Statement of Work.pdf

February 2025

Table of Contents

I. INTRODUCTION

A. General Description of the Requirement B. Location of Contract Activities C. Personnel Qualifications and Technical Competence D. Reference Material

II. SCOPE OF WORK

A. Contract Management B. Contract Staffing

1. Core Work Hours

2. Telework

3. Weekends, Holidays and Overtime

4. Essential Employees

5. Emergency Telephone Roster

C. Services Required

1. Work Conditions

2. Physical Effort

3. Hazardous & Radioactive Waste

4. Animal Support Services

5. Veterinary and Technical Services

6. Research Support Services by Research Support Specialists

7. Genotyping and Breeding Colony Services

8. Animal Care and Use Committee (ACUC) Support Services

9. Administrative Services

10. Importing and Exporting Laboratory Animals

11. Vermin Control Services

12. Government-Provided Transportation Services

13. Equipment

14. Supplies and Materials

D. Training E. Safety and Health

1. Safety and Health Plan

2. Occupational Safety and Health Training Program and Assurance Statement

3. Incidents and Accidents

4. Occupational Medical Program and Summary Reports

F. Quality Assurance

1. Contractor Quality Assurance Plan

2. Government Quality Assurance Surveillance Plan (QASP)

G. Other Requirements

1. Citizenship

2. Communication

3. Absences

4. Security

5. Environmental monitoring for hazards

6. Pre-employment evaluation and screening

7. Transition Plan

III. ATTACHMENTS

A. Table of URL Links for References B. Contract Deliverables C. Labor Categories D. Special Needs Employment Agencies E. Holiday Closing Matrix F. Contractor Training Plan

1. Initial Training

2. Technical Training

3. Training Documentation

4. Training Plan

G. Floor Plan

I. INTRODUCTION

The National Institute on Aging (NIA) is one of the 27 institutes and centers that comprise the National Institutes of Health (NIH). The Intramural Research Program (IRP) of the NIA requires animal research support services for on-going biomedical research projects.

The NIA IRP conducts biomedical, social, and behavioral research and training related to aging and the diseases and special problems of the aged. The NIA IRP requires a contractor to provide research support services for animal research. The Contractor shall provide services primarily at the Biomedical Research Center (BRC) building on the Johns Hopkins Bayview Campus, a leased facility used by investigators and staff of the IRP. The BRC consists of approximately 26,204 gross square feet of space. Researchers house approximately 17,500 mice, 800+ rats, and 20 rabbits in the BRC. Guinea pigs and Rhesus monkeys are housed intermittently.

The Comparative Medicine Section (CMS), under the NIA Office of the Scientific Director (OSD), provides oversight for the overall program of laboratory animal housing, care, and management to ensure compliance with the Institute of Laboratory Animal Research (ILAR) Guide for the Care and Use of Laboratory Animals, as interpreted by the Office of Laboratory Animal Welfare (OLAW), NIH Policy, and AAALAC International (AAALAC).

A. General Description of the Requirement

The purpose of this contract is to provide animal research support services to IRP investigators.

These services include but are not limited to animal husbandry for rodents, rabbits, guinea pigs, non-human primates, and other species; research technical support, to include surgical procedure training and assistance; breeding novel genetic models; routine maintenance of animal care equipment; logistical and clerical support; behavioral testing, phenotyping services; and other specialized services required as new animal study proposals (ASP) are introduced by IRP investigators.

Proper management the of animal care and use program is essential for the welfare of the animals, integrity of research data, and the health and safety of the animal care staff. All activities performed must be managed in a manner that is responsive to NIA requirements. NIA requires that all staff meet the highest standard of humane, appropriate care, and provide medical treatment to the animals in their charge.

Independently, and not as an agent of the Government, the Contractor will function as an integral part of the NIH intramural research program and shall provide a results-oriented approach with an emphasis on consistency in achieving uniformly superior results, professionalism, and a commitment to continuous improvement. The Contractor shall ensure that all animal care and use is conducted in accordance with NIA Requirements and report inconsistency or non-compliance to the Contractor Officer Representative and Alternate Contractor Officer Representative (both to be indicated hereafter as COR).

Use of the words ‘NIA Requirements’ shall hereafter be interpreted as strict adherence to: NIA supported institute Animal Care and Use Committee (ACUC) approved Animal Study Proposals

(ASPs) and Approved Policies; Investigator Orientations; established ACUC and CMS Standard Operating Procedures (SOPs) and Special Care Instructions; CMS Disaster Plan; NIA Safety requirements; and/or established performance standards and schedules as they are provided, developed, or revised by the Contracting Officer’s Representative (COR). See Appendices for references and websites.

• The Contractor shall provide all necessary staffing supplies and ancillary services (except for those to be furnished by the Government as may be specified elsewhere in the contract) to perform the work required by the contract as set forth below.

• The Contractor shall provide a consistently high-quality and wide range of technical research support services required for the proper care, use, and humane treatment of laboratory animals.

• The Contractor shall provide a consistent high-quality and wide range of technical services required for the scientific study, manipulation of animals, and animal products as described in the ASPs.

• General description of the functions for this requirement include:

1. clinical and board certified (or board eligible) veterinary medical assistance,

2. animal care, technical and surgical support,

3. production, breeding, weaning, and sampling genetically engineered rodents,

4. cage and environmental sanitation,

5. routine maintenance of animal care equipment and supplies,

6. property, animal census tracking, data entry, and management,

7. personnel, animal, and equipment transportation,

8. logistical, clerical, and administrative support,

9. supervision and management of Contractor staff.

• The Contractor shall support animal projects involving a wide range of biomedical research. This research may involve but not be limited to studies of behavior; the pathophysiology of a variety of organ systems, especially as related to the aging process;

and scientific disciplines using animal species that may include mice, rats, rabbits, guinea pigs, non-human primates, and other vertebrates and invertebrates.

B. Location of Contract Activities

Contract support will be required in the BRC located within the Government leased 251 Bayview Boulevard building in Baltimore Maryland. Periodic travel to Bethesda, MD, Poolesville, MD, and satellite storage locations that are not physically or operationally contiguous with other NIA animal facilities may be required. The Poolesville facility houses some non-human primates on an interim basis and contractor support services may be required from veterinarian staff approximately 1-3 times per month. Travel will be reimbursed in accordance with GSA Federal Travel Regulations.

C. Personnel Qualifications and Technical Competence

Requirements for personnel qualifications and technical competence are as detailed in Attachment C in the appendix. The Government does not require or expect all the defined category levels to be filled by personnel. Contractor proposed categories must include a description of position complexity, qualifications, requirements, and demonstrated proficiencies for the category.

The Contractor shall be responsible for the selection (subject to Government review of Key Personnel), certification, assessment, training, supervision, management, and control of personnel throughout the life of the contract in accordance with the policies and regulations specified in this Statement of Work. Contractor shall seek approval from the COR as it pertains to the hiring process of Key Personnel contract staff members only.

In performing its responsibilities under the contract, the Contractor shall fully train, technically proficient personnel that are qualified under the specific Labor Category criteria. All personnel assigned to work under this Contract must meet the minimum requirements/skill levels for the labor categories to which they are assigned and be capable of performing the functions of their duties in a competent and professional manner.

Contractor personnel shall possess a thorough knowledge of the mission, goals, and objectives of the NIH and the NIA program of animal care and use. The Contractor shall ensure that minimum competency skills are achieved before personnel are permitted to work unsupervised.

Within 30 calendar days after Contract initiation the Contractor shall provide the COR a list of Contractor employees by labor category (listed in hierarchal order) indicating degrees, formal training, and professional/technical certifications held along with a copy of each professional/ technical certificate listed; for board eligible veterinarians, submit an American College of Laboratory Animal Medicine (ACLAM) approved examination application notification letter.

For information on how to obtain an ACLAM examination application form, call 603-887-2467 or go to www.ACLAM.org for information on certification and applications.

The Contractor shall maintain a list of Contractor employees by labor category (listed in hierarchal order) indicating degrees, formal training, and professional/technical certifications held, this list shall be updated and included in the Monthly Progress Report. Any changes shall be indicated, and a copy of new professional/technical certificate shall be provided (evidence of professional/technical certifications held should be provided to the COR for each Contractor employee once).

D. Reference Material

For proposal submission purposes, a list of websites to references is provided in Appendix A.

References to contract policies and operational guidelines are provided to assist the Offeror with contract support operations and submitting a proposal to this Statement of Work.

II. SCOPE OF WORK

A. Contract Management

The Contractor shall provide prompt, efficient, and continuous high-quality animal research support services and animal care as set forth in applicable laws, regulations, guidelines, policies, intra-agency agreements and existing Animal Study Proposals, Standard Operating Procedures and ACUC Appendices at NIA and developed throughout contract performance. For the accurate http://www.aclam.org/ interpretation of laboratory results, experimental animals require carefully controlled conditions to minimize uncontrolled influences on research variables. Consequently, it is essential for the Contractor to foster conditions that minimize disruptive situations that potentially introduce variables that might invalidate experimental results. The Contractor shall prevent situations that adversely affect experimental conditions including, but not limited to, undue stress, disease, animal misidentification, and animal escape. The Contractor shall maintain strict adherence to ASPs and SOPs.

Services include, but are not limited to:

• Animal care including husbandry, technical support, health monitoring, nutrition, hygiene, and written and computerized record keeping in a research environment conducting animal bio-safety level II research.

• Animal handling, restraint, technical laboratory animal procedures, observations, and euthanasia.

• Veterinary medical care, veterinary medical, surgical assistance, and animal health quality assurance.

• Magnetic Resonance Imaging (MRI) procedure support, and animal irradiation.

• Assistance and operation of behavioral testing equipment, environmental chambers, and monitoring systems.

• Cleaning, sanitation, and sterilization of equipment, supplies and facilities.

• Equipment maintenance.

• Purchase and disbursement of personal protective equipment including facility dedicated scrubs and steel toe shoes which will need to be proposed by the Contractor and approved by the COR prior to purchasing as other direct costs on the contract.

• Purchase and disbursement of expendable supplies within the facility.

• Logistical support such as transportation of animals, samples, supplies, and equipment.

• Administrative support including but not limited to assistance with regulatory paperwork, inventory control, purchasing, animal census tracking, and facility maintenance request.

• Appropriate technical and developmental training for both Contractor and Government research personnel use SOPs and Institute policies along with contractor provided training such as AALAS certification training.

• Appropriate supervision, human resources support, and management oversight of Contractor personnel.

• Development, training, and implementation of new SOPs and revised existing SOPs.

The Government will provide SOPs upon initiation of the Contract. Subsequent revisions or additions to SOPs will be produced by the Contractor and approved by the COR. All newly developed SOPs shall be approved by the COR and shall be considered deliverables. All SOPs must follow the CMS standardized format and be succinct, in the active voice, and grammatically correct. Standard operating procedures will be posted on the NIA intranet for use by all NIA staff, in accordance with Section 508 compliance. The NIA shall have unlimited rights to, and ownership of all SOP deliverables provided under this contract.

• Preparation, maintenance, and distribution of reports related to animal care and use to include genotyping.

• Receipt, delivery, unpacking and completion of receiving documents for laboratory animals, supplies, and equipment ordered by the Government. Contract staff must sign packing slip, bill of laden, email statement of receipt to indicate delivery. The Contractor shall deliver items to the appropriate area(s); signed packing slip, bill of laden, email statement of receipt must be delivered to the government approving official and card holder employees within 48hrs.

• Assistance with import and export of laboratory animals and biological materials.

• Environmental monitoring and quality assurance.

• Environmental enrichment

• Research Laboratory support services

• Surgical research support and investigator training services including, but not limited to pre-operative care and handling, anesthesia and analgesia, catheterization, surgical techniques and procedures, post-operative care and recovery.

• Gross necropsy services to include identification of gross pathological changes.

• ACUC Support.

B. Contract Staffing

The Contractor shall manage and care for all species of animals in the BRC animal facility seven days a week, every day of the year including non- standard working hours, weekends, and Government holidays. The Contractor shall manage the labor hour mix to ensure contract staff coverage is provided that will successfully and adequately meet the goals and objectives of this Statement of Work. This may include providing unique contract staff coverage with different shifts work based on competing demands of the workflow throughout day-to-day activities, as further described below.

The Contractor's onsite management and supervisory staff shall be responsive to the specific objectives and requirements of the contract and provide proper oversight and supervision of all facility activities, animal care and use program management, facility management, animal care services, coordination of procedure and animal space usage, and preventive maintenance of equipment and facilities.

The Contractor shall be responsible for the delegation of duties for contract personnel. The Contractor shall be responsible for the selection (subject to Government review), certification, assessment, training, supervision, management, and control of personnel in performance of the Statement of Work and shall comply with the general intent and specific policies or regulations of NIH concerning conduct of personnel as referenced herein. However, when necessary to ensure continued satisfactory performance of the required services, the Government may request in writing (with an explanation) that the Contractor replace any person under this contract.

Reasons for requested removal include but are not limited to inappropriate behavior, poor performance, misconduct, endangering life, damage and/or abuse of Government property, and inhumane treatment of animals. The Contractor shall replace any such employee as requested.

Contractor personnel shall follow the NIH standards of conduct rules for non-employee staff of the Government, such as: the Contractor and Contractor's personnel shall only conduct business covered by this contract during periods paid for by the Government and shall not conduct other business on Government premises. The Contractor shall minimize interactions with Contractor staff except for general management purposes that relate directly to the activities and performance of tasks under this contract. Contractor personnel shall abide by the rules and regulations applicable to the Government premises on which they perform work, including any applicable security regulations. The Contractor's personnel shall only eat and drink in designated areas. Contract staff shall not take cameras or camera-equipped cell phones into the vivarium without prior permission from the COR. Any electronic communication devices, such as cell phones, used by contract staff for contract work will need to be approved by the COR prior to use and will not be reimbursed for cost on the contract.

The Contractor is expected to keep the COR informed of all emerging, discrepant, urgent, or emergency situations.

1. Core Work Hours During standard working hours, the Contractor shall provide coverage within the BRC animal facility. The Contractor’s on-site services shall encompass an 8½-hour workday, five days a week, Monday through Friday excluding Saturdays, Sundays, and Federal holidays. During the Monday through Friday workweek, the Contractor shall provide services primarily from 7:00 a.m. to 3:30 p.m. with the option of staggering personnel work hours until 5:00 p.m.

Services beyond the 7:00 a.m. to 3:30 p.m. timeframe may be required on an ongoing basis in locations where limitations in physical plant preclude completion of work within the established work period. Staggering start times on employee schedules should allow for all shift times to be covered. Where services are required before and after the established work period, the Contractor shall provide supervisory personnel to manage personnel staffing for the activities of the day. The COR reserves the right to alter facility work hours with 30 days advance notice. In the event of emergencies concerning the management of facility infrastructure or animal care and wellbeing, or other unforeseen circumstances, personnel may at times be required to vary their work schedules to provide support to facility activities with little if any advance notice.

2. Telework

In support of the NIH green initiative, CMS will consider telework for contract staff that are determined to be Key Personnel or are designated as administrative personnel. Work will need to qualify as being eligible for telework, and will be monitored by the COR.

The COR will have final approval of telework requests for contract staff, the COR can terminate contractor telework agreements at any time with or without cause. The contractor must provide the name of the individual and general duties that will be accomplished on dedicated telework days. The contractor must provide a telework agreement for individuals who are granted this privilege. The government will provide the agreement form post contract award and provide telework training for approved individuals.

Telework hours must mimic regular on-site work hours; any deviation from regular on-site hours and approved dedicated telework days must be pre-approved by the COR.

3. Weekends, Holidays and Overtime The Contractor shall provide required normal contract services to accomplish regular animal husbandry activities and technical project support on all Federal Holidays, Saturdays, Sundays, and on Government or facility closures, to include government shutdowns and at times approved by the COR on an "as needed basis," including overtime.

The Government may require staggered workday schedules to accomplish routine animal husbandry. The Contractor shall provide sufficient supervisory personnel for effective and productive staff management. The Government will require verification for contract personnel hours worked for which the Contractor requests cost reimbursement. Regular scheduled weekend work hours may be invoiced as overtime or may be offered compensation time for weekend hours worked during the same pay period.

Verification may take the form of a time-clock entry, a sign-in and sign-out sheet, hours worked monthly invoice, or any other method that provides incontrovertible evidence of the hours worked.

The COR must review the contractor's request for overtime and grant in writing approval or denial of the request within 24-hours after the receipt of the overtime request from the contractor, except in cases of emergencies as stated previously.

4. Essential Employees Unless otherwise specified, all Contractor personnel shall be deemed essential since they provide services that are vital to the survival and humane care of laboratory animals and to maintain the integrity of scientific research. Essential employees report for duty during periods of inclement or other government weather closures, furlough, pandemic outbreaks, unforeseen circumstances, or other adverse working conditions, even in situations when the facility closes temporarily (e.g. furlough), unless their supervisor approves their absence. Services may be required at times outside of normal working hours. The Contractor shall provide emergency services outside these hours by an "on call" system 24 hours per day, every day of the year to maintain facilities, equipment, and animal health in the event of emergencies (e.g., relocating animals in the event of HVAC failures, water main breaks, fire, structural failures). The Contractor shall maintain an accurate and up-to-date emergency telephone roster to mobilize personnel as required.

During times when contract staff are not at work for the day, multiple days, or part of a day, their position duties as necessary shall be fulfilled by means of a replacement. The contractor shall describe a corporate or organizational resource team of employees, including personnel titles and duties, for designation of replacements if needed. See replacement procedures in Table 2 Performance Standard Deliverables as an appendix Personnel Provisions

The Contractor will notify the COR and the CMS Administrative Officer at least five working days in advance when any new personnel are to start work under this contract.

The Contractor shall provide the necessary information to initiate the process for requesting ID badges, including if the individual has previously been the subject of national agency checks or background investigations, and completion of the Roster of Employees Requiring Suitability Investigations Form with the employee’s full name, e-mail address, phone number and position. In addition, each employee shall complete the Contractor Non-Disclosure Agreement and submit a copy to the COR prior to performing any work under this acquisition. The contractor shall ensure that prior to their start date and prior to expiration of ID badges, contract personnel comply with the conditions established for their designated position sensitivity level and complete all requirements for obtaining their ID card in a timely manner so as not to delay issuance of ID badges or renewal of ID badges. Contractor personnel may not begin work until after the fingerprint check has been completed. Contract personnel must always wear their ID badge while on duty.

The contractor shall ensure that all requirements for obtaining parking access are met within 15 calendar days of a start date and will ensure that all requirements for renewal are met prior to expiration.

The Contractor must immediately report all suspected or confirmed incidents involving the loss of ID cards.

The Contractor will notify the Contracting officer, the COR, and the CMS Administrative Officer within forty-eight working hours if an employee discontinues working under this contract or no longer needs facility access. The Contractor shall provide the COR with the name and position title for departing contractor employees and shall perform and document the actions identified in the NIA Employee Separation Checklist. All identification badges, keys, card keys, laptops, monitors, and other government furnished equipment if the individual had tele-work privileges and parking passes remain the property of the Government. The Contractor shall be responsible for the collection of these items from personnel immediately upon termination of employment with the Contractor and returning them to the COR within 7 calendar days.

Contract personnel working in the animal facility shall be required to wear uniforms and don appropriate personal protective clothing and equipment as per NIA Requirements.

The Contractor shall provide uniforms for its personnel that are readily identifiable with the Contractor’s name and must consist of a scrub shirt and scrub pants, or a scrub jumpsuit fulfilling the criteria may be worn instead of the scrub shirt and pants. Uniforms must be non-disposable; washable; clean and in good condition; and able to be steam sterilized and remain in good condition following steam sterilization.

Within ten days of hire, the Contractor shall furnish non-disposable uniforms, appropriate to their duties, to all employees assigned to the Contract who require such protection. An adequate supply of appropriate, clean uniforms shall be provided, and available for each employee, to enable personnel to change daily or more frequently when uniforms become heavily soiled or contaminated. Facility scrubs are not to be laundered at an employee’s home. The Contractor shall take care to maintain the quality/integrity of the uniforms (i.e.

replace torn or worn uniforms, etc.).

Within ten days of hire, the Contractor shall furnish steel toe safety shoes and/or boots appropriate to their duties to all employees assigned to the Contract who require such protection.

The Contractor shall provide towels or jackets/coats for its employees as necessary and/or to support IC research support requirements.

The Contractor shall provide full-face, fitted respirators and replacement cartridges or other protective apparel when medically indicated or research dictates. If re-imbursement by the Government is to be requested, the purchase of all such specialized equipment shall be approved in advance by the COR. All required maintenance, annual fit testing, and training on proper use of respirators will be the sole responsibility of the Contractor.

The Government will provide shared restrooms and lockers for Contractor personnel. The Government is not liable for the loss of personal possessions.

5. Emergency Telephone Roster The Emergency Telephone Roster will be a deliverable contained in the contract and is included in the deliverable chart in the appendix. Within one day of contract initiation, and within 24 hours of any change thereafter, the Contractor shall prepare and submit to the COR an emergency telephone roster to facilitate mobilization of personnel as required.

The Contractor shall be responsible for maintaining a copy of the emergency telephone roster and critical emergency information at all sites and for ensuring that all personnel are familiar with emergency procedures. The Contractor shall update the current NIA Animal Care Emergency Handbook that outlines the current emergency telephone roster, mobilization procedures, and emergency procedures no less often than semiannually.

C. Services Required

The AAALAC has accredited the NIA/BRC animal facility in the Intramural Research Program.

Therefore, the Contractor shall incorporate standards, policies, and procedures that are consistent with this accreditation. Facility management and supervisory staff, veterinary technicians, research support specialists, senior animal caretakers and animal care technicians must be certified. The level of certification is dependent on the nature and level of their responsibilities.

The Contractor shall ensure that its employees, and proposed contract employees, have earned certification, or capable of earning certification, from the American Association for Laboratory Animal Science (AALAS), within guidelines specified herein.

Cage wash, administrative staff, and staff indirectly involved with the animal care and use program are not required to achieve AALAS certification. Staff will be required to achieve the certification level for the respective position within one year of contract inception. The government will require the removal of contract employees who fail to meet the certification requirements within stated timeframe. A training program based on CMS SOPs, along with a documented competency check is expected for all non-AALAS certified staff positions.

1. Work Conditions Contractor employees shall work mostly inside. However, employees shall be required to work outside performing tasks associated with sanitizing outside receiving areas; picking up and delivering animals, samples, supplies and small equipment; transporting waste and moving equipment into and out of sanitation, sterilization, and storage locations.

Employees may be subject to adverse variables of weather.

2. Physical Effort Work under this contract may require frequent lifting (50 pounds or more); pushing or pulling racks, carts, and dollies; and walking, standing, sitting, and considerable arm and hand movements. Personnel must be able to operate the machinery appropriate to their duties. Drivers of vehicles must possess a valid state driver’s license and be capable of driving a variety of vehicles. Contract employees who cannot, upon determination by the Contractor’s physician, meet the above criteria may be reassigned to positions requiring less physical effort if such positions are available.

3. Hazardous & Radioactive Waste The Contractor shall process, package, and document the hazardous or radioactive waste materials for pickup in accordance with NIH MI-3032: Waste Management at NIH and any additional guidance stipulated by the Radiation Safety Branch or the Environmental Protection Branch and applicable SOPs. The Government will provide scheduled pickup of hazardous waste (animal carcasses, medical pathological, chemical, and radioactive).

4. Animal Support Services Continuous high-quality animal care shall be provided as set forth in the NIA Requirements. The Contractor shall furnish the necessary on-site management and personnel for performing the duties associated with animal husbandry, and the technical services related to animal care and use. The Contractor shall care for and maintain animals under carefully controlled conditions to minimize research variables, maintain scientific integrity, and enable valid and meaningful interpretation of research results. It is essential that animal colonies be properly maintained to avoid any situation or condition, such as undue stress, diseases, cross contamination, animal or cage misidentification, animal escape, and incomplete or inaccurate record keeping that might adversely affect experiments.

NIA prohibits personnel who are in contact with other laboratory animal species (e.g., pet rodents, pet rabbits) from entering our animal facilities for 24 hours after such contact ends. The COR may grant case-by-case exceptions but will likely require such personnel to undergo a complete-body shower and a change of clothing into sterile lab-wear. The specific numbers and workload below may vary as a function of scientific investigations.

Contractor personnel shall perform animal care and husbandry in support of studies conducting comprehensive phenotypic analysis of social, emotional, cognitive, and reward-related behaviors in genetically modified animals as part of programs of research to identify genetic, molecular, and neural pathways underlying the aging process.

Environmental concerns are of utmost importance for animals involved in behavioral testing or requiring special care. Provisions for care and handling of animals and cages must be conducted in such a way as to minimize research variables and ensure the health and welfare of the animals as not jeopardized and that it does not interfere with procedures and outcomes of behavioral scoring and assessment within and between experiments. Testing paradigms will include procedures to assess general health, neurological, sensory, and cognitive functions to include perception of sound (perceptible to humans and ultrasonic), vibration, touch, balance, coordination, grip strength, thermal insult, pain, and assessment of the presence or absence of anxiety and/or social and agonistic behaviors.

The contractor shall ensure that all activities and technical support of routine husbandry and special care are conducted in accordance with requirements and shall ensure that cages are changed on the agreed upon schedule and that they do not deviate from the schedule unless approved and agreed upon in advance. More frequent cleaning may be necessary if cages become soiled (e.g., during weekends or holidays) or an outbreak of disease occurs.

The Contractor shall provide Animal Care and Use Program Support Services to investigators, according to SOPs, as follows:

• Daily observations of each animal for deviations from normal behavior and health;

sanitary management of animal rooms, procedure rooms, adjacent corridors and loading dock areas.

• Animal husbandry for approximately 77 ventilated mouse racks and 33 ventilated rat racks, consisting primarily of daily health checks and cage changing once every 7-14 days depending on species and spot changes in between, when necessary, using aseptic technique in a laminar flow change station or biosafety cabinet following SOPs for gowning and infectious disease control.

• Animal husbandry for approximately 4 rabbit racks consisting primarily of daily health checks and cage changing once per week.

• Animal husbandry and feeding protocol for approximately 4 ventilated racks of caloric restricted mice and up 2 of rats; consisting primarily of daily food manipulations (cutting and weighing specific portions), daily health checks, and cage changing once per week.

• Health checks AM and PM of 5 CLAMS units and circadian units.

• Cage wash services for 130 racks and their associated caging components consisting of scraping, washing, autoclaving, supplying new bedding, and enrichment as required.

• Mouse and rat colony maintenance for ~360 current active strains including breeding, weaning, ear tagging, and collecting tail, toe or ear punch samples for genotyping following SOPs.

• Technical requests including but not limited to natural mating, blood sampling, euthanasia, and injections under various conditions for approximately 20-30 hours per week.

• In accordance with approved ASPs, ASP Appendices, written SOPs, and industry standards as set forth in the Guide, the Contractor shall:

o Provide special animal husbandry (e.g., medicated feed, treated water, and non-standard bedded caging) and animal care. Animal care includes environmental enrichment and socialization.

o Provide receipt, identification, housing, and animal inventory database updates.

o Provide support for approved scanning (MRI, NMR, dexa-scan) and irradiation procedures.

o Perform or assist with behavioral testing.

o Perform or assist with a variety of aseptic surgical procedures. Services may include but are not limited to administering preoperative anesthetics or medications; performing preoperative surgical procedures; administering injectable or inhalation anesthesia; monitoring animals under anesthesia for proper levels of anesthesia; assisting the surgeon by selecting the proper suture material, needle type and size, or selecting staples; and assisting in or monitoring postoperative recovery and support.

o Provide research and technical support services such as specimen collection, administration of oral or parenteral medication and research reagents, individual animal identification, animal restraint, maintenance of breeding colonies and records thereof, timed mating, and animal-health support services.

o Provide quality control and surveillance services including, but not limited to:

Maintaining the animal health surveillance program, Collecting appropriate specimens for monitoring the effectiveness of sanitization and sterilization procedures, Monitoring appropriate cage wash parameters, Monitoring incoming animal shipments for container integrity and animal health, Monitoring the heating, ventilation, and air conditioning system and internal facility monitoring data for deviation from pre-established norms, Other safety and quality control services as deemed necessary (e.g. RO water chlorination level).

o Provide proper care, use, and maintenance of equipment.

o Provide cage wash services, including:

Transport of clean and soiled caging to and from animal rooms, Proper disposal of soiled and potentially contaminated bedding, De-scaling of caging and cage wash machines, Sanitizing dirty caging, water bottles, sipper tubes, animal enrichment devices and other equipment such as mop buckets, mop handles etc.

Appropriate handling of biological waste and its disposal at designated sites, Cage drying and addition of clean bedding, Autoclaving of caging, equipment, and supplies as required, Decontamination of potentially contaminated equipment, supplies, and waste, Delivery of reserve clean caging to a dedicated storage area.

Sanitation and upkeep of the facility as required. The Contractor shall coordinate sanitization of animal rooms, procedure rooms, and corridors with researchers’ work to avoid creating unnecessary interference. On some occasions, the Contractor shall sanitize these areas outside the normal workday and workweek. Special procedures may be required under some circumstances such as when a room is emptied for a change of species, after a disease outbreak, or following fire, flood, renovation, or completion of new construction.

o Develop, implement, and train on new SOPs and revise existing SOPs related to the animal program and services CMS provides to researchers. SOPs are subject to approval by the Animal Program Director and ACUC to ensure they reflect currently acceptable practices.

o Manage animal imports and exports that involve coordinating with various Government offices, private sector research institutes, universities, and overseas contacts.

o Interact with various NIH personnel e.g. Office of Research Services, Office of Research Facilities, Safety Office, as directed by the COR.

o Manage areas designated for biohazard use, isolation, and quarantine.

o Ensure all animal activities and animal use are conducted according to:

ASPs approved by the NIA Animal Care and Use Committee, ACUC Appendices and CMS SOPs, And current animal welfare regulations.

• Report negligence and lack of compliance with applicable policies and regulations to the COR.

5. Veterinary and Technical Services The Contractor shall provide services including all aspects of, but not limited to, the following:

• Veterinary medical services, critical and nursing care, and post-surgical care. A

Laboratory Animal Medicine Board certified or eligible veterinarian must head this service. Individual veterinarians providing this service must have clinical veterinary experience treating the species used at NIA.

• After hours emergency coverage 24 hours a day, 365 days a year.

• Identify and report deviations from normal health.

• Perform preliminary health exam of abnormal or sick animals to include assessment of the health condition and initiation of a clinical record.

• Triage of sick animals and notification of veterinary staff accordingly.

• Administer treatments, medications, and ensure that they are provided as directed by the veterinarian.

• Perform all veterinary nursing care and treatments in a proficient, gentle manner and ensure that all medical, clinical, and surgery cases are routinely checked and followed up on until resolved.

• Maintain clinical and surgical records in a complete, neat, and accurate manner consistently.

• Provide animal handling, restraint, identification, technical laboratory animal procedures, euthanasia, and training of Investigators.

• Implement the health surveillance program to include obtaining animal specimens and submitting specimens or animals to the NIH Bethesda campus and other laboratories for testing with follow up and archiving of results.

• Provide technical assistance to Intramural investigators, including but not limited to:

o Identify approximately 20,000 laboratory animals/year using methods such as ear tags, notches, toe clipping, tattoos, microchips, or subcutaneous transponders.

o Rodent breeding, colony management, mouse genetics, timed mating, backcrosses, fostering, estrus synchronization, and the necessary database management of these activities.

o Provide detailed observations of disease or syndrome progression in experimental animals as part of an ASP.

o Immunize and bleed animals used in experiments in accordance with ASPs and SOPs. All technical staff shall be able to restrain, inject (IV, IP, IM, SQ, ID, orbital), and bleed (retrobulbar, cardiac, peripheral venous system including the marginal ear veins in rabbits) laboratory animals effectively and properly.

o Perform or assist with anesthesia, euthanasia, and gross necropsies.

o Aseptic collection of tissues or organs such as bone marrow, lymph nodes, oviducts, embryos, and spleens including tissue trimming and or preservation as required.

o Weigh animals, feed, and record dietary data (e.g., as part of food or liquid consumption studies, or caloric restriction studies).

o Calculate appropriate dosages of medications based upon body weight, make dilutions to obtain desired concentrations.

o Implant various subcutaneous or abdominal monitoring and experimental devices in animals of various species.

o Perform survival surgeries such as tumor removal, subcutaneous or intra-abdominal pump placement, mastectomies, splenectomies, wound repair, and indwelling catheter placement.

o Conduct behavioral testing.

o Complete laboratory submission forms, and o provide other technical services.

6. Research Support Services by Research Support Specialists The Contractor shall provide technical staff with animal experience and specialized knowledge who are dedicated to specific investigators in support of their research. The investigator may wish to review resumes and interview potential candidates prior to selection. Support must be provided to the following laboratories: TGB (de Cabo or laboratory specific research project support), 2 positions; LBN/CMS (Rapp and McDevitt for behavioral work), 1 position; CMS (McDevitt for behavioral work), 1 position; CMS (Animal Program Director for surgical training of investigators, upkeep of surgical services, and laboratory specific research project support) 1 position, individual must have rodent surgical experience. Support positions might be added or removed over the course of the contract depending on research needs.

Specific functions to be provided include but are not limited to:

• 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 Laboratory’s

ASPs to include, but not limited to weighing animals and feed, blood withdrawals, performing injections, operating behavioral equipment.

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

• Set up animal protocols to include following relevant SOPs.

• 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.

• Perform aseptic survival surgical procedures.

• Conduct behavioral studies.

• Practice universal precautions appropriate to different Animal Biosafety Levels

(ABSLs). Work safely with animal/human pathogen biohazards and assist in the maintenance of the research laboratory animal facility as a safe work environment/operation.

• Maintain optimum care and maintenance of research equipment for the routine hygiene and disinfection of research equipment.

• Schedule time for meetings with investigators, outside the facility, if necessary, to assist in coordinating animal research needs.

• Serve as “point of contact” or “liaison” for the Laboratory in conjunction with the

CMS contract staff and COR.

• Report any animal health, care, and/or well-being concerns to the appropriate facility management staff and facility veterinarians.

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

• Ability to work planned flexible hours to ensure research needs and experiments are carried out to comply with appropriate timelines to include weekends and holidays as needed.

• Ability to interact with all personnel in a manner which promotes a professional work environment.

• Perform other duties as assigned.

7. Genotyping and Breeding Colony Services The Contractor shall provide technical personnel with basic genetics training and a working knowledge of common genetic modifications of rodents and their associated impact on genotyping results. The knowledge level must allow the technician to assist investigators in figuring out genotyping inconsistencies between expected results and those received from the NIA genotyping service provider. Personnel will have the ability to work with investigative staff to investigate and resolve poor breeding colony performance.

8. Animal Care and Use Committee (ACUC) Support Services The Contractor shall provide a veterinarian boarded or board eligible (with 1-2 years of ACUC experience) by the American College of Laboratory Animal Medicine to act as the Attending Veterinarian on the ACUC. The individual will participate in semiannual and AAALAC program reviews; ASP review, renewal, and amendment processing; and review/revision of ACUC Appendices, policies, and CMS animal program SOPs. The individual will manage the health surveillance aspects of the animal order process, and animal import/export/transfer process. The individual will have some clinical responsibilities as directed by the NIA APD.

9. Administrative Services

Administrative services include but are not limited to:

• Purchasing support.

• Process animal orders by verifying vendor, availability (quantities), protocol and space requirements, using computer-based protocol tracking systems, and cage card generation.

• Maintain Progeny Database census on a day-to-day basis to ensure accurate census data.

• Administrative support to include telephone answering, filing, faxing, data entry, maintain animal inventories, database report generation, written and digital record keeping.

• Management and maintenance of equipment and supplies and other logistical support, management of property inventory within NIA property management system, including off-site locations.

• Develop, review, update, format, and post SOPs to the CMS website. Ensure SOP titles match the SOP Table of Contents. Coordinate with the COR when SOPs are no longer valid and need revisions and changes, submit revised SOPs to the COR for review and approval.

• ACUC and other CMS committee support functions, as needed.

• Prepare and submit other reports related to the animal program, as requested by the

COR.

10. Importing and Exporting Laboratory Animals The Contractor shall:

• Arrange and coordinate all animal imports and exports according to NIH policy and

International Air Transport Association requirements.

• Assist the Government in transferring of ownership and holding location of animals from internal and external sources.

• Ensure adherence to all pertinent, SOP’s, rules, regulations, policies, and guidelines.

• Coordinate and follow through on appropriate import and export documentation and logistical support as appropriate to the origin or destination, health status, and weather conditions.

• Coordinate shipments to the NIH quarantine station in Bethesda, MD (DVR); obtain test results and decide disposition of animals received e.g. allow to enter the BRC or require rederivation.

11. Vermin Control Services NIA has adopted an integrated pest management approach to vermin control. The Government will be responsible for determining and applying appropriate insecticides or entrapment and the selection of a contracted licensed pest control company. The Contractor will work in tandem with the pest control company, alerting the pest control company to any found insect or rodents, to inform the pest control representative of any changes to foot pattern or restricted room access.