National Select Agent
               Registry web site!
 Definition of a Restricted Person
  for Working with Select Agents
· is under indictment for a crime punishable by
  imprisonment for a term exceeding one year;
· has been convicted in any court of a crime punishable by
  imprisonment for a term exceeding one year;
· is a fugitive from justice;
· is an unlawful user of any controlled substance;
· is an alien illegally or unlawfully in the US;
· has been adjudicated as a mental defective or has been
  committed to any mental institution;
· has been discharged from the Armed Services of the
  United States under dishonorable conditions.
          Restricted Persons
· is an alien who is a national of a country as to
  which the Secretary of State has made a
  determination (that remains in effect) that such
  country has repeatedly provided support for acts of
  international terrorism.

· Iran, Iraq, Syria, Libya, Cuba,
  North Korea, Sudan.


   This may determine who can
        work in your lab!
       Restricted Chemicals
• The use of some hazardous chemicals is
  restricted in VA labs.

• Check with safety personnel for the
  current list of restricted chemicals.

• All chemicals must be listed in your
  chemical inventory.
          Again,
security restrictions may
determine who can work
  in your lab and what
dangerous agents are in
    your possession.
         Lab Accidents
• Lab Accidents do happen!

• The PI is responsible for
  promptly reporting them to
  Hospital and Safety personnel.
• Some local examples !!!
New Employees:
 Sometimes we forget how little
 students and new lab personnel
 know about lab safety. All new lab
 personnel must sign up in the
 Research Office before starting work.
Safety Glasses:
 Everyone in VA Research Service
 receives a free pair of safety glasses.
 Please ensure that all lab personnel
 use them !!!!
              Points to Consider
Unique Agents:
  Each lab frequently uses or creates unique protocols,
  reagents, genes or biological organisms. What safety
  issues are present? What is the proper response to an
  accident with these agents? What safety training is
  required?

Protocols:
  Approved IRB, Animal and Safety protocols are required
  for each project. Final approval is by the R&D
  committee.

Excess Reagents:
  A common and persistent problem is excess reagents
  and old reagents remaining in the labs.
Green Environmental Management System

• Research Service
  participates in the VA
  GEMS program.
   – Goals
      • Proper Pharmaceutical
        Waste Disposal
      • Decrease Fleet Fuel
        Usage
      • Water Conservation
      • Decrease Green House
        Gas Emissions
      • Pollution Prevention (P2)
        with Green Purchasing
                                                                                   Master Flowchart
    Hazardous                                      START HERE

       Waste                                  Is your material a WASTE?
                                               Refer to: Waste Definition
   Determination                                      YES
                                          Is your waste a SPECIAL WASTE?
    Flowchart                                  Refer to: Special Waste
                                                       NO
                                              Is your waste REACTIVE?
                                                  Refer to: Reactivity
                                                       NO
                                             Is your waste CORROSIVE?
                                                                 NO                  YES
                                                  Refer to: Corrosives             YES
                                                       NO                                           Your waste is:
                                                                                                 HAZARDOUS WASTE
                                              Is your waste IGNITABLE?             YES
                                                  Refer to: Ignitability                       Contact GEMS Coordinator
                                                                                   YES
                                                       NO                                       @ 3354 for proper disposal
     Your waste is NOT a         NO
      Hazardous Waste?                       Is your waste an OXIDIZER?                  YES
                                                  Refer to: Oxidizing
                                                       NO

            Physical                            Is your waste TOXIC?
  LIQUID     State                                Refer to: Toxicity
                         SOLID
                                                       NO

                                            Is your waste a Medical Waste?                       Consider your waste
                                                Refer to: Medical Waste                        HAZARDOUS and have a
                                                       NO                                       Waste Determination
                  Deface container                                                                  completed.
 Continue to:                                           STOP
                    label. Dispose
Drain Disposal                                                                       YES       Contact GEMS Coordinator
                   in regular trash   Still think your waste might be HAZARDOUS?                @ 3354 for proper disposal
                                                                         Reactivity
                  START HERE

                   Does the waste:
   React violently with water, or form potentially
          explosive mixtures with water?
                     NO
                                                        YES
                  Does the waste:
  Create toxic gases when in contact with water?
                                                       YES
                     NO
                   Does the waste:
    React violently when exposed to air or form        YES    HAZARDOUS CLASS
      potentially explosive mixtures with air?                       REACTIVE
                     NO                                YES    Contact GEMS Coordinator
                                                               @ 3354 for proper disposal
                  Does the waste:
                                                                           .
     Create toxic gases when exposed to air?           YES
                     NO
                    Is the waste:                      YES
Unstable (readily undergoes violent change with or
        without detonating or exploding?
                     NO
                    Is the waste:
A potential peroxide former that has either exceeded
   its open or shelf time limits or is stored in an
                 undated container
                     NO

 Material does NOT meet the definition of REACTIVE.
         Continue on Master Flowchart
                                                                                             Corrosives
                                            START HERE



                                              Physical State
    Aqueous                                                                         Non-Aqueous or
                                                    of
  Liquid Waste                                   Waste                              Non-Liquid Waste


                                          HAZARD CLASS                          When mixed with an equivalent
    Waste has:
                              YES        CORROSIVE ACID                           weight of water, the waste:
  A pH less than                                                        YES
                                                                                Produces a solution having
   or equal to 2                        Contact GEMS Coordinator
                                         @ 3354 for proper disposal             a pH less than or equal to 2
      (pH ≤ 2)
                                                                                           (pH ≤ 2)
      NO                                                                                        NO
     Waste has:                           HAZARD CLASS                          When mixed with an equivalent
   A pH greater                          CORROSIVE BASE                           weight of water, the waste:
                              YES                                       YES
   than or equal                                                                Produces a solution having
                                         Contact GEMS Coordinator
      to 12.5                             @ 3354 for proper disposal            a pH greater than or equal to
    (pH ≥ 12.5)                                                                       12.5 (pH ≥ 12.5)

                              NO                                         NO


                                                 Waste has:
                 YES                                                           NO
                                 The ability to cause destruction of living
                               tissue or steel surfaces by chemical action

 HAZARD CLASS
  CORROSIVE                                              Material does NOT meet the definition of CORROSIVE
Contact GEMS Coordinator                                           Continue on Master Flowchart
 @ 3354 for proper disposal
                                                                                    Ignitability
                                          START HERE



                                           Physical State
      LIQUID                                     of                                 SOLID
                                              Waste



  Is the flash point of
       the waste
(or any single phase if
      multi-phase)           YES         HAZARD CLASS                              Is the waste:
   ≤140oF (≤60oC)?                                                            Capable of causing fire
                                           IGNITABLE                  YES
                                                                             through friction, moisture
                                        Contact GEMS Coordinator
       NO                                @ 3354 for proper disposal         absorption, or spontaneous
                                                                                 chemical change?
   Is the waste:             YES
An aqueous solution
 containing ≥24%
     alcohol?



               NO         Material does NOT meet the definition of IGNITABLE.       NO
                                   Continue on Master Flowchart
                                                                                                              Toxicity
                       START HERE



                                                                     Toxic Hazardous Waste
■Waste displays the toxicity characteristic if it exceeds certain
                                                                     Arsenic                        5.0 ppm     D004
 concentration levels using specified test methods.                  Barium                         100 ppm     D005
■The toxicity characteristic leaching procedure (TCLP) is the        Benzene                        0.5 ppm     D018
 specified test method for determining if a waste is a toxic         Cadmium                        1.0 ppm     D006
 hazardous waste.                                                    Chloroform                     6.0 ppm     D022
nThe TCLP simulates the conditions in a landfill and then            Chromium                       5.0 ppm     D007
analyzes the concentrations of specifically listed chemicals         Lead                           5.0 ppm     D008
                                                                     Mercury                        0.2 ppm     D009
and heavy metals that could potentially leach into the
                                                                     Methyl Ethyl Ketone (MEK)      200 ppm     D035
groundwater.                                                         Selenium                       1.0 ppm     D010
nExamples of the most common toxic materials, their                  Silver                         5.0 ppm     D011
regulatory limits, and their corresponding waste codes are           Tetrachloroethylene            0.7 ppm     D039
listed right.                                                        Trichloroethylene              0.5 ppm     D040
                                                                     Vinyl Chloride                 0.2 ppm     D043
                                                                     Chloroform                     6.0 ppm     D022



                                                                    NOTE: The 8 compounds that appear in boldface
                                                                    are referred to as the “RCRA 8 metals” and are
    Material does NOT meet the definition of TOXICITY.              among the most common toxic wastes generated
             Continue on Master Flowchart                           at Stony Brook.
                                                                                                                                Oxidizing
                                      START HERE

                            Does the waste:
          Release oxygen when reacting with another chemical?
                                                                                                          YES
                                  NO                                                                                     HAZARD CLASS
                              Does the waste:                                                                              OXIDIZER
     React with organic materials (i.e., oils, greases, solvents, paper,
                                                                                                       YES              Contact GEMS Coordinator
      cloth, wood, etc.) resulting in fire or the generation of heat?                                                    @ 3354 for proper disposal
                               NO
                             Is the waste:                                                                YES
  A member of one of the common oxidizer categories listed below?
                                   or
  An aqueous solution of any of the common categories listed below
     which exhibits any of the oxidizing properties stated above?
                               NO

               Material does NOT meet the definition of OXIDIZER
                         Continue on Master Flowchart

Examples:
SOLIDS
• Bismuthates                   • Dichromates                       • Iodates                     • Periodic acid
• Bromates                      • Ferric sulfate                    • Iodine                      • Permanganates
• Chlorates                     • Ferric chloride                   • Manganese dioxide           • Permangic acid
• Chlorites                     • Ferric trioxide                   • Nitrates                    • Peroxides
• Chromates                     • Ferriccyanides                    • Perborates                  • Persulfates
• Chromium trioxide             • Hypochlorites                     • Perchlorates
LIQUIDS
• Bromine                       • Hydrogen peroxide                 • Perchloric acid (pH > 2)*   • Sulfuric acid (pH > 2)*
• Chromic acid (pH > 2)*        • Nitric acid (pH > 2)*
* Oxidizing mixtures having a pH £ 2 are classified as corrosive.
           Recent Changes
New information security requirements!

The VA Research Protocol Safety Survey (Biosafety
  Form) now requires a biological inventory for all
  BSL 2 and 3 agents in the lab if any bio agents
  are being used in a protocol. This is in addition
  to the chemical inventory.

DEA controlled substance issues.
  Ketamine, Barbitol, Chloral Hydrate, etc.
  Do not bring them into the VA. All controlled
  substances used in the VA must be obtained
  through the VA.
               Summary
• The PI of a research project is ultimately
  responsible for the safety of personnel
  and compliance with regulations.

• Extensive resources are available to assist
  the PI in meeting these requirements.
Required Training Credit 
• Complete the training credit
  form.                                 Click on Icon
                                   to Open/Complete/Print
 
   - Send a copy to the Research Office
     (C403) for training credit.
         Fax: 859-281-4989

  - Keep a copy in your training records!

                                                 49
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