Attachment 3_Animal Care SOW_10.12.23_Final.pdf

STATEMENT OF WORK (SOW)

Management, Operation, Professional, and Technical Support Services for NIAID Animal Care Facilities

BACKGROUND AND INTRODUCTION

The National Institutes of Health (NIH) is one of the world's foremost biomedical research organization. It is the principal Federal agency for the conduct and support of medical research in the United States.

The National Institute of Allergy and Infectious Diseases (NIAID) was established to conduct and support research to better understand the causes of allergic, immunologic, and infectious diseases, and to develop better means of preventing, diagnosing, and treating illness. In support of this mission, NIAID executes a Strategic Plan for Biodefense Research and Research Agenda for Emerging Infectious Disease. Much of this research depends on the study of laboratory animals. Proper management of the NIAID program of animal care and use is essential for the welfare of the animals, validity of research data, and the health and safety of the animal care staff.

The NIAID currently maintains animal facilities in seven (7) buildings on the Bethesda and Twinbrook campuses in Maryland (MD), five (5) buildings on the Rocky Mountain Laboratory (RML) Campus in Hamilton, Montana (MT), and maintains a research section in one (1) building on the Division of Veterinary Resources (DVR) operated NIH Animal Center (NIHAC) campus in Poolesville, MD. The NIAID is responsible for the operation of an NIH shared animal facility used by NIAID along with several other NIH Institutes (National Heart, Lung, and Blood Institute; National Human Genome Research Institute; National Institute of Diabetes and Digestive and Kidney Diseases; and National Institute of Arthritis and Musculoskeletal and Skin Diseases). The Scientific Directors of these Institutes have delegated, through Intra-Agency Agreements (IAA-s), the responsibility and authority for care of animals that are housed in the NIH shared animal facility to the Scientific Director of the NIAID. NIAID also maintains animals in NIH central animal facilities. All of the NIAID care and use of animals is conducted in compliance with applicable laws, regulations, and guidelines in order to maintain accreditation by the Association for assessment and Accreditation of Laboratory Animal Care International

(AAALACI).

Continuous high quality animal care shall be provided as set forth in applicable laws, regulations, guidelines and intra-agency agreements (IAAs). The NIAID experimental animals must be maintained under carefully controlled conditions to minimize research variables and allow the accurate interpretation of laboratory results. Consequently, it is essential that animal colonies be consistently and properly maintained to avoid any situation or condition such as undue stress, disease, animal misidentification, animal escape, etc., that might adversely affect experiments. The proper care of these animals is integral to the research performed at NIH. The Contractor shall maintain strict adherence to Animal Study Proposals (ASPs) and Standard Operating Procedures (SOPS) provided by the government.

Additionally, the management of these facilities and the data obtained from the animals therein is necessary to support the research being done. Therefore, the NIH looks to manage all of these interrelated functions through this one support contract.

SCOPE

To care for animals at NIH’s research facilities in ABSL1-ABSL4 environments and support the facility and the research being performed therein.

Contract support shall be provided on-site at locations that house NIAID research animals to include the NIH main campus in Bethesda MD, off-campus owned/leased facilities in Rockville MD, the NIH Animal Center (NIHAC) in Poolesville MD and the Rocky Mountain Laboratories (RML) in Hamilton MT. New NIH/NIAID installations that are not designated at the time of contract award shall be so served upon the request of the Contracting Officer and accomplished by a modification of the contract.

The Contractor shall provide a wide range of professional, technical and support services to the DIR Animal Care Program required for the proper care, use and humane treatment of laboratory animals, and to provide a wide range of technical skills required for the scientific study and manipulation of animals and animal projects. Functions include: veterinary medical care, animal care, technical support, data management, cost accounting, cage and environmental sanitation, routine maintenance of animal care equipment and supplies, transportation, logistical, clerical and administrative support. Services will be provided at various NIAID and Government facilities. Support is to be provided to animal projects involving the full range of biomedical research and scientific disciplines and animal species which may include: mice, rats, cotton rats, hamsters, guinea pigs, gerbils, rabbits, non-human primates, ferrets, chickens, frogs, mastomys, swine, goats, sheep, bats and other vertebrates and invertebrates depending upon facility location. All contract activities shall be responsive to the

NIH’s research requirements and comply with AAALACi criteria for accreditation at all times.

TECHNICAL REQUIREMENTS

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work as stated herein. The Contractor shall perform to the standards in this contract, utilizing the most current Comparative Medicine Branch series of Standard Operating Procedures.

Delegation of Duties and Conduct

Delegation of duties for Contractor personnel shall be the prerogative of the Contractor. The Contractor shall ensure all Contract personnel support the NIH mission, do not cause disruption of animal studies, heed verbal and/or written direction of Contractor management, provide human treatment of animals, behave and conduct themselves appropriately and do not endanger life or abuse Government property. That Contractor shall be responsible for the recruitment, selection, assessment, supervision, management, certification and control of employees in performance of the Statement of Work (SOW) and shall comply with the general intent and specific policies or regulations of NIH concerning conduct to include all NIH mandatory training classes.

Absences

The contractor shall staff the facilities and ensure the workforce is able to carry out day-to-day functions even when unforeseen absences of personnel occur. Daily routine husbandry procedures such as full and accurate observations and full cage changes must be maintained.

Any deviations from SOPs must be approved by the Government. For example, “spot changing” (not a full scheduled cage change) shall not occur due to Contractor staff shortages.

Husbandry and Technical Services

The Contractor shall provide animal husbandry and animal care (e.g. feed, water, clean caging, daily observations of each animal for deviations from normal behavior and health, sanitary management of animal rooms and adjacent corridors, etc.), to include environmental enrichment and socialization as required by SOP. The contractor shall ensure the adherence to all cleaning and sanitization SOPs for caging, equipment and facilities.

Provide laboratory animal veterinarians, as required, with training and experience sufficient to fulfill the responsibilities described in the American College of Laboratory Animal Medicine (ACLAM) Role Delineation Document and provide veterinary care consistent with the ACLAM definition of adequate veterinary care.

No contract personnel that come into contact with any other laboratory animal species or environments wherein laboratory animal species have been present shall be allowed to enter NIAID animal facilities within 24 hours. Exceptions may only be made with the prior approval of the COR or Facility Veterinarian who may impose requirements to shower and change into facility clothes prior to entry.

Ensure that all qualified staff to include Program Management assist in the daily animal husbandry tasks and general maintenance of facilities as necessary.

Additional Animal Support Services

• At a minimum, perform twice daily assessments and health checks of animals identified as experiencing morbidity to include administration of various medications and fluids to sick or abnormal animals as directed by the Facility Veterinarian.

• Animal care to include husbandry, health monitoring, housing, nutrition, hygiene, written and computerized record keeping in ABSL1, ABSL2, ABSL3 and ABSL4 environments

• Veterinary medical care in accordance with applicable regulations and standards and animal health quality surveillance

• Identify laboratory animals using methods such as ear tags, notches, beads, toe clipping, tattoos, or subcutaneous transponders.

• Breeding colony management, timed matings, backcrosses, fostering, estrus synchronization, embryo implantation.

• Provide detailed observations on disease/syndrome progression in experimental animals as part of an ASP.

• Immunize and/or bleed animals used in experiments in accordance with ASPs/ SOPs. ALL TECHNICAL STAFF shall receive and maintain training to be able to effectively and properly restrain, inject (IV, IP, IM, SQ, ID, orbital) and bleed (retrobulbar, cardiac, peripheral venous system including the marginal ear veins in rabbits) the laboratory animals housed in NIAID facilities.

• Perform or assist with gross necropsies; collect tissues or organs such as CSF, bone marrow, lymph nodes, oviducts, embryos, spleens aseptically

• Weigh animals and feed and record, i.e. as part of food or liquid consumption studies

• Make dilutions to obtain desired concentrations; calculate appropriate dosages of medications based upon body weight.

• Implant mini-osmotic pumps subcutaneously; perform survival rodent surgeries such as skin grafts, vasectomies, splenectomies, and embryo implantations on mice

• Complete laboratory submission forms, and provide other technical services as required by the

COR.

• Perform daily/monthly physicals and provide routine health maintenance to include checking and maintaining teeth and toenails.

• Maintain records in accordance with SOPs of animals received, mortality records, breeding records, controlled substances used, irradiations performed and records of diagnostic and technical procedures performed.

SOPs

Assist the Government to develop, review and edit SOPs and procedures to establish the means by which the animals and facilities will be cared for and NIAID’s needs met. The Contractor shall adhere to these SOPs and all Government developed/maintained ASPs unless deviation is requested by the Government via the COR.

Ordering, Receipt, Unpacking, and Housing of Laboratory Animals The Contractor shall order, receive, unpack, and house laboratory animals in accordance with ASPs and SOPs.

Import and Export of Laboratory Animals Assist the Government in transferring of ownership and holding location of animals, including quarantine as necessary. Ensure all pertinent rules, regulations, policies, and guidelines are followed. Coordinate and follow through on appropriate import/export documentation and logistical support as appropriate to the origin/destination, health status, and weather conditions.

Packaging and Shipment of Laboratory Animals

Perform packing and shipment of laboratory animals in accordance with ASPs and SOPs and regulatory requirements.

Animal Health Monitoring and Colony Maintenance

On weekdays, cages shall be checked once within two hours of the start of the workday and once within two hours of the close of the workday. Animals will be observed and cages checked at least once daily within two hours of the start of the work day on weekends and holidays. When specified, cages shall be checked more often as required in order to support research requirements in accordance with an approved ASP and SOPs.

Experimental animals that appear ill shall be brought to the attention of the Attending

Veterinarian and the investigator as directed by SOP. Such animals may then be submitted for pathologic evaluation. Records of animals submitted for pathologic evaluation and reports subsequently received shall be maintained by the Contractor in accordance with SOPs.

Administer drugs and routine treatments (i.e. adding antibiotics to drinking water, administer fluids parenterally) in accordance with SOPs / ASPs.

Traffic control and foot patterns of personnel is to be maintained in order to prevent the spread of disease, e.g. between buildings, between animal holding rooms or within animal holding rooms. The Contractor shall develop management procedures that minimize the opportunity for adventitious infectious agents present in one facility to be accidentally introduced into other animal facilities or rooms within animal facilities. The proposed procedures shall be approved by the COR prior to implementation.

Maintain a health monitoring program per ASPs and SOPs for all species through a sentinel/surveillance program as directed/determined by the veterinary staff.

Assist in obtaining risk assessment information about biologicals proposed for use on ASPs.

Assist with testing and tracking of biologicals used.

Management of Animal Holding and Procedure Space Usage

Monitor animal space availability as outlined in the allocation chart, “space bible,” on a no less than weekly basis and report any usage overage to the Principal Investigator (PI) and COR.

Coordinate the breeding, ordering, and receipt of animals so that no animals are housed in overcrowded conditions.

Coordinate animal requisitions with animal housing availability and ensure sufficient caging, autoclave capacity, and space for requested animals.

Coordinate and manage schedule of procedure rooms.

Animal procedures will be conducted within animal holding facilities or animals will be transported to NIAID laboratories. The Contractor may conduct procedures in the animal holding facilities or in NIAID laboratories. Some animals may return from laboratories or procedure locations for housing in animal holding facilities. In all cases, the Contractor must ensure compliance with the ASP’s and SOPs. Different species will be used in a variety of ASPs which often include the use of biological hazards, chemical hazards, or radioisotopes. The Government will furnish all laboratory animals.

Although animal populations will vary with time, the attached table (Technical Exhibit II) lists the anticipated average daily inventory of laboratory animals to be maintained in NIAID facilities by species.

The number of racks, cages and animals may change as required by the needs of the Government, and labor requirements may go up or down accordingly. A decrease in the number of animals may require a decrease in the animal care and /or technical work at the same level as determined for an increase.

Quality Control

The contractor shall possess and present to the Government a complete Quality Control Program that is acceptable to the Government.

Provide quality control and surveillance services for animal health surveillance programs, specimen collection for the monitoring of the effectiveness of sanitization and sterilization procedures such as ATP testing and monitoring, monitoring of the appropriate cage wash parameters (defined in the SOPs), monitoring of incoming animal shipments for container integrity and animal health, monitor the Building Automation System (BAS) and internal facility monitoring data for deviation from pre- established parameters, and other quality assurance services as deemed necessary (e.g. water cultures) by SOP’s.

Develop and maintain an effective quality control program to ensure services are performed in accordance with this SOW. The Contractor shall develop and implement procedures to identify, prevent, and ensure non-recurrence of defective services. The Contractor’s QC program is the means by which they validate that the work complies with the requirements of the contract. The Contractors QC program should encompass all aspects of the Contractors adherence to the SOW. The Contractor will have 5 days to make changes to the plan when requested by the Government. Changes to the quality control plan may be requested by the COR and the CO. After acceptance of the quality control plan the Contractor shall receive the Contracting Officer’s acceptance in writing of any proposed change to the QC system.

The Government will establish and maintain a QA Program designed to ensure that the Contractor has performed all work/services in accordance with the performance standards delineated in this SOW. The focus of the Government’s QA Program will be on what services are to be delivered by the Contractor and how well the Contractor is performing the required services. The QA Program will evaluate the Contractor’s technical and managerial performance in meeting the requirements of the Statement of Work. Monitoring will consist of, but not be limited to:

• Monitoring of ATP results, reports, and corrective actions on a monthly basis

• Physical inspections of facilities and surrounding spaces

• Observation of compliance with SOPs

• Review of all deliverables

• Biweekly progress meetings with the Contractors Program Management staff

• Random sampling of Investigator satisfaction

• Review of Contractors QC reports and repeated and corrected deficiencies

The Contractor agrees to attend any post award conference convened by the contracting activity. The contracting officer, COR, and other Government personnel, as appropriate, may meet periodically with the contractor to review the contractor's performance. At these meetings the contracting officer will apprise the contractor of how the government views the contractor's performance and the contractor will apprise the Government of problems, if any, being experienced. Appropriate action shall be taken to resolve outstanding issues.

Research Support Services by Laboratory Support Specialists

Services will be provided to laboratories as approved by the Scientific Director and requested from the COR. Specific functions to be provided are determined by each requesting Laboratory and include, but not limited to, duties outlined below:

Manage multiple animal studies running concurrently in different phases, by following and complying respectively with the ASPs.

Perform laboratory and animal technical duties associated with the lab’s ASPs to include, but not limited to: obtaining blood films, withdrawals and smears, performing injections, operating laboratory equipment (e.g. PCR, flow cytometry).

Maintain animal colonies and organization of animal inventory associated with the lab’s ASPs to include monitoring of procedures, maintaining the amounts of animals used and animal procurement.

Set up animal protocols to include following relative SOP’s.

Maintain integrity of the research process by following Good Laboratory Practices including detailed accurate record keeping of methods, routine animal observations, data collections as well as procurement, processing, and preservation of specimens to maintain sample identification and prevention of cross contamination.

Practice universal precautions appropriate to different ABSL. Work safely with animal / human pathogen biohazard’s, and assist in the maintenance of the research animal facility as a safe work environment / operation.

Maintain optimum care and maintenance of research equipment for the routine hygiene and disinfection of research implements, and act as a facilitator for entry to any space where the contractor is working for service personnel and facility users.

Meet with investigator’s, outside the facility if necessary, to assist in coordinating animal research needs.

Serve as a “point of contact" or “Liaison” for their assigned Laboratory/Branch/Section in conjunction with the Comparative Medicine Branch/Rocky Mountain Veterinary Branch (CMB/RMVB) contract staff and COR.

Report any animal health, care, and / or well-being concerns to the appropriate facility management staff and CMB/RMVB Facility Veterinarians.

Report any facility infrastructure issues, relative to the animal holding areas and support areas, to the appropriate facility management.

Provide research technical support services such as neurovirulence and emerging infectious disease necropsy support, specimen collection, administration of oral or parenteral medication and research reagents, individual animal identification, surgical support, animal restraint, maintenance of breeding colonies and records thereof, timed mating of mice, and animal health support services as required and in accordance with approved ASPs, SOPs, and IAA’s, and laboratory support services as directed by a designated Government Personnel, such as the COR, CO, or delegated Government Official in accordance with the SOW.

Provide expert pathology services such as necropsy, gross and microscopic examination, histology, in situ hybridization, immuno-histochemistry, interpretation and collaboration in the publication of studies involving laboratory animals.

o Provide, utilizing existing Research Support Staff at NIHAC, technical support for “Critical Care Studies” that entail care and observation of study animals over a 24 hour period

Facility Management

The Contractor shall have Facility Managers and/or Assistant Facility Managers in all DIR operated buildings where animals are housed no less than five days during a regular workweek. There is an expectation that Program Management will be present in animal facilities where FMs or AFMs are both absent. The Contractor shall have management available as necessary to supervise contractor personnel providing support in Shared and Central NIH animal facilities or other facilities where NIAID animals are housed. The Contractor shall also have personnel functioning as site leaders in the in the NIHAC Poolesville facility no less than five days during a regular workweek. These facility managers and site leaders shall be responsible for overseeing the daily activities, work assignments, work production, schedules, etc. of the animal care, technical and administrative staff. Animal procedures will be conducted within animal holding facilities or animals will be transported to NIAID laboratories. Based on job description/duties, personnel may work in NIAID animal facilities, NIH Shared and Central animal facilities, NIAID laboratories, and contracted facilities in support of scientific execution.

Different species will be used in a wide variety of ASPs which often include the use of biological hazards, chemical hazards, or radioisotopes. In all cases, the Contractor must ensure compliance with the SOPs.

Animal Facilities

1. Manage animal isolation, containment and quarantine areas based upon veterinarian direction.

2. Provide a full time courier to transport animals, mail, samples, supplies and equipment throughout the Bethesda and Rockville campus locations.

Contractor staff at NIHAC may be required to transport samples to campus utilizing a government vehicle when DVR cannot accommodate.

3. Provide cage wash services in compliance with SOPs, including:

a) Transport of caging to and from animal rooms;

b) Proper disposal of soiled and potentially contaminated bedding;

c) Routine maintenance of all cagewash machinery as outlined in SOPs;

d) Descaling of caging and cage washing machines;

e) Sanitization of dirty caging, water bottles and sipper tubes;

f) Cage building/set ups with appropriate feed and bedding;

g) Autoclaving of caging, equipment, and supplies as required;

h) Decontamination of potentially contaminated equipment, supplies, and waste;

i) Delivery of clean caging either to a storage area or animal rooms;

j) Sanitization and upkeep of support (e.g. procedure rooms) and “travel”

(corridors) areas as required;

k) pH neutralization of waste water.

l) Maintain a log and storage of all broken caging as requested by COR and inform the

Government of low inventory

4. Provide packaging, collection and handling of Medical Pathological Waste (MPW) and chemical waste in compliance with federal and state regulations, NIH policies, and facility SOPs, and provide delivery of such waste to designated areas.

5. Prepare requisitions for feed, bedding, supplies, and animals as needed to facilitate uninterrupted animal facility activities.

6. Monitor status of standing orders for items such as gas cylinders and printer maintenance and prepare follow on orders to avoid disruption of service

7. Maintain a current inventory of all supplies, e.g. caging, animal feed, bedding, cleaning, supplies and protective clothing. Establish critical re-order levels for each item to allow for unusual procurement delays so that no item in the inventory becomes depleted.

8. Monitor all standing orders for feed and bedding via IntraMalls and notify COR of impending shortages

9. Maintain a constant supply of appropriate gloving, shoe covering, surgical masks, respirators, hair covering, and clothing at gowning stations. Disposable garments will be purchased and disbursed by the Contractor.

10. Notify the COR via AMBIS, the government portal, when any supply item needs to be reordered. The Contractor puts an actual order into the system (the portal) and a government employee (the COR) approves the need and forwards it for placement by NIH procurement. The order shall contain a complete description of each item, quantity and required delivery date, in addition to who needs it and for what purpose (who, what, why and where). Completed orders will be forwarded to the COR via the portal for placement.

The Contractor shall be responsible for allowing procurement sufficient lead time for the type of item requested and will be responsible for understanding and adhering to the procurement deadlines and monetary thresholds

11. Notify the COR of receipt of all AMBIS ordered items to include the order number and a signed/dated receipt within 3 days of receipt in the designated facility. Respond to Government purchase agents’ requests for information, changes and receipt on orders.

12. Receive, store and stock all supplies in designated areas. Feed and bedding shall be stacked on sanitizable pallets, racks, or carts in accordance with SOPs

13. The Contractor shall assist in coordinating procedure room use. This involves keeping the rooms stocked with supplies such as syringes, needles, collection vessels, etc.

Facility Operations

1. The Contractor shall be responsible for routine preventative maintenance of all existing and future animal equipment; the inventory of equipment is fluid and will change as the science changes. The contractor is responsible for promptly notifying the

Government when repair of equipment is needed. Operation of HVAC (monitored via the BAS), cage washers, autoclaves, HEPA-filtered work stations, biological safety cabinets and change stations, ventilated racks, light timers, water acidifiers, bottle filling systems, floor scrubbers, microscopes, balances, pH meters, psychrometers, filter banks, etc. shall be observed on a regular basis to ensure normal operation. Service calls will be placed with the appropriate entity as outlined by SOP.

2. Perform routine minor maintenance and repair of carts, rodent racks, etc., including periodic lubrication of casters. Perform required preventative maintenance on rack/tunnel washers to include jet wands and baskets, autoclaves, bedding disposal stations, water bottle fillers and change hoods.

3. Respond promptly to problems either by performing the necessary pre-approved corrective actions or by notifying the appropriate personnel of the need for repair.

4. After using appropriate notification mechanism (vendor, ORF, etc), maintain a written record to document all equipment related problems, including date(s), names(s), action(s) taken, resolution(s), and problem(s) occurring to include items which may require COR intervention and attention.

5. Advise the COR when additional or replacement equipment is needed in order to properly manage the program. Maintain an appropriate amount of caging and accompanying equipment to ensure that day to day operations are carried out as per SOP; notify COR when levels may fall below allocations

6. Unpack, wash, sanitize and assemble new caging, equipment and accessories.

7. Ensure that all HEPA filtered equipment, scales and weights, pipette machines, and fire extinguishers in use are checked certified annually as required. Coordinate with COR any items that require Government facilitation (irradiators, anesthesia machines/vaporizers, cagewash equipment)

8. Follow established sanitization and sterilization monitoring procedures as described in the SOP’s. ATP monitoring may be performed more frequently or additional monitoring procedures may be required by the COR beyond those stated in existing SOPs. Logs shall be maintained and include the dates and results of all microbiological monitoring of sanitization and sterilization equipment. Abnormal results shall be reported in the Contractor's monthly progress report. A verbal report will be provided to the COR immediately if results demonstrate insufficient sanitization procedures or require revision of SOPs.

9. Monthly sanitization of animal rooms, procedure rooms and corridors as outlined in the SOPs shall be coordinated and accomplished so as not to create unnecessary interference with research being conducted.

10. Special procedures may be required when a room is emptied for a change in species, during or after a disease outbreak, or following damage or construction/renovation to any portion of the animal facility

Vermin Control

The NIH has adopted an Integrated Pest Management (IPM) approach to vermin control.

The Government will be responsible for the determination and application of appropriate insecticides or entrapment. The Contractor is responsible for correction of deficiencies in sanitation identified and facilitation of the IPM program. The Contractor shall inspect for and report holes, cracks, cavities, or other potential pest harborages to the COR. The Contractor shall be responsive to the IPM Program recommendations regarding sanitation. The Contractor shall instruct the IPM staff in the use of appropriate personal protective equipment in accordance with SOPs and observe for compliance. Deviations are to be brought to the attention of the COR. The Contractor is required to maintain facilities and supplies such that pest harborage is minimized.

Training

The Contractor shall maintain a training and recruitment program to provide the necessary management skills and personnel to efficiently provide continuous high quality animal care as set forth in federal, state and local regulations and guidelines in a research setting.

No new Contractor personnel or promoted animal care personnel shall be permitted to work without direct supervision and should be shadowed and mentored by trained individuals until they have demonstrated that they have achieved competence in their assigned duties.

Competence may be demonstrated by oral examination, written examination, or direct examination of work performance by the Contractor. Within thirty days of contract award, the Contractor shall provide to the COR a detailed written description of employee qualifications and evidence of professional/technical certifications held. An orientation training program will be coordinated by the Government for Key contract personnel who were not employed on the previous contract. This will include a general overview of ASPs, SOPs, NIH and NIAID guidelines, health and safety requirements, and current research programs. Continuing education and training of new personnel is the responsibility of the

Contractor.

The Contractor shall foster a culture of respect, civility, accountability and responsibility. The contractors training program shall routinely cover culture and civility, SOPs, ASPs, as well as on-the-job training in laboratory animal science and animal husbandry. This continuing education requirement may be given as weekly seminars/lectures occurring no less frequently than one hour per week. The continuing education program shall be structured to provide a clear understanding of the NIAID program of animal care and use and culminate in qualification for certification by the American Association for Laboratory Animal Science (AALAS). A list of the topics presented during each continuing education seminar will contain a list of those employees in attendance and those who were absent. The list of continuing education topics and attendance records will be provided on a monthly basis as requested by the COR. Retraining as requested by the COR upon adverse events will be completed and reported on a timeline determined by the COR. In addition, the Contractor shall maintain on site a file for each contract employee detailing all training topics to which that individual has been exposed. The Contractor shall provide the COR a detailed written operating plan and program for training personnel in all aspects of program support, health and safety requirements, terminology, identification and handling of animal caging, operation of equipment, etc.

Preparation and Training for staff entering an ABSL-4 environment will be provided by the NIAID staff at RML. The contractor is required to make available adequate ABSL-4 trainable staff as required by the COR. It is estimated that the ABSL-4 requirements in Hamilton, MT will represent 50% of Animal Care taking and Technical Staff.

Safety Training

A safety orientation training program will be conducted by the Government for Key Personnel who were not employed on the previous contract if requested. This orientation will include health and safety requirements, use of the OMS Clinic by Contractor personnel, waste management, hazard signage, and other safety related information. All new Key personnel must complete this training prior to starting work in the animal facilities. All Select Agent training will be conducted by the Government, the Contractor will provide all ABSL3 (non-SA) training once format and content are approved by the Government.

The program shall contain training in occupational health and safety and comply with all applicable sections of the Williams-Steiger Occupational Safety and Health Act of 1970, as amended (US Code of Federal Regulations, Title 29). The Contractor shall establish medical surveillance programs equivalent to those conducted by the NIH (Animal Exposure Surveillance Program, Retrovirus Exposure Surveillance Program, Hearing Conservation Program, Respiratory Protection Program, Laboratory Animal Allergy Prevention Program, etc.) for Government employees working with animals, with hazardous materials, and within hazardous working conditions.

The Contractor shall provide an effective program for training all employees in occupational health and safety. Prior to beginning any work, employees shall be properly trained in safe practices and informed of all hazards associated with their work by their supervisors. The Contractor shall provide its employees with an understanding of the special environment of animal facilities and medical research programs such as:

1. The presence of various hazardous agents (e.g., zoonoses, biohazards, carcinogens, caustic and / or toxic chemicals, radiation, and radioactive materials);

2. The presence of various- ABSL-2, ABSL-3 and ABSL-4 agents as well as Select Agents

3. The need for tools, parts, and miscellaneous equipment to be disinfected before and/or after use in some areas;

4. The need for personnel to don special personal protective clothing and/or equipment prior to entering specified areas;

5. Operation and daily maintenance of sterilization equipment;

6. The need to adhere to all practices and procedures necessary to reduce/minimize self- contamination and cross-contamination from room-to-room, etc.

Once each employee has completed the Contractor’s occupational health and safety training program, an assurance statement of program completion containing the signature of each employee adjacent to the date of completion is to be available to the COR. For incumbent staff, this assurance statement can be delivered thirty days from contract award. For non-incumbent staff, delivery shall occur within one week of the hire date. The Contractor shall implement animal care staff safety training on a continuing basis and shall provide the COR with documentation including the name of each attendant and signatory evidence of understanding.

Training shall include but not be limited to:

1. Emergency response and First Aid training to include review of pertinent disaster plans

2. Spill clean-up procedures

3. Fire extinguisher training

4. Respirator use training if warranted or required

5. Waste management procedures

6. Hazard communication training to include review of informational materials associated with each hazardous agent experimentally introduced in animal facilities where NIAID animals are held or used.

7. Use of personal protective equipment

8. Use of containment equipment to include biological safety cabinets

9. Training in the safe handling of radioactive material

10. How to access and use Safety Data Sheets (SDS)

11. Proper lifting techniques

12. Hazards of drug and alcohol abuse in the workplace

13. Safe operation of powered equipment

14. Use of medical gases; signs of over exposure

The NIH COR or their representative, the Department of Health and Safety (DOHS) and members of the Biosurety staff may provide site-specific instructions to the Contractor's on-site Manager and staff (e.g., on matters that deal with a particular animal study or material used in the animal facility) to augment the contract staff's basic safety awareness. The Contractor’s on-site Manager shall be responsible for demonstrating verbally or in writing their understanding of these instructions and for ensuring their staff is provided with, understand, and follow those safety instructions.

The contractor shall respect the authority and follow the directives of NIH Safety Officers and other DOHS personnel. Any questions regarding these directives shall be brought to the COR or Task Leader.

The Contractor will reply to all requests for information regarding accidents or exposures.

Employee Requirements

Physical Effort In performing the duties of this Statement of Work, frequent lifting (50 pounds or more) and pushing/pulling of racks, carts, and dollies will be required. Walking, standing, sitting, and considerable arm and hand movements will be required. Personnel must be able to operate the machinery appropriate to their duties.

Reassignment Contract employees shall not be reassigned or moved between animal facilities of differing health status without following SOPs or undergoing special procedures to protect against cross contamination. Reassignment of employees for other than temporary coverage shall be coordinated and approved by the COR or Task Leader.

Government Vehicle Insurance/Licenses Some Contractor personnel shall be authorized to drive Government vehicles. Each authorized driver shall obtain the appropriate motor vehicle clearances (e.g. Class C Drivers Permit) and provide evidence of a valid state driver’s license. The driver shall be responsible for any violations while in possession/operation of the Government vehicle.

Personal Protective Equipment The Contractor will place orders to provide single-use, disposable equipment such as disposable gloves, lab coats, jumpsuits, coveralls, head covers, shoe covers, undergarments, ear plugs or muffs, nuisance dust masks and accessory equipment required for research support. In addition, the Government will provide associated accessory equipment required for use at ABSL3 and ABSL4 as appropriate.

The Contractor shall provide their staff all personal protective equipment that is typically issued to a specific individual (e.g., safety shoes, prescription safety glasses) or for which OSHA regulations require certain conditions be met by the employer, such as non-disposable respiratory protective equipment (e.g., 29 CFR 1910.134: Respiratory Protection Programs).

The proper cleaning/disinfection of all reusable personal protective equipment or uniforms shall be the responsibility of the Contractor and in conjunction with applicable SOPs.

Uniforms Clean, non-disposable, sterilizable scrub suits will be provided by the Contractor. They are to be changed daily or more often if building requirements call for shower in/change clothes.

They are to be laundered off-site by the Contractor and not taken to employees’ homes for laundering. Specifications regarding uniforms are as follows,

1. The Contractor shall provide cloth and special material uniforms for its personnel.

2. At a minimum, newly laundered uniforms are to be worn each day by all personnel.

3. Uniforms are to be removed when leaving the work site. Uniforms are not to be worn to the cafeteria, library, or personal vehicle.

4. Personnel are not to wear their home clothing (i.e. pants) underneath their scrubs unless specifically granted permission by the COR.

5. Disposable undergarments may be required under conditions set forth by the DOHS

Environmental Monitoring for Hazards Periodically, NIH work sites may be monitored for the presence/absence of potentially hazardous materials or conditions. In such circumstances, workers in those areas will wear monitoring devices (e.g., film badges, personal dosimeters) which allow the NIH DOHS staff to properly assess potential exposures in those work sites. Contractor staff shall cooperate in such surveys when directed to by the NIH COR. In those instances where contract staff participates in the monitoring effort, the Contractor will be provided the resultant data in a timely fashion. The Contractor shall ensure that adequate environmental monitoring of the equipment and physical plant is accomplished in accordance with the ASPs and SOPs.

Identification of Contractor Employees All contract personnel attending meetings, answering Government telephones, and working in other situations where their contractor status is not obvious to third parties are required to identify themselves as such to avoid creating an impression in the minds of members of the public that they are Government officials. They must also ensure that all documents or reports produced by contractors are suitably marked as contractor products or that contractor participation is appropriately disclosed.

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 outside of normal working hours, weekends and Government holidays. Sufficient services shall be provided commencing at a time approved by the COR, on all Federal Holidays, Saturdays, Sundays, and on Government or NIH closure in order to satisfactorily accomplish regular animal husbandry activities and/or technical project support as required to meet various task goals. During the weekends and holidays, supervisory personnel shall be present and/or available to effectively manage personnel staffing for the activities of the day. Services outside of the normal working hours (Monday through Friday, 7:00am to 3:30pm) can be scheduled at the convenience of the staff, however, services shall commence no later than 8:00 am and, where appropriate, no earlier than the time the diurnal light cycle within the animal room switches to on.

Animal care personnel are designated as "essential employees." The Contractor shall organize the workforce in a way that critical functions are performed even when unforeseen absences of personnel occur. This may, during disaster situations, require Contractor personnel to remain in an animal facility or local hotel overnight or for several days until relief becomes available.

Services may be required at times outside of normal working hours. Emergency services shall be provided outside these hours by an "on call" system 24 hours per day; 365 days per year to maintain facilities, equipment, and animal health in the event of emergencies (e.g., relocate animals in the event of HVAC failures, water main breaks, fire, structural failure, etc.).

The Contractor shall maintain a current emergency telephone roster of Key personnel to facilitate mobilization of personnel as required. The Contractor shall provide the Government with updated and appropriate information on emergency personnel that will be maintained in the “NIH NIAID Division of Intramural Research Laboratory Animal Facilities Emergency Handbook”, on site, drafted and maintained (with input from the contractor as listed above) by the COR or designee. Subsequent additions and revisions to the handbook shall be produced in conjunction with the Contractor as deemed necessary by the COR. The Contractor shall be responsible for maintaining critical emergency information at all sites and ensuring that all personnel are familiar with the information provided. Additional services may be required in order to provide adequate disaster response.

Services provided in ABSL-4 and Critical Care environments will require an adjusted schedule to meet the needs of the program.

Employee Safety

Medical Surveillance Programs and Safety Requirements and Medical Care The Contractor shall assume full responsibility for the protection of the personnel furnishing services under this contract in accordance with the personnel policies of the Contractor, (e.g.

insurance, Workmen's Compensation, pre-employment, and health examinations). The Contractor shall be responsible for the development and implementation of an occupational safety and health program for all their employees (or subcontract employees) assigned to this NIH contract. In addition, the Contractor shall insure that their employees comply with all NIH on-site safety, fire protection, and security policies and other related guidelines or directives that the Contracting Officer or the COR may determine to be reasonably necessary.

Many of the animals used in NIH animal facilities are used in experiments which involve biological, chemical, and/or radioactive hazards. The Contractor shall work closely with the COR, the Facility Veterinarians and the NIH Division of Occupational Health and Safety (DOHS) to assure that all activities are conducted without hazard to the animal-care staff, other Building occupants, other laboratory animals and the environment. It shall also provide for competence in routine mechanical, fire and electrical safety practices. At a minimum, the Contractor shall comply with all NIH occupational safety and health requirements. The

Contractor's Occupational Safety and Health Program shall also include testing and reporting provisions necessary to protect the animal population from the transmission of human disease as appropriate for specific animal species.

The Contractor shall provide no less than semiannual reports of employee status under the Occupational Safety and Health Program detailing up-to-date vaccination and testing results.

In addition, the Contractor shall maintain on site a file for each contract employee detailing all vaccination and testing to which that individual has been exposed. At least two weeks prior to employment, a list of new contract personnel must be accompanied by a statement by the Contractor's physician for occupational fitness which states that "...this person is fit for duty."

Records of the physician’s physical examination, vaccinations and blood/serum test results if required must be kept on file and maintained by the physician or the Contractor for the duration of the contract and an appropriate time following completion of the contract. This period of time will be determined by the contractor’s physician in accordance with NIH Policy from DOHS.

The Contractor shall establish a medical surveillance program equivalent to the Animal Exposure Program (AEP) conducted by the NIH for employees working with rodent, rabbit, and nonhuman primate species. In addition, in conjunction with OMS, the Contractor will establish a medical surveillance program equivalent to the Retrovirus Exposure Surveillance Program (RESP) conducted by the NIH for employees working with retroviruses and human blood, body fluids, and tissue. Hazardous agents designated Animal Biosafety Levels (ABSL) 1, 2, 3 and 4 will be used in the research. The Contractor shall adhere to NIH safety procedures as they pertain to areas posted for the use of biological, chemical, radioactive or ionizing materials/equipment.

Appropriate medical care shall be provided consistent with the occupational hazards present at the work site as noted in the ASP or SOP.

Any proposed contract employee may be prohibited from working on NIAID facilities 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 able to perform duties without undue risk to themselves and the animals, and are not at increased risk of infection from biohazardous agents above that of the general population”;

inability to receive a vaccination required for working with agents housed in a facility; a positive drug or alcohol screen; or if required by their position, the inability to wear a positive pressure respirator discovered by pulmonary function testing. In the event that a medical question arises over the ability of an on-site Contractor employee to perform the assigned duties or be free of a communicable disease, the COR may require the Contractor to have an additional physical examination performed on the subject employee. The results of this examination will be referred to a competent medical authority of the Government's choosing for determination. Contract staff may be relocated to other facilities with less stringent health requirements (i.e.