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  1. GENERAL FEATURES

    1. Manager-Responsible person of the Pathology Laboratory should be a pathologist, and he/she should be responsible to a superior authority ((head psysician). Laboratory head is responsible for;
    2. i. Safety,

      ii. Managerial work,

      iii. Education,

      iv. Quality Assurance.


  2. PATHOLOGIST

    1. . Maximum 2000 surgical material and 1500 cytology a year must be provided for every pathologist at full time working training hospitals.
    2. i. These numbers must be lower if there is subspeciality branches.

    3. These numbers must be calculated not per tissue number but per case.

  3. TECHNICIAN

    1. Pathology laboratory technician(s) must be at least high school graduate(s). Health College Medical Laboratory Department or Pathology Laboratory Technicianship College graduates must be preferred.
    2. All personnel must be well educated. Positions in the work process and terms of references for all workers must be determined in written form.
    3. . An experienced tecnician with only routine work must be responsible for maximum 4000 surgical and 3000 cytology material in a year.
    4. Separate technician(s) for histochemistry, immunohistochemistry, immunflouresence, frozen section, molecular and cytogenetic methods, and autopsy must be assigned.

  4. SECRETARY

    1. There should be a secretary(ies) responsible for recording, report writing, result rendering and correspondence work
    2. Ideal number is to have a number of secretaries equal to the number of full-capacity working specialists.

  5. LABORATORY PHYSICAL ENVIRONMENTS

    1. Plate with the name and identity of the laboratory, personnel board and announcements regarding techniques applied and reporting period should be placed where they can be easily seen.
    2. There should be a place tag on all of the rooms.
    3. Laboratory floor should be covered with seramic, marble or chemical-resistant PVC. Workbenches should also be covered with material that is resistant to heat, cuts and chemicals.
    4. There should be sufficient water, electricity, light, air flow (fume hood or aspirator) system.
    5. Material receiving and report delivery section should be in a room or section which is separate from the laboratory and from which laboratory cannot be seen.
    6. A separate macroscopy room
    7. A separate tissue processing and embedding space
    8. A separate staining space
    9. A separate coverslipping space
    10. A separate microscopy room
    11. A separate technician room
    12. A separate material (tissue) storage space
    13. Block and slide archieve room
    14. A separate chemical storage space
    15. A separate flammable-dangerous substance storage space
    16. A separate document archieve space
    17. Secretary room (could be the same space where materials are received)
    18. Space for frozen apparatus
    19. Room for tissue processing, staining, covering apparatus
    20. Immunohistochemistry space
    21. Space for multi-headed microscope and/or training space with close-circuit television
    22. Cytology preparation space
    23. Microscopy room
    24. Common room
    25. Autopsy room
    26. i. Shower, dressing room

      ii. Report and preparation room

      iii. Organ exhibition room

      iv. Cooling room

      v. Tissue storage room


  6. LABORATORY EQUIPMENT

    1. Air conditioned cross section space
    2. Safety cabin
    3. Material storage cabinets
    4. Washing taps
    5. Fixtures (knife, penset, scalpel handle, scalpel head, dissection scalpel, scissors, coping saw, etc. , various sizes glass or hard plastic lidded jars, Petri’s dish, challet, beaker, flasks, pippettes, measuring cylinder, ruler, scale, etc.)
    6. Consumables (slide, lamel, casette, brush, slide writing pen, alcohol, xylol, formaline, paraffine, staining solutions, covering resin, absorbent paper, disposal containers, etc.)
    7. Adequate free spaces
    8. Tissue processing apparatus (or equipment)
    9. Mikrotom (s)
    10. 56 0sterilizer
    11. Water bath
    12. Tissue embedding apparatus (or equipment)
    13. Staining apparatus (or equipment)
    14. Covering apparatus (or equipment)
    15. Centrifuge apparatus
    16. Refrigerator
    17. Deep freezer
    18. pHmetre
    19. Alcoholometer
    20. Solution preparation apparatus
    21. Toxic disposal container (or system)
    22. Macroscopic material disposal system
    23. Microscope
    24. Secretarial writing system
    25. Tissue, paraffine block, slide, report archiving storage and system
    26. Fire extinguisher
    27. Chemical disinfectant
    28. Protective clothes
    29. First aid cabinet
    30. Back leaning, adjustable seats
    31. Frozen apparatus
    32. Mixer (vortex)
    33. Cytocentrifuge
    34. Photographing unit
    35. Microwave oven
    36. Autoclave
    37. Immunflorescent microscope

    Followings are the things that should be available according to needs:

    1. Immunohistochemistry apparatus
    2. Drying oven
    3. Liquid nitrogen tank
    4. Molecular and cytogenetic laboratory
    5. Electron microscopy room

    Following are the properties that are suggested to be provided according to the facilities of the unit:

    1. Fast washing system (for toxic and caustic chemicals)
    2. Eye washing station and eye washing apparatus
    3. Safety shower
    4. Automatic (fire) watering system

  7. LABORATORY PHYSICAL ENVIRONMENT MINIMUM SIZES

    1. PSpaces suggested for pathology laboratory (These spaces are for a pathology laboratory, in a hospital that serves a region with a population of 100.000 - 500.000, which has an annual 15.000 - 20.000 surgical material capacity and with 3 specialists working. Adaptations should be made according to population served, and surgical material capacity and the number of specialists, teaching staff, and residents)

    Region

    Area (m2)

    General laboratory area (3 microtomes)

    40

    Histopathology laboratory (staining, etc.)

    12

    Tissue processing (and if available staining and covering) equipment (s)

    8 (15)

    Frozen equipment space (or a separate room)

    4 (10)

    Histochemistry and immunohistochemistry space-room

    15

    Macroscopy

    25

    Cytopathology

    10

    Microscopy

    25

    Technician room

    15

    Physician room (each 10 m2x3)

    30

    Specialist student room

    12

    Secretary room

    12

    Chemical substance storage and preparation

    15

    Slide, block and report archieve

    20

    Supply storage

    10

    Tissue storage

    5

    Disposal room

    10

    Meeting room

    50

    Total

    318 (343)

    Spaces such as hallways and personnel rooms

    50

    Total laboratory space

    368 (393)


  8. REFERENCES

    1. http://www.cap.org/apps/cap.portal
    2. Standards for Laboratory Accreditation, College of American Pathologists, 1997.
    3. Guidance on the role of the pathology quality manager. IBMS guidance, 2004.
    4. Royal College of Pathologists.
    5. Zarbo RJ, Rickert RR. Quality control, assurance, and improvement in anatomic pathology. In: Silverberg SG (Ed) Principles and Practice of Surgical Pathology and Cytopathology. Churchill Livingstone, New York, 3rd ed., 1997, pp. 11-24
    6. Sheehan DC, Hrapchak BB (Eds). Quality Control. Theory and Practice of Histotechnology. Mosby, St. Louis, 2nd ed., 1980, pp. 406-439.
    7. Rosai J (ed). Appendix B. Quality control and quality assurance in surgical pathology. Rosai and Ackerman's Surgical Pathology. Mosby, Edinburgh, 9th ed., 2004, pp. 2793-2800.
    8. Simpson R, Marichal M, Uccini S. European Society of Pathology statement on minimal requirements for a pathology laboratory. Virchows Arch 436:509-526, 2000.


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