Design Requirements for Anatomical Pathology Departments Guideline

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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 Library

Guideline 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 Library

Guideline 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 Library

Guideline 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 Library

Guideline 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 Library

Guideline 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 Library

Guideline 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 Library

Guideline 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 nongynaecological 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 onsite 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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Guideline 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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Guideline 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: [email protected] 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

Page 19 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

Appendix A – Tissue Pathology Functional Components Diagram

suite & & suite

peripherals

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