Design Requirements for Anatomical Pathology Departments Guideline
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Design Requirements for Anatomical Pathology Departments Guideline
Guideline Design Requirements for Anatomical Pathology Departments NSWHP_PG_019 Contents Contents ......................................................................................................................................... 1 1. Purpose ................................................................................................................................... 3 2. Background.............................................................................................................................. 3 3. Scope ...................................................................................................................................... 3 4. Definitions ................................................................................................................................ 4 5. Policy Statement ....................................................................... Error! Bookmark not defined. 5.1 Key Planning Considerations................................................................................................ 4 5.2 Design Requirements of the Histopathology Laboratory ....................................................... 4 a) Specimen Reception/Accession ............................................................................................... 5 b) Fresh Tissue and Frozen Section ............................................................................................ 6 c) Cut-Up ..................................................................................................................................... 6 d) Tissue Processing.................................................................................................................... 7 e) Chemical Preparation and Decanting ....................................................................................... 8 f) Specimen Storage, Retrieval and Archiving ............................................................................. 8 g) Embedding, Sectioning and Staining ....................................................................................... 8 h) Embedding .............................................................................................................................. 9 i) Tissue Sectioning .................................................................................................................... 9 j) Tissue Staining and Coverslipping ......................................................................................... 10 k) Case Assembly, Checking and Case Allocation ..................................................................... 10 l) Slide Scanning for Whole Slide Imaging ................................................................................ 11 m) Immunohistochemistry........................................................................................................ 11 5.3 Storage .............................................................................................................................. 12 a) Chemical and Flammable Stores ........................................................................................... 12 b) Consumable Stores ............................................................................................................... 12 c) Slide and Block Storage ......................................................................................................... 12 5.4 Specialised Testing ............................................................................................................ 13 a) Cytology................................................................................................................................. 13 b) Immunofluorescence.............................................................................................................. 14 c) Molecular testing of cancer .................................................................................................... 14 d) Electron Microscopy............................................................................................................... 15 e) Autopsy.................................................................................................................................. 15 5.5 Design Requirements of the Histopathology Department ................................................... 15 a) Reporting and Consulting....................................................................................................... 15 b) Trainees................................................................................................................................. 16 c) Conference and Teaching Areas............................................................................................ 17 d) Administrative Office .............................................................................................................. 17 e) Staff Safety ............................................................................................................................ 18 f) Staff Facilities ........................................................................................................................ 18 6. Roles and Responsibilities ..................................................................................................... 18 7. Legal and Policy Framework .................................................................................................. 18 8. Review ................................................................................................................................... 19 9. Risk ....................................................................................................................................... 19 10. Further Information ............................................................................................................. 19 11. Version History ................................................................................................................... 19 Appendix A – Tissue Pathology Functional Components Diagram ................................................ 20 Page 2 of 20 Approver: Executive Director Clinical Streams, Version Number: V1.0, Publication Date: 4/12/2019 This document is subject to change and a printed copy may not be up to date. The current version is only available online in the NSW Health Pathology Policy Library
Guideline Design Requirements for Anatomical Pathology Departments NSWHP_PG_019 1. Purpose To define the design requirements for future developments of Anatomical Pathology Departments within NSW Health Pathology. 2. Background Anatomical Pathology (AP) involves the study of human tissues for diagnosis and monitoring of disease or directing treatment. This encompasses the study of: • Whole organs or samples of tissue in histopathology and electron microscopy • Isolated cells in cytopathology • The components of cells as in immunohistochemistry and • Somatic genomics. An AP Department contains a “clean” consultation/microscopy area including workspace for pathologists, registrars, cytologists and laboratory managers. Case reporting is performed by specialist anatomical pathologists examining tissue or cells at microscopic level and this comprises the “testing” component of AP. All cases are reported by a specialist anatomical pathologist except normal gynaecological cytology (LBC). The activities of the anatomical pathology laboratory may allow for flexibility in service design, including relocation of some activity off site. On site services should include specimen receipt and macroscopic examination of larger resection or biopsy specimens, and this is encompassed in the onsite preparation of specimens for the pathologist to examine, although other technical activity such as tissue processing and slide preparation may be performed off-site NSW Health Pathology AP Departments are hospital based and process a significant volume of specimens including a high volume of large and complex surgical specimens. The Australasian Health Facility Guidelines (AusHFG) state that there is a need to physically confine a laboratory based upon the physical, chemical or biological hazards generated in laboratories including AP. These laboratories must be physically separated from other laboratory work areas by walls and doors including air handling from other laboratory work areas. This guideline should be read in conjunction with NPAAC Requirements for Medical Pathology Services 2018 Standards S7A.1 and S7A.2 and work, health and safety (WHS) requirements. 3. Scope This guideline applies to all NSW Health Pathology AP Departments. It should be noted that some customisation may be necessary to meet local requirements. Mortuary facilities have specific design requirements that are not within the scope of this guideline. Electron microscopy laboratories have specific requirements and have not been specifically addressed in this document. Page 3 of 20 Approver: Executive Director Clinical Streams, Version Number: V1.0, Publication Date: 4/12/2019 This document is subject to change and a printed copy may not be up to date. The current version is only available online in the NSW Health Pathology Policy Library
Guideline
Design Requirements for Anatomical Pathology Departments
NSWHP_PG_019
4. Definitions
Clean area: A clean area is an area not used for the handling or processing of biological specimens.
Cytology: The study of tissue at an individual cell level.
Electron Microscopy: The high power microscopic study of tissue using an electron beam
Histopathology: The microscopic study of tissue using the visible light wavelength
Immunohistochemistry: The use of labelled antibodies to identify features in cells and tissue
Autopsy/post mortem: The examination of a dead body for pathological changes.
Macroscopic: Examination by naked eye.
Microscopic: Examination using magnification in a microscope
WSI: Whole slide imaging. The digital scanning of a microscope slide to produce an image.
Cut-up: The process of description of a specimen and if necessary dissection and selection of
representative samples for microscopic study.
ROSE: Rapid On-Site Evaluation. Microscopic assessment of cytology samples at the time of
collection to determine adequacy and provide feedback to the person collecting the sample.
FNA: Fine Needle Aspiration biopsy. The use of a narrow gauge needle to collect cytology
specimens in sites deep to the skin.
5. Guideline
5.1 Key Planning Considerations
Key considerations when planning future developments of AP departments include:
a) The AP activities and design requirements as defined in this guideline
b) Service configuration including the scope of service, activity, instrument specifications and
future plans for laboratory services
c) Distribution and consolidation of functions within laboratories for example centralised
specimen reception for tissue pathology disciplines
d) The changing nature of teaching, education and clinical engagement.
5.2 Design Requirements of the Histopathology Laboratory
The histopathology laboratory must accommodate the following components:
a) Specimen reception/accession area/administrative area which may include report
transcription, secretarial and managerial staff
b) Fresh tissue and frozen section area, including microscopic reporting space
c) Dedicated area for tissue cut up, which includes facilities for pathologist macroscopic
dictation and cassette printing (with dedicated ventilation)
d) Tissue processing area (with dedicated ventilation)
e) Chemical storage, preparation and decanting (with dedicated ventilation)
f) Specimen storage area (with dedicated ventilation)
g) Tissue embedding and sectioning stations
h) Staining area includes both routine staining (haematoxylin and eosin) and special stains
i) Immunohistochemistry staining area
j) Case assembly, checking and case allocation
k) Whole slide imaging area
Page 4 of 20
Approver: Executive Director Clinical Streams, Version Number: V1.0, Publication Date: 4/12/2019
This document is subject to change and a printed copy may not be up to date.
The current version is only available online in the
NSW Health Pathology Policy LibraryGuideline
Design Requirements for Anatomical Pathology Departments
NSWHP_PG_019
l) Emergency shower and eye wash stations
m) Bulk chemical and flammable stores
n) Emergency shower and eye wash stations
o) Chemical and flammable stores
p) Consumable stores
q) Slide and block storage.
This is necessary for a standard, essential, on site AP service. Please refer to Appendix A –
Tissue Pathology Functional Components Diagram.
Further space allocation may need to be considered for more specific, specialised testing that the
laboratory may offer including, but not limited to:
a) Cytology
b) Immunofluorescence
c) Molecular testing of cancer
d) Electron Microscopy
e) Autopsy.
Detailed discussion of the design requirements of the histopathology laboratory is provided below:
a) Specimen Reception/Accession
Description of Activity
Specimen reception and accession is the process whereby:
a) Specimen identity is checked against request forms
b) Demographic data is entered into the LIS and
c) A unique AP laboratory number is attached to all paperwork and specimen containers to preserve
specimen identity through the entire laboratory pathway.
Design Requirements
The specimen reception/accession area must:
a) Be located near an entry point accessible to couriers and theatre staff that may use trolleys to
transport specimens
b) Have provision for other specimen delivery systems such as pneumatic tubes
c) Include adequate bench space to sort specimens and for interim storage before they are
moved to the cut-up or fresh tissue areas. The amount of bench space will vary with laboratory
workload
d) Include computer terminals for data entry and document scanners for request forms
e) Separate the handling of paper work from the specimen receipt desk to separate clean and
dirty activities.
Page 5 of 20
Approver: Executive Director Clinical Streams, Version Number: V1.0, Publication Date: 4/12/2019
This document is subject to change and a printed copy may not be up to date.
The current version is only available online in the
NSW Health Pathology Policy LibraryGuideline
Design Requirements for Anatomical Pathology Departments
NSWHP_PG_019
b) Fresh Tissue and Frozen Section
Description of Activity
Fresh human tissue has biological risk but must be examined and sampled for a number of diverse
purposes such as frozen section, tissue banking, microbial culture, photography and as preparation
prior to fixation.
Design Requirements
The fresh tissue and frozen section area must have:
a) Separate fresh tissue handling from other areas to minimise contamination by biological
hazards
b) Easy access to personal protective equipment (PPE) and eyewash stations
c) A Class II biohazard cabinet for the dissection of fresh tissue
d) Cryostats for cutting frozen section within this area
e) A dedicated staining area for frozen section staining, usually bench top
f) A specimen photography station within this
g) A ‘dirty’ sink and sharps disposal access
h) Interim storage for biobanking prior to transport to longer-term storage in minus 80-degree
freezers.
c) Cut-Up
Description of Activity
This process involves the dissection of human tissue or body parts to describe the macroscopic
pathology and to select tissue samples for microscopic examination. Some samples are very
small and are transferred whole for processing (direct transfer). All tissue handling needs
fastidious concentration to avoid loss or misidentification.
NSWHP laboratories frequently receive large surgical specimens. These can be visually
confronting, on occasions release noxious odors, and can release significant volumes of
formalin into the laboratory environment when handled.
Some dissection processes, such as the use of band saws to cut bone, are noisy and produce
dust and odors.
Design Requirements
The cut-up area must:
a) Be out of the general view of the laboratory, office or any public entry points and access should
be restricted to those with a professional reason to be there. Many large specimens are visually
confronting for untrained staff, including office staff or any outside visitor. Patient privacy must
also be protected. The cut-up area should ideally be close to the specimen reception/accession
area so that specimens will not need to be transported too far after accessioning to be available
for cut up.
Page 6 of 20
Approver: Executive Director Clinical Streams, Version Number: V1.0, Publication Date: 4/12/2019
This document is subject to change and a printed copy may not be up to date.
The current version is only available online in the
NSW Health Pathology Policy LibraryGuideline
Design Requirements for Anatomical Pathology Departments
NSWHP_PG_019
b) Be away from general traffic and disturbance. This is critical to allow staff to concentrate on
their job and minimise the risk of identification errors and losing small pieces of tissue. This is
particularly the case where direct tissue transfer of small specimens is taking place. Dictation
systems are also in operation and this can be disturbed by unnecessary ambient noise
c) Be within purpose designed cut-up bench areas with appropriate ventilation, usually down draft,
water supply and drainage
d) An adequate number of cut up stations must be available for the volume of activity and the
different ranges of activity that may occur across this site in the working day. These must be
acoustically isolated one from the other, have adequate, usually natural, light but not have a
window arrangement that directly faces onto Northern or Western sunlight. Steady laminar
airflow over the dissection bench should be available, but not inconsistent or variable
e) Ensure dangerous equipment such as band-saws are away from trafficked areas and have
extraction ventilation
f) Make spill kit, fire extinguishers, PPE, eyewash stations and an emergency shower available
close to the area
g) Include cupboard space for disposables, utensils, etc.
d) Tissue Processing
Description of Activity
This is the process where the tissue selected for microscopy, encased in a labelled plastic cassette,
is dehydrated and all the water component of the tissue slowly replaced by molten paraffin wax. This
occurs in a sealed vessel within a machine.
Equipment failures are uncommon but the tissue processors do contain a significant volume (about
80L) of heated, flammable and toxic chemicals under pressure in a machine combined with electrical
equipment. The fluid is within plastic tubing and the machine is not totally sealed to prevent leakage
onto the floor.
In larger laboratories there may be a bank of up to 10 processors.
Design Requirements
The tissue processing area must
a) Allow space for technical/lab scientist staff to load/unload tissue specimens and decant
solvents from the processor.
b) Be of sufficient size to accommodate the number of processors to handle the workload, taking
likely growth or changes in equipment size into account within a fire-rated room equipped with an
automatic fire extinction system
c) Be fitted with adequate ventilation and extraction for formalin and xylene fumes
d) Ensure the entrance is designed to contain spillage of flammable fluid preventing it from flowing
out to the general laboratory
e) There are specific requirements for the distribution of processors in the space in relation to
powerpoints and alarm systems.
Page 7 of 20
Approver: Executive Director Clinical Streams, Version Number: V1.0, Publication Date: 4/12/2019
This document is subject to change and a printed copy may not be up to date.
The current version is only available online in the
NSW Health Pathology Policy LibraryGuideline Design Requirements for Anatomical Pathology Departments NSWHP_PG_019 e) Chemical Preparation and Decanting Description of Activity Chemicals used in specimen fixation, specimen processing and staining include numerous hazardous agents like formalin, xylene (or other organic solvents), alcohols and acids. Some are required in bulk. Where possible premixed chemicals and sealed system equipment is used to minimise contact but some open handling is likely to continue for many years. Design Requirements The chemical preparation and decanting area must: a) Allow for the preparation of chemicals and formalin decanting to be done in a well-ventilated (ie actively exhausted to an external flue) and contained area away from other laboratory activities particularly to minimise the effects of any spill accidents b) Include flammable cabinets for storage. Only appropriate small volumes may be housed in the laboratory as per work, health and safety (WHS) standards. f) Specimen Storage, Retrieval and Archiving Description of Activity Specimens including empty specimen containers are required to be stored for 1 month from the time the report is finalised to meet NPAAC “Requirements for the Retention of Laboratory Records and Diagnostic Material (Seventh Edition 2018)” Standard 2.7. These can be stored away from the main area of the laboratory but specimens may need to be repeatedly accessed particularly in the few days after cut-up in some cases. The area required will be dependent on caseload and proportion of large specimens. Design Requirements The specimen storage area must: a) Be in ventilated cabinets for specimen storage in formalin in a well-ventilated (ie actively exhausted to an external flue) and contained area away from other laboratory activities particularly to minimise the effects of any spill accidents b) Include cabinets or shelving with bunding which is able to collect small to medium volume spills. g) Embedding, Sectioning and Staining Description of Activity These processes are sequential and the laboratory space should allow workflow to occur with minimal cross traffic and backtracking. These activities occupy the largest number of scientific and technical staff and frequently continue to run simultaneously during the day particularly in larger laboratories. Page 8 of 20 Approver: Executive Director Clinical Streams, Version Number: V1.0, Publication Date: 4/12/2019 This document is subject to change and a printed copy may not be up to date. The current version is only available online in the NSW Health Pathology Policy Library
Guideline
Design Requirements for Anatomical Pathology Departments
NSWHP_PG_019
Design Requirements
The embedding, sectioning and staining area must make available spill kit, fire extinguishers, PPE,
eyewash stations and an emergency shower close to this area.
h) Embedding
Description of Activity
This process involves:
a) Opening the cassettes after tissue processing
b) Checking the identity and number of tissue fragments
c) Placing the tissue fragment in a mould in the correct orientation for sectioning
d) Placing the labelled cassette on top of the mould
e) Filling the mould with molten wax and
f) Allowing the wax to set into a solid block.
g) These activities are performed at an embedding centre which occupies about 1200mm of bench
space.
Design Requirements
This embedding area must:
a) Include computer access to check the details of each specimen to inform the process
b) Be away from laboratory traffic flow as the embedding process requires concentration and manual
dexterity in order that small pieces of tissue are correctly orientated and not lost.
c) Include sufficient circulating and bench space for the number of embedding centres, which is
dependent caseload and projected growth.
i) Tissue Sectioning
Description of Activity
In this process the cassette barcode will be scanned and a slide writer produces ‘on demand’ the
required number of patient labelled slides at each microtomy station. Manual processes are still
prevalent but it is intended that all laboratories will soon have internal specimen tracking to prevent
identification errors. The cassette is then placed in the microtome which is a manually driven
bench top machine allowing transparently thin slices of tissue to be cut from the paraffin tissue
block. The thin tissue slices are floated onto the surface of a temperature-controlled water bath
and then picked up onto the correctly labelled glass microscope slide.
The number of microtomy stations depends on the workload.
Design Requirements
The tissue sectioning area must:
Page 9 of 20
Approver: Executive Director Clinical Streams, Version Number: V1.0, Publication Date: 4/12/2019
This document is subject to change and a printed copy may not be up to date.
The current version is only available online in the
NSW Health Pathology Policy LibraryGuideline
Design Requirements for Anatomical Pathology Departments
NSWHP_PG_019
a) Have each workstation fitted with a microtome, water bath, cold plate for cooling blocks prior
to sectioning, tablet device, barcode reader, slide printer and racks for completed slides and
blocks. The configuration each microtomy station must be ergonomically sound.
b) Have no through traffic in the cutting area
c) Have closely controlled room temperature as excessive heat causes the thin slices of
paraffin to melt onto the operator’s fingers
d) Be sited on a bench that is free from vibration
e) Be free from cross drafts.
j) Tissue Staining and Coverslipping
Description of Activity
This process involves using dyes to make various components of the transparent tissue on the
glass visible under the microscope. The routine stain is Haematoxylin and Eosin (H&E) but there
is a broad range of other histochemical stains (special stains) still routinely in use in our
laboratories.
Automated or semi-automated H&E staining is almost universal in our laboratories. Automation of
commonly used special stains is more common in larger laboratories. The capability of performing
less commonly used special stains manually is retained in most larger laboratories.
Coverslipping involves placing a thin layer of glass or plastic over the tissue with a transparent
adhesive. Larger labs have automated this process. Manual coverslipping is still practiced in
smaller laboratories but there is a move to automation statewide.
Design Requirements
The tissue staining and coverslipping area must:
a) Be adjacent to the microtomy area for optimal workflow, at least for routine H and E staining
b) Include plumbing, extraction and/or adequate ventilation dependent on the staining machine
c) Include a manual special stains area adequate to perform the stain and to make solutions as
required
d) Include appropriate storage for stains, solutions and chemicals for stains to be performed
within the vicinity. This includes but is not limited to fridges, freezers, low volume flammable
cabinet, small volume corrosives cabinet and dark cupboard for reagents that are light
sensitive.
This area may also require ovens, water baths, stirrers, pH meters and microwave ovens as required.
k) Case Assembly, Checking and Case Allocation
Description of Activity
This activity includes assembling all the stained slides to ensure all are present, checking the slides
against blocks to ensure all tissue has been sectioned and checking section and stain quality. The
assembled slides are then checked against the paperwork and the case allocated to a pathologist
for reporting.
Page 10 of 20
Approver: Executive Director Clinical Streams, Version Number: V1.0, Publication Date: 4/12/2019
This document is subject to change and a printed copy may not be up to date.
The current version is only available online in the
NSW Health Pathology Policy LibraryGuideline
Design Requirements for Anatomical Pathology Departments
NSWHP_PG_019
Design Requirements
The case assembly, checking and case allocation area must include:
a) Adequate clear desk space for the volume of cases and slide trays
b) Computer access for allocation, worksheets, etc
c) A barcode reader for specimen tracking.
l) Slide Scanning for Whole Slide Imaging
Description of Activity
This is an additional step which will be required after the introduction of reporting using digital images
rather than light microscopy.
Design Requirements
The number of scanners required will be dependent on case volume as well as the capacity of the
instruments. Sufficient space should be allocated for this to occur. Scanning of slides may occur in
a region of the routine laboratory, depending upon the WSI workflow and scanner size and number,
but it is likely that a case assembly and reconciliation area may need to be allocated also.
m) Immunohistochemistry
Description of Activity
Immunohistochemistry uses antibodies to identify particular features in the tissue sections then uses
further antibodies and chemicals to make these features visible under the microscope. It is a
complex automated process which takes several hours to complete.
The machines for this and fluorescent in–situ hybridisation are relatively large. Larger laboratories
require multiple machines.
Design Requirements
The immunohistochemistry area must include:
a) Sufficient space for the required machines
b) Computer access
c) A coverslipping machine or ventilated bench space
d) Bench space for case sorting
e) Microscope for checking
f) Storage for control blocks
g) Fridges and freezers for antibodies
h) Cupboards for chemicals and other stores
i) Spill kit, fire extinguishers, PPE, eyewash stations and an emergency shower must be
available close to this area
j) Emergency Shower and Eye Wash Stations.
Page 11 of 20
Approver: Executive Director Clinical Streams, Version Number: V1.0, Publication Date: 4/12/2019
This document is subject to change and a printed copy may not be up to date.
The current version is only available online in the
NSW Health Pathology Policy LibraryGuideline Design Requirements for Anatomical Pathology Departments NSWHP_PG_019 The AP laboratory presents a variety of chemical, infectious and physical risks requiring the presence of both emergency showers and eyewash stations in addition to fire blankets and extinguishers. The flammable chemicals introduce the risk of fire including ignition of clothing. Formalin, in particular, is a serious chemical irritant causing skin irritation and if splashed in the eye severe chemical burns. Infectious material can also be splashed onto skin or into eyes. Immediate irrigation of the eyes by fresh water is necessary for both chemical and infectious splashes. 5.3 Storage a) Chemical and Flammable Stores Description of Activity Histopathology and cytology laboratories are large consumers of flammable liquids and only small volumes can be stored on the bench or in the open. Design Requirements There is a requirement for larger volumes to be stored in flameproof cabinets or other specifically designed storage facilities. b) Consumable Stores Description of Activity Storage of reagents and other consumables sufficient to ensure continuity of service. Some of these are relatively bulky. “Just in time” ordering is not always appropriate in the acute hospital setting where there can be sudden increases in demand and these may occur in a disaster situation where supply chains can be disrupted. Design Requirements There must be sufficient storage space available in the lab to allow storage of at least working quantities of consumables and close accessible storage of larger quantities, so that continuity of service can be assured. c) Slide and Block Storage Description of Activity Slide and block storage is mandated for 10 years for adults and 7 years from the age of majority for minors whichever is greater as set out in the NPAAC Standards “Requirements for the Retention of Laboratory Records and Diagnostic Material (Seventh Edition 2018)”. In practice, it is useful to have at least 3 years of material available on site as the greatest need for access is within a short time of the episode. The remainder can be stored off-site. Page 12 of 20 Approver: Executive Director Clinical Streams, Version Number: V1.0, Publication Date: 4/12/2019 This document is subject to change and a printed copy may not be up to date. The current version is only available online in the NSW Health Pathology Policy Library
Guideline Design Requirements for Anatomical Pathology Departments NSWHP_PG_019 Design Requirements Slides are heavy and there is a need for storage on a strong floor, usually concrete. The on site storage of glass slides may be modified by the enactment of WSI and digital AP reporting. In these circumstances on site storage of slides is unnecessary almost immediately after scanning and routine delivery to off site/distant low cost secure storage may be desirable and advantageous. Blocks need to be stored in a vermin free environment with temperature maintained below the melting point of paraffin wax. 5.4 Specialised Testing a) Cytology Description of Activity Cytology involves the examination of constituent cells of aspirated tissue samples and fluids, or exfoliated cells from surface sites, particularly to determine the presence of cancer or precancerous changes. Where gynaecological cytology (LBC) is still performed the specimens are received in a fluid medium and in many cases part of the specimen has to be sent on for HPV testing. The remaining specimen will have a thin monolayer of cells deposited on a slide This tissue is processed and stained and examined microscopically by a scientist and sometimes subsequently by a pathologist. Public cytology services are largely engaged in non-gynaecological cytology and fine needle aspiration biopsy (FNA) and this is certainly the case at NSW Health Pathology. These are either prepared outside as slides or, if they are in a fluid, the specimens are prepared in a biohazard unit in the cytology laboratory. The cytology laboratory and microscopy should be co-located where possible with the other components of the AP Department to allow appropriate workflow and supervision. Screening of the cytology cases requires a high level of concentration so that noise and disturbance should be minimised and cytology reporting should be isolated from the adjacent cytology laboratory activities. A multiheaded microscope in a separate room is a sensible reporting and consultation instrument in the cytology reporting environment. Where FNA is performed on site, a clinic room and waiting area accessible to patients is required. Design Requirements The cytology preparation room/laboratory must include: a) An accessioning, computer, biohazard cabinet, staining machine or manual stainer for non- gynaecological specimen preparation with the laboratory preparation room b) Good chemical fume extraction Page 13 of 20 Approver: Executive Director Clinical Streams, Version Number: V1.0, Publication Date: 4/12/2019 This document is subject to change and a printed copy may not be up to date. The current version is only available online in the NSW Health Pathology Policy Library
Guideline Design Requirements for Anatomical Pathology Departments NSWHP_PG_019 c) Liquid Based Cytology (LBC) machine for gynaecological cytology or where FNA or nongynaecological cytology requires it d) Triaging and aliquoting bench for gynae cytology if performed e) A confidential room/office for the Cytology manager to meet with staff f) A separate clinical room for onsite FNAs containing an examination couch, chair, small writing desk, microscope for specimen evaluation during the procedure, handwashing sink, small or mobile biohazard cabinet which can contain cytology stains, cupboard for needles, supplies, local anaesthetic linen etc and sharps disposal g) Safe and easily accessible storage area for laboratory consumables which include hazardous chemicals h) Mobile trolley storage area for attending off site FNAs i) Clean area for screening which is quiet and enclosed and has good natural light j) Area for a multiheader microscope for case reviews, consultation and teaching. b) Immunofluorescence Description of Activity Direct immunofluorescence is used mainly to detect immune complex depostis in kidney, skin and muscle biopsies. Frozen sections of fresh tissue are stained using fluoroceinated antibodies and the coverslipped slide is then exmained in a fluorescent microscope. Design Requirements A small area of bench space is required for slide staining. The fluorescent microscope should be housed in a microscopy suite /work station which can be darkened to allow optimal viewing. A cupboard or similar storage area for recent cases which is shielded from light is also required. c) Molecular testing of cancer Description of Activity Detection of mutations within DNA in cancer. This can be used in diagnosis of specific cancers or to indicate sensitivity to specific therapies. Design Requirements This is likely to be performed only in a minority of anatomical pathology laboratories for small range of tests. Fluorescent in situ hybridisation is the most commonly used method. This uses fluorescent probes to detect genes in cancer tissue. The staining process is mechanised and performed usually within the immunhistochemsitry laboratory. Interpretation is performed by a pathologist using a fluorescent microscope which should be in an enclosed work space / reporting suite which can be darkened. This could be shared with the immunofluorescence area. Specific equipment for other types of molecular testing currently used such as the Idylla platform require a small area of bench space but this is an area of rapid change and should be reviewed as needed. Page 14 of 20 Approver: Executive Director Clinical Streams, Version Number: V1.0, Publication Date: 4/12/2019 This document is subject to change and a printed copy may not be up to date. The current version is only available online in the NSW Health Pathology Policy Library
Guideline Design Requirements for Anatomical Pathology Departments NSWHP_PG_019 d) Electron Microscopy Description of Activity Examination of very thin sections of tissue using an electron beam instead of light to allow very high levels of magnification. Its main use is in renal biopsies but other rare diseases are also diagnosed using this instrument. Design Requirements These units are few in number. There are however some general requirements. Electron microscopes must be sited away from strong electromagnetic fields, for instance away from large electric cables, large metal pipes etc and ambient fields have to be measured to ensure that they do not interfere with the electron beam in the microscope column. Vibration also has to be minimized both for the microscope and the ultramicrotomes used in cutting the specimen grids for examination. Fume extraction cabinets have to deal with highly toxic chemicals such as osmium. The tissue processors also vent into this system. Electron microscopes are usually large pieces of equipment and need to be isolated to allow for the operator to concentrate. As re-development occurs infrequently for these units, detailed specifications will have to be developed when this is required. e) Autopsy It is not anticipated that new hospital based autopsy facilities will be built in NSW. Body storage will continue to be needed at hospitals but may be managed by LHDs rather than NSW Health Pathology. 5.5 Design Requirements of the Histopathology Department a) Reporting and Consulting Description of Activity Reporting and consulting spaces need to be separate from the general laboratory area but must be easily accessible to all staff. The presence of pathologists on acute hospital sites is necessary to fulfill their roles in FNA, Frozen Section, clinical liaison, MDT, clinical leadership and research. Digital pathology offers the possibility of extending this engagement to hospitals without current on- site AP services. However, case reporting will remain the largest component of a pathologist’s work and this is a highly focused activity that requires enclosed work spaces (reporting suites), to prevent distractions and interruption, as well as sound attenuation for dictation. The production of these essential reports is the main objective of the AP Department. While digitisation may allow the reporting component to occur away from existing hospital locations it will still need to meet these requirements, as well as patient privacy and confidentiality Page 15 of 20 Approver: Executive Director Clinical Streams, Version Number: V1.0, Publication Date: 4/12/2019 This document is subject to change and a printed copy may not be up to date. The current version is only available online in the NSW Health Pathology Policy Library
Guideline Design Requirements for Anatomical Pathology Departments NSWHP_PG_019 obligations. The division of labour between the AP Pathologists may change over time but the current reality is that a pathologist’s time is split between many of these activities in a single working day, with reporting being interleaved with other activities. Apart from face to face meeting attendance and lectures these are also predominantly based at the computer or microscope. Histopathology reporting by specialists, cytology screening, trainee (registrar) workstations laboratory managers and clerical staff should be located adjacent to each other. If multi-disciplinary team (MDT) meetings are held within the department, meeting rooms should also be in a clean area. Reporting and consulting spaces should be connected to the intra and internet for distance as well as onsite learning, training and quality opportunities. AP is medically labour-intensive as every case is reported by a specialist pathologist. There is a much smaller requirement for out of department activities such as MDT meetings, off site frozen sections, student teaching etc. 0.8-1.0 FTE pathologists require their own enclosed reporting suite/ work space. Part-time pathologists may share reporting suites but this should not be at the same time, to allow full concentration in reporting and privacy of clinical consults. The large proportion of time spent reporting cases and thus the need for high levels of concentration, access to personal and sometimes confronting images of specimens, the maintenance of patient confidentiality and the risk of error favours the use of partitioned work spaces for this purpose. Design Requirements The process of reporting and consulting requires a work space that: a) Includes a desktop computer, screen and microscope with a teaching side arm if the department has trainees b) Includes three high resolution computer screens to replace the microscope when digital pathology is introduced. This will not significantly reduce the area of desk space required c) Arrange and store the cases that are awaiting reporting d) Store research and printed materials including text books and professional files e) Is free from ambient noise, overheard conversations and passing foot traffic f) Is within a quiet environment for report dictation/voice recognition g) Ensures patient privacy for phone calls, staff counselling, confidential teleconferences and registrar feedback, etc. b) Trainees Design Requirements Trainees require: a) A desk, chair, microscope, computer with internet access and shelving for books and slides b) A further screen for digital pathology once available c) Library facilities Page 16 of 20 Approver: Executive Director Clinical Streams, Version Number: V1.0, Publication Date: 4/12/2019 This document is subject to change and a printed copy may not be up to date. The current version is only available online in the NSW Health Pathology Policy Library
Guideline
Design Requirements for Anatomical Pathology Departments
NSWHP_PG_019
d) Access to teaching/multiheaded microscopes and intra/internet as above.
A shared enclosed work space for case reporting by trainees should be available.
The trainee desks can be in a common area but should be in close proximity to the specialists and
close to the workflow leaving the laboratory.
c) Conference and Teaching Areas
Design Requirements
To hold MDT/Clinical Meetings, teach AP trainees and consult with cytology scientists, there must
be:
a) Access to adequate teaching facilitates depending on the size of the laboratory and number
of trainees
b) Multiheaded microscopes and /or high quality digital viewing system for multiple viewers
should be available in a training area.
c) Connection to the intra and internet for distance as well as onsite learning, training and
quality opportunities.
d) Administrative Office
Design Requirements
Directors
For Directors to combine clinical and administrative duties, there must be:
a) A slightly larger room than a regular reporting suite to accommodate an additional 2 to 3
chairs for meetings, counselling and interviewing staff.
b) The room must be private to allow confidential conversations and staff management to occur.
Senior Laboratory Staff
Some of the senior staff performing work within the laboratory will require access to a work station
for managing inventories, updating manuals, rosters etc.
These should be available in an area sufficiently quiet to allow concentration on these tasks.
Managers
The laboratory manager also requires a confidential room to allow staff management issues to be
discussed.
Administrative staff
The administration area must include (and may be shared with the overall laboratory):
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Approver: Executive Director Clinical Streams, Version Number: V1.0, Publication Date: 4/12/2019
This document is subject to change and a printed copy may not be up to date.
The current version is only available online in the
NSW Health Pathology Policy LibraryGuideline
Design Requirements for Anatomical Pathology Departments
NSWHP_PG_019
a) A reception desk close to the main public entry point of the laboratory so provide monitoring
of entry as well as projecting a professional and welcoming first contact with the NSWHP
facility.
b) A separate general entry to the administration area separate from the specimen
reception/accession area.
e) Staff Safety
Description of Activity
Formalin is extremely irritating to eyes and causes a severe chemical burn. Facilities must be
available in the laboratory area close to the greatest risk of injury ie specimen cut up, storage and
chemical preparation.
Design Requirements
a) An emergency shower
b) An eye-wash station connected to a potable water source.
f) Staff Facilities
Description of Activity
AP staff work in some areas of the laboratory, such as cut-up, where clothing other than normal
street wear is essential. These areas are also subject to occasional spills and contamination of
clothing despite the wearing of PPE.
Design Requirements
a) Change and shower facilities should be available close to the laboratory
b) Lockers should be available for all staff without a lockable office
c) Toilets should be in individual ventilated private rooms with a hand basin rather than
cubicles, particularly if they are not segregated by gender
d) A clean staff resource room away from laboratory sights, smells and contamination should be
available for breaks and meals.
6. Roles and Responsibilities
Pathology Services Planners will be responsible for complying with this guideline when planning
developments to, and modifications of, AP laboratories and briefing Health Infrastructure NSW.
AP Directors, Operations Directors and Laboratory Managers will be responsible for complying with
this guideline when planning developments, modifications and the purchase of equipment.
7. Legal and Policy Framework
Australasian Health Facility Guidelines (AusHFG)
NPAAC “Requirements for Medical Pathology Services” 2018 Standards S7A.1 and S7A.2
NPAAC “Requirements for the Retention of Laboratory Records and Diagnostic Material (Seventh
Edition 2018)” Standard 2.7
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Approver: Executive Director Clinical Streams, Version Number: V1.0, Publication Date: 4/12/2019
This document is subject to change and a printed copy may not be up to date.
The current version is only available online in the
NSW Health Pathology Policy LibraryGuideline
Design Requirements for Anatomical Pathology Departments
NSWHP_PG_019
8. Review
This guideline will be reviewed by 31/12/2021.
9. Risk
Risk Statement Compliance with this guideline will ensure that NSW Health Pathology
continues to provide high quality AP services to our customers including
accurate reporting, that meets quality standards and NPAAC and WHS
requirements.
Risk Category Clinical Care and Patient Safety
10. Further Information
For further information, please contact:
Policy Contact Officer Position: Anatomical Pathology Clinical Stream Lead
Name: Paul McKenzie
Telephone: 02 9515 6111
Email: Paul.McKenzie@health.nsw.gov.au
11. Version History
The approval and amendment history for this document must be listed in the following table.
Version Effective Approved Approval Policy Author Risk Rating Sections
No Date By Date Modified
1.0 04/12/2019 Executive 26/09/2019 Anatomical Medium New policy.
Director, Pathology
Clinical Clinical Stream
Streams Lead
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Approver: Executive Director Clinical Streams, Version Number: V1.0, Publication Date: 4/12/2019
This document is subject to change and a printed copy may not be up to date.
The current version is only available online in the
NSW Health Pathology Policy LibraryTissue Pathology Functional Components Diagram
Laboratories
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Anatomical Pathology Cytology Immunohistochemistry EM
NSWHP_PG_019
Guideline
Specimen Cut-Up / Wet H&E Slide Slide Spec. Spec. Slide Ab Bulk IHC Spec. Spec.
Tissue Stain Slide Receipt EM suite &
Receipt & FS / Fresh Specimen Microtomy and distrib- & Receipt Prep & FNAC mgt. storage soln stainer processing/
Processing Embedding & CS returns & peripherals
Booking Specimen Storage & Re-cuts Special ution & Block & Storage Clinic & & prep storage - bench microtomy
Room Area & filing Booking
Area Handling Area Stains returns filing Booking area label area & prep or floor /staining
Area area area (fridge) area +/- CS area
Consultation, Reporting and Management
NSW Health Pathology Policy Library
Clinical Directors Office
Pathologists Consultation Registrars Reporting Space Cytology Screening & Tissue Pathology Managers Laboratory Supervisor
(Consultation & Clinical
Offices (Individual) (Open plan) Reporting Room (Open plan) Office (Operational Mgt) Offices
Service Management) (AP, Cyto, IHC, EM)
The current version is only available online in the
Teaching / Education / Customer & Clinical Engagement Staff Amenities
Multiheader MDT Space/s with Library Digital Scanning Tearoom Toilets & Shower Staff Meeting Room Staff Lockers
Microscope/s teleconference (Future)
Clinical Operation Imperatives Laboratory Operation Imperatives
Transcription and Referrals MDT Department Block / Slide
Research Chemical Flammable Waste Wash Dry
Administration
This document is subject to change and a printed copy may not be up to date.
Coordination Coordination Coordination Support Store Store Store Up Area Store Archive
Support Services
Notes Services and Design Considerations
Design Requirements for Anatomical Pathology Departments
1. Each site would need to consider service configuration (scope of service, activity and instrument specifications, future • Hydraulic
plans) to determine space requirements. For example: some sites perform IF and FISH within the department and • Electrical
manage the Mortuary, others don’t provide these services. • Data
2. Consideration could be given to the consolidation of some functions within each lab ie. centralised specimen
Approver: Executive Director Clinical Streams, Version Number: V1.0, Publication Date: 4/12/2019
reception for Tissue Pathology disciplines. • Air handling and extraction
3. Changing expectations for clinical engagement ie. MDTs occurring at Multiheaders will inform equipment
requirements.
External Relationships Internal Relationships Services and Design Considerations
• Operating Theatres, Endoscopy, Day Surgergy etc • Specimen Reception • Hydraulic • Structural Engineering (weight
• Radiology • Microbiology • Electrical of slides)
• Oncology • Immunology • Data
• Delivery Dock and Waste Disposal Storage/Pick Up area • Haematology • Air handling and extraction
Appendix A – Tissue Pathology Functional Components DiagramYou can also read
