design requirements for anatomical pathology departments

Design Requirements for Anatomical Pathology Departments Guideline

Guideline Design Requirements for Anatomical Pathology Departments

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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

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

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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.


https://healthfacilityguidelines.com.au/full-guidelines

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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



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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.



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b) Fresh Tissue and Frozen Section


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


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.



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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


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.



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e) Chemical Preparation and Decanting


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


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


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.


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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


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


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:



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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


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


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.



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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


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


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.



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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


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


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


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.


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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


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



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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


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


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.



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d) Electron Microscopy


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


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



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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



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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):



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


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


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


https://healthfacilityguidelines.com.au/full-guidelines





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: [email protected]

11. Version History

The approval and amendment history for this document must be listed in the following table.

Version No

Effective Date

Approved By

Approval Date

Policy Author Risk Rating Sections Modified

1.0 04/12/2019 Executive Director, Clinical Streams

26/09/2019 Anatomical Pathology Clinical Stream Lead

Medium New policy.



NSWHP_PG_019


Appendix A – Tissue Pathology Functional Components Diagram

Tiss

ue P

atho

logy

Fun

ctio

nal C

ompo

nent

s D

iagr

am

Labo

rato

ries

Cons

ulta

tion

, Rep

orti

ng a

nd M

anag

emen

t

Teac

hing

/ E

duca

tion

/ C

usto

mer

& C

linic

al E

ngag

emen

t St

aff A

men

itie

s

Clin

ical

Ope

rati

on Im

pera

tive

s La

bora

tory

Ope

rati

on Im

pera

tive

s

Not

es

Serv

ices

and

Des

ign

Cons

ider

atio

ns

1. E

ach

site

wou

ld n

eed

to c

onsi

der

serv

ice

conf

igur

atio

n (s

cope

of s

ervi

ce, a

ctiv

ity

and

inst

rum

ent s

peci

ficat

ions

, fut

ure

plan

s) t

o de

term

ine

spac

e re

quir

emen

ts. F

or e

xam

ple:

som

e si

tes

perf

orm

IF a

nd F

ISH

wit

hin

the

depa

rtm

ent

and

man

age

the

Mor

tuar

y, o

ther

s do

n’t

prov

ide

thes

e se

rvic

es.

2. C

onsi

dera

tion

cou

ld b

e gi

ven

to t

he c

onso

lidat

ion

of s

ome

func

tion

s w

ithi

n ea

ch la

b ie

. cen

tral

ised

spe

cim

en

rece

ptio

n fo

r Ti

ssue

Pat

holo

gy d

isci

plin

es.

3. C

hang

ing

expe

ctat

ions

for

clin

ical

eng

agem

ent

ie. M

DTs

occ

urri

ng a

t M

ulti

head

ers

will

info

rm e

quip

men

t re

quir

emen

ts.

• H

ydra

ulic

• El

ectr

ical

• D

ata

• A

ir h

andl

ing

and

extr

acti

on

Exte

rnal

Rel

atio

nshi

ps

Inte

rnal

Rel

atio

nshi

ps

Serv

ices

and

Des

ign

Cons

ider

atio

ns

• O

pera

ting

The

atre

s, E

ndos

copy

, Day

Sur

gerg

y et

c

• R

adio

logy

• O

ncol

ogy

• D

eliv

ery

Doc

k an

d W

aste

Dis

posa

l Sto

rage

/Pic

k U

p ar

ea

• Sp

ecim

en R

ecep

tion

• M

icro

biol

ogy

• Im

mun

olog

y •

Hae

mat

olog

y

• H

ydra

ulic

• El

ectr

ical

• D

ata

• A

ir h

andl

ing

and

extr

acti

on

• St

ruct

ural

Eng

inee

ring

(wei

ght

of s

lides

)

Regi

stra

rs R

epor

ting

Spa

ce

(Ope

n pl

an)

Path

olog

ists

Con

sult

atio

n

Off

ices

(Ind

ivid

ual)

Cy

tolo

gy S

cree

ning

&

Repo

rtin

g R

oom

(Ope

n pl

an)

Clin

ical

Dir

ecto

rs O

ffic

e

(Con

sult

atio

n &

Clin

ical

Serv

ice

Man

agem

ent)

Ana

tom

ical

Pat

holo

gy

Spec

imen

Rece

ipt

&

Book

ing

Are

a

Cut-

Up

/

FS /

Fre

sh

Spec

imen

Han

dlin

g

Tiss

ue

Proc

essi

ng

Room

Em

bedd

ing

Cyto

logy

Mic

roto

my

& R

e-cu

ts

H&

E

and

Spec

ial

Stai

ns

Are

a

Spec

.

Rece

ipt

&

Book

ing

Spec

.

Prep

&

Stor

age

area

Stai

n

& C

S

Are

a

Slid

e

dist

rib-

utio

n &

retu

rns

Slid

e

retu

rns

& fi

ling

Slid

e

mgt

.

&

labe

l

area

Imm

unoh

isto

chem

istr

y

Wet

Spec

imen

Stor

age

Are

a

Bulk

soln

stor

age

& p

rep

area

IHC

stai

ner

- ben

ch

or fl

oor

+/- C

S

Tiss

ue P

atho

logy

Man

ager

s

Off

ice

(Ope

rati

onal

Mgt

)

Labo

rato

ry S

uper

viso

r O

ffic

es

(AP,

Cyt

o, IH

C, E

M)

EM

Spec

.

Rece

ipt

&

Book

ing

Tear

oom

To

ilets

& S

how

er

Staf

f Mee

ting

Roo

m

Staf

f Loc

kers

Spec

.

proc

essi

ng/

mic

roto

my

/sta

inin

g

area

EM s

uite

&

peri

pher

als

FNA

C

Clin

ic

Slid

e

&

Bloc

k

filin

g

area

Ab

stor

age

& p

rep

area

(fri

dge)

Tran

scri

ptio

n an

d

Adm

inis

trat

ion

Supp

ort

Chem

ical

Stor

e

Blo

ck /

Slid

e

Arc

hive

D

ry

Stor

e Fl

amm

able

Stor

e

Ref

erra

ls

Coor

dina

tion

MD

T

Coor

dina

tion

R

esea

rch

Coor

dina

tion

Was

te

Stor

e

Dep

artm

ent

Supp

ort

Serv

ices

Was

h

Up

Are

a

Mul

tihe

ader

Mic

rosc

ope/

s

MD

T Sp

ace/

s w

ith

tele

conf

eren

ce

Libr

ary

Dig

ital

Sca

nnin

g (F

utur

e)


design requirements for anatomical pathology departments

Documents