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technical requirements iso 15189 section 5.2 accommodation and environmental conditions

D. Keane Sept. 2005. 2. Accommodation and Environmental Conditions. 5.2.1- The Laboratory shall have space to perform its workload in a manner that does not compromise:-Quality of work (sufficient segregation between processes)Quality controlSafety of personnel (debris, clutter free)Patient care services (outpatients queuing etc)..

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technical requirements iso 15189 section 5.2 accommodation and environmental conditions

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    1. D. Keane Sept. 2005 1 Technical RequirementsISO 15189 Section 5.2 Accommodation and Environmental Conditions

    2. D. Keane Sept. 2005 2 Accommodation and Environmental Conditions 5.2.1 - The Laboratory shall have space to perform its workload in a manner that does not compromise:- Quality of work (sufficient segregation between processes) Quality control Safety of personnel (debris, clutter free) Patient care services (outpatients queuing etc).

    3. D. Keane Sept. 2005 3 Accommodation and Environmental Conditions contd 5.2.1 - Management should ensure:- that there is sufficient space for the tasks to be performed. that the lab is maintained in a functional and reliable state for the work performed.

    4. D. Keane Sept. 2005 4 Accommodation and Environmental Conditions contd 5.2.2 - The design and workflow of the Laboratory should be such that there is clear segregation between:- Laboratory areas Clerical areas Phlebotomy areas Why? - Minimise risk of injury - Minimise risk of occupational illness

    5. D. Keane Sept. 2005 5 Accommodation and Environmental Conditions contd 5.2.3 - The facilities should be designed and meet the requirements of outpatients with disabilities who use Laboratory services (ramps, seating).

    6. D. Keane Sept. 2005 6 Accommodation and Environmental Conditions contd 5.2.4 - The environment in which Phlebotomy and testing takes place should not:- invalidate test results effect the quality of any measurement

    7. D. Keane Sept. 2005 7 Accommodation and Environmental Conditions contd 5.2.4 - Laboratory facilities should be such that where testing is performed there is:- adequate lighting adequate power source (3 phase power) adequate water supply adequate ventilation provision for adequate disposal of biological and non biological waste adequate environmental conditions

    8. D. Keane Sept. 2005 8 Accommodation and Environmental Conditions contd 5.2.4 - We must be able to control environmental conditions that may impact on the quality of the test result/ product:- Sterility cleanliness (bugs/ dust) Electromagnetic (equipment performance) Radiation Humidity (dry air in cleanrooms why?)

    9. D. Keane Sept. 2005 9 5.2.4 - We must be able to control environmental conditions that may impact on the quality of the test result/ product:- Temperature (testing conditions or product storage) Sound (quiet environment make less mistakes (radios) Vibration (weighing/ pipettes) Accommodation and Environmental Conditions contd

    10. D. Keane Sept. 2005 10 Accommodation and Environmental Conditions contd 5.2.5 - Must have a policy/ procedure to monitor control and record environmental conditions Out of specification non conformance Where environmental factors are known to effect the quality of the final result then they must be monitored and reviewed.

    11. D. Keane Sept. 2005 11 5.2.6 - Segregation of laboratory activities where activities are incompatible or may effect the result/ product:- Class 100,000 room for blood component preparation Class III room for analysis of faeces e.coli 0157 or myco bacteria Accommodation and Environmental Conditions contd

    12. D. Keane Sept. 2005 12 Accommodation and Environmental Conditions contd PCR amplification technology Separate room for cytology screening process Why? quiet environment, manual test, no interruptions Computer room (dedicated controlled environment temperature) Eating, drinking, personal items

    13. D. Keane Sept. 2005 13 Accommodation and Environmental Conditions contd 5.2.7 - Must control access to your Laboratory. A security system should be in place to:- prevent access by patients control access by service engineers etc Why? Safeguard resources (5 Ms)

    14. D. Keane Sept. 2005 14 Accommodation and Environmental Conditions contd 5.2.8 - Should have a good communication system within the laboratory (electronic/ manual).

    15. D. Keane Sept. 2005 15 5.2.9 - Must have sufficient storage space for:- archiving of documentation archiving of specimens/ preparations These storage areas must ensure continuing integrity of material. Accommodation and Environmental Conditions contd

    16. D. Keane Sept. 2005 16 5.2.10 - Storage and disposal of dangerous material shall meet statutory regulations. Must have clean Laboratories and be well maintained. Accommodation and Environmental Conditions contd

    17. D. Keane Sept. 2005 17 5.2.10 - Storage and disposal of dangerous material shall meet statutory regulations. Must have clean Laboratories and be well maintained. Accommodation and Environmental Conditions contd

    18. D. Keane Sept. 2005 18 Summary of Requirement

    19. D. Keane Sept. 2005 19 Summary of Requirement

    20. D. Keane Sept. 2005 20 Summary of Requirement

    21. D. Keane Sept. 2005 21 Summary of Requirement

    22. D. Keane Sept. 2005 22 Summary of Requirement

    23. D. Keane Sept. 2005 23 Summary of Requirement

    24. D. Keane Sept. 2005 24 Summary of Requirement

    25. D. Keane Sept. 2005 25 Summary of Requirement

    26. D. Keane Sept. 2005 26 Summary of Requirement

    27. D. Keane Sept. 2005 27 Summary of Requirement

    28. D. Keane Sept. 2005 28 Summary of Requirement

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