Attachment 0004C_SPS Design Guide.pdf

PG-18-9 Space Planning Criteria PG-18-5 Equipment Guide List PG-18-12 Design Guide

284: Logistics Service 285: Sterile Processing Service

October 1, 2015 - revised September 1, 2022

PG-18-12: STERILE PROCESSING SERVICE AND LOGISTICS SERVICE September 1, 2022 i

TABLE OF CONTENTS

SECTION 1: FOREWORD

SECTION 2: ACKNOWLEDGEMENTS

DEPARTMENT OF VETERANS AFFAIRS

PRIME CONSULTANT

SUB CONSULTANT

SECTION 3: INTRODUCTION

VA HEALTHCARE SYSTEM

SECTION 4: DEFINITIONS

SECTION 5: ABBREVIATIONS

SECTION 6: STERILE PROCESSING SERVICE (SPS)

PLANNING AND DESIGN CONSIDERATIONS (SPS)

ARCHITECTURAL DESIGN (SPS)

INTERIOR DESIGN (SPS)

MEDICAL EQUIPMENT (SPS)

MECHANICAL DESIGN (SPS)

ELECTRICAL DESIGN (SPS)

PLUMBING DESIGN (SPS)

STRUCTURAL DESIGN (SPS)

FUNCTIONAL CONSIDERATIONS (SPS)

SPATIAL RELATIONSHIPS (SPS)

SECTION 7: FUNCTIONAL DIAGRAMS (SPS)

SECTION 8: STERILE PROCESSING SERVICE ROOM TEMPLATES (SPS)

LEGENDS AND SYMBOLS

DECONTAMINATION ROOM (SC861)

SCOPE PROCESSING ROOM (SC885)

SCOPE STAGING/STORAGE (SC891)

CLEAN INSTRUMENT SET ASSEMBLY WORKROOM (SC892)

STEAM STERILIZATION ROOM (SC902)

SECTION 9: LOGISTICS SERVICE (LOG)

PLANNING AND DESIGN CONSIDERATIONS (LOG)

ARCHITECTURAL DESIGN (LOG)

INTERIOR DESIGN (LOG)

MECHANICAL DESIGN (LOG)

ELECTRICAL DESIGN (LOG)

STRUCTURAL DESIGN (LOG)

FUNCTIONAL CONSIDERATIONS (LOG)

SPATIAL RELATIONSHIPS (LOG)

SECTION 10: FUNCTIONAL DIAGRAMS (LOG)

SECTION 11 LOGISTICS SERVICE ROOM TEMPLATES (LOG)

LEGENDS AND SYMBOLS

ii

STERILE CONSUMABLES (SOFT GOODS) STORAGE (SB644)

MAILROOM (SB653)

HIGH VOLUME REPRODUCTION ROOM (SB661)

TABLE OF FIGURES

Figure 1: Decontamination Area (SPS) Figure 2: Preparation and Assembly Area (SPS) Figure 3: Steam Sterilization Room (SPS) Figure 4: Process Flow Diagram (SPS) Figure 5: Decontamination Room (SPS) Figure 6: Automated Cart Washer (SPS) Figure 7: Scope Staging Room (SPS) Figure 8: Scope Processing Room (SPS) Figure 9: Instrument Set Assembly / Clean Workroom, View A (SPS) Figure 10: Instrument Set Assembly / Clean Workroom, View B (SPS) Figure 11: Steam Sterilization Room (SPS) Figure 12: Low Temperature Sterilizer (SPS) Figure 13: Front Loading Steam Sterilizer (SPS) Figure 14: Loading Area (LOG) Figure 15: Warehouse Area (LOG) Figure 16: Cantilever Rack (LOG) Figure 17: Movable Shelf Rack (LOG) Figure 18: Loading Area (LOG) Figure 19: Warehouse Area (LOG) Figure 20: Bulk Items Storage (LOG) Figure 21: Sterile Consumables Storage (LOG)

TABLE OF DIAGRAMS

Diagram 1: Room Relative Pressure (SPS) Diagram 2: Decontamination Area (SPS) Diagrams 3.1 and 3.2: Scope Processing Area (SPS) Diagram 4: Preparation and Assembly Area (SPS) Diagram 5: Sterilization Area (SPS) Diagram 6: Receiving, Storage & Dispatch Area (SPS) Diagram 7: Staff and Administrative Area (SPS) Diagram 8: Functional Relationships (SPS) Diagram 9: Process Flow (SPS) Diagram 10: Staff Flow (SPS) Diagram 11: Loading Dock (LOG) Diagram 12: Warehouse (LOG) Diagram 13: Postal / Mail Service (LOG) Diagram 14: Staff and Administrative Area (LOG) Diagram 15: Functional Relationships (LOG) Diagram 16: Material Flow (LOG)

Foreword 1

SECTION 1: FOREWORD

VA Program Offices, project teams, designers and constructors, are obligated to our Nation's Veterans and taxpayers to make the most effective and efficient use of resources, by providing a continuum of safe, secure, high quality, high performance, and high value environments of care and service for Veterans. The VA Office of Construction & Facilities Management (CFM) supports the Department's mission through development and application of standards as a basis for disciplined planning, design, and construction of VA facilities.VA Standards are the culmination of a partnership among the Department of Veterans Affairs (VA), the Veterans Health Administration, Program Officials, Clinicians, Industry, Academic and Research Organizations, Consultants, and the Office of Construction and Facilities Management. Design Guides are developed through integration of VA-specific requirements, Federal law and regulation, benchmarking of industry best practice, evidence-based research and design, and value-based analysis of leading-edge innovation. The result is the establishment of best value standards for optimum functionality, safety, operability, performance, and quality throughout the VA environment of care and service.

Design Guides (PG-18-12) are a critical component of the VA Technical Information Library (TIL) (www.cfm.va.gov/TIL) which provides standards for all VA planning, design, and construction projects.

Design Guides focus on selected healthcare departments and services and include an overview narrative of VA-specific planning and design principles and concepts, room templates, equipment lists, and basic technical/engineering requirements. They communicate the basis of design and are required to be utilized by project teams working on new construction and renovations of existing facilities. Design Guides will maximize the effectiveness and efficiency of the planning and design process and ensure a high level of design, while controlling construction, operating, and maintenance costs.

The material contained in Design Guides constitutes a Standard for VA Planning, Design and Construction. For all VA projects, it is required that project teams comply with the following in all phases of project development:

1) All applicable VA Standards published in the VA Technical Information Library (TIL) shall be applied as a basis, foundation, and framework in planning, design, and construction. Any substantial variance from Standards shall be considered only as required to accommodate specific site, functional, and operational conditions. Upon consideration of variance CFM shall be consulted, and each Administration will function as Authority Having Jurisdiction for decision.

Each substantial variance shall have a basis rationale and be documented in the project record.

2) Clinicians, providers, primary users, and other stakeholders shall be involved in all phases of project development to best adapt Standards for specific functional, operational, and site conditions, and to provide optimum service environments for Veterans. This also includes installations and modifications of systems or technology involving safety, security, functionality, or environmental quality. Stakeholder involvement shall be documented in the project record.

Design Guides are not project‐specific. It is impossible to foresee all rapidly evolving requirements of healthcare facilities and each site or project will have unique requirements or conditions. Site‐specific issues must be addressed within the context of these standards and

Foreword 2 applied to each individual project. Use of this Guide does not preclude the need for, nor absolve planners, designers, and constructors of their responsibility to provide complete, functional, safe, and secure designs suited to the unique requirements of each project, within budget, and on schedule.

Materials, equipment and systems are shown in an illustrative, performance-based format and are not intended to depict, suggest, or otherwise constitute endorsement of any specific product or manufacturer. Manufacturers should be consulted for actual dimensions, configurations, and utility requirements.

All participants in the project development process must embrace VA Planning, Design and Construction Standards as fundamental in providing optimum environments for Veterans’ care and services, in fulfilling VA's mission.

Donald L. Myers, AIA, NCARB Director, Facilities Standards Service US Department of Veterans Affairs Office of Construction & Facilities Management

PG-18-12: STERILE PROCESSING SERVICE AND LOGISTICS SERVICE October 1, 2015

Acknowledgements 3

SECTION 2: ACKNOWLEDGEMENTS

The following individuals provided guidance, insight, advice and expertise in the development of this Design Guide:

DEPARTMENT OF VETERANS AFFAIRS

VHA Advisory Board

Sterile Processing Service (SPS) Teresa Wells Director, National Office for Sterile Processing

Seaton West Deputy Director, National Program Office for Sterile Processing

Sherri Bull Health System Specialist, National Program Office for Sterile Processing

Mark Kambeitz Health System Specialist, National Program Office for Sterile Processing

Jay Jensen Health System Specialist, National Program Office for Sterile Processing

Donald Fisher Health System Specialist, National Program Office for Sterile Processing

James T. Brockway Chief, Sterile Processing Service, Central Arkansas Veterans Healthcare System

Ray Baker Interim VISN SPS Program Manager / Chief of SPS, Memphis, VAMC

Glen LaBlanc Chief SPS / Nurse Manager, Albany Stratton VAMC

Logistics Service (LOG) Duane Waldo Project Manager – Vendor Relations, Program Executive Office

Environmental Programs Service (EPS) Christine Johnson Program Manager, Interior Design

Vonda Broom Deputy Director, Environmental Programs Service

Infection Control Marissa Jones Lewis Infection Control Practitioner, Charlie Norwood VAMC / SCIU

Acknowledgements 4

Interior Design Rochelle Landowski Interior Designer, NCIDQ, VA Pittsburgh Health Care System

April Johnson Interior Designer, VA Sierra Nevada Health Care System (Reno)

Office of Construction and Facilities Management (CFM)

Stella Fiotes Executive Director, Office of Construction and Facilities Management

Lloyd Siegel Associate Executive Director, Office of Facilities Planning

Donald Myers Director, Facilities Standards Service

Gary Fischer Senior Healthcare Architect, Facilities Standards Service

Zoltan Nagy Senior Healthcare Architect, Facilities Standards Service

Orest Burdiak Principal Interior Designer, Facilities Standards Service

Alejandra de La Torre Associate Architect, Facilities Standards Service

Lam Vu Electrical Engineer, Facilities Standards Service

Mahmut Nazli Mechanical Engineer, Facilities Standards Service

Michael Taylor Mechanical Engineer, Facilities Standards Service

Fei (Linda) Chan Planner, Facilities Planning and Development Service

Acknowledgements 5

PRIME CONSULTANT

HDR

Ronald Villasante, MRCP, MArch, RA Director of Federal Healthcare Planning

Scott Speser, RA, LEED BD+C Federal Healthcare Architect

Michael Roughan Healthcare Design Principal

Lisa Ahlers, MArch, MPhys Medical Equipment Planner

Cynthia Adams Healthcare Planner

Usman Tariq Engineering Director

Gary Kleman Senior Electrical Engineer

Stephen Sandrock Senior Mechanical Engineer

Kirby Cave Architectural BIM Specialist

Heather Medlin, Assoc. AIA Architectural Project Coordinator

Michaela Mansfeld Graphic Editor

SUB CONSULTANT

CT + Associates

Christian L Troiano President

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Introduction 7

SECTION 3: INTRODUCTION

VA Design Guides are developed as a tool to assist VA medical center staff, planners and architects, project design teams, and consulting architects and engineers (A/Es) with the understanding of the unique requirements of the VA model of care related to a specific project type.

The material contained in the Sterile Processing Service (SPS) / Logistics Service (LOG) Design Guide is the culmination of a coordinated effort among the Department of Veterans Affairs (VA), the Veterans Health Administration (VHA), the Office of Construction & Facilities Management (CFM), and the consulting architects and engineers. The goal of this Design Guide is to maximize the efficiency of the design process for VA healthcare facilities and ensure a high level of design, reflect the VA model of operation, and assist in controlling construction and operating costs.

This Design Guide is part of the VA Program Guides used to establish planning and design standards. This PG-18-12 Design Guide document covers both Logistics Service and Sterile Processing Service and complements the following space planning criteria standards; PG-18-9:284 Logistics Service and PG-18-9:285 Sterile Processing Service, and the following Equipment Guide Lists standards; PG-18-5:284 Logistics Service and PG-18-5:285 Sterile Processing Service. These documents can be accessed at the VA Technical Information Library (VA-TIL) at www.cfm.va.gov/til/dGuide.asp.

VA HEALTHCARE SYSTEM

The Department of Veterans Affairs (VA) operates one of the largest healthcare systems in the United States. The country’s Veterans are provided healthcare in over 150 hospitals and medical centers and over 800 outpatient clinics. In addition to the basic healthcare needs, Veterans are provided with specific clinical services due to a higher prevalence of disabilities from traumatic injuries, post-traumatic stress disorder (PTSD) and neurological disorders. To respond to these needs, VA is in the process of developing and integrating a patient centered care delivery. This approach allows healthcare providers to enhance healing and support better outcomes and mirrors general trends in healthcare. In order to integrate knowledge derived from other industry efforts, the VA teamed with Planetree, an organization with expertise in patient centered care, in 2010-2012 to help develop a care model based on personalizing, humanizing, and demystifying the healthcare experience for patients and their families.

As a result, VA defines Veteran Centered Care as follows:

“A fully engaged partnership of veteran, family, and healthcare team established through continuous healing relationships and provided in optimal healing environments, in order to improve health outcomes and the veteran’s experience of care.”

https://www.cfm.va.gov/til/dGuide.asp https://www.cfm.va.gov/til/dGuide.asp

Introduction 8

Based on this, Veteran Centered Care is provided following twelve core principles:

1. Honor the veteran’s expectations of safe, high quality, accessible care.

2. Enhance the quality of human interactions and therapeutic alliances.

3. Solicit and respect the veteran’s values, preferences, and needs.

4. Systematize the coordination, continuity, and integration of care.

5. Empower veterans through information and education.

6. Incorporate the nutritional, cultural and nurturing aspects of food.

7. Provide for physical comfort and pain management.

8. Ensure emotional and spiritual support.

9. Encourage involvement of family and friends.

10. Ensure that architectural layout and design are conducive to health and healing.

11. Introduce creative arts into the healing environment.

12. Support and sustain an engaged work force as key to providing veteran centered care.

Definitions 9

SECTION 4: DEFINITIONS

AAMI: Acronym for the Association for the Advancement of Medical Instrumentation. AMMI is the source for all practice and design standards for decontamination, disinfection, and sterilization.

ANSI: Acronym for the American National Standards Institute. ANSI supports the development and approval of national voluntary standards, develops accreditation programs, and serves as the U.S.

representative to the International Standards Organization (ISO).

Automated Endoscopic Reprocessor (AER): A fully automated device for testing, cleaning and high-level disinfection of various types of flexible fiber optic scopes used to minimize the use of hands in the cleaning process and eliminate soaking scopes in toxic chemical agents. AERs can assist in standardizing scope processing and promote a consistent level of care.

Automated Transport: A computer-controlled materials handling system that moves carts along pre-programmed paths to deliver goods. Also referred to as an Automated Guided Vehicle System (AGVS).

Biomedical Engineering: A support department that inspects, repairs, tests, and maintains a wide range of patient care equipment. Biomedical Engineering may provide primary response for maintaining SPS equipment. It also works closely with Logistics Service for the temporary storage of new equipment items before they are released for medical use in the facility, and for existing items awaiting repair or parts. Biomedical Engineering may also be called Clinical Engineering.

Bulk Item Storage: A high-bay storage of supplies method for items purchased in large quantities, including full pallets, and case-lots. If not available for purchase in a more convenient format, bulk supplies may be broken down into packages or low unit of measure before being transferred to Unit Item Storage. Bulk item storage may also accommodate pandemic supplies, disaster preparedness supplies, and similar items not typically required for routine operation in the healthcare facility.

Case Cart: A physical cart, and also a supply concept, whereby most supplies and instruments needed for a surgical procedure are pre-assembled, and placed into a cart, the case cart. Its contents are selected for a specific procedure, a specific surgeon, and / or a specific patient that is scheduled for an assigned time and location (procedure room). Case carts are typically pre-assembled 24-hours in advance or can be assembled as needed, in which case it is called a “just-in-time cart”.

Clean Linen Storage: An area where clean linen is stored for issue. Clean linen distribution may be the responsibility of either Logistics Service or Environmental Programs Service (EPS) at the discretion of the particular medical facility.

Clean Loading Dock: Accommodates loading truck bays for vehicles unloading clean material and equipment delivered to the healthcare facility. Separation between clean and soiled loading docks must be maintained.

Container Rack: A specialty cart used in conjunction with an automatic cart washer, which accommodates rigid instrument containers and covers for cleaning and disinfection.

Definitions 10

Decontamination - Soiled Work: An area that accommodates receiving, cleaning and disinfection of surgical instruments, scopes, reusable medical devices, carts and related patient care items that require decontamination and / or sterilization.

Exchange Cart Replenishment: A system where patient care areas are restocked with supplies, or clean linens, based on predetermined schedules. While one exchange cart is in use within a patient area, another is being restocked in Logistics Service or Environmental Program Service (EPS) as a replacement.

Flex Storage: A temporary holding space for incoming supplies and medical equipment items that are not ready for delivery or installation. These items include beds, stretchers, etc.

Functional Area (FA): A grouping of rooms and spaces based on their function within a clinical service.

Infection Control Risk Assessment (ICRA): A multidisciplinary, organizational, documented process that considers the medical facility’s patient population and mission to reduce the risk of infection based on knowledge about infectious agents and the care environment, permitting the facility to anticipate its potential impact.

Logical Unit of Measure (LUM): A supply delivery model, also referred to as Low Unit of Measure, whereby medical products are ordered, received, and replenished directly to end users in a ready-to-use format. This model is part of a “just in time” vendor supported replenishment system.

Logistical Category (Log Cat): A system used by the VA to classify the procurement and installation of equipment.

Logistics Receiving, Storage and Dispatch: An area that accommodates receiving and storage of clean and sterile supplies and instruments within a controlled environment prior to distributing them to end users.

Low Temperature Sterilization: A sterilization method by which medical devices that are heat and / or moisture sensitive are sterilized by using hydrogen peroxide. As used in this document, low temperature sterilization refers to sterilizers which have chambers in which properly prepared medical devices can be sterilized by exposure to one of the two primary technologies currently available.

PG-18-5 Equipment Guide List: Standard for planning and developing equipment requirements, also know as Room Contents. There is a PG-18-5 standard corresponding to each PG-18-9 standard for each clinical and non-clinical department in a VA healthcare facility.

PG-18-9 Space Planning Criteria: Standard for allocating and planning space requirements for VA facilities. There is a PG-18-9 corresponding to a PG-18-5 standard for each clinical and non-clinical department in a VA healthcare facility.

PG-18-12 Design Guide: Standard that provides in-depth planning and design information for VA facilities. A PG-18-12 standard can cover more than one department in a VA healthcare facility.

Pandemic Storage: A portion of the medical center’s disaster preparedness provisions that would complement the Pharmacy Cache with non-prescription related medical supplies. Items required in the Cache may vary by geographic region, VISN or by medical center, but would typically include storage of syringes, masks, gloves and assorted Personal Protective Equipment (PPE).

Definitions 11

Personal Protective Equipment (PPE): Specialized clothing worn by SPS employees to prevent exposure to blood borne pathogens and other infectious elements.

Preparation and Assembly – Clean Work: An area within SPS where inspection, reassembly, functional testing and re-packaging of instruments, instrument sets, scopes and related medical devices occurs prior to final sterilization.

Receiving / Processing: An area within Logistics Service, where the detailed inspection of material and equipment takes place. Logistics Service staff will complete the appropriate receiving reports, and the sorting of all items for delivery to the appropriate storage location. Boxes and packing material are broken down into smaller quantities for placement on shelves or delivery to end users.

Reusable Medical Equipment (RME): RME is any medical equipment designed by the manufacturer to be reused for multiple patients. SPS must follow the reprocessing instructions provided by the manufacturer to ensure proper use.

Reverse Osmosis Deionized (RO / DI) Purified Water: Water suitable for sterile processing applications with specific resistivity of 0.1 megohm per cm. RO / DI purified water is required for the final rinse cycle of instrument washer-decontaminators, at the clean-up sinks, and is used in ultrasonic cleaners.

Soiled Loading Dock: Accommodates one or more truck bays for the interface with trash compactors, recycling compactors / dumpsters, on-site treatment of regulated medical waste (if authorized), and the removal of soiled linen, sharps, and other soiled materials. The Soiled Loading Dock may be located adjacent to, but must be physically separated from, the Clean Loading Dock.

SPS: Acronym for Sterile Processing Service.

SPS Reprocessing: The cleaning, disinfection, testing, repair, repackaging and sterilization of contaminated reusable medical equipment (RME) in order to make them available for use in patients.

Standard Storage Unit: A metric for planning SPS and Unit Item Storage requirements. It uses modules representing typical 24” D x 60” W x 72” H open wire shelves.

Sterilization: The elimination of all living microorganisms through the use of high temperature and, in some cases, chemical elements.

Transport Cart: A mobile cart used to transport instruments, scopes or supplies between Sterile Processing Service and patient care areas; also referred as Transfer Cart.

Truck Bay: A space at the loading dock that accommodates one delivery truck. Loading docks are comprised of multiple truck bays to accommodate deliveries and may incorporate dock lifts and leveling devices.

Unit Item Storage: Accommodates the storage of medical and non-medical supplies that are dispensed in less than case-lot quantities, including logical (low) unit of measure.

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Abbreviations 13

SECTION 5: ABBREVIATIONS

A Amps A/E Architectural / Engineering Firm ABA Architectural Barriers Act AC Air Conditioning AC/HR Air Changes per Hour ACT 1 Acoustical Tile ACT 2 Cleanroom Acoustical Tile and Grid ADA Americans with Disability Act ADAAG ADA Accessibility Guidelines (ADAAG) AHJ Authority Having Jurisdiction AIA American Institute of Architects AMMI Association for the Advancement of Medical Instrumentation ANSI American National Standards Institute AR As Required ASHRAE American Society of Heating Refrigerating & Air-Conditioning Engineers BGSF Building Gross Square Feet BTU British Thermal Unit CFM Cubic Feet per Minute DGSF Departmental Gross Square Feet DOE Department of Energy DVA Department of Veterans Affairs FAR Floor Area Ratio FC Foot Candle GSF Gross Square Feet GSM Gross Square Meters GWB Gypsum Wall Board HAI Hospital Acquired Infection(s), also known as Nosocomial Infections HIPAA Healthcare Insurance Portability and Accountability Act HP Horsepower HVAC Heating, Ventilating and Air Conditioning IAQ Indoor Air Quality IBC International Building Code IDS Input Data Statement LB Pound Log Cat V V: Department of Veterans Affairs furnished and installed - Medical Care Appropriations Log Cat V C: Department of Veterans Affairs furnished and Contractor installed - Medical Care

Appropriations for Equipment and Construction Appropriations for Installation Log Cat C C: Contractor Furnished and Installed - Construction Appropriations

Abbreviations 14

Log Cat C F: Construction Appropriations - Department of Veterans Affairs furnished - Installed by the Contractor

LUX Lumen per Square Meter NEC National Electrical Code NFPA National Fire Protection Association NHCU Nursing Home Care Unit NSF Net Square Feet NSM Net Square Meter(s) NTS Not to Scale NUSIG National Uniform Seismic Installation Guidelines OCFM Office of Construction and Facilities Management OSHA Occupational Safety and Health Administration PFD Program for Design PG-18-5 VA Program Guide: Equipment Guide List PG-18-9 VA Program Guide: Space Planning Criteria PG-18-12 VA Program Guide: Design Guide PPE Personal Protective Equipment P1 Painted / Semi-gloss P2 Painted / Epoxy PVCF PVC – free Resilient Flooring RB Rubber Base RCP Reflected Ceiling Plan RES Resinous Flooring with Integral Base RH Relative Humidity RME Reusable Medical Equipment RO Reverse Osmosis SF Square Feet, Square Foot SMACNA Sheet Metal and Air Conditioning Contractor’s National Association SM Square Meter(s) SS Stainless Steel TJC The Joint Commission (Accreditation of Healthcare Organizations), formerly JCAHO TIL Technical Information Library TV Television UBC Uniform Building Code UFAS Uniform Federal Accessibility Standards V Volts VA Department of Veterans Affairs VACO Department of Veterans Affairs Central Office VAMC Department of Veterans Affairs Medical Center VHA Veterans Health Administration VISN Veterans Integrated Service Network

PG-18-12: STERILE PROCESSING SERVICE (SPS) September 1, 2022

Sterile Processing Service (SPS) 15

SECTION 6: STERILE PROCESSING SERVICE (SPS)

PLANNING AND DESIGN CONSIDERATIONS (SPS)

The Sterile Processing Service main function is to ensure adequate and timely provision of properly cleaned, disinfected and sterilized semi-critical and critical Reusable Medical Equipment (RME) for all supported clinical procedure rooms in the facility (ORs, DTRs, Specialty Procedure Rooms, etc.). Thus, instrument sets, patient care equipment, and other medical devices must be processed and distributed in an accurate and timely manner so that veterans care is not adversely affected. SPS workflow begins with the recapture of all RME at the point of use and ends with reprocessing and packaging of sterilized RME before delivery to the point of use. Thus, SPS’s role in the provision of quality healthcare services to Veterans is of utmost importance. The Sterile Processing Service role and function at the Department of Veterans Affairs is regulated through various Directives, Handbooks and Policies; refer to the most current. The following documents were reviewed during the development of this Design Guide:

VHA-D-2009-04; VHA-D-2009-31; VHA-D-2009-62; VHA-D-2010-18; and VHA-D-2011-37.

Based on SPS’s distinct functions, it is organized in six Functional Areas (FAs). Refer to PG-18-9: 285 Sterile Processing Service.

1. Decontamination Area

2. Scope Processing Area

3. Preparation and Assembly Area

4. Sterilization Area

5. Receiving, Storage and Dispatch Area

6. Staff and Administrative Area

The Decontamination Area is where RMEs are received from the point of use. A Soiled Transition / Drop-off is provided as well as a PPE area to dispense and don protective clothing for staff prior to entering the Decontamination Area. The Decontamination Area is a key space in this FA; it houses the manual and automated equipment (instrument washer disinfectors, cleanup / washbasins, ultrasonic cleaners, etc.) as well as furnishings (SS counters and cabinets, etc.) used in the decontamination of RME.

The room arrangement shall facilitate the one directional flow of RMEs onto the Preparation and Assembly Area. It has dedicated storage space for chemicals to be used for instrument and cart washers and also supports RO/DI water purification equipment. This may include RO/DI water at each clean-up sink and the final rinse cycle on the washer disinfector.

Figure 1: Decontamination Area (SPS)

Sterile Processing Service (SPS) 16

Figure 2: Preparation and Assembly Area (SPS)

The Scope Processing Area is where the flexible endoscopes are reprocessed. The Scope Processing Area consists of an Ante Room, Decontamination, Scope Processing, and Clean Scope Storage.

Equipment in this area includes an Automatic Endoscope Reprocessor (AER) and a soaking station to perform High Level Disinfection.

The Preparation and Assembly Area is where Reusable Medical Equipment (RME) items are inspected, re-assembled and packaged for sterilization. Packaging methods may include non-woven (disposable) instrument wrappers, rigid instrument containers, and peel pouches for individual items. Items are then transferred to the Sterilization area. The Preparation and Assembly Area includes the Instrument Set Assembly, Clean Workroom, and the Sterile Processing Supplies Storage.

Steam sterilization is the primary method for achieving terminal sterilization. Items which cannot withstand exposure to high-heat and/or moisture will be sterilized by low temperature sterilization (gas plasma, ethylene oxide (EtO) ). EtO sterilization requires an aeration cycle following sterilization to remove all traces of hazardous EtO gas remaining on the medical device via aeration. The Sterilization Area includes the Steam and Low Temp Sterilization Areas, an Unloading / Cooling Area and a Cart Return Area, if authorized, an area for Clean Steam Generator Equipment, the Ethylene Oxide Gas Sterilization (EtO) Room and the Ethylene Oxide Gas Sterilization (EtO) Abator Room may also be included.

Receiving and Storage area is where instrument sets and other soft goods are stored for case cart assembly and dispatch. It accommodates the Vendor Drop-off / Pick-up Area, Sterile Durables (Sterile Instruments) Storage, Dispatch Area including a Workstation, case cart assembly, and a dedicated HAC.

The Sterile Durables (Sterile Instruments) Storage is the largest space in this FA as it shall be sized based on the number of ORs and Procedure Rooms it will be serving. This is where assembled sterilized instrument sets, as well as scopes and associated hard goods to support surgery and other areas are stored.

The Staff and Administrative Area provides office and workstation space for the SPS personnel as well as Conference / Training Room, Copy / Office Supply Room and Staff Lounge, Changing Lockers and Toilets.

Future Trends The increased use of vendor loaner instrumentation for installing and / or revising spinal, neurological and orthopedic implants, in addition to the prevalence of loaner instruments require adequate space to receive, document and stage these items. As more robotic equipment in surgical and endoscopic

Figure 3: Steam Sterilization Room (SPS)

Sterile Processing Service (SPS) 17 procedures are used, sterile processing and sterilization workload will increase; hence space allocation in the Decontamination, Scope Processing and Sterilization areas shall be sized to accommodate new instrument requirements. The space criteria for these spaces in PG-18-9: 285 Sterile Processing Service allow this flexibility in the foreseeable future.

Technological advances also include RME management information and tracking systems, as well as automated equipment interfaces for decontamination and sterilization documentation. There is a growing trend in surgical suite design to eliminate the traditional sub-sterile and satellite reprocessing areas and shift all decontamination and sterilization activities to the Sterile Processing Service. Similarly, SPS is increasingly becoming the center of excellence for reprocessing all scopes. Scopes for all specialties: arthroscopy, bronchoscopy, colonoscopy / sigmoidoscopy, cystoscopy / ureteroscopy, laparoscopy, and upper gastrointestinal endoscopy and the various technologies to reprocess them require, space, infrastructure, equipment and skills/special training for SPS and its staff.

This document incorporates standards outlined in VHA Sterile Processing Service Handbook relative to the use of a four-zone SPS design approach which incorporates air-locks / vestibules and pass-thru sterilization equipment.

Lean Approach A Lean analysis, sometimes called a Process Improvement Project (PIP), is recommended prior to beginning the design process of a SPS Project in order to facilitate operational improvement by identifying waste, encouraging standardization, streamlining operational practices, and eliminating unnecessary steps.

This process includes the analysis of adjacencies, vertical and horizontal, between SPS and Surgical Service; consideration of alternative transport systems for supplies, instruments, equipment and soiled materials; use of case cart systems, rapid instrument turnaround considerations, fast-track system, instrument management software and tracking systems; and point of use supply / replenishment systems that remove clinical professionals from the day to day supply chain activities. Manufacturers are responding to Lean process improvement initiatives by offering new sterilizer designs which feature smaller chamber sizes to facilitate faster throughput, sterilizers with vertical-drop and horizontal-slide doors, and sterilizers with automated loading and unloading capabilities. They also continue to enhance sustainable decontamination and sterilization equipment features which significantly reduces water consumption.

Location Typically, Surgical Service is the main user of Sterile Processing Service; hence, SPS shall be located in close physical proximity to avoid long travel distances for the RME items. In most cases, this is achieved by aligning vertically SPS with Surgical Service and connecting them via dedicated soiled and clean elevators. Other clinical areas SPS serves are the Dental Clinic, the Endoscopy Suite, and the procedure rooms in all the other clinics in the facility including the Primary Care – Patient Aligned Care Team (PACT) Clinic. Due to floor loading requirements and service / maintenance to the SPS equipment, a ground floor location is preferred.

Sterile Processing Service (SPS) 18

Infection Control Healthcare-associated Infections (HAI) inflict a high cost to patients including hospital re-admittance, disability, and even death. SPS can address infection control through proper handling and storage of sterilized RME and materials. Design / implementation of a workflow process that segregates handling and manipulation of contaminated and sterilized RME to avoid cross contamination shall be provided. In addition, selecting finishes resistant to moisture and mold and easily cleaned; providing proper ventilation and HVAC systems and control, and consistent use of PPE will contribute to control spread of infection.

Ethylene Oxide (EtO) The use of EtO gas to sterilize RMEs which may be sensitive to high temperatures and/or moisture when exposed to steam-based sterilization processes, has generally been replaced by other methods of low-temperature sterilization. VA is in the process of phasing out the us of EtO as an RME sterilization method. Some VA facilities, however, may still use EtO due to existence of instruments in their stock that can only be sterilized using this method. Since EtO is highly flammable, toxic, and carcinogenic, care must be taken to ensure that staff is not exposed to EtO during the sterilization or aeration processes.

The EtO sterilizers / aerators must be located in a fully contained room with an adjacent dedicated Abator room to ensure proper containment of gases. See ANSI/AAMI ST41 for design recommendations for EtO facilities and ANSI/AAMI ST58 for design recommendations for other types of chemical sterilization. OSHA currently regulates the use of and exposure to EtO under title 29 Code of Federal Regulations (CFR) 1910. 1047. Federal and state Environmental Protection Agencies (EPA) regulate EtO waste emissions and typically require construction, installation, replacement and operating permits.

Sterile Consumables (Soft Goods) Storage Although this space is provided in PG-18-9: 286: Logistics Service (FA 3, Room 9); its function is related to SPS and should be located in the SPS Receiving and Storage Area.

Scope Processing Since scope processing is managed and staffed by SPS; a centrally located area within the main SPS department is preferred to maintain and control consistent scope reprocessing. It may, however, be remotely located within the medical facility closer to the point-of-use. See ANSI / AAMI ST91 and ANSI / AAMI ST58 for design recommendations for scope reprocessing areas.

Other Planning Considerations The SPS layout design must provide physical separation between work areas for handling clean / sterilized instrument assembly, preparation, storage and dispatch and soiled materials. A soiled transition room must be provided between an adjacent circulation corridor and the main soiled work areas. Since Surgical Service is the largest user of SPS; SPS should be vertically stacked or located on the same level, adjacent to the Surgical Service.

If SPS is stacked vertically with the OR, dedicated clean and soiled cart transport elevators must be provided; the elevator shall be sized to accommodate transport case carts only. Dedicated dumbwaiters may be considered as back up for use during maintenance and unscheduled elevator down time.

Sterile Processing Service (SPS) 19

The internal workflow of SPS should be unidirectional so that soiled items flow progressively to the clean work areas. Similarly, clean items should flow to sterilization, to storage, to case cart staging, and finally to dispatch / issue.

Careful consideration must be given to both the type and placement of hand-washing stations and emergency eye-wash stations. Hand-washing sinks and alcohol-based hand-rub dispensers must be visible and accessible in all work areas as well as in the staff locker rooms, lounge and conference rooms. Refer to ANSI Z 58. 1-2009 and VHA-D-2009-29 for emergency eye wash / deluge shower requirements.

SPS should be designed for flexibility and adaptability to accommodate future expansion, storage capacity, and equipment / technology. Design for flexibility might include provision of space for utilities for additional instrument washer-decontaminator, steam sterilizers, and sterile supply storage equipment. Provide access panels where required to facilitate installation of future equipment.

VA healthcare facilities must plan for the event of catastrophic events such. SPS must have the ability to continue operations and /or assist other healthcare providers during times of need.

Space Planning The Department of Veterans Affairs’ PG-18-9: 285: Sterile Processing Service provides the Space Planning Criteria to be used in generating a baseline space program for a Sterile Processing Service project. It also includes background information relative to planning this department. PG-18-9: 285:

Sterile Processing Service has been implemented in the Space and Equipment Planning System (SEPS). A project created in SEPS will generate a Program for Design (PFD) based on answers to the Input Data Statements (IDSs) –PG-18-9: 285: Sterile Processing Service, Section 4- These statements relate to Mission, Workload, and Staffing parameters for the specific project. Once the PFD is generated, planners shall use it as a basis to develop the Space Program for the project by making the necessary adjustments, project based room nomenclature, NSF, or by adding or deleting specific rooms.

Codes and Standards Refer to the current applicable national, regional, and local codes and standards in addition to the VA specific guidelines and directives when designing a Sterile Processing Service department. Additional codes and standards, not listed below, may also apply.

VA Program Guides

VA Technical Information Library (TIL) https://www.cfm.va.gov/til/

1. PG-18-1: Master Construction Specifications

2. PG-18-3: Design and Construction Procedures

3. PG-18-4: Standard Details

4. PG-18-5: Equipment Guide List

5. H-18-8: Seismic Design Handbook

6. PG-18-9: Space Planning Criteria (implemented in SEPS) https://www.cfm.va.gov/til/ https://www.cfm.va.gov/til/

Sterile Processing Service (SPS) 20

7. PG-18-10: Design Manual (by discipline)

8. PG-18-10: Signage Design Manual

9. PG-18-13: Topic Specific Standards and Criteria

10. PG-18-14: Room Finishes, Door, and Hardware Schedule

11. Environmental Planning Guidance

VHA Directives, Handbooks and Manuals https://www.va.gov/vhapublications/

National Codes, Standards and Guidelines

1. AAMI TIR34: Water for the Reprocessing of Medical Devices. Association for the Advancement of Medical Instrumentation

2. ANSI ST Z358: Emergency Eyewash and Shower Equipment

3. ANSI / AAMI ST15883-1: Washer–Disinfectors

4. ANSI / AAMI ST41: Ethylene Oxide Sterilization in Health Care Facilities: Safety and Effectiveness

5. ANSI / AAMI ST58: Chemical Sterilization and High-Level Disinfection in Health Care Facilities

6. ANSI / AAMI ST77: Containment Devices for Reusable Medical Device Sterilization

7. ANSI / AAMI ST79: Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities

8. ANSI / AAMI ST91: Flexible and Semi-rigid Endoscope Processing in Health care Facilities.

9. ANSI / AAMI / ISO TIR 17665-2: Sterilization of Health Care Products

10. ANSI/ASHRAE/IESNA: Standard 90. 1

11. ASME A 17. 1: Safety Code for Elevators and Escalators

12. ASME B-31: Boiler and Pressure Vessel Code

13. Centers for Disease Control and Prevention (CDC): Guidelines for Environmental Control in Health-Care Facilities

14. Facility Guidelines Institute (FGI): Guidelines for Design and construction of Hospitals and Outpatient Facilities

15. General Services Administration (GSA): ABA Accessibility Standard for Federal Facilities

16. IES (Illuminating Engineering Society): Lighting Handbook.

17. International Building Code (IBC): Mechanical and Plumbing Codes

18. NFPA 70: National Electric Code

19. NFPA 99: Health Care Facilities Code

20. NFPA 101: Life Safety Code https://www.cfm.va.gov/environmental/ https://www.cfm.va.gov/environmental/ https://www.va.gov/vhapublications/ https://www.va.gov/vhapublications/

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21. The Joint Commission (TJC): Comprehensive Accreditation Manual for Hospitals

22. The Joint Commission (TJC): Environment of Care Emergency Management and Life Safety Standards

23. U. S. Access Board: American with Disabilities Act and Architectural Barriers Act Accessibility Guidelines (ADAAG)

24. U. S. Code: The Public Buildings Amendment Act, PL 100-678, (Nov 1988)

25. U. S. Department of Health and Human Services: Health Information Privacy (HIPPA)

26. U. S. Department of Justice: ADA Standards for Accessible Design

27. U. S. Department of Labor, Occupational Safety and Health Administration: OSHA 1910-1030 Blood borne Pathogens

28. U. S. Department of Labor, Occupational Safety and Health Administration: OSHA 3151-12R Personal Protective Equipment

29. U. S. Department of Labor, Occupational Safety and Health Administration: OSHA Title 29, Part 1910. 1047: Occupational Exposure to Ethylene Oxide

30. U. S. Department of Labor, Occupational Safety and Health Administration: OSHA Title 29, Part 1910. 95: Occupational Noise Exposure

31. U. S. Department of Labor, Occupational Safety and Health Administration: OSHA Title 29, Part 1926. 101: Hearing Protection

32. U. S. Environmental Protection Agency (EPA): Hospitals and Healthcare Facilities Must Use a Single Chamber when Sterilizing Medical Equipment with ETO

33. U. S. Food and Drug Administration (FDA): Guidance Document for Washers and Washer– Disinfectors Intended for Processing Reusable Medical Devices

34. U. S. Food and Drug Administration (FDA): Guidance for Industry and for FDA Staff— Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals

35. U. S. Access Board: Uniform Federal Accessibility Standards (UFAS)

36. United States Green Building Council (USGBC): Leadership in Energy and Environmental Design (LEED) Project Certification

Conflicts between nationally recognized codes and standards and VA requirements shall be brought to the attention of the VA. The resolution of conflict shall be made by the Authority Having Jurisdiction (AHJ) within VA to ensure consistency system-wide.

ARCHITECTURAL DESIGN (SPS)

Process Flow All SPS spaces shall be consolidated physically in one location with controlled access / egress for soiled and cleaned RMEs as well as staff. The Scope Processing Area may, however, be located closer to the point of use at a particular facility if authorized. The floor plan layout should reflect the SPS workflow

Sterile Processing Service (SPS) 22 and provide physical separation of soiled, cleaned and sterilized items in order to avoid the possibility of cross contamination.

To this end, the process flow shall be from the Decontamination Area to the Preparation and Assembly Area to the Storage Area. Also, HVAC and plumbing systems shall also follow this separation principle to avoid cross contamination opportunities. Design modularity shall be based on the type of equipment selected (sterilizers, washers, etc.) to allow for expansion in the future. If use of EtO is authorized, the design layout shall also provide adequate means of containment and purification of exhaust emissions;

locate the EtO room adjacent to the EtO Abator Room and the exterior envelope of the building in compliance with local, state and national regulations.

Figure 4 illustrates the process flow of Reusable Medical Equipment (RME) in the Sterile Processing Service department. It demarcates the soiled and clean sections and the relative location of the access / egress and vertical circulation within the facility.

Life Safety Fire Protection, Sprinkler Systems and Fire Alarm Systems shall be designed following criteria outlined in PG-18-10: VA Fire Protection Design Manual as well as all applicable local, state and national codes. The Sterilization Area shall be provided with fire separation (fire rated walls / partitions and doors). The fire exits shall be marked with illuminated signage. Fire alarms and extinguishers shall be provided in all work areas. All supplies must be stored at least 18 inches from sprinkler heads.

Accessibility Refer PG-18-13: VA Barrier Free Design Standard in addition to the Architectural Barriers Act Accessibility Standards (ABAAS) Standards: Appendices C and D to 36 CFR Part 1191; and ADA Standards for Accessible Design: (28 CFR Part 36).

Acoustics and Noise Control Provide acoustical separation between Decontamination, Scope Processing and Sterilization areas and any non SPS clinical or staff and administrative adjacent spaces. Also, provide sound-attenuation devices / elements in the Decontamination Room, the Instrument Assembly Clean Workroom and the Sterilization Area to control noise levels.

Figure 4: Process Flow Diagram (SPS)

Sterile Processing Service (SPS) 23

Security Access to the Sterile Processing Service work areas should be provided for authorized staff only. Refer to PG-18-10: Physical Security and Resiliency Design Manual for VA Facilities for information related to security for SPS.

Additional Architectural Design Considerations It is important to determine the security requirements of SPS facilities during the design process. SPS departments will be classified as Mission Critical. As a result, the design must be coordinated with each Medical Center to establish specific planning requirements related to the facilities’ security classification. This may include the requirement for, emergency power, alternate utility sources, and building hardening. At least one administrative office should have a direct line of sight into the clean work areas of the department.

INTERIOR DESIGN (SPS)

Refer to PG-18-10: Interior Design Manual for the Staff and Administrative Area and to PG-18-14: Room Finishes, Door, and Hardware Schedule for all Functional Areas.

Interior finishes of the SPS work areas should be aimed at promoting an adequate and safe environment for staff recognizing the unique function of each of the following Functional Areas: Decontamination, Scope Processing and Sterilization Areas. Durability, moisture and mold resistance, cleanability and high performance should be sought in selecting material and finishes for all work areas and support areas including storage spaces.

Flooring Floors shall be level with no ridges or bumps in order to prevent pools of water from forming, creating a slipping hazard. A level floor also promotes ease of movement of transport carts, case carts, and other wheeled equipment. Durable flooring materials that can withstand daily or more frequent cleaning as well as the application of chemical agents must be specified. Decontamination, Scope Processing and Sterilization work areas shall be specified with Epoxy based seamless flooring with a built-in waterproofing membrane. The floor to wall transition shall be coved to allow proper cleaning in order to preclude growth of microorganisms in the crevices.