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					Institution                                                                         Code:
Laboratory name                         Biosafety Manual                            Version: no.
Location                                                                            Date: of release
Head/Responsible person   Responsibilities of the biosafety officer and             Page: 1 of 3
                                    biosafety committee

  1. Responsibility, Biosafety officer and Biosafety Committee


  2. Objectives and scope

  Mycobacteria are dangerous pathogens that can cause life-threatening illnesses or death.
  These pathogens are acquired mainly through inhalation. When you perform TB culture
  and sensitivity testing, the risk of lab acquired TB infection is 21-24 times higher
  compared to the general population. The risk of infection can be effectively minimized by
  following scientifically proven well managed policies and practices in the TB laboratory.
  This SOP describes the tasks, duties, responsibilities and accountabilities of individual
  staff, the biosafety officer and biosafety committee in preventing laboratory-acquired TB
  infections. It also describes how the laboratory hierarchy of management shall be
  organized with regard to biosafety.

  This SOP is applicable to all employees of the laboratory.


  3. Abbreviations, definitions and terms

      •    N.A.     Not Applicable
      •    BO       Bio safety Officer
      •    QM       Quality Manual
      •    SOP      Standard Operating Procedure
      •    NTP      National Tuberculosis Program


  4. Tasks, responsibilities and accountabilities

    Task                             Responsible                     Accountable
    Train new laboratory             Bio safety officer              Lab manager
    employees on safety
    Responsibility for safety and    All lab personnel               Lab director
    safety of others


  5. Safety and environment

  N.A.


  6. Procedure

  6.1 Safety Training

  All new employees of the laboratory will receive a Safety Orientation from the Laboratory
  Manager. Safety training will be renewed annually.

  6.2 General Rules

      1. The laboratory shall have a comprehensive safety policy, a safety manual, and
         supporting programmes for their implementation.
      2. Employees at the laboratory shall be expected to perform their work safely and
         should report any unsafe acts, conditions or incidents to their supervisor.
      3. The bio safety of workers at the laboratory will be the responsibility of the
         laboratory director
      4. This responsibility may be delegated in writing to a bio safety officer


  Source: GLI Stepwise Process towards TB Laboratory Accreditation
Institution                                                                    Code:
Laboratory name                         Biosafety Manual                       Version: no.
Location                                                                       Date: of release
Head/Responsible person   Responsibilities of the biosafety officer and        Page: 2 of 3
                                    biosafety committee

      5. Individual workers shall be responsible for their own safety and that of their
         colleagues.
      6. Periodic safety audits by internal or external personnel will be arranged annually.

  6.3 Bio safety officer

      1. The director of the laboratory in conjunction with the Laboratory Manager shall
         appoint a bio safety officer to ensure that bio safety policies and programmes are
         followed consistently throughout the laboratory.
      2. The bio safety officer shall posses a minimum of a bachelor’s degree in
         Microbiology or Bio-medical sciences with proven specialized training in laboratory
         safety.
      3. The bio safety officer shall possess the professional competence necessary to
         suggest, review and approve specific activities that follow appropriate bio-
         containment and bio safety procedures
      4. The bio safety officer shall have knowledge of the laboratory and clinical practices
         and safety, including containment equipment, and engineering principles relevant
         to the design, operation and maintenance of TB facilities.
      5. The bio safety officer shall be a person with capacity to apply relevant national
         and international rules, regulations and guidelines, as well as assist the
         laboratory in developing standard operating procedures.
      6. The bio safety officer shall have the capacity to communicate effectively with
         administrative, technical and support personnel.
      7. The bio safety officer shall report directly to the director laboratory.
      8. The bio safety officer shall execute bio safety duties on behalf of the laboratory
         director.


  6.4Duties of the bio safety officer

      1. The bio safety officer shall draft new safety SOPs or review existing SOPs suggest
          changes and present them to the bio safety committee for approval
      2. The laboratory supervisor and not the bio safety officer shall enforce staff
          compliance with bio safety, bio security rules and regulations at the laboratory.
      3. The bio safety officer shall discuss violation of bio safety protocols or procedures
          with the appropriate persons.
      4. The bio safety officer shall conduct annual bio safety audits on technical methods,
          procedures and protocols, biological agents, materials and equipment.
      5. The biosafety officer shall organize and verify that all staffs have received
          appropriate bio safety training.
      6. The biosafety officer shall provide continuing education in bio safety.
      7. The biosafety officer shall investigate incidents involving the possible escape of
          potentially infectious or toxic material, and report findings and recommendations
          to the laboratory director and biosafety committee.
      8. The biosafety officer shall coordinate with the medical staff regarding possible
          laboratory-acquired infections.
      9. The biosafety officer shall ensure appropriate decontamination of the lab following
          spills or other incidents involving infectious material(s).
      10. The biosafety officer shall ensure that appropriate decontamination of any
          apparatus is done prior to repair or servicing.
      11. The biosafety officer shall ensure that laboratory waste is managed properly.
      12. The biosafety officer shall ensure maintenance of awareness of community
          attitudes regarding health and environmental considerations.
      13. The biosafety officer shall ensure establishment of appropriate procedures for
          import/export of pathogenic material to/from the laboratory, according to
          regulations published by the Uganda National Council for Science and Technology,
          and other national or international rules.


  Source: GLI Stepwise Process towards TB Laboratory Accreditation
Institution                                                                        Code:
Laboratory name                          Biosafety Manual                          Version: no.
Location                                                                           Date: of release
Head/Responsible person   Responsibilities of the biosafety officer and            Page: 3 of 3
                                    biosafety committee

        14. The biosafety officer shall review the bio safety aspects of all plans, protocols and
            operating procedures for research work involving infectious agents, prior to the
            implementation of these activities.
        15. The biosafety officer shall institute a system to deal with emergencies.


  6.5Bio safety committee

        1. The director of the laboratory in conjunction with the NTP Manager shall appoint a
           bio safety committee.
        2. The bio safety committee shall develop laboratory bio safety policies and codes of
           practice.
        3. The bio safety committee shall also review research protocols for work involving
           infectious agents, animal use, recombinant DNA and genetically modified
           materials.
        4. Other functions of the committee may include risk assessments, formulation of
           new safety policies and arbitration in disputes over safety matters.
        5. The membership of the bio safety committee shall include 6 members, 4 of which
           shall constitute a quorum for the purpose of meetings and decision making:
               i.  Bio safety officer/Scientist as chair person
              ii.  Two in-charges of rooms in the laboratory – ‘clean’ and ‘dirty’ rooms.
             iii.  Representative from an external TB.
            iv.    Laboratory Manager
              v.   Quality manager
        6. The biosafety committee shall meet monthly to deliberate on biosafety issues at
           the laboratory. Meetings may also be called by the biosafety officer as need may
           arise.

           Where need arises, the bio safety committee shall seek advice from different
           departmental or specialist safety officers (e.g. fire/radiation/electricity/medical
           safety specialists, etc).

           The committee may at times seek assistance from independent experts in various
           associated fields, local authorities and national regulatory bodies.

           The committee may also consult community members for help if there is a
           contentious or sensitive protocol under discussion.


  7. Related documents


  8. Related forms

  Biosafety check list for periodic auditing of status of biosafety at the laboratory.


  9. References

  N.A


  10. Attachments / Annexes

  N.A




  Source: GLI Stepwise Process towards TB Laboratory Accreditation

				
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