Attachment 1 Animal Husbandry Statement of Work 2023 (003).pdf

ATTACHMENT #1

NIEHS LABORATORY ANIMAL HUSBANDRY AND TECHNICAL SUPPORT

SERVICES

TABLE OF CONTENTS

I. BACKGROUND

II. SCOPE OF WORK

III. KEY PERSONNEL AND POSITION REQUIREMENTS

IV. STATEMENT OF WORK STATEMENT REQUIREMENTS

V. NIEHS ANIMAL FACILITY DESCRIPTION AND OPERATIONS

VI. SPECIFIC TASKS

1. Animal Husbandry

2. Animal Care Support

3. Animal Data/Transportation

4. Feed and Bedding Technical Support

5. Animal Facility Maintenance/Housekeeping

6. Breeding Colony Technical Support

7. Transgenic Technical Support

8. Isolator Technical Support

9. Facility Data Management Support

10. Animal Feed and Bedding Support

11. Facility Operations Support Service

12. Module Supervisory Support

13. Remote Facilities Support

14. ACUC Support

15. Program Support

16. Project Support

17. Animal Health Technical Support

18. QAL Technical Support

19. Toxicology Technical Support

Optional Positions

20. Laboratory Animal Veterinary Support

21. Information Technology Support

22. Aquatics Technical Support

23. Administrative Support

I. REPORTING AND DELIVERABLES

A. Biweekly Reports B. Monthly Progress Report and Animal Census Reports C. Monthly Labor Summary D. Report of Employee Health Status

I. BACKGROUND

The National Institute of Environmental Health Sciences (NIEHS) is one of 27 institutes and centers of the National Institutes of Health (NIH), which is a component of the U.S. Department of Health and Human Services (HHS). NIEHS is in Research Triangle Park (RTP), North Carolina. NIEHS’s broad focus on the environmental causes of disease makes the institute a unique part of the NIH. NIEHS is home to the National Toxicology Program (NTP), the nation’s premier program for testing and evaluation of agents in our environment. The focus of the NIEHS research is to discover how the environment affects people in order to promote healthier lives. At the NIEHS, we incorporate sustainability into our mission to ensure that we have, and will continue to have, the resources needed to protect human and environmental health indefinitely. The NIH and NIEHS recognize that sustainable operations align with our mission to enhance our current understanding of the relationship between human and environmental health.

The Animal Husbandry Support Contract for the National Institute of Environmental Health Sciences provides care, maintenance, and technical services for laboratory animals, seven (7) days per week, including weekends and holidays, for 72,447 square feet of laboratory animal facility space (which includes ancillary support areas outside of the main facility, including a separate facility located approximately one mile from the main facility). This contract supports the work of approximately 40 Principal Investigators, with over 137 Animal Study Proposals, and a daily inventory of 44,000 animals, including over 500 transgenic strains. The animals must be maintained under carefully controlled conditions to allow the accurate interpretation of research results. The contractor is responsible for the care and maintenance of the animals, the sanitation of equipment, technical training, and the general maintenance of the facilities in such a manner as to maintain the highest level of Accreditation from the Association for Assessment and Accreditation of Laboratory Animal Care, International (AAALAC, Intl.) The services provided by this contract are considered mission critical.

II. SCOPE OF WORK

The objective of this contract is to provide uniform, consistent, high-quality animal husbandry, and technical support services by utilizing experienced and well-trained staff, preferably certified by the American Association for Laboratory Animal Science (AALAS). The Contractor shall furnish the necessary personnel, materials, and services (except as otherwise specified) for the efficient performance of duties commonly termed "animal care services" in support of the Performance Work Statement for the operation of the NIEHS Animal Facility. The contract staff will function as an integral part of the Government’s research program by providing basic animal husbandry, technical and support services to the NIEHS institute. The Contractor shall provide a results-oriented approach with an emphasis on quality, consistency in the level of effort, professionalism, continuous improvement, and excellence.

Principle functions include, but are not limited to:

The contractor will be responsible for establishing pedigreed rodent breeding colonies, performing complicated surgical techniques, supporting complex behavioral research and equipment, and diagnostic evaluation of laboratory animals in support of research programs and objectives. The contract will be responsible for the breeding, perpetuation, and potential expansion of the various strains of research colony rodents, which includes over 500 transgenic knock-out/knock-in and mutant mouse lines. The contractor will also evaluate the reproductive efficiency of all in-house rodent breeding colonies including transgenic colonies and identify reproductive problems and make recommendations for improvement. The contractor will prepare working protocols for each breeding colony, including the determination of strain viability, production rate, data collection and data assimilation, and unique phenotypic characteristics. This must be accomplished by establishing and maintaining excellent working relationships with the principal investigators. The contractor is also charged with the production, husbandry, and sample collection of an in-house sentinel program; to include maintenance of a specific pathogen-free gnotobiotic program; to include maintenance of a specific pathogen-free gnotobiotic colony of rodents.

The Contractor will also be responsible for all aspects of husbandry and animal care which includes feeding and watering animals; animal health surveillance; monitoring animal micro and macro environment conditions; monitoring and maintaining Individually Ventilated Cage

(IVC) systems, sanitation and cleaning of cages and rooms, ensuring that biosecurity and biocontainment are maintained across areas with varying animal health/pathogen status. The contract is also responsible for any aquatic research animals that may be introduced to the program during this contract performance period. This includes but is not limited to the care and husbandry of various species and strains of aquatic animals, water testing and monitoring to maintain acceptable variables, health assessments, and medical treatments.

The contractor will perform technical procedures (e.g. injections, gavage) in direct support of researcher experiments and will perform researcher training on animal handling. The contractor will also identify animals by performing ear punches; tail, toe, or foot pad tattoos; or microchip implantations as directed. The Contractor will collect tissue samples for rodent genotyping, perform anesthesia for procedures, and perform humane euthanasia as dictated by the regulatory committees overseeing animal research.

The Contractor will administer routine treatments to animals when prescribed by veterinary staff. The Contractor will order, receive, inspect, and inventory deliveries of feed, bedding, equipment, and supplies, and maintain animal room equipment and inventory. The Contractor will receive, inspect, deliver shipments of in-house animals/caging/tissue samples within a 25 mile radius of NIEHS, and prepare animals for both intra and intercontinental shipments. The Contractor will operate and monitor the performance of autoclaves, cage washers, rack washers, bedding dispensers, bottle washers, and bottle fillers, vacuum cleaners, and floor scrubbers. The Contractor will provide housekeeping to the entire animal facility and support areas.

The Contractor will provide around-the-clock coverage for routine scheduled maintenance outages as well as coverage for unforeseen outages as needed (to be billed outside of fixed pricing with the approval of the COR). The Contractor will perform the data management of animal inventory, cost accounting, and animal study proposals using Sirius animal facility management software.

The Contractor will perform necropsies and record findings on Animal Health Reports and perform sample collection (urine, feces, tissues, whole blood and/or blood products, parasites, microbiological cultures) fixation and/or freezing of samples.

The Contractor will be responsible for training all new contract employees as well as providing a minimum of 20 hours per contract year of on-going training for the entire staff.

The Contractor will be responsible for providing a facility orientation and handling and technical procedure training to new lab personnel working on an approved Animal Study Proposal and confirm competency prior to the ACUC office’s approval for facility access.

The contractor will train laboratory personnel on advanced technical procedures upon request.

The Contractor will ensure that all activities are performed in compliance with all CMB/NIEHS safety and sanitation policies relating to COVID 19 (or any other human health circumstances), to include, but not limited to maintaining social distancing, wearing of masks (or other NIEHS-mandated PPE), and heightened sanitation procedures. To comply with social distancing requirements, the Contractor may have to alter or stagger onsite staffing levels or employee breaks or operate outside of normal working hours with approval of the COR.

III. KEY PERSONNEL AND POSITION REQUIREMENTS

a. Commitment of Personnel

i. Contractor personnel shall provide services and work in a professional and courteous manner and abide by applicable NIEHS rules, regulations, and procedures when working at NIEHS. The level of competence/certification as described will apply throughout the life of the contract unless otherwise mutually agreed upon by the Government and the Contractor. Personnel failing to achieve certifications within the specified time period may be granted extensions if mutually agreed upon by the Government and the Contractor. It shall be a goal of the Contractor that personnel become AALAS certified at the highest levels. All personnel having contact with animals shall become certified at the ALAT level within 12 months after beginning work. Incumbent employees shall become certified within 1 year of the anniversary date. Additional certifications are required for specific positions as noted with the positions descriptions that follow. Personnel assigned by the contract to perform the work described must pass a government background check and be literate in English.

Key Personnel

ii. For the success of the performance of this contract, the following positions are designated as “Key Personnel”.

The Contractor shall assign “key personnel” to work under this contract, and shall not reassign them without the approval of the COR. The following positions have been designated as “Key Positions” under this contract.

Project Manager Assistant Project Manager Colony Management Supervisor Breeding Specialist ACUC Coordinators Veterinary Technician Information Technology Specialist Facility Data Manager Veterinarian * Compliance Specialist * Technical and Remote Support Specialist Program Support Coordinator Projects Support Coordinator

iii. *Optional Positions should not be considered a factor for fixed pricing. Optional positions, if exercised with COR approval, will be billed as additional labor hours.

The contractor shall submit to the COR the recommendation, resume and copies of certifications /educational degrees for key positions within 15 days prior to the employee’s anticipated start date. The Government will review and evaluate the qualifications and experience of individuals applying for all positions before acceptance by the Government to work on the contract. The level of competence required for each position as outlined in “Position Descriptions and Qualifications of Personnel” shall apply through the lifetime of the contract unless otherwise mutually agreed upon by the Government and the contractor. Upon receipt of the resumes, the Government will notify the contractor within (10) working days if the recommendations for the key positions are acceptable. No substitutions of Key Personnel shall be made within the first (90) ninety days of performance unless necessitated by attrition. It is the expectation of the Government that incumbent employees be offered the first right of refusal for positions on the contract.

b. On-Site Project Manager

i. Position Description: The responsibilities of the Project Manager shall include but not be limited to the following:

direct on-site management of project/contract, general supervision and control of staff resources, assure accomplishment of performance goals, provide contract deliverables, assure compliance with facility SOP’s, maintain a health and safety program, provide a continuous improvement and training program for staff, provide management guidance to the Assistant Project Manager and Supervisors, and meet with the COR weekly or as needed.

ii. Qualifications: Shall be certified by the American

Association for Laboratory Animal Science (AALAS) as Laboratory Animal Technologist (LATG) with at least 6 years of experience in an animal facility, three of which shall have been in a supervisory capacity. Experience in the management of operations in highly populated rodent facilities, and oversight of multiple supervisors and facilities, and/or functional groups is strongly preferred. A strong understanding of the requirements for AAALAC accreditation and site visits and the NRC Guide for the Care and Use of Laboratory Animals (the Guide) and a working knowledge of computer software, particularly eSirius or a comparable electronic facility management system, Microsoft WORD and Excel are essential for job performance.

c. On-Site Assistant Project Manager

i. Position Description: The responsibilities of the Assistant

Project Manager shall include but not be limited to, the following: direct on-site supervision and training of supervisors, planning and control of staff resources to assure coverage of all tasks, conducting quality assurance inspections, assure compliance with facility SOP’s provide a continuous improvement and training program, provide technical and management guidance, assure performance goals are achieved, to confer with the COR as needed and act as on-site Project Manager in the absence of the Project Manager.

Laboratory Animal Technologist (LATG). If not certified upon employment, LATG certification is mandatory within one year. Must have 4 years’ experience in a rodent animal facility, two of which shall have been in a supervisory capacity. Formal education may be substituted for experience with approval from the COR.

Additional training in microbiology, biology and animal husbandry and rodent breeding is required. Familiarity with the requirements for AAALAC accreditation and the NRC Guide for the Care and Use of Laboratory Animals (the Guide) and a working knowledge of computer software, particularly eSirius or a comparable electronic facility management system, Microsoft WORD and Excel are essential for job performance.

d. Colony Management Supervisor

i. Position Description: The Colony Management Supervisor oversees all aspects of contract-supported breeding, colony management, and genotyping activities.

The Colony Management Supervisor works with the NIEHS Investigators and Veterinarians in coordinating new and ongoing rodent breeding studies. This position reports directly to the Contract Manager/Assistant Manager. The Colony Management Supervisor will provide direct supervision to the Colony Managers, and will provide supervision of, in coordination with the Module Supervisors, the Breeding Technicians. Overseen responsibilities shall be performed as outlined in the

Statement of Work.

ii. Qualifications: Shall have at least 4 years of experience in a rodent lab animal facility and be knowledgeable in transgenic rodent breeding techniques and must have at least three years of experience with rodent production colonies. Must have at least two years of supervisory experience. Must be AALAS certified at the Laboratory Animal Technologist (LAT) level; Laboratory Animal Technologist (LATG), encouraged and preferred.

Knowledge of computer software, particularly Microsoft WORD and Excel are essential for job performance.

e. Breeding Specialist

i. Position Description: The Breeding Specialist reports to and works at the direction of the Colony Management Supervisor. The Breeding Specialist assists the Colony Management Supervisor in the oversight of contract supported breeding activities, manages colonies including performing quality assurance activities and assuming Colony Management Supervisor responsibilities in their absence. The Breeding Specialist will possess a strong understanding of all contract-supported colonies, so they can fill in for absent Breeding Technicians and Colony Managers and perform contact breeding duties as needed.

ii. Qualifications: Shall have at least 3 years of experience in a rodent lab animal facility and be knowledgeable in transgenic rodent breeding techniques and must have at least two years of experience with rodent production colonies. Must be AALAS certified Laboratory Animal Technologist (LATG); if not certified upon employment, LATG certification is mandatory within one year.

Knowledge of computer software, particularly Microsoft WORD and Excel are essential for job performance.

f. ACUC Coordinators

i. Position Description: The ACUC Coordinators will report directly to the Contract Manager and coordinate activities with CMB Animal Care and Use Program

Coordinator. The ACUC Coordinators will occasionally receive guidance and input from the Chief/Deputy Chief of the Comparative Medicine Branch and other on-site Government personnel. Responsibilities shall be performed as outlined in the Statement of Work.

ii. Qualifications: Shall have at least 2 years of experience in a research animal setting. Must be AALAS certified Laboratory Animal Technologist (LATG); if not certified upon employment, LATG certification is mandatory within one year. CPIA certification is preferred and encouraged.

Knowledge of computer software, particularly Sirius or comparable facility management system, Microsoft WORD and Excel are essential for job performance. Must have excellent interpersonal, as well as, communication skills, both oral and written, and knowledge of lab animal regulations and policies. AALAS certification preferred, but not mandatory.

g. Veterinary Technician

i. Position Description Veterinary Technicians provide primary clinical care to NIEHS research animals and are responsible for managing the Animal Health Report mechanism. Veterinary Technicians assess animals reported to be sick, initiate a course of action or treatment plan, and communicate that plan to research and animal care staff. Veterinary Technicians perform and direct supportive care activities for sick animals and monitor and document all active clinical cases. Veterinary Technicians also provide a wide range of researcher technical support and training activities, including animal surgery, behavioral equipment and study support, and imaging activities.

ii. Qualifications: Shall be certified by the American Association for Laboratory Animal Science (AALAS) as a Laboratory Animal Technician (LAT) and/or a current Registered/Licensed Veterinary Technician (RVT) credential, acquired through a program accredited by the American Veterinary Medical Association (AVMA)/Committee of Veterinary Education and Activities (CVTEA). Prefer at least three years of veterinary technician experience, a year of which in a laboratory animal setting. If not currently certified at the LAT level, must be able to sit for the exam within 6 months.

i. Information Technology Specialist: (Optional)*

i. Position Description: The Information Specialist will report directly to the Contract Manager but will occasionally receive guidance and input from the Chief Animal Resources Section, Chief/Deputy Chief of the Comparative Medicine Branch and other on-site Government personnel. Responsibilities shall be

ii. Qualifications: Formal education must include a minimum of a B.S. degree in computer sciences. Formal education may be substituted for experience and extensive experience may be substituted for formal education with approval from the COR. Knowledge of computer hard and software, program development, Sirius, Microsoft WORD and Excel are essential for job performance. Evaluate programs and make recommendations for purchase of hardware and software applications. Certification by the American Association for Laboratory Animal Science is not mandatory.

h. Facility Data Manager

i. Position Description: The Facility Data Manager will report directly to the Assistant Manager/Contract Manager, however, will occasionally receive guidance and input from on-site Government personnel. Responsibilities shall be performed as outlined in the Statement of Work.

ii. Qualifications: Shall have a minimum of a high school diploma or GED equivalent with a minimum of one to two years of experience in computer applications and services.

Must have working knowledge of software applications (MS Word, Excel, Power Point, and Access). Ability to use eSirius application will be mandatory. Ability to be multi-task oriented, generate query reports, being a team player and organizational skills are essential. AALAS certification is preferred but not mandatory.

i. Veterinarian: (Optional)*

i. Position Description: The Veterinarian will report directly to the Contract Manager but will receive direction from the Chief/Deputy Chief and Veterinarians of the Comparative Medicine Branch. Responsibilities shall be performed as outlined in the Statement of Work.

ii. Qualifications: Shall have strong rodent clinical skills and preferably have experience with transgenic rodents.

The Veterinarian must be a DVM or VMD licensed in a state and have at least 5 years of experience, as a veterinarian, in a lab animal program. ACLAM board certification or eligibility strongly preferred.

j. Technical and Remote Support Specialist

i. Position Description: The Technical and Remote Support Specialist will report directly to the Contract Manager/Assistant Manager. The Technical and Remote Support Specialist will oversee training and competence activities for contract technical staff and will oversee animal care and technical support services for remote facilities, including the Conventional Animal Facility (CAF) and C129. Ensure compliance, including the social housing program, review of animal rooms and husbandry documentation, and management of cubicle space. Review and development of Standard Operating Procedures (SOP) in conjunction with the Animal Resources Program Manager. Responsibilities shall be

Association for Laboratory Animal Science (AALAS) as a Laboratory Animal Technician (LAT) with at least 3 years of experience in an animal facility; certification as and Laboratory Animal Technologist is encouraged and preferred. At least one year of experience in supporting rodent breeding colonies, performing rodent technical procedures (e.g. injections, gavage, etc.), and providing and overseeing training and technical competence in other personnel is preferred. Knowledge of computer software, particularly PowerPoint, Microsoft WORD and Excel are essential for job performance.

k. Program Support Coordinator

i. Position Description: The Program Support Coordinator provides support services to CMB across a wide range of animal care program activities. The incumbent oversees the Experimental Study Sheet (ESS) process, which is the primary mechanism to communicate animal study information and coordinate animal study support across all parties involved (researchers, supervisors and facility management, animal care and technical support staff, and veterinary staff.) The incumbent receives ESS from NIEHS research personnel, compares proposed study activities to Animal Study Proposals to ensure compliance, and communicates with animal facility management personnel to facilitate animal housing and technical support. The incumbent works extensively with the eSirius census and protocol management program, providing IACUC support, assisting with animal procurement and delivery activities, and facilitating the animal transfer and transport process, whereby animals are transferred from breeding to experimental protocols and transported to study locations. The incumbent also facilitates the ordering of animal facility supplies, working with internal NIEHS warehouse personnel as well as with external vendors

Laboratory Animal Technologist (LATG) with at least 3 years’ experience in an animal facility, with a strong background in providing and coordinating support across multiple functional groups. Experience in working with the eSirius system, and with procurement of animals and ordering of supplies. Experience with IACUC protocol review, and familiarity with the requirements for AAALAC accreditation and the NRC Guide for the Care and Use of Laboratory Animals (the Guide).

l. Project Support Coordinator

i. Position Description - The Project Support Coordinator assists both CMB and NIEHS researchers in the performance of both one time and ongoing projects. The incumbent assists CMB and NIEHS researchers in the design, implementation, and interpretation of research studies. The incumbent also supports, coordinates, and implements CMB improvement projects, including the integration of technology to enhance efficiency and workflow to include, but not limited to, animal census, reporting, tracking and documentation of clinical cases, and genotyping and rodent colony management activities.

The incumbent works with both CMB personnel and external vendors to facilitate implementation, training, and troubleshooting of associated devices and programs.

Laboratory Animal Technologist (LATG) with at least 3 years’ experience in an animal facility. Formal education must include a minimum of a B.S. degree in the animal or other biological sciences, e.g. zoology, biology, microbiology, veterinary science (MS preferred).

Additional experience in the performance of experimental/study activities in a biomedical research setting is required. Experience with rodent colony management, and a working knowledge of computer software, particularly eSirius or a comparable electronic facility management system, Microsoft WORD and Excel are essential for job performance.

m. Compliance Specialist (Optional*)

i. Position Description Monitors all animal care and support activities to ensure compliance with established Standard Operating Procedures. The assessment will focus on the condition of the facility and associated documentation. Assessment of areas will be included, but not limited to inspections of animal and procedure room, feed and bedding areas (both bldg. 101 and 104), clean corridors, cage wash areas, the conventional animal facility. Position will maintain an inventory of all equipment requiring certification, perform light level readings, coordinate SOP reviews, organize facility walk throughs in preparation for AAALAC site visits. Oversee the tracking of the animal studies and cubicle space, attend study meetings, and ensure contract staff are familiar and understand special requirements per study.

Laboratory Animal Technologist (LATG) with at least 3 years’ experience in an animal facility. Laboratory animal experience in a supervisory capacity preferred. A working knowledge of computer software, particularly eSirius or a comparable electronic facility management system, Microsoft WORD and Excel are essential for job performance.

n. Other Personnel: All positions listed below are designated as

“other personnel”. The Contractor shall provide the COR for review and comment, within (5) five working days of the initial start date of employment, the resume of the proposed employee with related work qualifications, education, and certificate or proof of AALAS certification along with medical and security clearances. All employees will have a minimum of a high school diploma or GED equivalent. Other necessary minimal certifications are listed with specific positions. Incumbent employees, who have not met the certification requirements for their current positions, shall be granted 12 months to obtain certification. New employees or newly promoted employees will have 12 months to register for the AALAS certification appropriate for their position and an additional 12 months to obtain the required certification. (The COR may waive the certification requirement based on experience and performance).

Positions Certification Level Breeding Technician LAT Cage wash Technician N/A

Colony Managers LATG Data/Transport Coordinator ALAT Feed and Bedding Technician N/A Housekeeping Technician N/A Husbandry Technician ALAT Isolator Technician ALAT Module Supervisor I LAT Module Supervisor II LAT Support Operations Supervisor LAT Operations Ass. Supervisor LAT Animal Bedding, Feed and Transport Supervisor LAT

QA Technician LAT Toxicology Technicians LAT

o. The performance of duties shall conform to the most recent version of the NRC Guide for the Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/Guide-for-the-care-and-use-of-laboratory-animals.pdf) as well as the PHS Policy for Humane Care and Use of Laboratory Animals, the Animal Welfare Act PL 89-544 and amendments, NIH Manual Policy 3040-2, and the Association for the Assessment and Accreditation of Laboratory Animal Care, International (AAALAC International) standards.

p. Contractor activities shall be conducted in Government owned or leased facilities within the designated contract service area.

The Government shall provide animal holding, surgical and procedure space, cage wash facilities, office and laboratory space, restroom, shower and locker areas, storage and other support space required to conduct the contract. These facilities may be shared with Government staff. No detergents, disinfectants, pesticides or other materials shall be provided by the Contractor unless approved by the head of the NIEHS CMB Quality Assurance Laboratory (QAL) via submission to the Contracting Officer’s Representative (COR).

q. All animal room space assignments shall be made by the COR or his/her designee.

http://grants.nih.gov/grants/olaw/Guide-for-the-care-and-use-of-laboratory-animals.pdf

r. Where corrective actions by the Contractor are required which could in any way affect research programs, the Contractor shall inform the COR prior to taking any action unless an emergency which threatens the well-being of the animals, and the research mission requires immediate action. In the case of such an emergency, the Contractor may take remedial action deemed appropriate by the industry for an animal research environment such as NIEHS, followed by immediate notification of the

COR.

IV. STATEMENT OF WORK REQUIREMENTS

1. The Contractor shall submit all deliverables to the Contracting

Officer’s Representative for inspection and acceptance.

2. The contractor shall establish pedigreed rodent breeding colonies, performing complicated surgical techniques, and diagnostic evaluation of laboratory animals in support of research programs and objectives.

3. The contractor shall provide breeding, perpetuation, and potential expansion of the various strains of research colony rodents, which includes over 500 transgenic knock-out/knock-in and mutant mouse lines.

4. The contractor shall evaluate the reproductive efficiency of all in- house rodent breeding colonies including transgenic colonies and identify reproductive problems and make recommendations for improvement.

5. The contractor shall prepare working protocols for each breeding colony, to include determination of strain viability, production rate, data collection, project goals and data assimilation. Establishing and maintaining excellent working relationships with the principal investigators is necessary to accomplish this goal.

6. The contractor shall provide the production, husbandry, and sample collection of an in-house sentinel program; to include maintenance of a specific pathogen free gnotobiotic colony of rodents. This will include operation and maintenance of the isolator units as well as well as collecting samples for quality assurance and preparation and sterilization of feed, water and other supplies used in the isolators.

7. The contractor shall provide all aspects of husbandry and animal care which includes feeding and watering animals; animal health surveillance; monitoring room environment conditions; monitoring and maintenance of Individually Ventilated Caging (IVC) systems, sanitation and cleaning of cages and rooms.

8. The contractor shall provide support for any aquatic research animals. (Currently there are no aquatic animals housed in the animal facility) This includes, but is not limited to the care and husbandry of various species and strains of aquatic animals, water testing and monitoring to maintain acceptable water quality for the species being housed (as determined be the facility veterinarian), health assessments and medical treatments.

9. The contractor shall identify animals by performing ear punch; tail, toe or foot pad tattoos; or microchip implantations as directed.

Collection of tissue samples for rodent genotyping, performing anesthesia for procedures, and humane euthanasia as prescribed by the standard operating procedure for euthanasia.

10. The contractor will support use of the primary NIEHS genotyping service. Ensure sample drop box/kiosk is stocked with needed supplies and tissue samples shipped at scheduled intervals.

Support associated web-based colony management software, interfacing with the vendor, NIEHS researchers, and contract staff.

11. The contractor shall administer routine treatments to animals when prescribed by veterinary staff. They will perform necropsies and record findings on Animal Health Report. Perform sample collection (urine, feces, tissues, whole blood and/or blood products, ecto/endo parasites, and microbiological cultures) and process by fixation and/or freezing of samples.

12. The contractor will provide animal study support to NIEHS researchers. Perform technical support to include weighing and dosing. Provide animal handling and technical procedure training to NIEHS research personnel. Support on weekends and holidays may be required.

13. The contractor will provide training to NIEHS animal users, Facilities Management Branch (FMB) personnel, and contractors/vendors. Provide animal facility orientation to the building 101 and the CAF animal facilities for animal users as a prerequisite to their gaining animal facility access. Training will focus on safely working with facility equipment and compliance with CMB policies and procedures. Training to FMB and contractors will focus on maintaining biosecurity while performing work in the vivarium.

14. The contractor shall maintain animal room equipment and inventory. Order, receive, inspect, and inventory deliveries of feed, bedding, equipment, and supplies. Receive and house animal from outside vendor sources and notify Animal Resources Management promptly if any discrepancies with the orders are identified. Receive, inspect, deliver shipments of in-house animals within a 25-mile radius of NIEHS, and prepare animals for intra and intercontinental shipments in accordance with state, federal and international regulations.

Instructions for preparing individual shipments will be provided to the contractor by NIEHS import/export staff. Operate and monitor performance of autoclaves, cage washers, rack washers, bedding dispensers, bottle washers and bottle fillers, vacuum cleaners, and floor scrubbers.

15. The contractor shall provide housekeeping to entire animal facility and support areas. Provide around the clock coverage for routine scheduled facility maintenance outages that have an impact the animal housing environment, as well as coverage for unscheduled emergency situations. Perform the data management of animal inventory, cost accounting, and the animal study proposals using the eSirius animal facility management software. The contractor shall train all new employees as well as provide on-going training for the entire staff.

16. Safety and Health: Many of the animals used by NIEHS scientists are on experiments that involve chemicals, radioactive hazards, blood borne pathogens, radioisotopes or other biologic hazards.

The Contractor shall work closely with the COR and the NIEHS Health and Safety Branch to assure that all experiments are conducted without hazard to the animal-care staff, other facility occupants, and laboratory animals. As part of this safety program, contractors shall wear safety shoes. Open toed shoes (sandals) or shorts are not allowed while working in the animal facility. The Contractor shall provide an effective program for employee training in occupational health and safety. This program is to include the use of bio-safety cabinets and other equipment used in high hazard studies involving animals and also provides competence in routine mechanical, fire and electrical safety practices. Training must also specifically facility safety address procedures associated with COVID 19 and/or other health concerns. Once each employee has completed the Contractor’s occupational health and safety program, the assurance statement of program completion containing the signature of each employee adjacent to the date of completion is to be delivered to the COR.

Prior to starting work in the animal facility, the contractor resume must be accompanied by a statement by the Contractor’s physician for occupational fitness that state that “…this person is fit for duty.” Records of the physicians physical examination, vaccinations and other test results must be kept on file and maintained by the physician or the contractor for the duration of the contract and for the period of time upon completion of the contract as specified by OSHA 29.CFR, 1910.20 and 1920.1030 (Blood Borne Pathogens) and any other applicable local, state, and Federal regulations.

The contractor shall provide pre-employment medical screening.

The screening must include, as a minimum, a complete medical examination demonstrating fitness for work. This screening must include a physical examination, complete blood count, serum chemistries, up-to-date vaccinations including hepatitis and tetanus, complete drug screen to be reviewed by a physician for occupational fitness. In addition, the Contractor shall establish a medical surveillance program equivalent to the Medical Surveillance Program, conducted biennially for each employee by the NIEHS for employees working in the animal facility, as well as a surveillance program for employees exposed to radioisotopes.

Physicals for incumbent employees shall be scheduled 24 months from their last exam. The Contractor shall, at any given point, conduct a random drug test if deemed necessary or if required by the government in a case where drug paraphernalia is found in the animal facility.

Any proposed contract employee may be refused a position if there is a history of abnormal health findings disclosed by the medical examination; an inability to obtain a statement from the Contractor’s occupational fitness physician that this person is “fit for duty”; a positive drug or alcohol screen; or inability to wear a positive pressure respirator discovered by pulmonary function testing.

V. NIEHS ANIMAL FACILITY DESCRIPTION AND

OPERATIONS

1. Physical Security: NIEHS Security services are provided under separate contract to the NIEHS; however, the Contractor shall be responsible for safeguarding all Government property within the Contractor’s designated work areas. At the end of each work period, all facilities and equipment shall be secured, and any missing or damaged items must be promptly reported to the COR or NIEHS Security Services if the COR is unavailable.

2. Service Hours: The Contractor shall provide personnel to manage and care for all animals maintained in these facilities 7 days a week, 365 days a year to include weekends and Government holidays. The contractor’s on-site services shall encompass a 9 hour work period, five days a week, Monday through Friday exclusive of Saturdays, Sundays, and Federal Holidays. During the Monday through Friday work week, the Contractor shall provide coverage in the facility from 7:00 to 5:00 p.m., this allows for an 8.5-hour flexible work schedule for facility personnel.

Personnel may at times be required to vary their work schedules in order to provide support to the activities of the facilities. The lunch break shall not be omitted to reduce the span of the work schedule.

3. Weekend/Holiday: Weekend/Holiday services shall be provided commencing no later than 8:00 a.m. (but no earlier than the light cycles in the animal rooms allow) on all federal holidays, Saturdays, Sundays and on NIEHS closure days in order to satisfactorily accomplish all regular animal husbandry and technical services as required to meet various task goals. During the weekends and holidays, supervisory personnel shall be on-site to effectively manage personnel staffing for the activities of the day and shall provide a written report detailing the weekend’s activities and any animal health issues identified during the shifts.

Staffing on weekends shall be no less than 5 animal care staff, one of which shall be a supervisor, and a minimum of one breeding technician or colony manager.

4. The Federal Government’s holidays are listed below:

New Year's Day January 1st Martin Luther King Day Third Monday in January Presidents Day Third Monday in January Memorial Day Last Monday in May Juneteenth June 19th Independence Day July 4th Labor Day First Monday in September Columbus Day Second Monday in October Veteran's Day November 11th Thanksgiving Day Fourth Thursday in November Christmas Day December 25th

5. In the case of an additional holiday being added by executive order, the contractor will be required to provide normal facility coverage. The contractor may be dismissed early at the discretion of the COR.

6. Extended Services:

Special and emergency situations (unusually heavy workload, Government equipment breakdowns, planned or unplanned physical plant outages, pandemics/public health concerns, emergency services, and inclement weather) as determined by the COR, may necessitate that the Contractor provide additional or staggered level of effort to operate on an extended basis.

The Contractor shall provide extended or staggered services as requested by the COR or his/her designee. The extended or staggered hours to be worked shall be specifically authorized in advance by the COR or his/her designee and may be billed under Optional OT hours.

As required in specific extended or staggered service instances, actual tasks to be performed will be selected from the overall general tasks required for routine services, or from the NIEHS Disaster and Pandemic Plans, at the discretion of the COR.

7. Description of Work Conditions and Work Environment:

a) Employees are subject to adverse variables of environmental conditions, both inside and outside. Work areas are often hot, humid, and noisy due to operation of cage washing machines and autoclaves. Employees are potentially exposed to minor injuries such as cuts, bites, scrapes, pulled muscles, burns and unpleasant odors, and the possibility of exposure to hazardous materials including radioisotopes. Employees are exposed to animals and animal urine, feces, and dander that can act as allergens or as potential sources of zoonotic disease.

b) Duties require constant lifting (sometimes greater than 50 pounds) and pushing and pulling of carts and dollies. Duties also require continuous walking, standing, sitting, and considerable arm and hand movements.

c) The primary NIEHS animal facilities are located in the basement of Building 101. The facility consists of 3 separate modules, each consisting of animal holding/breeding rooms, containment rooms and shared procedure space. Module C houses multiple specialized procedure rooms, surgical suites, and imaging room. Support areas consist of 2 cages wash areas, storage areas, offices, locker rooms, rest rooms and employee break rooms. An additional housing room (C129), operated with specific biocontainment procedures, is located on the first floor of building 101. The Conventional Animal Facility (CAF) is located in building 104, approximately one mile from building 101, and consists of one rodent housing room, a procedure room, and a small storage area.

d) The primary NIEHS animal facility is managed as an SPF

(specific pathogen free) facility using clean/return corridor concept, with access limited to approved personnel and animal resources. The majority of NIEHS animals are bred in-house or received from NIEHS approved vendor sources. Animals from non-approved sources must undergo rederivation prior to admittance to the facility. Incoming animals and equipment are received at a centralized loading dock (shipping and receiving) and are transported to animal rooms or storage areas in the animal facility via the return corridor. Clean equipment is supplied to animal rooms via the clean corridor. Soiled/used equipment is returned the cage wash areas via the return corridor. Modules C and D share a common cage wash area;

Module E has a separate cage wash facility. Animal feed and bedding is received and sterilized in E152. Sterilized feed and bedding is stored and dispensed into the Ducon feed/bedding delivery system in room E151 (clean side of Animal Bedding and Feed). C129 is operated as a “clean quarantine” space.

Clean caging is supplied by the cage washing operation in the basement of building 101. Soiled caging is sterilized in E152 prior to being processing. The CAF houses specialized mouse strains that cannot be directly imported into the primary NIEHS vivarium due to current health status. The CAF utilizes disposable cages and water bottles, which are delivered directly there and filled onsite.

e) Rodents are housed in individually ventilated cages (IVC) or static microisolators. The average census is ~19000 (18,800 mice/200 rat) cages with 85-90% being individually ventilated cages. IVC cages are changed at a minimum of every 2 weeks.

Microisolator cages are changed at a minimum of once per week and rat cages are changed 2 times per week.

f) Animal care personnel are required to wear a contractor supplied, washable cotton/polyester two-piece uniform of scrub pants and a long sleeve, snap-front shirt (a one piece cotton coverall may be substituted), safety shoes, disposable shoe cover, head cover, surgical mask), and gloves when working in the animal rooms.

Cage wash staff are required to wear a contractor supplied, washable cotton/polyester two-piece uniform of scrub pants and a long sleeve, snap-front shirt, safety shoes, disposable shoe cover, head cover, surgical mask (clean side cage wash), N95 or PAPR (dirty side cage wash), and gloves when working in cage wash areas or on the clean corridor.

Stations stocked with disposable PPE (lab coats or coveralls, shoe covers, head covers, surgical masks, gloves) are located in the return corridors at the entrance to the animal rooms.

Protective clothing is required to be worn by ALL personnel entering an animal room from the return corridors. The disposable PPE identified above is furnished by the Government.

The contractor is responsible for an annual fit test of all personnel required to wear an N95 respirator.

VI. SPECIFIC TASKS

Standard operating procedures (SOPs) are provided by the Government for all duties and are created with input from the contractors. The SOPs can be changed unilaterally at the discretion of the government. This in no way precludes the Contractor from submitting written suggestions to the Contracting Officer’s Representative for improvements to operation procedures. Such submissions are encouraged but shall be contingent upon review and approval by the COR, with implementation, if desired by modification to the existing SOP. All suggested changes to SOPs must have the approval of the COR, prior to implementation.

The performance of duties shall conform to the most recent version of the NRC Guide for the Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/Guide-for-the-care-and-use-of-laboratory-animals.pdf) as well as the PHS Policy for Humane Care and Use of Laboratory Animals, the Animal Welfare Act PL 89-544 and amendments, NIH Manual Policy 3040-2, and the Association for the Assessment and Accreditation of Laboratory Animal Care, International (AAALAC International) standards.

Contractor activities shall be conducted in Government owned or leased facilities within the designated contract service area. The Government shall provide animal holding, surgical and procedure space, cage wash facilities, office and laboratory space, restroom, shower and locker areas, storage and other support space required to conduct the contract. These facilities may be shared with Government staff. No detergents, disinfectants, pesticides or other materials shall be provided by the Contractor unless approved by the head of the NIEHS CMB Quality Assurance Laboratory (QAL) via submission to the Contracting Officer’s Representative (COR).

Where corrective actions by the Contractor are required which could in any way affect research programs, the Contractor shall inform the COR prior to taking any action unless an emergency which threatens the well-being of the animals and the research mission requires immediate action. In the case of such an emergency, the Contractor may take remedial action deemed appropriate by the industry for an animal research environment such as NIEHS, followed by immediate notification of the COR.

The Animal Resources Section (ARS)…