NIH Design Requirements Manual
Section 2.3
November 27, 2012 Draft
Section 2.3
Animal Research Facility (ARF) Programming
2.3.1 General
This section describes planning and programming requirements for animal facilities constructed for biomedical research at animal biosafety level 2 (ABSL-2) or lower. There are a wide range of animal facility types including small animal facilities used primarily for rodents, rabbits and other small mammalian species; large animal facilities used primarily for cats, dogs, sheep, swine, non-human primates and other mid-sized mammalian species; farm animal facilities, breeding facilities, and others. This document focuses on small and large animal facilities which comprise most projects constructed for the NIH. For laboratory planning and programming, reference Section 2.1 (link). For ARF specific requirements, abide by this section. Additional requirements for facilities supporting ABSL-3 research are included in Sections 2.5 and 2.6.
NIH animal facilities shall be planned to ensure the welfare of both research animals and facility staff. Research facilities requiring animal use shall conform to The Guide for the Care and Use of Laboratory Animal, 8th edition (the guide). Conformance with this standard is required for accreditation by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC). Another primary standard used by AAALAC to evaluate animal care and use programs is the Guide for the Care and Use of Agricultural Animals in Research and Teaching (Ag Guide).
Animals shall not be housed in laboratories or spaces other than approved animal housing facilities for periods exceeding 24 hours unless the area is established as a satellite animal housing facility.
The NIH requires an integrated planning and design process which seeks the active and continuing participation of all stakeholders who are affected by the project from planning through activation and operation. A list of stakeholders to be involved is included in Section 2.1.1. Additional stakeholders that must be included for animal facility projects are veterinary, animal care and animal facility management staff. These individuals are the primary users and may reside within the facility. Investigators utilizing research animals housed within the facility may also need to be included to gain an understanding of research-specific procedures, equipment, and protocols that may affect facility design.
2.3.2 ARF Programming
Research animal facilities are process-driven workplaces. Material flow and standard operating procedures inform planning and design. Programming requires a thorough understanding of the specialized processes and activities to be conducted. Designers must verify the specific animal species to be housed, special procedures in place to ensure animal health and research integrity, animal husbandry processes and other factors that impact requirements. ARFs may be designed for small animals, large animals or a mix of species. Other specialized functions may include aquatics holding, insectaries and other less common animal models. Facilities shall be generically planned with the flexibility to accommodate multi-species housing to the greatest extent possible.
2.3.2.1 Project Parameters
Program development shall include identification of limitations and constraints that frame the project scope. The design team shall identify limitations during the programming phase so the challenges may be addressed appropriately in the design phase. Specific areas to be investigated are identified in section 2.1.2.1. Additional areas of concern for animal facilities are as follows:
a) Infrastructure: Utility services serving animal facilities require enhanced performance for dependability, control, airflow and redundancy. Infrastructure that is suitable for laboratories may not meet the requirements for animal facilities. Refer to engineering sections for further information.
b) Schedule and Phasing: Expanding or renovating existing, functioning animal facilities requires special consideration to ensure that ongoing operations are not disrupted or compromised since a variety of animal species are intolerant of noise and vibration. Utility outages are also problematic since research animals should not be exposed to environmental fluctuation and cannot be easily moved.
2.3.2.2 Data Collection
A needs assessment shall be conducted, starting with completion of the ARF Program Questionnaire. (link). The program questionnaire collects data on the general mission of the animal facility, species and quantities to be housed, animal health status, biosafety level(s), existing and projected staffing, procedure space requirements, equipment requirements, standard operating procedures, storage needs, and use/storage of hazardous chemicals, biologics, and radiologicals. Specific data to be collected is identified in section 2.1.2.2 (as applicable), supplemented as follows:
a) User Questionnaire: An ARF-specific questionnaire shall be completed by users. <LINK>
b) Animal Census: Quantity and species of resident animal colonies and their attendant caging requirements are primary factors affecting facility design. Caging may be fixed or mobile, static or ventilated. Cage size is governed by the guide as well as specific research protocols. Caging may be cleaned in place or require special laminar flow containment equipment for change-out and animal transfer.
c) Animal Health Status: Research animals are often purpose-bred and certified to be free of specific pathogens that can be transmitted to other animals or affect research outcomes. Specific Pathogen Free (SPF) animals require special handling procedures to ensure that their health status is not compromised. SPF animals may also need to be housed in barrier facilities separated from conventional, non-SPF animals.
d) Equipment: Animal facilities equipment typically includes caging, cage sanitation and decontamination equipment, procedure room equipment including biosafety cabinets, treatment tables and lights, surgical equipment, etc. An equipment schedule shall be used to collect the data, supplemented with manufacturer data sheets that identify variability in size, service clearances, utility demands, heat output, etc <LINK TO SCHEDULE>.
e) Standard Operating Procedures: Facility design and operating procedures are interdependent, and incomplete understanding of SOPs often results in functional design deficiencies. Every effort shall be made during the programming phase to document SOPs that have a direct affect on design. These include, at a minimum:
· Use of personal protective equipment (PPE)
· Entry and exiting procedures for different zones within the facility
· Cage handling and sanitation procedures
· Decontamination procedures (waste, space, caging, animal carcasses and material)
· Security protocols
· Feed, bedding and animal drinking water use, storage and disposal
· Animal intake and quarantine procedures
· Emergency management procedures
· Maintenance and repair procedures
2.3.2.3 Data Recordation
Comply with section 2.1.2.3. Additionally, record SOPs in either narrative or flow chart format.
2.3.3 ARF Planning
2.3.3.1 Location Considerations
Several factors should be considered in locating the ARF within a research building. Since these facilities typically require access to loading docks and heavy use of water prone to leakage to lower levels, a lower level location may be optimal. Other factors that may affect facility location include:
· investigator access
· animal transport
· security and intrusion protection
· environmental issues (odors, vibration, noise)
· utility maintenance access
· material handling
There may also be risk factors such as natural hazard mitigation and biosafety that should be considered to establish acceptable locations for the ARF within a building.
2.3.3.2 Space Requirements
Calculating optimal size for a vivarium begins with determining the animal holding capacity and procedure space requirements. These functions typically occupy approximately 50% of the overall net usable area for facilities operating at ABSL-2 or lower. Other functions will include sanitation (cage wash, decontamination), animal health (treatment, surgery, quarantine), personnel support (office, break) and logistics (loading dock, receiving, storage). The following chart illustrates proportional net space allocation for typical facilities.
This rule of thumb does not take into account special functions that may be incorporated such as advanced animal imaging, research-specific procedure rooms, isolation suites for barrier colonies, biocontainment suites, etc. Factors that affect animal holding and procedure space requirements are listed in section 2.4.5
2.3.3.3 Contamination Control
Layout, engineering controls and SOPs play a coordinated role in controlling the spread of infection within research animals housed in a facility. Animals, materials and personnel can be characterized as “clean” or “dirty”, referring to their potential for transmitting diseases to resident animals. For example, animals from an unapproved source are considered “dirty” until they have been evaluated for health status during a quarantine period. Feed, bedding and other incoming materials may also be considered “dirty” until decontaminated. Animal bedding and caging that is soiled from use may be considered “dirty” until it has been sanitized. Staff must also follow designated SOPs for gowning, hand wash, and circulating through the facility to minimize opportunities for cross contamination.
Areas of the animal facility that are prone to contamination and need to be protected by contamination control SOPs are located within a contamination control “Barrier”. Typically, these areas comprise animal holding and procedure rooms as well as animal support areas where caging is cleaned and decontaminated and “clean” expendable materials used within the facility are stored. The barrier is defined as the assembly of partitions, floors and ceilings that encapsulate this area. Personnel entering into the barrier must gown per established SOPs. Material entering into the barrier must be decontaminated. Anterooms typically afford access in and out of the barrier so that directional airflow can be maintained and gowning SOPs facilitated. Circulation of animals, materials, personnel and waste within the barrier should be configured to move from cleaner towards dirtier areas of the facility whenever possible to minimize opportunity for contamination.
In some facilities, additional suites are located within the overall vivarium barrier that require enhanced protection or containment. The perimeters of these suites are also protected by barrier-type enclosures and subject to additional SOPs and directional airflow.
2.3.3.4 Functional Relationships
The zones within an animal research facility include animal holding and procedure, vivarium support, personnel support, and logistics. Grouping compatible functions within their respective zones enhances contamination control and facilitates workflow. Circulation pathways between zones should be designed to facilitate directional movement of “clean” and “dirty” materials, animals, caging, waste, and personnel. The HVAC design must also be coordinated with the zoned planning approach to facilitate directional airflow from cleaner to dirtier areas. The following diagram illustrates the relationship among typical animal facility zones:
ARF Typical Relational Diagram
The Project Officer and the Programmer shall work with the facility representatives to prepare functional and adjacencies flow charts that will facilitate the design process. Adjacencies shall be planned to facilitate operational procedures, enhance contamination control and maintain zonal relationships. Proper arrangement of critical adjacencies enhances the process of animal based science, improves the quality of life of the animals, and facilitates animal caretaking SOPs. Appropriate adjacency planning also helps isolate noise and vibrations, economize circulation routes, and simplify facility operations.
a) Personnel Support Zone
The personnel support zone includes an administrative office area serving the facility manager, administrative staff, and technician cubicles where staff wear street clothes. It may also include a veterinarian office and conference/training room. This area should be located to serve as a “gateway” into the ARF, so that incoming staff, visitors and investigators can be received or observed prior to entering secure areas of the facility. The personnel support zone is categorized as “dirty” because there is limited control of potential contaminants in this area. Toilet / locker / gowning areas serve as a transition into the barrier, and should be located between the administrative area and the facility barrier. Gowning vestibules for donning PPE may be separate from the toilet / locker / shower room, and must be provided with sufficient floor area for PPE storage racks and disposal bins so as not to obstruct required circulation and egress paths. A break room is required for facility staff to use for consumption of food outside the barrier. In some cases, it may be appropriate to locate a staff write-up area and break facility within the barrier for caretaker convenience, but this requires special SOPs and must be approved by the veterinarian and facility manager. Separate toilet / shower / locker facilities are required for men and women, except in very small facilities.
b) Animal Holding and Procedure Zone
The animal holding and procedure zone is considered to be a “clean” area located within the barrier. Personnel entering this area must be gowned using PPE established by SOP. Material entering this area must be decontaminated per SOPs. Clean caging enters this area after sanitation in the cage wash area. Soiled caging is returned to the cage wash area via a separate pathway, or along the same path utilizing a movement/timing pattern that minimizes cross contamination between clean and soiled items. Animal holding and procedure spaces are often comingled so that animals do not need require excessive transport.
Procedure space may be general, shared rooms designed for generic procedures or highly specialized space customized for specific uses. In some cases, the program may require dedicated procedure rooms interconnected with the holding rooms they serve. Specialty procedure functions may include surgical rooms or suites, behavioral suites, animal imaging rooms, irradiation rooms, and other purpose-built areas. The number of required procedure rooms varies in accordance with species, equipment needs, and animal transport restrictions, however, sufficient generic procedure space should be provided to ensure flexibility for both current and future research initiatives.
c) Vivarium Support Zone
The primary activity within the vivarium support zone is cage processing including cleaning and decontamination of caging and caging accessories, soiled bedding removal, and preparing caging for return to animal holding rooms. Many of these activities occur in the cage wash area, which shall be divided with a dirty side for incoming soiled caging and a clean side for caging that has passed through sanitation equipment. Facilities housing SPF animals may also require a sterile caging area adjacent to clean cage wash for caging set-ups that have been autoclaved. Other areas include feed and bedding storage, clean cage storage, and diet kitchen for large animal facilities that prepare fresh feed. Soiled caging and waste shall be routed along separate pathways than clean material and caging to the greatest extent possible. If separate clean and dirty circulation cannot be fully achieved, a single corridor may be utilized with one-way circulation or time separated clean and dirty use. Cage processing SOPs must be confirmed by veterinary and caretaker staff, and proposed SOPs must be described.