PWS_Annex_2_Revision_1_(MRC-MOD-1).pdf

FDA-SOL-1153590 PWS ANNEX 2

Revision 1

Animal Husbandry Support for the FDA Animal Care and Use Programs (ACUP)

Center for Food Safety and Applied Nutrition (CFSAN) Muirkirk Road Complex – MRC/MOD-1 October 27, 2016

1. SCOPE. Independently and not as an agent of the Government, the Contractor shall furnish the necessary personnel, materials, services, and otherwise do all things necessary for or incident to provide animal husbandry and technical procedures support services equivalent to or exceeding the accepted standards and practices of the Laboratory Animal Care industry to the FDA Research Facility at the Muirkirk Road Complex – MOD-1 as described herein.

1.1. Background. The Food and Drug Administration (FDA) is the regulatory agency responsible for the safety of foods, cosmetics, drugs, biological products, medical devices and radiological products. The Center for Food Safety and Applied Nutrition (CFSAN) within FDA has specific responsibility for ensuring the safety of foods and cosmetic products. Extensive research programs on the nutritional quality of foods (i.e. natural occurring food toxins, special nutritional compounds) are performed by CFSAN.

Animal based research performed by the Center is conducted at the FDA Research Facility at the Muirkirk Road Complex – MOD-1 (MRC/MOD-1) in Laurel, Maryland. The MRC/MOD-1 houses laboratory animals, primarily rodents, in an environmentally controlled animal facility that utilizes a clean/dirty corridor system. A Biosafety Level 3 (BSL-3)/ Animal Biosafety Level 3 (ABSL-3) Special Pathogens suite is located in the vivarium also. Entrance into the animal facility is through controlled locker rooms. In exceptional circumstances where MOD-1 space is either unavailable or inappropriate for a specific animal study, animal husbandry services will be required in FDA’s MOD 2 facility immediately adjacent to MOD-1. Such studies must be approved by the MOD-2 Director, Office of Research, Center for Veterinary Medicine, and the Contracting Officer (CO).

1.2. Objective. The purpose of this contract is to provide animal husbandry services to CFSAN’s animal research program, specifically the provision of quality care to all research animals, sanitation of all animal care and formulation facilities and provision of protocol-specified technical procedures support. Ancillary tasks necessary to accomplish these services are also included (i.e.: quality control, occupational safety and health, inventory control, equipment maintenance, development and maintenance of standard operating procedures, and a comprehensive employee training program). The need for these services is paramount as the preponderance of CFSAN’s research mission can only be accomplished through animal research. Animal-based research projects are highly regulated and demand exemplary execution.

1.3. List of Appendices. The attached appendices are included to assist in providing a complete record of the services that have been previously provided, as well as to outline the expected level of services required under this contract. Appendices are attached immediately following this Annex.

Appendix 1: CFSAN MRC/MOD-1 Government Furnished Property (GFP) Appendix 2: CFSAN MRC/MOD-1 Quality Assurance Surveillance Plan (QASP)

2. APPLICABLE DOCUMENTS. To ensure the successful accomplishments of CFSAN’s research mission, animal care services, at a minimum, shall comply with the following regulations and guidelines, as well as any amendments or revisions thereto.

2.1. Federal Regulations, Policies and Procedures. Federal regulations have been identified in the main PWS and apply to these Centers.

2.2. Availability of Federal Regulations, Policies and Procedures. Unless otherwise indicated, copies of the aforementioned documents are available for free distribution online.

2.3. Center-Specific Policies and Procedures.

a. Biosafety Manual/FDA MOD-1 Special Pathogens Facility.

b. Sharma Biosafety Manual Muirkirk Road Complex (MRC) Version 8.

c. FDA/CFSAN MOD-1 Select Agent Program.

d. Muirkirk Road Complex (MRC) Integrated Contingency Plan (ICP).

e. CFSAN Hazardous Waste Management Program.

f. CFSAN Animal Program Standard Operating Procedures

g. CFSAN Chemical Hygiene Plan

h. Bloodborne Pathogens Plan

2.4. Availability of Center-Specific Policies and Procedures. CFSAN specific documents can be accessed at the facility’s on-site library.

3. DEFINITIONS. As outlined in the main PWS.

4. REQUIREMENTS.

4.1. General Requirements. The Contractor shall provide animal husbandry services that include, but are not limited to, feeding, watering, maintaining a clean environment, and observations of research animals in addition to parameter checks of the facility. The services may be performed in an Animal Biosafety Level 1 (ABSL-1), Animal Biosafety Level 2 (ABSL-2) or an Animal Biosafety Level 3 (ABSL-3) environment.

The Contractor shall provide technical assistance in support of approved protocols for animal studies associated with, but not limited to, the use of invertebrates, rats, mice, rabbits, guinea pigs, hamsters, sand rats, gerbils, miscellaneous rodents, and/or other species of laboratory animals, including poultry and swine. Experimental procedures include administration of substances by subcutaneous, intravenous, and/or intraperitoneal injections, gavaging, collection of tissues and body fluids, behavioral observations, and surgical support. The number of dose groups, the concentration(s), volume and methods of administration are dictated by the experimental protocol and design. The Contractor shall also provide analytical support for approved research protocols.

The Contractor shall also provide parameter checks of the facility and report any deviations to the Contracting Officer Representative (COR). In the case of emergency situations that threaten animal welfare, the Contractor shall report the problem immediately to the COR and/or Building Management.

4.1.1. Hours of Operation. The working core hours for Contractor operations shall be 7:00 AM to 5:00 PM Monday through Friday, Eastern Time. Continuous service shall be provided during the core hours that shall be based on staggered start times not to exceed a normal 8.5 hour workday (which includes .5 hours for lunch and .5 hours for up to two breaks) for each contract employee. On rare occasions, the Contractor may be required to extend operations to outside core hours when continued work is required to assure uninterrupted animal protocol support.

Work requests that fall outside the normal core hours will be arranged in advance whenever possible to permit adjustment of the work schedule to the convenience and satisfaction of both the Contractor and the Government.

Contractor staff shall be flexible in their core work hours to allow for emergency responses and increased surge capability as may be needed.

Weekend work is required to provide routine animal husbandry and animal observations for both Saturday and Sunday. Two Contract personnel are required to work together on the weekends for safety reasons and the amount of time anticipated per weekend day is two hours per person per day.

In the event of inclement weather when the Federal Government is closed, the Contractor will still be required to provide on-site routine husbandry services. The Contractor is required to follow, as a minimum, other directives issued by the U.S. Office of Personnel Management or other such official for late arrivals due to inclement weather (unless otherwise specified in the contract).

In the event the Federal Government is closed by order of the President of the United States or the U.S. Office of Personnel Management for any reason, or the agency, the center or the building is closed for administrative or safety reasons, the Contractor shall follow directives issued by responsible officials concerning reporting for work.

The Contractor may not bill the Government for any hours that Contractor employees did not work due to any Government closure (e.g. applicable under a Labor Hour contract).

For on-site support at the FDA facility, unless otherwise directed, the Contractor should adhere to standard work hours, working no more than forty (40) hours per week. Any necessary overtime shall be authorized in advance by the COR or Contracting Officer.

4.1.2. Observance of Federal Holidays & Other Government Closings. Observed Federal Holidays are outlined in the main PWS. The Contractor will be required to provide routine husbandry services during Federal Holidays.

4.1.3. Place of Performance. The work shall be performed at FDA Research Complex - Muirkirk Road Complex (MRC/MOD-1) at 8301 Muirkirk Road, Laurel, Maryland.

4.1.4. Physical Security. As outlined in the main PWS.

4.1.5. Key and Access Card Control. As outlined in the main PWS.

4.1.6. Standard Operating Procedures. As outlined in the main PWS.

4.1.7. Quality Control. As outlined in the main PWS.

4.1.8. Personnel. The qualifications required for personnel employed to provide services on this contract are described for each position level listed below. Except where specified, these position levels should not be considered as the absolute requirement, type, or number of positions required for the duration of the contract. The Contractor should constantly seek to provide an organizational structure/labor mix which will operate the most efficiently and effectively.

The Contractor shall follow RFP instructions to identify all key personnel for this Contract. Prior to diverting any of the specified individuals to other programs, the Contractor shall notify the Contracting Officer reasonably in advance and shall submit justifications (including proposed substitutions) in sufficient detail to permit evaluation of the impact on the program. No diversion shall be made by the Contractor, provided that the CO may ratify in writing such a diversion and such ratification shall constitute the consent of the CO required by this clause. This contract may be modified from time to time during the course of the period of performance to either add or delete personnel, as appropriate.

4.1.8.1. Project Manager. The on-site Project Manager or, in his/her absence, the Assistant Project Manager, Floor Supervisor or Lead Technician, as per requirements, shall have full authority to act for the Contractor in all matters relating to the daily operation of this contract and shall provide competent on-site supervision to ensure that all functions of the contract are carried out in an efficient, courteous and professional manner and shall assure that the policies and procedures for the Program are followed.

At a minimum, the Project Manager shall be certified as a Laboratory Animal Technologist (LATG) and have at least 5 years of training and experience in supervising and managing a full service animal facility, knowledge and training of laboratory animal technician duties, an understanding and experience in research techniques and technical procedures and knowledge of Federal regulations governing animal husbandry requirements. CMAR and/or a bachelor’s degree is desirable.

4.1.8.2. Assistant Project Manager. The Assistant Project Manager shall have similar requirements as the Project Manager, except the person should have at least 2 years of training and experience in supervising and managing a full service animal facility, knowledge and training of laboratory animal technician duties, and knowledge of Federal regulations governing animal husbandry requirements.

4.1.8.3. Supervisor/Supervisor Trainer/Lead Animal Technician. Shall be Laboratory Animal Technician (LAT)-certified at the time of employment and LATG-certified within two (2) years of employment. Shall have a working knowledge of and two (2) years’ experience in laboratory animal research and the performance of animal husbandry and technical procedures and shall provide technical assistance, as requested, for the in-life phases of animal studies as required by approved protocols. Examples of (but procedures will not necessarily be limited to) current and anticipated studies involve (1) dosing by gavage, skin painting, intraperitoneal and intravenous injection,

(2) collection of blood by intravenous (including jugular, aka, subclavian, or vena cava), intracardiac, or orbital sinus routes, (3) collection of tissues or necropsy, (4) the assembly, use of and disassembly of metabolic caging. Shall be responsible for training animal technicians and caretakers in the various means of proper animal restraint, how to administer test materials by various routes (i.e. - subcutaneous and intraperitoneal injections, gavage, etc.), blood collection, the approved methods of euthanasia, tissue collection, performing sterile surgical techniques, and necropsies.

4.1.8.4. Cage Wash Attendant/Supervisor/Foreman/Material Handler. Shall be Assistant Lab Animal Technician (ALAT) within one (1) year of employment. Cage Wash Foreman shall have a working knowledge of cage wash machinery and autoclave equipment used in cleaning and sanitizing all animal related equipment; shall supervise cage wash contract employees in the autoclaving, cleaning, washing, and reassembling of cages and equipment; shall anticipate and maintain a sufficient inventory of supplies; identify potential problems with equipment and bring these to the attention of the Project Managers and COR. The Cage Wash Foreman shall have good organizational and leadership skills to manage the Cage Wash staff and sanitation processes for the vivarium. Cage Wash Attendant is desirable to have cage wash experience but not necessary for employment. Cage Wash Attendant Ancillary duties include laundering of soiled cloth lab clothing (scrubs and lab coats) as necessary (average is twice per week).

4.1.8.5. Floor Leader. Shall be certified at the Laboratory Animal Technician (LAT)-at the time of employment.

Shall have a working knowledge and one year experience in laboratory animal research and the performance of animal husbandry and technical procedures. This position will require knowledge of record keeping, animal related technical procedures, facility operation including cage wash, animal health and disease and sanitation processes including autoclaving. This position will assist with training animal technicians and caretakers in the various means of proper animal husbandry and care. Shall receive animal observation record sheets for health issues and notify researchers of these issues. Shall follow up on health issues with animal care staff. This position will also perform routine animal husbandry. Other duties as assigned.

4.1.8.6. Lead Technician/Animal Health Technician I/II. Shall be LAT-certified, CVT, or RVT at time of employment; shall be Laboratory Animal Technologist (LATG) certified at employment. Lead Technician/Animal Health Technicians in addition to animal husbandry tasks, shall provide technical assistance, as requested, for animal studies as required by approved protocols. A partial list of representative examples associated with current and anticipated studies involve (1) dosing of animals by oral gavage, skin painting, and/or injection (intraperitoneal, intramuscular, and/or intravenous), (2) collection of blood by intravenous (including peripheral vessels and/or the jugular vein, aka, subclavian, or vena cava), intracardiac, or orbital sinus routes, (3) collection of physiologic data, tissues and/or necropsy information, (4) observation and recording of animal activity and/or behavior, (4) induction and maintenance of anesthesia, (5) pre-surgical preparation and post-surgical monitoring of animals, (6) the assembly, use of and disassembly of metabolic caging.

4.1.8.7. Animal Caretaker I/II. Animal Caretaker II shall be Assistant Laboratory Animal Technician (ALAT) at employment and the Animal Caretaker I shall be Assistant Laboratory Technician (ALAT)-certified within (1) year of employment. Animal Caretakers II shall have training and experience working in a laboratory animal facility performing animal husbandry duties. Animal Caretakers II must have demonstrated knowledge and skill in handling various animal species. They must recognize the appearance of normal animals and be able to maintain the animals in a clean environment. This position shall perform daily observations of animals for health issues and report findings to appropriate staff. Shall record animal births, deaths and health issues in a timely manner. Animal Caretaker I can be an entry-level position with on the job training provided, some animal experience is desirable but not necessary for employment.

4.1.8.8. Animal Program Administrative Assistant. Shall demonstrate computer competency and have a good working knowledge of programs such as MS Word and MS Excel. Provides administrative support to include answering phones, receiving packages, maintaining hard copy and electronic files also prepare standardized reports and facility records that correspond to the research animal program (census information, annual animal use, animal orders, etc.). Additionally, the Administrative Assistant will prepare purchase orders, maintain IACUC approved protocols ensuring information is complete and updated as required. Also provides budget and inventory tracking, data analysis and specialized information gathering in support of the CFSAN Animal Research Program.

4.1.9. Employee Training. As outlined in the main PWS.

4.1.10. Occupational Safety and Health. In addition to the information outlined in the main PWS, The Contractor’s employees in the MOD-I facilities shall:

• eat and drink only in designated locations in the building;

• use only freight elevators to transport equipment and supplies;

• not block emergency showers and exits with carts or equipment;

• not bring children into the animal facility; and

• not perform work activities in the facility without convenient contact with another co-worker in the event of an unanticipated emergency situation.

For safety reasons, there is a required “Buddy System” where two (2) Contractor employees must be together at all times when in the vivarium. This requirement is strictly enforced.

4.1.11. Medical Examinations. As outlined in the main PWS.

4.1.12. Data Management. As outlined in the main PWS.

4.1.13. Contractor Furnished Materials. The Contractor shall be responsible for providing the necessary safety items (e.g., rubber boots, safety shoes, respirators, safety glasses/goggles, etc.) the Contractor deems as adequate and necessary to assure maximum safety for staff performing all tasks considered a safety hazard.

4.1.14. Government Furnished Property (GFP). All Government facilities, supplies, and information provided to the Contractor are to be used by the Contractor in carrying out responsibilities set forth in this PWS. Ownership of GFP remains that of the Government at all times (unless and until consumed or expended in the normal course of business) and all GFP shall be returned or accounted for upon completion of the contract.

As outlined in the RFP, Government furnished property shall be managed in accordance with FAR 52.245-1.

4.1.15. Equipment Inventory Control. As outlined in the main PWS Government Furnished Property is listed in Appendix 1 to this Annex.

4.1.16. Estimated Workload. All essential animal care and husbandry support must be performed daily. Unless work has been prioritized by the COR, the Contractor shall, on a first-come-first-served basis, provide animal care and technical support services requested by Principal Investigators. The government will not hold the Contractor responsible for work that cannot be performed due to its priority in the queue.

The Animal Care Support for each protocol will be requested by email by the Principal Investigator or representative listed on the protocol. The COR must be notified during the planning or review stages of any issues or concerns identified by the Contractor that would hinder or prevent provision of any support services for the protocol.

While not anticipated, if significant changes occur in the protocol such as addition of animals, change of dose concentration, change in the number of dose levels, work description changes, or any other significant/material change resulting in a significant increase in required contractor-provided support, these changes will be reviewed by the COR and Contracting Officer for a final determination on level of support required from contractor personnel and effect these changes may have on the overall contract.

CFSAN’s animal care support services are based on current requirements and projections; however, animal population may fluctuate depending on an increase or decrease in the number of studies initiated, thereby increasing or decreasing contractor workload and support required. The Contractor should have or quickly develop the ability to make staffing adjustments to provide the support required during these fluctuations.

Historically and currently, the CFSAN animal population is as follows:

• 2,000 to 3,000 rodents, 50 rabbits, 30 guinea pigs, 10 swine, 150 chickens and an incidental number of other miscellaneous species.

• Analytical research support shall be provided for approximately fifteen (15) to twenty (20) studies per year.

4.2. Specific Requirements. All services required to maintain various species of animals under laboratory conditions shall be performed in accordance with SOPs. Required services are as below:

4.2.1. Animal Care. Specific functions Contractor personnel shall be required to perform:

4.2.1.1. Inspect the bags or bales of feed/bedding received for visible signs of damage at the time of delivery and before accepting the order. Sanitize (disinfect) the outside of the bags or bales before storing materials as specified by the Center. Sterilize and/or repackage feeds that require no further mixing. Manage inventories of commercially available feed and bedding as required by the research program. For inventory management, take into account the expiration dates of the feed supply on hand. As part of this inventory management, records documenting the type of feed/diet, manufacturer, manufacturing date, lot number, date received, and expiration date shall be maintained. As required by the protocol or COR, feed, water, or bedding that requires sterilization shall be autoclaved according to standard sterilization or protocol specific procedures.

4.2.1.2. Change the bedding and litter pans and caging to assure a clean and hygienic environment for laboratory animals. More frequent changes may be implemented by the Government according to an approved protocol, SOP, or the COR’s directions. Animal waste, carcasses, and other materials containing toxic test substances shall be discarded according to regulations and procedures provided by CFSAN's Safety Team.

4.2.1.3. Scrape, wash, and sanitize litter pans, plastic and stainless steel caging materials and racks for all laboratory animals in accordance with SOPs. Once the litter pans and caging are cleaned and sanitized, clean bedding or pan liners shall be placed in the pans or cages, as appropriate. Feeder cups, sipper tubes and water bottles shall be emptied, cleaned, washed and sanitized. Following the completion of an experimental study, animal housing units, including all accessories, shall be removed, cleaned, washed and sanitized.

4.2.1.4. Check water bottles daily to ensure their proper maintenance, cleanliness and operation, and to assure a sufficient amount of water is available for animals. If a bottle does not meet these criteria, it shall be exchanged for a sanitized, freshly filled bottle of water or by direction of the Principal Investigator.

4.2.1.5. Distribute animal feed and experimental diets according to the approved protocol, SOP, or upon the COR's instructions.

4.2.1.6. Assure that palatable, non-contaminated and nutritionally adequate feed is distributed and available to laboratory animals. Animals on restrictive feeding or on experimental diets shall be fed according to directions contained in an approved protocol, SOP, or the COR’s instructions.

4.2.1.7. Prepare dosed feeds, diets, gavage solutions, or dosed drinking water, which may be semi-purified, purified, or include test articles that may be carcinogenic, radioactive, or potentially hazardous. The concentration of the test or control articles in diet preparations shall be specified in the protocol and an adequate amount of time shall be given to allow the Contractor to order and receive the components of the diet, test or control articles, or other materials necessary to perform this work. Provide the Principal Investigator with diet, feed, and/or solution samples for microbiological, nutrient, and/or chemical analysis, as requested, so he/she can determine the acceptance of a prepared diet or solution. Documentation shall be generated for study accountability and audit purposes.

4.2.1.8. If any of the preparations requires the use of hazardous materials, the Principal Investigator or CFSAN Safety Team will provide information on the hazards of the materials and precautionary measures that need to be taken in handling the materials prior to Contractor personnel being required to handle the hazardous materials.

4.2.1.9. Monitor the environment (temperature, humidity, and/or light cycle) from the instrumentation specified by the COR.

4.2.1.10. Clean and sanitize rooms, sinks, cabinets, counter tops, corridors, walls, elevators, the cage washing and marshaling areas, animal rooms and support areas (animal receiving bay, biohazard containment suite and neurobehavioral suite), and special use cubicles (including walls, doors and ceilings) shall be cleaned and sanitized according to approved SOPs. The sanitizing procedure shall be of such a level to minimize the presence of microbiological organisms and conditions which may adversely affect the health of all animal species housed in the animal facility. All disinfectants and cleaning solutions used will be approved by the COR. Premises will be monitored for adequate sanitation as part of the quality control program. Clean all spaces within the animal husbandry area, including locker rooms, maintain security, and minimize other Contractors’ access to the area.

4.2.1.11. Empty all trash receptacles daily on the floors. Properly contain and segregate refuse into nonhazardous and hazardous wastes and deposit the wastes into the designated containers. Provide proper labeling of the specific wastes as indicated by the CFSAN Safety Team. Dispose of the wastes as per approved SOPs.

Contact the CFSAN Safety Team for further information and instructions, as necessary.

4.2.1.12. Conduct preventive maintenance for movable equipment (i.e. - grease, replace casters, identify areas that need to be welded or painted) and distribute movable equipment to the animal rooms on an as needed basis.

Maintain the cage washing equipment (cleaning, changing water, adding approved detergents and performing routine maintenance) according to established procedures. Provide laundry services for the Government-furnished clothing provided for use in the animal facility.

4.2.1.13. Maintain husbandry and technical information for each animal room as described in an approved protocol, SOP, or by the COR’s instruction.

4.2.1.14. Transport animals to or from local metropolitan area airports, and to or from other animal facilities located in the Baltimore Washington metropolitan area. The climate controlled vehicles for this transport service will be provided by the Government.

4.2.2. Technical Services. The Contractor shall:

4.2.2.1. Provide Animal Technicians to perform technical services in support of approved protocols for the in-life phases of animal studies associated with, but not limited to the use of invertebrates, rats, mice, rabbits, guinea pigs, hamsters, miscellaneous rodents, swine, gerbils, poultry or other species of laboratory animals. These Animal Technicians shall have demonstrated expertise in experimental procedures including (1) administration of substances by subcutaneous, intravenous, intramuscular, intradermal, or intraperitoneal injections, gavaging, euthanasia of animals, skin painting, (2) collection of physiologic data, tissues, body fluids or blood by intravenous (including peripheral vessels and the jugular vein, aka, subclavian, or vena cava) intracardiac, and/or orbital sinus routes, (3) necropsy, (4) tattooing or identification of animals, (5) routine husbandry procedures (animal weights, trimming teeth, trimming nails, provision of exercise to dogs), (6) euthanasia, (7) anesthesia and surgical assistance, (8) the observation and recording of animal activity and/or behavior, (9) electronic data entry, and (10) quality control activities (microbiological surveillance, collection of diagnostic samples, etc.).

Any reassignment of Contractor personnel working on an active protocol/study to any other protocol/study conducted at MOD-1 shall occur only with the concurrence of the COR. Contractor is expected to submit requests for such reassignment with as much notice as possible.

4.2.2.2. Assist the CFSAN Veterinary Medical Officer(s) in maintaining the animal facility’s acclimatization procedures, restraining animals, and making daily health observations of all animals. The Contractor shall immediately report abnormal findings directly to the Principal Investigator/Study Director and the Center veterinarian(s) verbally or by email and initiate a written medical record when appropriate. The veterinarian(s), in conjunction with the Principal Investigator/Study Director or designee, will recommend procedures to be taken for the well-being of the animals in question.

4.2.2.3. Perform environmental surveillance of the animal facility to include microbiological sampling of the facility on a schedule specified by the COR or designee with expertise in Microbiology. The monitoring shall include but is not limited to sampling the facility walls, cabinets, doors, carts, tables, caging, water bottles and enrichment devices. Samples shall be cultured on appropriate culture media and the results reported to the COR or designee.

Additional sanitation or changes to the sanitation procedures may be directed by the COR or designee based on the surveillance results.

5. DELIVERABLES. The Deliverables list in the main PWS is further supplemented to include the following list of CFSAN-required deliverables which are required to be submitted electronically, in Microsoft Word, PDF, or Excel compatible format, and are subject to the inspection and acceptance by the COR (or as otherwise applicable). Other special reports may be requested on an as needed basis.

Schedule of Deliverables

Scheduled Item Submit To Due Date

5.1. Safety Inspection Report COR Quarterly

5.2. Consumable Supplies Report COR NLT 10th of each month for the preceding month.

5.3. Quarterly Report COR NLT 10th of the first month of a new quarter

5.4. Report on Access to Government

Property COR, copy CS/CO As required

5.1. Safety Inspection Report. Provide quarterly assessments of the safety status for personnel, equipment documenting the conditions, inspections of all animal care, and diet preparation facilities. Items inspected shall include but not be limited to: performance in compliance with SOPs; housekeeping and sanitation status of physical plant; up-to-date calibration of equipment; adherence to preventive maintenance schedules; expiration dates of chemicals, feed, bedding, etc.; proper use of required PPE; correct recordkeeping (documents, reports, logbooks, etc.).; adherence to safety rules; other inspections as directed by the Government.

5.2. Consumable Supplies Report. Provide a quarterly list of consumable supplies used for the performance of the contract. In addition for CFSAN’s animal program, the Contractor shall prepare a monthly animal research consumable supplies usage report to reflect the number of items used, the type of item, and a cost accounting for each active CFSAN protocol.

5.3. Quarterly Report. Provide quarterly reports indicating the activities that have taken place during the preceding quarter (employee training, environmental monitoring results, active protocols and any important information needing to be addressed by the Government).

5.4. Report on Access to Government Property. Provide an annual summary of the Contractor’s program for the protection, preservation and maintenance of all Government property, procedures to educate contractor employees concerning individual responsibilities for Government property, and efforts to monitor and assess the Contractor’s property control system.

End of PWS