Animal_Care_SOW_11.19.pdf

SOURCE SELECTION INFORMATION SEE FAR 2.101 and 3.104

NIH/NIAID/OA/AMOB

ATTACHMENT 3: STATEMENT OF WORK

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

NIHAO201800001

1) BACKGROUND AND INTRODUCTION

The National Institutes of Health (NIH) is one of the world's foremost biomedical research organizations. 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 one (1) building on the Division of Veterinary Resources (DVR) operated NIH Animal Center (NIHAC) campus in Poolesville, MD. The NIAID is also responsible for the operation of an NIH shared animal facility used by NIAID along with several other NIH Institutes (National Heart, Lund, and Blood Institute; National Human Genome Research Institute; National Institute of Diabetes and Digestive and Kidney Diseases;

National Institute of Neurological Disorders and Stroke; and National Institute on Deafness and Other Communication Disorders). 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. The NIAID also maintains animals in NIH central animal facility. 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).

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.

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.

2) SCOPE

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

3) 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.

Specifically, the Contractor shall:

Develop SOPs and ASPs 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 ASPs unless deviation is requested by the Government.

Animal Care

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 necessary.

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 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.

Additional Animal Support Services

At a minimum, perform twice daily 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.

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

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

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

iv. Immunize and/or bleed animals used in experiments in accordance with ASPs

/ SOPs. All technical staff shall 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.

v. Perform or assist with gross necropsies.

vi. Collect tissues or organs such as CSF, bone marrow, lymph nodes, oviducts, embryos, spleens aseptically

vii. Weigh animals and feed and record, i.e. as part of food or liquid consumption studies viii.Perform cell counts, making dilutions to obtain desired concentrations;

calculate appropriate dosages of medications based upon body weight.

ix. Implant mini osmotic pumps subcutaneously in mice per year.

x. Perform survival rodent surgeries such as skin grafts, vasectomies, splenectomies, and embryo implantations on mice

xi. Complete laboratory submission forms, and provide other technical services as required by 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.

i. 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.

ii. Ensure technicians assist in the daily animal husbandry tasks and general maintenance of facilities as necessary

iii. Maintain rodent and rabbit toe nails and incisors at a satisfactory length.

xii.

Animal Health Surveillance

The Contractor shall be responsible for conducting animal health surveillance including the maintenance of animal isolation facilities in accordance with ASPs and SOPs.

On weekdays, cages shall be checked once within two hours of the start of the work day and once within two hours of the close of the work day. Cages shall be checked on weekends and holidays once within two hours of the start of the work day. Cages shall be checked on weekends and holidays a second time 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. 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 of animal care 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.

Obtain 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 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, appropriate specimen collection for the monitoring of the effectiveness of sanitization and sterilization procedures, monitoring of the appropriate cage wash parameters (defined in the SOPs), monitoring of incoming animal shipments for container integrity and animal health, monitor the Heating, Ventilation, and Air Conditioning (HVAC) 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 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 Programwill evaluate the Contractor’s technical and managerial performance in meeting the requirements of the Statement of Work.

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

Responsibilities will be provided to laboratories as approved by the Scientific Director and requested from the COR. Specific functions to be provided are 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 so as 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 acting 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 contact and 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.

Facility Management

The Contractor shall have facility managers in all DIR operated buildings where animals are housed no less than five days during a regular workweek. 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.

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) Descaling of caging and cage washing machines;

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

e) Cage drying and addition of clean bedding;

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

g) Gas sterilization of reusable 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.

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. Maintain a current inventory of all supplies, e.g. 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.

7. 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.

8. Notify the COR via 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. 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 receiving items in the portal on a timely basis.

9. Store all supplies in designated storage areas. Feed bags and bedding shall be stacked on sanitizable pallets, racks or carts.

10. 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, cage washers, autoclaves, HEPA filtered work stations, Class II biological safety cabinets, 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.

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

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

4. Maintain a written record to document all equipment related problems, including date(s), names(s), action(s) taken, resolution(s), and problem(s) occurring which require COR intervention and attention.

5. Advise the COR when additional or replacement equipment is needed in order to properly manage the program.

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

7. Ensure that all HEPA filtered equipment, X ray machines, and fire extinguishers in use are certified annually.

8. Follow established sanitization and sterilization monitoring procedures as described in the SOP’s. Microbial 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.

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.

Training The Contractor shall maintain a training and recruitment program so as 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 shall be permitted to work without direct supervision 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 training program shall cover 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. 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. 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, this requirement is dramatically reduced at the other NIAID locations.

Safety Training

A safety orientation training program will be conducted by the Government for Key Personnel.

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 personnel must complete this training prior to starting work in the animal facilities.

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 NIH with documentation including the name of each attendant and signatory evidence of understanding.

Training shall include:

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 desired

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 Material Safety Data Sheets (MSDS)

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 may provide site specific instructions to the Contractor's on site Manager (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 insuring their staff is provided with, understand, and follow those safety instructions.

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.

Government Vehicle Insurance/Licenses

Some Contractor personnel shall be designated authorized drivers of Government vehicles. The Contractor shall provide a copy of the insurance policy, including standard automobile insurance which provides protection against any potential liability claims against the Contract driver. 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.

Personal Protective Equipment

The Contractor will provide single use, disposable equipment such as disposable gloves, lab coats, jumpsuits, coveralls, head covers, shoe covers, undergarments, nuisance dust masks and accessory equipment required for research support. If hearing protection is required in certain job sites (e.g., cage wash areas), the NIH will provide appropriate ear plugs or muffs, unless the individual needs customized equipment, which shall be provided by the Contractor. In addition, the NIH 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.

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 it’s 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. Uniforms are not to be worn outside the facility unless covered by disposable clothing that is removed prior to re entering the facility as per appropriate SOP’s

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 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, all contract personnel resumes 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 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”; 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.

Contractors working in ABSL3 and 4 and with Select Agents will be required to be enrolled in the NIH DOHS Biosurety program and will receive additional medical screening and evaluation.

Safety Requirements

The Contractor shall ensure that their employees will comply with all NIH on site safety, fire protection, and security policies and other related guidelines or directives that the Contracting Officer or COR may determine to be reasonably necessary.

The Contractor shall report within fifteen minutes all spills or accidents involving hazardous or reactive material to the COR and appropriate safety office. The Contractor shall assist in the clean up of contaminated bedding, feed, urine or other substances resulting from spills or accidents involving hazardous or radioactive materials in accordance with appropriate safety Standard Operating Procedures. The Government shall inform the Contractor of site specific hazards (e.g. presence of asbestos, disease outbreak or research associated hazards).

If the Contract staff bring any potentially hazardous materials to NIH work sites (e.g. cleaning agents), the Contractor shall retain copies of the Material Safety Data Sheets (MSDS) on site, and provide a copy to the NIH COR on request.

The Contractor shall comply with all procedures prescribed by the NIH Safety Officers for the control and safety of persons visiting the job site, and shall take precautions to prevent accidents.

The Contractor shall adhere to NIH safety procedures as they pertain to areas posted for the use of biological, chemical, or radioactive materials.

The Contractor shall adhere to all NIH SAP training requirements and procedures for the safe handling of Select Agents and animals exposed to Select Agents. The Contractor shall develop and maintain a database of all Select Agent Program (SAP) participants, their training status and their SAP status. This information shall be made available to the COR as requested.

The Contractor shall participate in the NIH Occupant Evacuation Plan and Emergency Preparedness.

The Contract employees shall not place equipment or other obstacles in personnel egress or ingress lanes or in other locations in such a manner as to create safety hazards and shall follow the NIH Corridor Utilization Policy.

The Contractor shall process, package, and document the waste 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 SOP’s.

Medical Care

The Contractor shall provide their employees appropriate medical care as well as pre employment and periodic medical evaluations (including vaccinations) consistent with the occupational hazards present in the work site (including zoonotic diseases particular to the animal species covered under the contract). Emergency medical treatment for injuries sustained at the NIH Bethesda Campus work site is available to Contractor staff at the NIH Occupational Medical Services (OMS) clinic. In such instances, the patient will be stabilized and then referred to a local hospital or a specific health care provider designated by the Contractor's on site manager. For persons stationed at the Twinbrook II Building and the Twinbrook III Building, medical treatment is available through the local 911 emergency medical system and local hospitals. For injuries sustained at the Rocky Mountain Laboratories, emergency medical treatment is available to the Contractor staff at the RML OMS office. If additional emergency medical treatment is warranted, the patient will be stabilized then referred to a local hospital or health care provider, as designated by the Contractor’s on site manager and/or OMS staff, depending on the nature of the injury.

The Contractor’s occupational safety and health program shall include testing and reporting provisions needed to protect the animal population from the transmission of human disease as appropriate for specific animal species; and provisions needed to protect personnel from transmission of zoonotic diseases to them by the animals.

Audiometric, pulmonary function, and respirator fit testing, as warranted, is the responsibility of the Contractor and their medical care provider. If required due to inclusion in the NIH Biosurety Program, OMS will provide serum banking. All Contractor personnel working with animals and/or hazardous substances shall undergo a periodic (12 18 month intervals) occupational health surveillance examination by the Contractor's physician. The content of this examination shall be specific to each employee's planned or current occupation and take into account potential occupational exposures; shall be reviewed by the NIH DOHS to ensure that the content of the examination is comparable with those offered to NIH staff by the NIH OMS;

shall be consistent with generally accepted good medical practice; and shall be provided off site. Personnel working with Mycobacteria shall have a TB test yearly. Certain agents may require additional TB testing as determined by DOHS. A medical certificate indicating fitness to work and assurance of a tetanus/diphtheria vaccine within the last ten years shall be available to the NIH COR before a contract employee is assigned to duty.

The Contractor shall provide the NIH COR a written report, within two days of all incidents in which Contractor staff sustain an injury or suspected job related illness; that report will contain a description of the incident, the causal factor(s) involved, and the procedures to be implemented to prevent recurrence.

NOTE: All certifying physicians must have written instructions supplied by the Contractor containing the items outlined above prior to their certification.

Administrative Functions

The Contractor shall provide administrative support both within the facility and with regard to the animals and trials therein.

Provide scientific/clerical/administrative/computer management (database, internet webpage, intranet webpage) supporting the ACUC in coordination with the NIAID program of animal care and use and support to user IC’s in accordance with IAA’s.

1. Answer phones;

2. Respond to inquiries;

3. Receive and announce visitors;

4. Order animals in accordance with ASPs;

5. Order materials and supplies & maintain a record of supplies ordered;

6. Clarify discrepancies that occur in the ordering process;

7. Perform extensive record keeping;

8. Photocopy;

9. Complete various NIH forms;

10. Maintain a current list of all individuals with card key access to animal facilities by building

In conjunction with NIH Information Technology guidelines:

1. Translate files to different software or to different platforms (from PC to Mac and vice versa) whenever necessary, so they can be used by the rest of CMB/RMVB personnel.

2. Design and maintain CMB/RMVBWeb page(s) (internet and intranet).

3. Automate forms that are used by the CMB/RMVB and give support for users.

4. Assist CMB/RMVB personnel with the design of graphics as needed.

5. Program and support the ASP database.

6. Automate the ASP database to generate tracking lists presently in use.

7. Provide support to NIAID and other IC investigators and CMB/RMVB personnel as required to include troubleshooting database issues, providing training to ICs in shared facilities, assisting with inventory passwords, and assisting with software issues, etc.

8. Maintain the animal inventory database and all other animal facility databases to enable provision of services to users. The contractor shall input change logs and correct animal database errors in a timely manner, generally 48 72 hours.

9. Critical training will be provided to the contractor key personnel on animal inventory database management by the Government. In turn the key personnel will be responsible for training all other Contract personnel.

10. Maintain electronic ASPs, SOPs, Human Pathogen Registration Document (HPRD) and rDNA documents along with any amendments.

11. Send notices to Investigators for amendment or renewal of their ASPs.

12. Assist the CMB/RMVB ACUC Chairman…