IUSS HEALTH FACILITY GUIDES

Transcription

1 IUSS HEALTH FACILITY GUIDES Central Sterile Service Department Gazetted 30 June 2014 Task Team: B:08 Supported by:

2 Document tracking Version Date Name Edited 13 th March 2014 Beverley van Reenen Technical review 20 th March 2014 Kevin Poggenpoel References updating 24 th March 2014 Tichaona Kumirai Proposal V2 Front pages updated 13 May 2014 Peta de Jager Proposal V2 Formatting 6 July 2014 Sheldon Bole Gazetted 30 June 2014 National Health Act,2003(Act no.61 of 2003) INFORMATION NOTES Form: Health facility guides Status: Gazetted, 30 June 2014 Title: Original Title: Description: Central Sterile Service Department Central Sterile Supply Unit Reference: CSIR 59C1119 B: Authors: IUSS N and S task team B:08 Stakeholders: National Department of Health, Provincial Departments of Health and Public Works

3 Accessing of these guides This publication is received by the National Department of Health (NDoH), IUSS Steering Committee Chairman, Dr Massoud Shaker and Acting Cluster Manager: Health Facilities and Infrastructure Management, Mr Ndinannyi Mphaphuli. Feedback is welcome. The CSIR and the NDoH retain the moral rights conferred upon them as author by section 20(1) of the Copyright Act, No. 98 of 1978, as amended. Use of text, figures or illustrations from this report in any future documentation, media reports, publications, competition entries and advertising or marketing material is solely at the discretion of the Health Infrastructure Norms Advisory Committee and should clearly reference the source. This publication may not be altered without the express permission of the Health Infrastructure Norms Advisory Committee. This document (or its updates) is available freely at or the forthcoming Department webportal. Application and development process These IUSS voluntary standard/ guidance documents have been prepared as national Guidelines, Norms and Standards by the National Department of Health for the benefit of all South Africans. They are for use by those involved in the procurement, design, management and commissioning of public healthcare infrastructure. It may also be useful information and reference to private sector healthcare providers. Use of the guidance in this documentation does not dissolve professional responsibilities of the implementing parties, and it remains incumbent on the relevant authorities and professionals to ensure that these are applied with due diligence, and where appropriate, deviations processes are exercised. The development process adopted by the IUSS team was to consolidate information from a range of sources including local and international literature, expert opinion, practice and expert group workshop/s into a first level discussion status document. This was then released for public comment through the project website, as well as national and provincial channels. Feedback and further development was consolidated into a second level development status document which again was released for comment and rigorous technical review. Further feedback was incorporated into proposal status documents and formally submitted to the National Department of Health. Once signed off, the documents have been gazetted, at which stage documents reach approved status. At all development stages documents may go through various drafts and will be assigned a version number and date. The National Department of Health will establish a Health Infrastructure Norms Advisory Committee, which will be responsible for the periodic review and formal update of documents and tools. Documents and tools should therefore always be retrieved from the website repository or Department webportal (forthcoming) to ensure that the latest version is being used. The guidelines are for public reference information and for application by Provincial Departments of Health in the planning and implementation of public sector health facilities. The approved guidelines will be applicable to the planning, design and implementation of all new public-sector building projects (including additions and alterations to existing facilities). Any deviations from the voluntary standards are to be motivated during the Infrastructure Delivery Management Systems (IDMS) gateway approval process. The guidelines should not be seen as necessitating the alteration and upgrading of any existing healthcare facilities. Acknowledgements This publication has been funded by the NDoH. Acknowledgements also to Beverley Van Reenen the editor, Sheldon Bole, Claire du Trevou, Kumirai Tichaona and Mokete Mokete All photographs supplied by Mrs Denise Sheard.

4 Co-authors: Denise Sheard MSc Nursing (UCT) DNEd (WITS) Sterile Services Training Specialist Western Cape CSSD Forum and CFSA National Chairperson AUTHOR: Deon Steyn M Arch MBA Pr Arch Pr CPM SCION ARCHITECTS and PROJECT MANAGEMENT

5 TABLE OF CONTENTS TABLE OF CONTENTS... 1 LIST OF FIGURES... 7 LIST OF DRAWINGS... 8 LIST OF PHOTOGRAPHS... 9 LIST OF TABLES PART A - GENERAL PLANNING CONSIDERATIONS STERILISATION DEPARTMENT IN A HOSPITAL LOCATION and FUNCTIONAL RELATIONSHIP Functional relationships to other departments Deliveries and transportation routes Access for plant and equipment maintenance PRIMARY FUNCTION OF A CSSD Support zone ACTIVITIES IN A CSSD Decontamination Inspection Packing Sterilisation Storage PART B - FUNCTIONAL REQUIREMENTS ACTIVITY ZONES IN A TYPICAL CSSD DECONTAMINATION ZONE INSPECTION AND PACKING ZONE (IAP ZONE) STERILE ZONE SUPPORT ZONE FUNCTIONAL RELATIONSHIP BETWEEN ACTIVITY SPACES WORKFLOW MATERIAL FLOW PERSONNEL FLOW AIR FLOW PART C - GENERAL DESIGN CONSIDERATIONS DESIGN FOR INFECTION CONTROL DESIGN FOR OCCUPATIONAL, HEALTH AND SAFETY

6 3. DESIGN FOR CHANGE AND TECHNOLOGY ERGONOMIC AND USER-COMFORT CONSIDERATIONS SOUND NATURAL LIGHT NATURAL VENTILATION COMMUNICATION PART D - CSSD AREA DETERMINATION DETERMINANTS OF SIZE AND LAYOUT Determining factors external to the CSSD Determining factors internal to the CSSD CSSD area determination PROPORTIONAL ALLOCATION OF SPACE IN A CSSD FACILITY TYPICAL FLOOR LAYOUTS PART E - INDIVIDUAL SPACE REQUIREMENTS CSSD LAYOUT UNPACKED RECEIVING AND SORTING Function Location and Relationship Activities Requirements Fixtures, fittings and equipment Services WASTE DISPOSAL Function Location and relationship Activities Requirements Fixtures, fittings and equipment SLUICE Function Location and relationship Activities Requirements Fixtures, fittings and equipment TROLLEY WASH AND STORAGE Function

7 5.2. Location and relationship Activities Requirements Fixtures, fittings and equipment Services DECONTAMINATION AREA Function Location and relationship Activities Requirements Fixtures, fittings and equipment Services RAW MATERIALS AND CHEMICALS STORE Function Location and relationship Activities Requirements Fixtures, fittings and equipment PPE AREA - GOWNING (TO CONTAMINATED AREA) Function Location and relationship Activities Requirements Fixtures, fittings and equipment INSPECTION AND PACKING AREA (IAP AREA) Function Location and relationship Activities Requirements Fixtures, fittings and equipment Services RAW MATERIALS STORE FOR IAP AREA Function Location and relationship Activities Requirements Fixtures, fittings and equipment

8 11. TEXTILE ROOM Function Location and relationship Activities Requirements Fixtures, fittings and equipment Building services PPE GOWNING AREA (TO CLEAN AREA) Function Location and relationship Activities Requirements Fixtures, fittings and equipment STERILISATION AREA Function Location and relationship Activities Requirements Fixtures, Fittings and Equipment COOLING AREA Description and function Location and relationship Activities Requirements Fixtures, fittings and equipment STERILE STORES Description and function Location and relationship Activities Requirements Fixtures, fittings and equipment DISPATCH DESK Function Location and relationship Activities Requirements Fixtures, fittings and equipment

9 17. OFFICE Function Location and relationship Activities Requirements Fixtures, fittings and equipment Services KITCHENETTE Function Location and relationship Activities Requirements Fixtures, fittings and equipment STAFF REST ROOM Function Location and relationship Activities Requirements Fixtures, fittings and equipment FEMALE CHANGE ROOMS Description and function Location and relationship Activities Requirements Fixtures, fittings and equipment MALE CHANGE ROOMS Function Location and relationship Activities Requirements Fixtures, fittings and equipment STERILISER PLANT ROOM Function Location and relationship Activities Requirements Fixtures, fittings and equipment

10 22.6. Services PART F - BUILDING AND SERVICES BUILDING COMPONENTS, MATERIALS AND FINISHES Floors Walls Ceilings Windows Doors Hatches Ducts FIXTURES, FITTINGS AND EQUIPMENT Sterile storage shelving Worktop furniture Hand-wash basins Ultrasonic cleaners Automated washers / Washer-disinfectors Sterilisers (autoclaves) ELECTRICAL Specialist electrical installations Electrical points Lighting MECHANICAL HVAC BUILDING SERVICES PLANT AND SERVICES PART G - DEFINITION OF TERMS REFERENCES ANNEXURE 1. CSSD FORUM STANDARD OPERATING PROCEDURE FOR STERILE SERVICE DEPARTMENTS ANNEXURE 2. SOUTH AFRICAN LEGISLATION AND GUIDELINES

11 LIST OF FIGURES Figure 1: Departmental relationships (IUSS:GNS Adult inpatient services) Figure 2: Decontamination life cycle Figure 3: Work flow through the primary zones Figure 4: The decontamination life cycle at a glance Figure 5: Dispatch points in the decontamination cycle Figure 6: Configuration of activity spaces Figure 7: Areas related to the decontamination zone Figure 8: Areas related to the inspection and packing zone Figure 9: Areas related to the clean zone Figure 10: Areas related to the support zone Figure 11: Functional relationship between activity spaces Figure 12: Work flow through the zones Figure 13: Material flow through the zones Figure 14: Personnel flow through the zones Figure 15: Air flow through the zones

12 LIST OF DRAWINGS Drawing 1: Typical floor layout (small - 250m² gross area) not to scale Drawing 2: Typical floor layout (medium - 400m² gross area) not to scale Drawing 3: Typical floor layout (large - 600m² gross area) not to scale Drawing 4: A generic layout to illustrate room layouts Drawing 5: Receiving and sorting Drawing 6: Waste disposal Drawing 7: Sluice area Drawing 8: Trolley wash and storage Drawing 9: Automated cleaning area Drawing 10: Raw materials and chemicals store Drawing 11: PPE gowning area Drawing 12: Inspection and packing area Drawing 13: Raw materials store for IAP area Drawing 14: Textile room Drawing 15: PPE gowning area (IAP area) Drawing 16: Sterilisation area Drawing 17: Cooling area Drawing 18: Sterile pack store Drawing 19: Dispatch desk Drawing 20: Office Drawing 21: Kitchenette Drawing 22: Staff rest room Drawing 23: Female change room Drawing 24: Male change room Drawing 25: Steriliser plant room Drawing 26: Generic layout indicating air pressure and air-flow direction

13 LIST OF PHOTOGRAPHS Photograph 1: Manual cleaning Photograph 2: Automated cleaning Photograph 3: Automated cleaning (Tygerberg Hospital) Photograph 4: Packing Photograph 5: Sterilisers (autoclaves) (Tygerberg Hospital) Photograph 6: Sterile storage (Tygerberg Hospital) Photograph 7: Trolley pass-through hatch (Tygerberg Hospital) Photograph 8: Soiled-linen trolleys Photograph 9: Infectious-waste and sharps-disposal containers Photograph 10: High-pressure water gun Photograph 11: Drip sink with hinged bucket grid Photograph 12: Double-bowl sink unit Photograph 13: Trolley pass-through hatch (Tygerberg Hospital) Photograph 14: Trolley cleaning (Tygerberg Hospital) Photograph 15: Washer/disinfectors (Tygerberg Hospital) Photograph 16: Washer/disinfector trays returned to decontamination area via pass-through hatch (Tygerberg Hospital) Photograph 17: Pass-through hatch between decontamination and IAP areas (Tygerberg Hospital) Photograph 18: Visual inspection of a device set following a cleaning process Photograph 19: Textile folding tables (Tygerberg Hospital) Photograph 20: Stainless steel worktop (Tygerberg Hospital) Photograph 21: Textile folding table Photograph 22: Autoclave trolley ready for loading (Tygerberg Hospital) Photograph 23: Various types of automated washers and washer-disinfectors

14 LIST OF TABLES Table 1 : IUSS:GNS Reference Documents Table 2: Ratio of hospital bed to CSSD area Table 3: Ratio of MSO bed to CSSD area Table 4: Comparative recommendations for estimating the size of a CSSD (Putsep and Cowan, 1983, p. 8) Table 5: Space allocation in a CSSD (Putsep and Cowan, 1983, p.9) Table 6: Proportional space allocation Generic Layout (600 m 2 Gross Area) Table 7: proportional space allocation - generic layout without staff facilities and CSSD departmental corridor (450 m2 gross area) Table 8: Summary of building requirements Table 9: Summary of lighting requirements Table 10: Summary of environmental requirements

15 Table 1 : IUSS:GNS Reference Documents CLINICAL SERVICES Adult Inpatient Services Clinical Diagnostic Laboratory Guidelines Mental Health Adult Critical care Emergency Centres Maternity Care Facilities Adult Oncology Facilities Outpatient Facilities Paediatrics and Neonatal Facilities Pharmacy Essential x Recommended Primary Health Care Facilities Diagnostic Radiology Adult Physical Rehabilitation Adult Postacute Services Facilities for x Surgical Procedures TB Services Colours Legend x SUPPORT SERVICES Administration and Related Services General Hospital Support Services Catering Services for Hospitals Laundry and Linen Department Hospital Mortuary Services Nursing Education Institutions Health Facility Residential Central Sterile Service Department Training and Resource Centre Waste Disposal Essential x x x x x Recommended HEALTHCARE ENVIRONMENT/ CROSSCUTTING ISSUES Generic Room Requirements Hospital Design Principles Building Engineering Services Environment and Sustainability Materials and Finishes Future Healthcare Environments Healthcare Technology Inclusive Environments Infection Prevention and Control Information Technology and Infrastructure Regulations Essential Recommended PROCUREMENTand OPERATION Essential x Integrated infrastructure planning x x Briefing Manual x x Space Guidelines x Recommended x Cost Guidelines x x Procurement x x Commissioning Health Facilities x Maintenance x x x x Decommissioning Capacity Development x x Consultants Administrators Related documents 11

16 PART A - GENERAL PLANNING CONSIDERATIONS 1. STERILISATION DEPARTMENT IN A HOSPITAL The sterilisation department in a hospital is known by many acronyms, e.g.: CSD CPD SSD TSSD TSSU CSSD Central Sterilisation Department Central Processing Area Sterile Service Department Theatre Sterile Service Department Theatre Sterile Service Unit Central Sterile Service Department (the most widely used term in the South African context) 2. LOCATION and FUNCTIONAL RELATIONSHIP 2.1. Functional relationships to other departments See Figure 1. The CSSD should be centrally located with ready access to all related service areas, such as the ICU, in-patient units and emergency unit. The department should also have direct access, either horizontally or vertically, to the operating theatres Deliveries and transportation routes Trolleys are used as mode of transport for both receivables and deliveries. In order to cater for the high volume of trolleys to and from the CSSD receiving and dispatch areas, the entry/exit points should ideally be separated to create a uni-directional traffic flow and also to avoid cross-contamination through the division of the clean and dirty material Access for plant and equipment maintenance Plant and equipment in service areas would need access from outside the CSSD, in order not to compromise the desired level of cleanliness in the unit. In some situations direct access between the plant area and the steriliser is required in order to allow access for maintenance staff to the equipment controls in the CSSD area side. 12

17 HOSPITAL SUPPORT SERVICES WARDS CLINICAL SUPPORT SERVICES REHABILITATION SERVICES RADIOLOGYY OBSTETRIC WARDS PHARMACY OUTPATIENT SERVICES Ambulance Maternity Entrance Helipad Visitors /staff PARKING Car drop off OUTPATIENTS MAIN ENTRANCE Public and Patient registration ADMISSION Emergency Unit Obstetrics Delivery THEATRES & CSSD ICU SURGICAL WARDS MEDICAL WARDS MENTAL HEALTH WARD ORTHOPAEDIC WARDS NEONATES TB/INFECTIOUS DISEASES WARD PAEDIATRIC WARDS HOSPITAL SUPPORT SERVICES SERVICE ENTRANCE FIGURE 1: DEPARTMENTAL RELATIONSHIPS (IUSS:GNS ADULT INPATIENT SERVICES) 3. PRIMARY FUNCTION OF A CSSD The primary function of a CSSD is to provide an efficient, economic, continuous and quality supply of sterilised items, when needed, to all patient-care service points in the hospital, and to receive returned contaminated items for cleaning. This process is generally referred to as the decontamination life cycle (see Figure 2). 13

18 FIGURE 2: DECONTAMINATION LIFE CYCLE Activities in a CSSD can functionally be sorted under the following primary zones: Dirty Decontamination Zone Clean IAP (Inspection and Packing Zone) Sterile Clean Zone In addition to the above primary zones, supporting activities are accommodated in the CSSD Support zone In order to identify the functional relationship between the various spaces, the convention is used throughout this guide to indicate the respective zones in the following colours: DIRTY : DECONTAMINATION ZONE CLEAN : IAP (INSPECTION and PACKING ZONE) STERILE : CLEAN ZONE SUPPORT ZONE In order to create a work space for maintaining a clean environment suitable for handling sterile articles, access to the red, blue and green zones is restricted and subjected to red-line principle. In addition to the above, the red area (decontamination zone) is divided with a hard barrier from the IAP area, in order to prevent contaminated particles from freely entering the relatively cleaner IAP area. This barrier could be a solid brick wall, or glass wall. Activities comprising the decontamination cycle should allow a progressive work-flow pattern that commences with a dirty entry and receiving area, proceeds to a cleaning, decontamination and drying area, into a sorting and packing area, through to sterilisation and cooling area, to finish with sterile storage, distribution and exit areas. 14

19 FIGURE 3: WORK FLOW THROUGH THE PRIMARY ZONES 4. ACTIVITIES IN A CSSD The main activities of the decontamination life cycle taking place in a CSSD can be listed as follows: receiving of soiled (and contaminated) returns cleaning of trolleys sorting returned trays sorting, disassembling, cleaning and drying of all returned medical devices checking functionality and cleanliness of cleaned medical devices assembling, packing and wrapping of trays sterilisation cooling of sterile packs storage of sterilised items dispatching of orders quality control maintenance record keeping receiving new supplies. These activities can be classified under the following functional areas: 4.1. Decontamination Decontamination involves the use of automated and manual cleaning to remove harmful blood-borne pathogens on the surfaces of equipment and instruments. Soiled items for re-use (medical devices, textiles and equipment) are received in the sterilising department after use in the various clinical departments. These could be operating theatres, emergency department and various wards. Medical devices, equipment and other contaminated articles will be sorted, disassembled, pre-rinsed and cleaned in the decontamination/dirty area. Used linen is put into linen bags and sent to the laundry. Waste items are sorted into suitable containers, according to policy, for appropriate disposal methods. If items are heavily soiled a manual washing procedure will precede the automated cleaning process by washer-disinfectors. For manual cleaning, a double- (two-) sink arrangement is optimal, one for cleaning and one for rinsing. Automated washers or washer-disinfectors can be provided as single or double-door designs (the latter to allow for physical separation of the dirty and clean areas of the decontamination area). 15

20 PHOTOGRAPH 1: MANUAL CLEANING PHOTOGRAPH 2: AUTOMATED CLEANING 4.2. Inspection Decontaminated medical devices and equipment are visually inspected for functionality, damage and cleanliness according to required standards, the manufacturer s instructions and written protocols. PHOTOGRAPH 3: AUTOMATED CLEANING (TYGERBERG HOSPITAL) 4.3. Packing Decontaminated instruments, equipment and other articles are sorted, assembled, counted and packed prior to sterilizing. 16

21 PHOTOGRAPH 4: PACKING 4.4. Sterilisation Sterilisation is a defined process used to render a surface or product free from viable organisms, including bacterial spores. Depending on the product this procedure could vary from steam sterilisation, dry heat sterilisation, to low temperature sterilising processes. PHOTOGRAPH 5: STERILISERS (AUTOCLAVES) (TYGERBERG HOSPITAL) 4.5. Storage Sterile items are stored in a clean controlled environment to prevent re-contamination before use. 17

22 PHOTOGRAPH 6: STERILE STORAGE (TYGERBERG HOSPITAL) 18

23 FIGURE 4: THE DECONTAMINATION LIFE CYCLE AT A GLANCE 19

24 PART B - FUNCTIONAL REQUIREMENTS 1. ACTIVITY ZONES IN A TYPICAL CSSD FIGURE 5: DISPATCH POINTS IN THE DECONTAMINATION CYCLE Figure 5 above is a variation of the generic decontamination life cycle, indicating the various dispatch points in the cycle. Based on this principle, the activity spaces in a CSSD could be organised as per figure 6 FIGURE 6: CONFIGURATION OF ACTIVITY SPACES 20

25 2. DECONTAMINATION ZONE Receiving and sorting Waste disposal Cleaner/sluice Trolley wash Manual cleaning Automated cleaning Raw materials and chemicals storage PPE area (gowning). FIGURE 7: AREAS RELATED TO THE DECONTAMINATION ZONE 3. INSPECTION AND PACKING ZONE (IAP ZONE) Inspection and packing (IAP) Sterile pack Textile folding Raw materials storage PPE area (gowning). FIGURE 8: AREAS RELATED TO THE INSPECTION AND PACKING ZONE 21

26 4. STERILE ZONE Sterilisation Cooling Sterile pack storage Dispatch. FIGURE 9: AREAS RELATED TO THE CLEAN ZONE 22

27 5. SUPPORT ZONE Office Staff rest room Kitchenette Female change room Male change room Manager s office Steriliser plant room. FIGURE 10: AREAS RELATED TO THE SUPPORT ZONE 6. FUNCTIONAL RELATIONSHIP BETWEEN ACTIVITY SPACES FIGURE 11: FUNCTIONAL RELATIONSHIP BETWEEN ACTIVITY SPACES 23

28 7. WORKFLOW Design solutions should follow work-flow principles, separating dirty and clean areas. The workspaces in the decontamination and clean areas should be designed as open-plan work areas subdivided by benches and/or equipment into functional work areas. These work areas should be arranged to allow for a progressive work flow that commences with a dirty entry and receiving area, proceeding to a cleaning, decontamination and drying area, into a sorting and packing area, through to a sterilisation- and cooling area, with sterile storage, distribution and exit areas completing the process. It is critical to the functional efficiency and safety of the CSSD that these spaces are sequentially linked for one-way flow-through of instrumentation. The separation between the dirty area, where soiled goods are collected, and the clean area where washed and disinfected instruments are inspected, sorted and packed, is realised by a high throughput pass-through washer disinfector barrier. Treated instruments are unloaded and managed directly in the clean packing area by different staff. 24

29 FIGURE 12: WORK FLOW THROUGH THE ZONES 25

30 8. MATERIAL FLOW FIGURE 13: MATERIAL FLOW THROUGH THE ZONES 26

31 9. PERSONNEL FLOW FIGURE 14: PERSONNEL FLOW THROUGH THE ZONES 10. AIR FLOW FIGURE 15: AIR FLOW THROUGH THE ZONES 27

32 PART C - GENERAL DESIGN CONSIDERATIONS 1. DESIGN FOR INFECTION CONTROL The design of a CSSD plays an essential role in addressing infection control issues to minimise the risk of infection transmission. Planning and design features to support infection control should include the following: Restricted/controlled access Unidirectional work flow, progressing from dirty to clean to sterile areas Controlled air flow with positive air pressure from clean to dirty areas Containment of steam and moisture, preventing potential contamination of stored sterile articles. Building and layout details that would facilitate easy cleaning Selection of suitable building materials and finishes Selection of fixtures, fittings and equipment with suitable detail, materials and finishes for easy cleaning, and prevention of build-up of harmful organisms Adequate facilities for cleaning and waste management Access to the area should be limited and controlled. This should prevent any unauthorised person from entering the area without permission Staff/visitors should have access to hand-washing facilities, separate from those used for cleaning devices, before entering or leaving the areas. The flow of both staff and equipment must allow no cross-over of soiled and clean materials The operating procedure for infection control in a CSSD falls outside the scope of this guideline. 2. DESIGN FOR OCCUPATIONAL, HEALTH AND SAFETY Planning and design features to support occupational health and safety include the following: Selection of floor finishes with a non-slip finish Selection of fixtures, fittings and equipment with suitable detail, materials and finishes to prevent personal injury through accidents or misuse Provision of suitable and adequate facilities to support and encourage a high level of personal hygiene, with special reference to hand hygiene Provision of adequate dispensing points for the appropriate personal protection items (PPE) for the specific area to enable strict enforcement of PPE requirements in the protection of healthcare workers, especially as preventive measures against HIV aids Top-loading, worktop equipment should be accessible to staff members of all heights Ill-considered dimensions and layouts of fixtures and fittings could have a significant negative effect on occupational health and safety of staff. As the requirements of the Occupational Health and Safety Act will apply, this section needs to be read in conjunction with the OHS-related guidelines. 28

33 3. DESIGN FOR CHANGE AND TECHNOLOGY Although it is difficult to predict future trends in CSSD technology, it is advisable to allow some flexibility and adaptability in space requirements, electrical consumption and layout, and also in air-handling capacity. Current trends that need to be considered are the following: The increasing complexity of surgical procedures requires more intricate equipment and instruments that need specialised care and handling during the sterilisation procedure Integrated computerised tracking facilities have become widely used and have become an essential tool in the validation of the sterilisation process Changing staff-flow patterns due to changing work-flow patterns as a result of procedural and/or equipment innovations Design towards sustainable architecture, i.e. water-saving equipment, and equipment with reduced toxic emissions. Constant improvements and innovations lead to products that run more economically and reach a higher level of environment compatibility The facility should be able to reasonably accommodate access and positioning of possible outsize equipment. Consideration for this possibility should be given from (and including) point of delivery to point of positioning It is advisable to allow capacity for extra machinery in the event of increased production demand. 4. ERGONOMIC AND USER-COMFORT CONSIDERATIONS Sterile services departments should be designed to protect staff from avoidable risks of injury. Badly designed elements such as height, depth and design of workstations and counters, shelving and the layout have an impact on the occupational health and safety of staff. Workspaces should therefore be sufficiently flexible and adaptable to accommodate adequate working space for individual comfort, and to reduce any unnecessary physical stress or risk of injury to the body from any repetitive and/or periodic actions such as lifting, pulling, pushing, etc. Ergonomics considers the understanding of human-equipment interaction and design to minimise safety risks and achieve the optimum use of equipment. When particular high risks are identified, these should be minimised when designing the facility while providing good lighting (preferably natural light), adequate ventilation, plenty of space, and comfortable humidity/temperature conditions. Workbenches and chairs must be height-adjustable, allowing staff to adopt the correct posture when sitting or standing. Enough space must be available to allow for organisation of the workspace. All materials, for example those in the packing area, should be located within easy reach of the workbench (packaging materials, indicators, etc.). A similar concept should apply to device-sorting or manual-cleaning areas. There should be adequate space to manoeuvre, queue, and unload trolleys or other means of transportation. This will allow not only for good ergonomics but also for efficient work practices. The provision of a pleasant interior environment can contribute to staff morale. Temperature and humidity control (air-conditioning), in particular in areas where heat-associated equipment (such as steam sterilisers and thermal washer-disinfectors) is used, is preferred. Provision must be made for adequate heat extraction systems from heat generating equipment such as autoclaves and instrument washers. This should be done as close to the source as possible i.e. above autoclave doors and instrument washers. This heat source can be utilized to pre-heat water going to the boilers. Consideration should also be given to ensure there is adequate lighting (preferably natural) and noise control. For larger facilities, provision may need to be made for managers offices, general staff areas (for eating and drinking) and storage areas that are separated from the decontamination area. Good interior design also contributes to staff morale. The aim should therefore be to create an attractive and cheerful environment throughout the department. 29

34 5. SOUND Noise must be controlled A threshold of 60dBA (decibel) must not be exceeded The walls and ceilings should be made of absorbent materials so that they do not reflect sound Insulation of sterilisers and washer-disinfectors in technical walls will reduce the noise level Offices should allow confidential discussions to take place in privacy, away from noisy mechanical or high-volume human areas. 6. NATURAL LIGHT Natural lighting is highly desirable, especially in the work areas, and should be used wherever possible, especially in areas such as the cleaning and packing areas. However, direct sunlight on work spaces should be avoided. 7. NATURAL VENTILATION Natural ventilation through opening-section windows should be limited to offices and staff rooms. However, this is not recommended as it could promote contamination of the internal space by outside sources. Mechanical ventilation should be provided through the remainder of the CSSD, with good primary and secondary filters which must be monitored with differential manometers linked to an alarm system. 8. COMMUNICATION Provision must be made for communication systems to minimise the passage of staff to and from the clean zone. Glass partitions, communication panels, IT and video links for data transfer, intercom and telephones can serve as appropriate means of communication. Glass partitions should be used to permit observance of the activities within the clean zone (from the outside) without having to enter it. The glass panels must be of a non-opening design and must be waterproof and flush-mounted. 30

35 PART D - CSSD AREA DETERMINATION 1. DETERMINANTS OF SIZE AND LAYOUT The size of a CSSD in a hospital is unique to that hospital, as the size, layout and function of a CSSD are defined in the Operational Policy Statement that guides the operational management of the hospital. The operational policies specific to the CSSD precede sketch design stage. These policies are developed by the project team in consultation with health; service stakeholders, who should have the knowledge and experience to analyse the various processes in and related to the CSSD. These operational policies define the What, How, When, Where, Who and With What of any activity and/or process and are major space determinants which could significantly affect the planning and design of the CSSD, as they can have an impact on the size, configuration and the nature of accommodation. Operational policies will vary from unit to unit depending on a wide range of factors, both external and internal to the CSSD Determining factors external to the CSSD Examples of these space determinants could include the following: number of theatres/case mix surgical procedures extent of storage in the theatres and wards distribution system that will be used (vertical, horizontal, trolleys, lifts) amount of space needed for waste management processing needs for re-usable textiles (receiving, transporting, collecting, storing) staff facilities to be shared with adjacent departments. See annexure A for a generic set of Standard Operating Policies (SOP) for a typical sterile service department Determining factors internal to the CSSD Examples of these space determinants could include the following: types of processing equipment to be used (washer, washer-disinfectors, single- or multi-chamber washers, ultrasonic cleaners, endoscope processors) types of packaging to be used (disposable wraps and pouches, re-usable wraps, rigid containers technology to be used for sterilisation (high temperature or low temperature sterilisation, other chemical sterilants, steam) anticipated inventory storage anticipated volume of consumable supplies type of documentation and record-keeping system to be used (manual vs computerised) instrument inventory equipment inventory projected workload staffing structure number of offices staffing policy - number of staff to be accommodated types of cleaning equipment selected such as multi chamber or single chamber number of sterilisers and whether front or double sided loading emergency sterilisation requirements. 31

36 1.3. CSSD area determination Hoët (1989 cited in AFS Working Group, 2008b, p.281) has estimated the following ratios as a broadbased calculation of CSSD space: 0.7 m²/bed from 0 to 300 beds 0.6 m²/bed from 300 to 600 beds 0.5 m²/bed for more than 600 beds. Based on these ratios, the following table can be compiled: TABLE 2: RATIO OF HOSPITAL BED TO CSSD AREA BED SIZE CALCULATION SURFACE AREA 200 BEDS 0.7 m² /bed 210 m² 400 BEDS 0.6 m² /bed 240 m² 600 BEDS 0.5 m² /bed 300 m² 800 BEDS 0.5 m² /bed 400 m² 1000 BEDS 0.5 m² /bed 500 m² 1200 BEDS 0.5 m² /bed 600 m² AFS Working Group (2008b, p.291) states that the CSSD has few internal corridors, the commonly used net to department functional factor adopted is The 1.30 factor anticipates that the internal circulation must be added to connect functional areas and individual rooms. This minimal surface area required can be estimated as being 200m² useful and 260m² net floor areas. Based on the above assumption, AFS Working Group (2008b, p.291) calculates the useful surface area using the MSO ratio based on the number of beds used for Medical Surgery Obstetrics (MSO), using the following calculation basis: TABLE 3: RATIO OF MSO BED TO CSSD AREA MSO NR OF BEDS USEFUL SURFACE AREA/BED USEFUL SURFACE AREA NET SURFACE AREA < 200 BEDS m² 260 m² BEDS 1,5 m² /bed m² m² BEDS 1,2 m² /bed m² m² BEDS 1,0 m² /bed 450 m² 600 m² Studies done by Putsep and Cowan (1983, p.8) produced the following ratios depending on the active nature of the bed. 32

37 TABLE 4: COMPARATIVE RECOMMENDATIONS FOR ESTIMATING THE SIZE OF A CSSD (PUTSEP AND COWAN, 1983, P. 8) NR OF SCANDINAVIA BELGIUM NETHERLANDS RSA 1 BEDS m² PER BED 200 BEDS 1,1 m² /bed 0,6-1 m² /bed 0,7 m² /bed 1,0 m² /bed BEDS 1,1 m² /bed 0,6-1 m² /bed 0,6 m² /bed 1,0 m² /bed 500 BEDS 1,1 m² /bed 0,6-1 m² /bed 0,5 m² /bed 1,0 m² /bed 750 BEDS 1,1 m² /bed 0,6-1 m² /bed 0,4 m² /bed 1,0 m² /bed Based on the above data, the areas are as follows: NR OF SCANDINAVIA BELGIUM NETHERLANDS RSA 3 BEDS TOTAL AREA 200 BEDS 220 m² 160 m²* m² 200 m² 350 BEDS 385 m² 280 m² * 210 m² 350 m² 500 BEDS 550 m² 400 m² * 250 m² 500 m² 750 BEDS 825 m² 600 m² * 300 m² 750 m² As the schedules of accommodation on which the above analyses are based have not been included in the study, the equitability of the comparisons is in doubt. It is however; clear that the size of a CSSD cannot be generically determined on the basis of statistics or averages. Every CSSD has its own set of area determinants that need to be logically evaluated in order to arrive at an area that is the optimal combination of functionality and cost effectiveness. 1 The South African recommendation shown in the table above is that of a Norms Working Panel that was appointed in 1982 to make proposals regarding the revision and updating of the official norms as contained in the National Plan and Norms for Health Service Facilities. According to the official norms the size of the CSSD depends upon the volume of packs to be sterilised per week. 2 With a minimum size of department of 120m² gross. 3 The South African recommendation shown in the table above is that of a Norms Working Panel that was appointed in 1982 to make proposals regarding the revision and updating of the official norms as contained in the National Plan and Norms for Health Service Facilities. According to the official norms the size of the CSSD depends upon the volume of packs to be sterilised per week. 4 0,8 m² used as an average 33

38 2. PROPORTIONAL ALLOCATION OF SPACE IN A CSSD FACILITY TABLE 5: SPACE ALLOCATION IN A CSSD (PUTSEP AND COWAN, 1983, P.9) AREA NUFFIELD PROVINCIAL HOSPITALS TRUST ESTIMATED AVERAGE SWEDISH PRACTICE NORWEGIAN RECOMMENDATIONS (1978) HOET (1981) (1963) RECEIVING WASHING DECONTAMINATION CLEAN AREA STERILISATION AREA STERILE SUPPLY STORE DISPATCH BULK STORE STAFF AREA OFFICE HOUSEKEEPING AFS Working Group (2008b, p.291) states that the areas within the CSSD can be sub-divided as follows: Receiving: 10% of the surface area Decontamination: 25% of the surface area DIRTY 35% IAP: 35% of the surface area CLEAN 35% Sterile Storage: 20% of the surface area STERILE 20% Annexes: 10% of the surface area SUPPORT 10% If the generic plan used as basis for this study (LAYOUT 2.1) is subjected to an area analysis, the following table can be compiled (TABLE 4.5) for an autonomous (support services not shared) CSSD of 600m². If 34

39 staff facilities and corridors are shared with another department (e.g. theatre department), the CSSD s size reduces to 450m² as per TABLE 4.6, illustrating the difficulty in achieving universally applicable areas, and the effect of hospital-specific policies. It is significant that the percentage of total areas of TABLE 4.6 compares favourably with the AFS Working Group s recommendations. TABLE 6: PROPORTIONAL SPACE ALLOCATION GENERIC LAYOUT (600 M 2 GROSS AREA) DIRTY CLEAN STERILE SUPPORT Area (m²) Area (m²) Area (m²) Area (m²) WASTE DISPOSAL 12 SLUICE 12 RECEIVING & SORTING 25 TROLLEY WASH 5 TROLLEY HOLDING 5 STORE 12 PPE TO DECON AREA 8 DECONTAMINATION AREA 100 PPE TO IAP AREA 8 STORE 12 TEXTILE AREA 16 INSPECTION & PACKING 100 STERILIZATION 30 DISPATCH 15 STERILE STORE 40 COOLING 30 STERILIZER PLANT ROOM 18 OFFICE 12 KITCHENETTE 12 STAFF REST ROOM 35 FEMALE CHANGE 30 MALE CHANGE 15 CSSD CORRIDOR 48 TOTAL AREA (SQ M) % OF TOTAL AREA 30% 28% 14% 28% 35

40 TABLE 7: PROPORTIONAL SPACE ALLOCATION - GENERIC LAYOUT WITHOUT STAFF FACILITIES AND CSSD DEPARTMENTAL CORRIDOR (450 M2 GROSS AREA) DIRTY CLEAN STERILE SUPPORT Area (m²) Area (m²) Area (m²) Area (m²) WASTE DISPOSAL 12 SLUICE 12 RECEIVING & SORTING 25 TROLLEY WASH 5 TROLLEY HOLDING 5 STORE 12 PPE TO DECON AREA 8 DECONTAMINATION AREA 100 PPE TO IAP AREA 8 STORE 12 TEXTILE AREA 16 INSPECTION & PACKING 100 STERILIZATION 30 DISPATCH 15 STERILE STORE 40 COOLING 30 STERILIZER PLANT ROOM 18 OFFICE 12 TOTAL AREA (SQ M) % OF TOTAL AREA 39% 36% 18% 7% 3. TYPICAL FLOOR LAYOUTS The following generic plans are included to illustrate the combined effect of gross floor area allocation, proportional space allocation, and work-flow requirements. DRAWING 1: TYPICAL FLOOR LAYOUT (SMALL - 250M² GROSS AREA) NOT TO SCALE PROPORTIONAL NET SPACE ALLOCATION DIRTY 37% CLEAN 36% STERILE 21% SUPPORT 6% 36

41 DRAWING 2: TYPICAL FLOOR LAYOUT (MEDIUM - 400M² GROSS AREA) NOT TO SCALE PROPORTIONAL NET SPACE ALLOCATION DIRTY 38% CLEAN 33% STERILE 22% SUPPORT 7% DRAWING 3: TYPICAL FLOOR LAYOUT (LARGE - 600M² GROSS AREA) NOT TO SCALE PROPORTIONAL NET SPACE ALLOCATION DIRTY 30% CLEAN 28% STERILE 14% SUPPORT 28% 37

42 PART E - INDIVIDUAL SPACE REQUIREMENTS 1. CSSD LAYOUT UNPACKED Due to the uni-directional sequential nature of the work flow in the CSSD, activities are interrelated and inter-dependent. It is, therefore, critical to the functional efficiency and safety of the CSSD that those areas are sequentially linked for uni-directional flow-through of instrumentation, with no room for back tracking. The above work flow and interrelationship between the adjacent areas dictates the characteristics of each space. In order to discuss each area individually, it is necessary to have a base plan as a reference point. The typical floor layout based on a 600m 2 unit will be used for this purpose. DRAWING 4: A GENERIC LAYOUT TO ILLUSTRATE ROOM LAYOUTS 2. RECEIVING AND SORTING 2.1. Function This is the area where all soiled articles for reprocessing are received on trolleys from the main corridor from user departments throughout the hospital Location and Relationship Close to main entry doors to the CSSD unit Visual access to main entry. 38

43 DRAWING 5: RECEIVING AND SORTING 2.3. Activities Access for deliveries of supplies, return of contaminated goods and the collection of waste and contaminated linen Contaminated articles are received at a counter with a trolley hatch, where the articles are logged, sorted and forwarded to the decontamination area Contaminated linen is put into linen bags and stored in the waste-disposal store for transport to the laundry Supplies are received in the supplies store where they are opened and packaging is discarded in the waste-disposal store Trolleys are sent to the trolley wash bay Requirements Visual access to entrance doors All entrances should be secure and controlled by means of communication to prevent access by unauthorised people A glass partition with lockable sliding hatch between this area and the corridor A lockable hatch for trolleys The red-line principle is applicable at the receiving area; only material and trolleys are to enter the CSSD via this entrance Worktop for unpacking and sorting Hand-washing facilities. 39

44 2.5. Fixtures, fittings and equipment Receiving counter with pass-through hatch and trolley hatch, acting as red line Sorting work tables standing height Clinical hand-wash basin, complete with liquid soap dispenser and paper-towel dispenser Space should be allowed for record-keeping and record-keeping supplies. PHOTOGRAPH 7: TROLLEY PASS-THROUGH HATCH (TYGERBERG HOSPITAL) 2.6. Services 2 x telephones 2 x data points CSSD technician call system Power outlets for computer points, computer, fax and printer Access control to outside door. 40

45 3. WASTE DISPOSAL 3.1. Function Contaminated waste articles are stored for collection and transport to the respective disposal areas Location and relationship Attached to the receiving area. DRAWING 6: WASTE DISPOSAL 3.3. Activities The sluice area and waste-disposal area could be combined in smaller units Contaminated waste articles are temporarily stored for collection and transport to the respective disposal areas Contaminated linen is temporarily stored in canvas bags for collection and transport to the laundry Third-party collection area (depot). Categories of waste stored in the waste-disposal area could include: Health-care waste, infectious waste, sharps General office waste Packaging and cartons from bulk supplies stored in the unit Linen bags used to collect reusable items Sharps from theatres. 41

46 3.4. Requirements An independent secure area for temporary storage of clinical waste awaiting collection in accordance with local waste management policy The door to the receiving/sorting area side should be lockable from the CSSD side to prevent unauthorised entry Room layout should allow for easy recycling/re-use/disposal policy Space for linen bags and waste containers An impermeable, hard-wearing floor with good drainage; it should be easy to clean and to disinfect, with an accessible water supply for cleaning purposes The area should be protected from outside elements, inaccessible to animals, insects or birds and not situated in close proximity to fresh food stores, food preparation areas or patient waiting areas It should be sized according to the volume of waste generated by the facility as well as the frequency of collection. A bumper rail to protect the wall behind the trolleys Containers according to waste policy. PHOTOGRAPH 8: SOILED-LINEN TROLLEYS PHOTOGRAPH 9: INFECTIOUS-WASTE AND SHARPS-DISPOSAL CONTAINERS 3.5. Fixtures, fittings and equipment Clinical hand-wash basin, complete with liquid-soap dispenser and paper-towel dispenser. 42

47 4. SLUICE 4.1. Function Heavily soiled items are rinsed and waste items are discarded in suitable containers Location and relationship DRAWING 7: SLUICE AREA 4.3. Activities Cleaning of heavily soiled items Storing and cleaning of domestic cleaning equipment and holders (buckets, etc.) Requirements Some lumens may require irrigating with a high pressure water-jet spray gun Heavily soiled instruments should be pre-rinsed using a submerged high-pressure water gun in a sluice area Fixtures, fittings and equipment Above-sink storage facilities for cleaning material and equipment Sluice unit Bucket sink Mop/broom rail. 43

48 PHOTOGRAPH 10: HIGH-PRESSURE WATER GUN PHOTOGRAPH 11: DRIP SINK WITH HINGED BUCKET GRID PHOTOGRAPH 12: DOUBLE-BOWL SINK UNIT 44

49 5. TROLLEY WASH AND STORAGE 5.1. Function Area for washing, disinfecting and storing of trolleys Location and relationship DRAWING 8: TROLLEY WASH AND STORAGE 5.3. Activities This area receives returned contaminated trolleys from the decontamination area Trolleys are washed and cleaned before being moved through a trolley hatch to the holding bay Washed trolleys are temporarily stored in the holding bay until required Requirements Trolleys must be transferred via a trolley hatch to prevent entry The floor in the washing bay needs to have a gradient and floor drain, as well as hosing facilities Trolley-washing facilities with adequate drainage. 45

50 5.5. Fixtures, fittings and equipment Trolley pass-through hatch Stainless steel sink Water hose with hand-spray. PHOTOGRAPH 13: TROLLEY PASS-THROUGH HATCH (TYGERBERG HOSPITAL) PHOTOGRAPH 14: TROLLEY CLEANING (TYGERBERG HOSPITAL) 5.6. Services Cold water for water hose Floor drain in vicinity of wash stations and equipment loading/unloading areas. 6. DECONTAMINATION AREA 6.1. Function This area is used to sort instruments followed by manual or automated cleaning. Soiled instruments are placed in a pass through washer disinfector that will deliver clean instrumentation to the IAP Area. Selected items may be manually cleaned, because they are either too delicate or will not fit into the washer disinfector, then forwarded to the clean area via a pass-through hatch. 46

51 6.2. Location and relationship DRAWING 9: AUTOMATED CLEANING AREA 6.3. Activities Selective manual cleaning of instruments and equipment not suitable for automated cleaning. Disassembly and inspecting of contaminated returns Rinsing of instruments and equipment Sorting and loading of medical instruments and equipment into trays/washer-disinfectors and other automated cleaning equipment Requirements Sufficient wall-mounted brackets for cleaning chemicals and brushes Sealed closed windows to the outside would be desirable Space to park trolleys is essential Automated double-sided washer-disinfectors and ultrasonic cleaners are required for cleaning and drying of all suitable instruments and equipment. A minimum of two washing units should be provided to allow for maintenance and down-time Transfer hatch with sliding opening section (upwards or sideways) for the transfer of handwashed items and return of emptied disinfector trays 47

52 The decontamination area has to be divided with a hard barrier from the IAP area, in order to prevent contaminated particles from freely entering the relatively cleaner IAP area. This barrier could be a solid brick wall or washer-disinfectors with panelling. A glass partitioning will contribute to an open-plan environment Adequate space should be allowed for trolleys to be manoeuvred without interfering with the work stations The distance between tables should be about 1.5m and between a table and the wall not less than 1,2m Fixtures, fittings and equipment Stainless steel standing-height sorting tables with high-level shelves Ultrasonic cleaner, according to service requirements Washer-disinfectors with a drying cycle for instruments and tubing, according to service requirements De-ionised, distilled, or reverse osmosis (RO) water for final rinsing is preferable Drying rack - work space must be available for drying manually cleaned instruments Double-bowl stainless steel pot-wash type sink with draining boards on both sides Tubing manifolds (air and water) and additional water outlets for water pistols A 1000mm-long flexible hose with a tapered-nozzle water pistol for cleaning narrow-bore tubes should be fitted over the space between the bowls All taps to sinks should have threaded nozzles to allow for the fitting of a variety of cleaning gadgets Compressed-air outlets and pressure guns are required at all cleaning sinks Clinical hand-wash basin, complete with liquid-soap dispenser and paper-towel dispenser Wall-mounted cartridge soap dispenser Eye wash and first aid area Automated washer disinfectors with a choice of racks for respiratory equipment washer, bowls, basins, containers, etc. Transfer trolleys Waste container for non-regulated waste and sharps One height-adjustable chair per table A silent clock Storage shelving. PHOTOGRAPH 15: WASHER/DISINFECTORS (TYGERBERG HOSPITAL) 48

53 PHOTOGRAPH 16: WASHER/DISINFECTOR TRAYS RETURNED TO DECONTAMINATION AREA VIA PASS-THROUGH HATCH (TYGERBERG HOSPITAL) PHOTOGRAPH 17: PASS-THROUGH HATCH BETWEEN DECONTAMINATION AND IAP AREAS (TYGERBERG HOSPITAL) 6.6. Services Services to automated disinfectors as per manufacturers specifications Floor drains Trap for equipment drainage. 7. RAW MATERIALS AND CHEMICALS STORE 7.1. Function Storage of consumables, raw goods and materials, and chemicals used in the decontaminated area. 49

54 7.2. Location and relationship DRAWING 10: RAW MATERIALS AND CHEMICALS STORE 7.3. Activities Receiving and storing of raw materials and consumables Distribution of goods to process areas Facilitating the disposal of transport packaging Storage of consumables, raw goods and materials, and chemicals used in the decontaminated area Requirements Lockable transfer hatch on top of a worktop between this area and the department corridor Suitable slatted shelving for the range of consumables and chemicals that are stored in this room Space for receipt, quarantine, inspection and acceptance of materials The store should be lockable Fixtures, fittings and equipment Slatted shelving Transfer hatch. 50

55 8. PPE AREA - GOWNING (TO CONTAMINATED AREA) 8.1. Function The PPE (personal protective equipment - gowning) room provides the only access to and from the decontamination area for staff, after putting on the appropriate PPE over garments and footwear Location and relationship The PPE room is the only human entry/exit point between the decontamination area and the CSSD departmental corridor. DRAWING 11: PPE GOWNING AREA 8.3. Activities The PPE gowning room provides the only access to and from the decontamination area for staff. Facilities are provided for the storage and dispensing of personal protective equipment (PPE) over garments and footwear suitable for the decontamination-room activities It provides facilities for hand-washing before/after activities in the decontamination area The PPE area serves as transfer point into/out of the red-line area. 51

56 8.4. Requirements PPE dispensers. Red-line demarcation barrier, with step-over wall There should be vision panels in doors and walls Fixtures, fittings and equipment Shelving for PPE dispensers Footwear and over-garment storage Waste containers either foot-operated or wall-mounted Clinical hand-wash basin complete with liquid-soap dispenser, paper \-towel dispenser, and mirror. 9. INSPECTION AND PACKING AREA (IAP AREA) 9.1. Function Decontaminated instruments, equipment and other articles are inspected and packed here Location and relationship The IAP area must be divided by a hard barrier from the decontamination area, in order to prevent crosscontamination. This barrier could be a solid brick wall or built in washer-disinfector with panelling, but a glass wall will contribute to an open-plan environment. DRAWING 12: INSPECTION AND PACKING AREA 52

57 9.3. Activities Inspecting, functionality testing, assembling and packing cleaned and disinfected medical devices and accessories, according to predetermined required standards, in preparation for sterilisation Packs are checked, reassembled, double-wrapped, labelled, dated, and signed on the checklist by the packer Delivering items to the steriliser loading area Returning racks to the decontamination area Requirements Sufficient wall-mounted brackets for equipment Sealed closed windows to the outside would be desirable Space to park trolleys is essential Automated double-sided washer-disinfectors and ultrasonic cleaners are required Transfer hatch with sliding opening section (upwards or sideways) for the transfer of manually cleaned items, and return of empty washer racks The IAP area must be divided by a hard barrier from the decontamination area, in order to prevent cross-contamination Adequate space should be allowed for trolleys to manoeuvre without interfering with the work stations The distance between tables should be about 1.5m, and that between a table and the wall not less than 1.2m Packing tables require power and ICT connections for use with computers and instrument scanners Space for mobile shelving units containing the items awaiting packaging. Sterilisation wrap storage space/rack Hand rub station Clean environment with good lighting for inspections There should be vision panels in doors and walls. PHOTOGRAPH 18: VISUAL INSPECTION OF A DEVICE SET FOLLOWING A CLEANING PROCESS 9.5. Fixtures, fittings and equipment Packing table(s) 2000mm x 700mm, by 800mm high, with a shelf below its surface and a basket rack above it Stainless-steel worktop space for a variety of activities Stainless-steel storage for raw materials High level storage for tray checklists 53

58 Mobile, height-adjustable chairs/stools Table mounted lighted magnifiers Hand rub station. PHOTOGRAPH 19: TEXTILE FOLDING TABLES (TYGERBERG HOSPITAL) PHOTOGRAPH 20: STAINLESS STEEL WORKTOP (TYGERBERG HOSPITAL) 9.6. Services Sufficient plug points for power to equipment on the packing tables should be ceiling-suspended Medical-grade compressed air. 54

59 10. RAW MATERIALS STORE FOR IAP AREA Function Storing of materials used for processing in the clean side of the CSSD Location and relationship DRAWING 13: RAW MATERIALS STORE FOR IAP AREA Activities Storing of materials used for processing in the clean side of the CSSD Requirements Lockable transfer hatch on top of a worktop between this area and the department corridor. Suitable slatted shelving for the range of consumables and chemicals that are stored in this room Fixtures, fittings and equipment Slatted shelving Transfer hatch. 55

60 11. TEXTILE ROOM Function Receiving, folding, packing, and storing of textile materials Location and relationship The textile room should be in close proximity to the IAP area, but also have a hatch to the CSSD departmental corridor to receive deliveries from the laundry. DRAWING 14: TEXTILE ROOM Activities Due to linting, linen MUST be folded in a separate room with its own air-conditioning. Once laundered, ironed, checked and folded, clean unwrapped textiles should be handled as little as possible and be placed in a positive-pressure, temperature-controlled, and properly ventilated area with limited access in order to prevent accumulation of dust and lint Requirements Receiving hatch to departmental corridor side The area used for the textile preparation should be physically separated from all other areas The ventilation system should be designed so that air flows into the textile preparation area (via negative pressure) The air flow should be of a down-draft type, and the number of air exchanges per hour should be sufficient to minimise lint particles in the air Vision panels in doors and walls. 56

61 11.5. Fixtures, fittings and equipment Clinical hand-wash basin, complete with liquid-soap dispenser and paper-towel dispenser An illuminated linen inspection and folding table, 1800mm x 1250mm by 800mm high, with a foot switch to operate the light only during inspection. An acid-etched glass with the etched surface facing inwards would reduce the glare Shelving Stainless steel standing-height processing tables Pass-through window. PHOTOGRAPH 21: TEXTILE FOLDING TABLE Building services Extraction with lint filter. 12. PPE GOWNING AREA (TO CLEAN AREA) Function The PPE (gowning) room provides the only access to and from the decontamination area for staff, after putting on the appropriate PPE (personal protective equipment - over garments and footwear) Location and relationship The PPE room is the only human entry/exit point between the clean/iap/steriliser/sterile storage area and the CSSD departmental corridor. 57

62 DRAWING 15: PPE GOWNING AREA (IAP AREA) Activities The PPE (gowning) room provides the only access to and from the clean/iap/steriliser/sterile storage area for staff Facilities are provided for the storage and dispensing of PPE (personal protective equipment - over garments and footwear) suitable for the decontamination room activities The room provides facilities for hand decontamination before/after activities in the clean (IAP) area It serves as transfer point into/out of the red-line area Requirements PPE dispensers. Red-line demarcation barrier, with step-over wall There should be vision panels in doors and walls Fixtures, fittings and equipment Shelving for PPE dispensers Footwear and over-garment storage Waste containers either foot operated, or wall-mounted Clinical hand-wash basin, complete with liquid-soap dispenser, paper-towel dispenser and mirror. 58

63 13. STERILISATION AREA Function Area where loading trolleys are parked, sterilisers are loaded, sterilisation cycles are run, sterilisers are unloaded, sterilised packs are cooled, following completion of the sterilisation cycle. The size of the area will be dependent on the number and type of sterilisers installed and whether single- or double-door Location and relationship This area is the transition from clean to sterile area The sterilisation area should be adjacent to the preparation and packaging area. DRAWING 16: STERILISATION AREA Activities Receiving packaged products from IAP A holding area for loaded and empty sterilisation trolleys Loading sterilisers Unloading single-door sterilisers Facilitating validation and routine testing of sterilisers Cooling of sterilised goods Where single-door autoclaves are installed, the autoclaves will be loaded and unloaded in the same area Where double-door autoclaves are installed, the unloading area is separate from the loading area 59

64 In both cases, a separate cooling area from the loading area is required Requirements Sufficient sterilisers to meet hospital needs Preferably sterilisers should be located in a restricted access area Autoclaves should not be located in high-traffic areas or near any potential sources of contamination, wash sinks, or containers for the disposal of linen and trash Material should flow from the preparation and packaging area to the sterilisation area and then on to sterile storage or distribution The ventilation system should be designed so that air flows out of the sterilisation area (via positive pressure) Circulation space for the free and unhindered manoeuvring, loading and unloading of steriliser trolleys Exhaust over the front of the steriliser doors to extract heat and steam, in order not to compromise the HVAC air flow and temperature. An extraction system which is activated by the autoclave door opening rather than a constant extraction system should be considered It is generally advisable to install two smaller autoclaves rather than one large one An extra autoclave should be provided to cater for exceptional demand, maintenance and breakdown A clear space of 2m in front of the autoclave is needed to facilitate the handling of loading trolleys No partition wall should be closer than 750mm to any autoclave The autoclaves must be well insulated. The emission of heat to the environment must be minimal, and adequate extraction facilities should be provided to remove hot air and steam from the autoclave at a rate equivalent to 15 air changes per hour Require separate installation and accommodation according to manufacturer's recommendations The size of the area will be dependent on the number and type of sterilisers installed and, importantly, whether the sterilisers are single- or double-sided A duct enclosure can also minimise heat build-up within the workroom. An exhaust over the front of the steriliser(s) should be considered, to extract both heat (cabinet) and steam (opening door) Fixtures, Fittings and Equipment Adequate space should be allowed for sterilisers and aerators; loading, cooling of autoclave racks, storage of long, heat-resistant gloves Autoclave cleaning supplies. PHOTOGRAPH 22: AUTOCLAVE TROLLEY READY FOR LOADING (TYGERBERG HOSPITAL) 60

65 14. COOLING AREA Description and function This area is used for the cooling of sterilised items on trolleys after being removed from the sterilisers. The size of the area will be dependent on the number and type of sterilisers installed Location and relationship This area is directly adjacent to the sterilisation area. Sterile items are temporarily stored here until cooled. DRAWING 17: COOLING AREA Activities Cooling of sterilised items Transferring cooled items to storage Requirements Sufficient space for trolleys to stand and manoeuvre until they have been cooled and inspected This should be a clear open space with sufficient room to manoeuvre sterilising trolleys Demarcated bay floor marking Fixtures, fittings and equipment 61

66 15. STERILE STORES Description and function A dedicated sterile storage and dispatch area Location and relationship The sterile storage area should be located adjacent to the sterilisation area preferably in a separate, controlled, enclosed, limited-access area, the only function of which is to store sterile supplies. DRAWING 18: STERILE PACK STORE Activities Storing of sterile packs Requirements Supply air pressure should be positive with respect to surrounding areas and the level of filtration should be equal to that in an operating theatre There should be vision panels in doors and walls Area to be protected from direct sunlight Adequate and appropriate stainless steel slatted shelving in a clean environment Adequate and appropriate mobile storage systems and trolleys Fixtures, fittings and equipment Closed or covered mobile storage systems are preferable for high-traffic areas Open or wire shelving is suitable for confined storage areas, provided that proper attention is given to traffic control, area ventilation, and housekeeping Hand rub station. 62

67 16. DISPATCH DESK Function Distribution of sterile items to the various user departments Location and relationship DRAWING 19: DISPATCH DESK Activities Dispatch of sterile items to the theatres and wards Loading of sterile articles on trolleys Logging of dispatched deliveries Requirements Counter with service hatch and trolley pass-through hatch Red-line principle is applicable No general access is allowed into the sterile storage and dispatch area Fixtures, fittings and equipment Trolley pass-through hatch and counter hatch Clinical hand-wash basin, complete with liquid-soap dispenser and paper-towel dispenser Stainless steel shelving Filing cabinet Desk Chair Telephone Work surface Hand rub station. 63

68 17. OFFICE Function A space for administration/management Location and relationship Visual access to clean and sterile areas. DRAWING 20: OFFICE Activities Making and receiving phone calls Writing reports Access and printing data from computer Unit management Shift handover meetings Staff management Record keeping and storage Requirements The office should be lockable No direct access from this area to the work areas is allowed. This area can also have a hatch link to the main hospital passage so that suppliers can interact with the unit manager without coming into the unit. This would be an infection risk. 64

69 17.5. Fixtures, fittings and equipment Desk/sitting-height worktop Pinning board Whiteboard with marker tray Blinds for privacy Chairs Filing cabinet Shelving Filing cabinet Stationery cupboard Services IT and data connections Electrical points Telephone point. 18. KITCHENETTE Function Preparation of light meals and refreshments Location and relationship Outside the core activity area of the CSSD. DRAWING 21: KITCHENETTE Activities Storing lunch packs Preparing light meals Making coffee/tea. 65

70 18.4. Requirements Work surface, storage space, cupboards Place for a fridge Position for food trolleys from catering service Fixtures, fittings and equipment Standing-height worktop Standing-height double-end, double-bowl wash-up sink on fixed legs Fridge Microwave oven Toaster Storage cupboards Hydroboil. 19. STAFF REST ROOM Function Space for staff to take tea and lunch breaks The space could also be used for staff meetings and training A minimum area of 15² is required, allowing 1.5m² per person. Size is dependent on the number of staff using the facility and the usage of the facility In district and regional hospitals, the staff room may also be used as a training area Location and relationship Outside the core activity area of the CSSD. DRAWING 22: STAFF REST ROOM

71 19.3. Activities Eating Relaxing Informal meetings Requirements Area for relaxing Fixtures, fittings and equipment Desk/sitting-height worktop Pinning board Whiteboard with marker tray Chairs and tables Water cooler Hot-water boiler Comfortable chairs Tables Clinical hand-wash basin, complete with liquid-soap dispenser and paper-towel dispenser. 20. FEMALE CHANGE ROOMS Description and function Female toilets and change area Location and relationship Outside the core activity area of the CSSD Close to departmental entrance. DRAWING 23: FEMALE CHANGE ROOM 67

72 20.3. Activities Shower Grooming Hand wash Use of WC or urinal Requirements Secure storage of personal property is essential Staff to provide their own padlocks Fixtures, fittings and equipment Clothes lockers with bench Sanitary o Shower o WC o Hand-wash basins Hand-towel dispensers Soap dispenser Mirrors Toilet-roll holders. 21. MALE CHANGE ROOMS Function Male toilet and change area Location and relationship Outside the core activity area of the CSSD Close to departmental entrance. 68

73 DRAWING 24: MALE CHANGE ROOM Activities Shower Grooming Hand wash Use of WC or urinal Requirements Secure storage of personal property is essential Staff to provide their own padlocks Fixtures, fittings and equipment Clothes lockers with bench Sanitary o Shower o Urinals o WC o Hand-wash basins Shoe racks Hand-towel dispensers Soap dispenser Mirrors Toilet-roll holders Laundry bag holders. 69

74 22. STERILISER PLANT ROOM Function Service area of the sterilisers Location and relationship DRAWING 25: STERILISER PLANT ROOM Activities Maintenance and repair of autoclaves by trained technical staff Sampling facilities for steam and water quality Limited access to trained skilled maintenance personnel only Requirements Technical personnel need to access the steriliser controls through the PPE room Waterproof, hardwearing floor, with a gradient in the direction of a floor drain Clearances as per specifications as steriliser manufacturers Adequate space for maintenance and periodic testing is essential. 70

75 Access to the maintenance area of the autoclaves must not interfere with the CSSD activities. For singledoor autoclaves, there must be no connecting door between the maintenance area and the sterilised supply store. The maintenance area in particular should be well ventilated by natural means assisted by mechanical extraction if necessary. Note that this only achievable with single door autoclaves. Where double door autoclaves are used care must be taken to identify an access point from within the unit, which causes least disruption Fixtures, fittings and equipment As per manufacturer s specifications Services As per manufacturer s specifications. 71

76 PART F - BUILDING AND SERVICES 1. BUILDING COMPONENTS, MATERIALS AND FINISHES 1.1. Floors Carpet or similar soft flooring should be avoided. Impermeable, non-slip floor covering is recommended. PVC welded sheet vinyl, coved up the wall, ensures a watertight, hygienic surface which will withstand daily cleaning. Small-diameter coving puts undue stress on the floor vinyl and is prone to cracking over time. Largerdiameter coving has the added advantage that in certain cases it prevents trolley wheels from being pushed against the wall, acting as an added wall protection Walls Walls should be washable, preferably cladded by welded sheet vinyl. Durable polyurethane wall finishes are rapidly appearing on the market and selected products could also be suitable in certain circumstances. Walls should be adequately protected against damage by loose equipment and wheeled traffic by buffer rails and corner guards, which should be appropriately sited to reflect the specifications of trolleys in use. Protruding elements of different trolleys are of varying height. This should be considered in the selection of wall protection Ceilings Suspended modular ceilings with inlay panels are not suitable. A minimum below-ceiling height of 2 800mm is recommended. If ceilings are lower, precautions must be taken with respect to the arrangement and number of air vents as well as to the temperature of the air circulated. This below-ceiling height will have implications for the noise level prevailing within the CSSD. Ceilings should be: washable, impermeable and non-porous sealed to prevent ingress of airborne particles or other contaminants from the ceiling void resistant to humidity in zones where steam and moisture may be encountered Windows The walls and partitions must feature as many glass panels as possible to facilitate supervision, and also to create a feeling of spaciousness. Windows to the outside are highly desirable in the working areas. However, these windows should be non-opening, sealed and preferably flush fitting, in order to prevent the windowsills from being used as storing space. If this is unavoidable, the sills should be angled. 72

77 1.5. Doors Doorways should be positioned to allow trolley movement, and doors and corridors should be wide enough to accommodate trolley turning circles and protruding trolley fittings. Door frames and door leaves should be designed and finished with protection cladding and bumper rails to withstand the inevitable bumps by trolleys. Doors should be adequately sized to allow clear passage of current as well as possible future equipment. Automatic/semi-automatic doors make it easier for collection and distribution of trolleys. If not automated doors should be self-closing. If the design allows it, doors should open towards the higher pressure side where possible to overcome problems with weakening door closers, which may lead to lock-outs. Vision panels should be provided Hatches Where hatches are required to accommodate transfer of articles between the decontamination area and IAP area, for example, they should have purpose-designed close-fitting sections to preserve the integrity of the ventilation system Ducts Service ducts should: allow easy access and should ideally not be in the clean and sterile areas be protected as far as possible from unauthorised entry allow for eventual removal and replacement of major plant and equipment allow enough space to access equipment for cleaning or replacement. 2. FIXTURES, FITTINGS AND EQUIPMENT The selection of equipment should be fully coordinated with the facility s design in order that utility and space requirements are considered during design development Sterile storage shelving Packs should be stored away from direct sunlight and water and should not be stored next to or under sinks, or on the floor where they are likely to get wet or damaged. Sterile packs should be stored at least 250 mm above the floor, and 450mm below the ceiling or sprinkler heads and at least 50 mm from side walls to allow for air circulation in the room and to prevent contamination during cleaning. The shelves should be 400mm apart and be adjustable in increments of about 50mm. Shelving should be stainless steel, slatted, 375mm deep, easily cleaned and allow air to circulate around stored packs. Freestanding or mobile shelving provides a practical solution for handling the flow of products in and out of storage and cleaning. It allows staff to access all sides of the storage area for rotation of sterile packs. Open shelving is more commonly used as it allows dust to pass through making them easier to clean than solid shelves. 73

78 2.2. Worktop furniture Work benches for standing activities should have a worktop height of 900mm and be constructed of stainless steel. Furniture should be movable with height adaption facilities Hand-wash basins Hand washing remains one of the most significant ways in which cross-infection through contact can be avoided. To enhance this, staff should be aware of its importance and hand-wash facilities should be available in appropriate places and be accessible. The selected system for soap- and towel-dispensers is a hospital policy and dictates the type of dispenser to be specified Ultrasonic cleaners Ultrasonic cleaners are mechanical pre cleaners and often used as an initial step in the process of cleaning surgical instruments. Ultrasonic cleaners are a mechanical system that uses sound waves along with water and detergent to remove soil from instruments. Both tabletop and floor units are available. Floor units are designed to accommodate large quantities of instruments at one time and can have either single or double chambers. Following the ultrasonic cleaning process, instruments are placed into washer/disinfectors. Instruments and trays are loaded into the unit on the decontamination side of the CSSD facility, and removed upon completion of the cycle on the clean side of the facility. PHOTOGRAPH 23: VARIOUS TYPES OF AUTOMATED WASHERS AND WASHER-DISINFECTORS 2.5. Automated washers / Washer-disinfectors Washer-disinfectors are used to clean and disinfect a range of devices and materials that are intended to be re-used. The cleaning and disinfection process is intended to make the items clean but also safe (microbiologically) for staff to handle (as a prerequisite for packaging and sterilisation), reducing the load of microorganisms on device surfaces and also often for direct/indirect use with a patient (in particular non- and semi-critical devices). 74

79 There are many different sizes and types of washers. They may be single or multi-chamber, single (one) or double (two) door, and varying in size/design. In single-door designs, the devices or materials (referred to as the load ) are introduced and removed from the same door, while double-door designs allow for the introduction and removal through separate doors (pass-through design). The pass-through door washers are preferable, as contaminated items can be loaded in the dirty area and removed in the clean. The disadvantage of a single-door washer is that the contaminated and clean items are loaded and unloaded through the same door from the dirty side Sterilisers (autoclaves) For maintenance purposes, the side, back, and top panels of free-standing sterilisers should be easily removable and replaceable. Special foundations are not normally required. The weight of the steriliser, which can be as much as 2 000kg when fully loaded, should be borne by at least four pads, each measuring at least 150 x 150mm. Floor mountings should be designed to minimise vibration. A steriliser installation will normally be separated into two areas: a plant room containing the steriliser itself, services and ancillary equipment; and an adjacent loading area from which the steriliser is loaded and unloaded. The areas are divided by a partition wall into which the front panel and door of the steriliser are set. Maintenance staff should be able to enter the plant room without passing through the loading area. Direct access between the plant room and loading area should be provided for use during testing. 75

80 TABLE 8: SUMMARY OF BUILDING REQUIREMENTS WINDOWS OTHER BUILDING REQUIREMENTS ESSENTIAL & WITH A VIEW DESIRABLE NOT ESSENTIAL NOT RECOMMENDED IF PROVIDED MUST BE SEALED WALL & DOOR PROTECTION SECURE TROLLEY HATCH RECEIVING & SORTING WASTE DISPOSAL SLUICE TROLLEY WASH/STORAGE DECONTAMINATION AREA TASK LIGHTING HIGH-PRESSURE AIR HIGH-PRESSURE WATER TELEPHONE IT & DATA * LOCKABLE DOORS STAINLESS STEEL SHELVING STAINLESS STEEL WORKTOPS STAINLESS STEEL SINK FLOOR DRAIN HAND WASH FACILITY SPECIALIST EQUIPMENT ** RAW MATERIALS STORE PPE TO CLEAN AREA INSPECTION & PACKING IAP STORE TEXTILE AREA PPE TO CLEAN AREA STERILIZATION AREA COOLING AREA STERILE PACK STORE DISPATCH OFFICE KITCHENETTE DINING ROOM FEMALE CHANGE MALE CHANGE STERILIZER PLANT ROOM * IT & DATA IT & dta requirements as per hospital policies and procedures ** SPECIALIST EQUIPMENT Building services and environmental requirements as per manufacturer's specifications 3. ELECTRICAL 3.1. Specialist electrical installations Rapid development of technological innovations in all spheres of electronic devices demands up-to-date knowledge which cannot be captured in a design guide of this nature. It is therefore imperative that all power be fully accommodated, and that the systems are designed to be responsive to specific equipment. The specific choice of equipment must be established early on to promote a consistent and coordinated plan. Careful attention must be given to the location and capacity of electric outlets to ensure capacity and compatibility with the equipment to be installed. 76

81 3.2. Electrical points Sufficient 13-amp outlets should be provided to supply all portable appliances. Designers should ensure that they have access to a complete schedule of the equipment that requires electrical supplies and a clear understanding of the operational policies regarding the use of all equipment. Switched socket-outlets should be provided in corridors and in individual rooms to enable domestic cleaning appliances to operate over the whole facility. Appliances requiring a three-phase supply or those rated in excess of 13-amp single phase should be permanently connected to separate fused sub-circuits. The sub-circuits should be fed from the distribution board and terminate at a local isolator. Designers should agree on the location, type (flush- or surface-mounted), form of indication, type of cable outlet, facilities for locking of isolator in the off position, and labelling of such isolators with the planning team Lighting The layout of artificial lighting should be designed in a modular fashion to accommodate future changes, yet take into consideration current workspace layout. Light fittings are potentially major sources of dust- and dead-insect build-up. Recessed and sealed fittings utilising recessed fluorescent luminaries with acrylic prismatic lenses would greatly contribute to overcome this problem. However, regular maintenance policies still need to be put in place by hospital management to maintain a clean environment. It would be preferable to have pendants above workspaces in the IAP area. Examination lighting (examination lamps with foot-operated switches) is required in the IAP (equipment examination) areas. Light switches with occupancy sensors should be considered to reduce energy consumption. Emergency lighting is not considered to be essential. TABLE 9: SUMMARY OF LIGHTING REQUIREMENTS RECOMMENDED LIGHTING LEVELS (lux) minimum average maximum GENERAL INSPECTION DETAILED INSPECTION WASH AREAS GENERAL WORK AREAS STORAGE AREAS MECHANICAL 4.1. HVAC A well-designed HVAC system is a critical element in the design for infection control. Through constantspace airflows and differentiation in air pressures, contamination can be contained and clean environments can be maintained. In order to achieve this it is imperative that 100% constant fresh air is provided to the CSSD through a dedicated air-handling unit complete with primary air heating, cooling, humidification, dehumidification, and filtration. The HVAC must be engineered with excellent energy efficiency through performance management. Refer to IUSS:GNS Building engineering services. 77

82 Air flow should be designed so that air flows out of clean areas into dirty areas via positive pressure. Positive air pressure is required in the "clean" areas of the unit to reduce air movements into these areas from the "dirty" areas of the unit, as per the diagram below. DRAWING 26: GENERIC LAYOUT INDICATING AIR PRESSURE AND AIR-FLOW DIRECTION 78