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Risk Assessment [5199(f)(2)]

The Biosafety Officer shall perform a risk assessment in accordance with the methodology included in Section II of the BMBL for each agent and procedure involving the handling of ATPs-L. The Biosafety Officer shall record the safe practices required for each evaluated agent/procedure in the Biosafety Plan.

Implementation of Control Measures [5199(f)(3)]

The Blood Center shall implement feasible engineering and work practice controls, in accordance with the risk assessment performed in the Risk Assessement section, to minimize employee exposures to ATPs-L. Where exposure still remains after the institution of engineering and work practice controls, the blood center shall provide, and ensure that employees use, personal protective equipment and, where necessary to control exposure, respiratory protection. Control measures shall be consistent with the recommendations in BMBL.

Written Local Biosafety Plan [5199(f)(4)]

The Blood Center shall establish, implement, and maintain an effective written local Biosafety Plan (BSP) to minimize employee exposure to ATPs-L that may be transmitted by laboratory aerosols. The BSP may be incorporated into an existing local Exposure Control Plan for bloodborne pathogens and shall do all of the following:

  • Identify a biological safety officer(s) with the necessary knowledge, authority and responsibility for implementing the BSP. [5199(f)(4)(A)]
  • Include a list of all job classifications in which all or some employees have occupational exposure, and a list of all tasks and procedures in which employees have occupational exposure. [5199(f)(4)(B)]
  • Include a list of ATPs-L known or reasonably expected to be present in laboratory materials and the applicable biosafety measures. [5199(f)(4)(C)]
  • Include a requirement that all incoming materials containing ATPs-L are to be treated as containing the virulent or wild-type pathogen, until procedures have been conducted at the laboratory to verify that a pathogen has been deactivated or attenuated. [5199(f)(4)(D)]
  • Identify and describe the use of engineering controls, including containment equipment and procedures, to be used to minimize exposure to infectious or potentially infectious laboratory aerosols. [5199(f)(4)(E)]
  • Establish safe handling procedures and prohibit practices, such as sniffing in vitro cultures, that may increase employee exposure to infectious agents. [5199(f)(4)(F)]
  • Establish effective decontamination and disinfection procedures for laboratory surfaces and equipment. [5199(f)(4)(G)]
  • Identify and describe the use of the appropriate personal protective equipment to be used to minimize exposure to infectious or potentially infectious laboratory aerosols. [5199(f)(4)(H)]
  • Identify any operations or conditions in which respiratory protection will be required.
  • Establish emergency procedures for uncontrolled releases within the laboratory facility and untreated releases outside the laboratory facility. These procedures shall include effective means of reporting such incidents to the local health officer. [5199(f)(4)(J)]
  • Include procedures for communication of hazards and employee training that complies with the Training Section. This shall include training in the Stanford University ATD Program, the Blood Center’s Biosafety Plan, and emergency procedures. [5199(f)(4)(L)]
  • Include an effective procedure for obtaining the active involvement of employees in reviewing and updating the Biosafety Plan with respect to the procedures performed by employees in their respective work areas or departments on an annual (or more frequent) basis. [5199(f)(4)(M)]
  • Include procedures for inspection of laboratory facilities, including an audit of biosafety procedures. These inspections shall be performed at least annually. Hazards found during the inspection, and actions taken to correct hazards, shall be recorded. [5199(f)(4)(O)]

Training [5199(i)]

Training shall be provided to all employees with occupational exposure as follows: [5199(i)(2)]

  • At the time of initial assignment to tasks where occupational exposure may take place.
  • At least annually thereafter, not to exceed 12 months from the previous training.
  • When changes, such as introduction of new engineering or work practice controls, modification of tasks or procedures or institution of new tasks or procedures, affect the employee's occupational exposure or control measures. The additional training may be limited to addressing the new exposures or control measures. Training shall include the following elements: [5199(i)(4)]
  • An accessible copy of the regulatory text of 8CCR 5199 and an explanation of its contents. [5199(i)(4)(A)]
  • A general explanation of ATDs including the signs and symptoms of ATDs that require further medical evaluation. [5199(i)(4)(B)]
  • An explanation of the modes of transmission ATPs-L. [5199(i)(4)(C)]
  • An explanation of the Stanford University ATD Program and the local Biosafety Plan, and the means by which the employee can obtain a copy of these written plans and how they can provide input as to its effectiveness. [5199(i)(4)(D)]
  • An explanation of the appropriate methods for recognizing tasks and other activities that may expose the employee to ATPs-L. [5199(i)(4)(E)]
  • An explanation of the use and limitations of methods that will prevent or reduce exposure to ATPs-L including appropriate engineering and work practice controls, decontamination and disinfection procedures, and personal and respiratory protective equipment. [5199(i)(4)(F)]
  • An explanation of the basis for selection of personal protective equipment, its uses and limitations, and the types, proper use, location, removal, handling, cleaning, decontamination and disposal of the items of personal protective equipment employees will use. [5199(i)(4)(G)]
  • A description of the University’s TB surveillance procedures, including the information that persons who are immune-compromised may have a false negative test for LTBI. [5199(i)(4)(H)]
  • Information on the vaccines made available by the employer, including information on their efficacy, safety, method of administration, the benefits of being vaccinated, and that the vaccine and vaccination will be offered free of charge. [5199(i)(4)(J)]
  • An explanation of the procedure to follow if an exposure incident occurs, including the method of reporting the incident, the medical follow-up that will be made available, and post-exposure evaluation. [5199(i)(4)(K)]

The training program shall include an opportunity for interactive questions and answers with a person who is knowledgeable in the subject matter of the training as it relates to the workplace that the training addresses and who is also knowledgeable in the Stanford University ATD Program and the local biosafety plan.

Facility Design and Construction

The Biosafety Officer shall review plans for facility design and construction that will affect the control measures for ATPs-L. [(5199(f)(4)(N)]