Checklist Phase 3 - Facilities and Safety

Is access to first aid ensured at the laboratory?

Activity

In laboratories where the presence of first aid providers is necessary: have enough staff members been appointed as first aid provider such that continuous presence of at least one first aid provider is ensured?

Activity

Is the training of the first aid providers up-to-date?

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Does the Biosafety Manual contain an explanation of the tasks and responsibilities of first aid providers?

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Is the laboratory staff aware of who the first aid providers are?

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Have the Personal Job Descrptions of the first aid providers been adapted to reflect the authorizations of their position as first aid provider?

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Is the biosafety level III laboratory equipped with a negative pressure system?

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Is the pressure of the biosafety level III regularly monitored and recorded?

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Is the negative pressure system connected to a backup electricity supply to ensure that it keeps functioning during a power failure?

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Is the negative pressure system included in the preventive maintenance program of the laboratory?

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Is access into the BSL III laboratory controlled to prevent unauthorized access?

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Is a primary sample collection facility available and physically separate from the laboratory activities?

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Are patients in the waiting area and primary sample collection facility protected against rain and direct sunlight?

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Does the patient sample collection facility allow for the protection of privacy of patients?

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Are there enough chairs in the waiting area and primary sample collection facility so that every patient can sit?

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Is the waiting area and primary sample collection facility accessible for physically handicapped patients?

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Are samples stored under appropriate conditions, protected from unauthorized access and demonstrably easily retrievable?

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Are all reagents and supplies stored under the proper conditions, protected from unauthorized access and easily retrievable?

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Is equipment stored under appropriate conditions protected from unauthorized use?

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Is defective equipment demonstrably contaminated and stored outside the laboratory protected from use?

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Are documents and records stored under appropriate conditions, protected from fire, insects, humidity and other harmful elements?

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Are documents and records protected from unauthorized access?

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Are documents and records stored in a logical manner so that they are demonstrably easily retrievable?

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Does the retention schedule for storing different types of materials include the storage durations for samples and slides?

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Does the retention schedule for storing different types of materials include the following documents:

  • Replaced SOPs
  • Completed worksheets
  • Completed log sheets
  • Completed Request Forms
  • Patient reports
  • Result registers
  • All contracts of the laboratory with external parties
  • Personnel data

Activity