RFP_75D301_19R_68018.doc

SOLICITATION, OFFER AND AWARD

1. THIS CONTRACT IS A RATED ORDER

UNDER DPAS (15 CFR 700)

RATING

PAGE OF

2. CONTRACT NO.

75D30119C05684

3. SOLICITATION NO.

75D301-19-R-68018

4. TYPE OF SOLICITATION

X

NEGOTIATED (RFP)

5. DATE ISSUED

06/28/2019

6. REQUISITION/PURCHASE NO.

000HCVLH-2019-34965

Centers for Disease Control and Prevention (CDC)

Office of Acquisition Services (OAS)

2900 Woodcock Blvd, MS TCU-4

Atlanta, GA 30341-4004

Approved as to Form and Legality: _____________________________

NOTE: In sealed bid solicitations “offer” and “offeror” mean “bid” and “bidder.”

SOLICITATION

9. Sealed offers in original and handcarried, in the depository located in 2:00pformtext until local time 07/28/2019 CAUTION -- LATE Submissions, Modifications, and Withdrawals: See Section L, Provision No. 52.214-7 or 52.215-1. All offers are subject to all terms and conditions contained in this solicitation.

10. FOR INFORMATION

CALL:

A. NAME

Gordon D. Barritt

B. TELEPHONE (NO COLLECT CALLS)

AREA CODE NUMBER: EXT:

(770) 488-2724

C. E-MAIL ADDRESS

Ins4@cdc.gov

11. TABLE OF CONTENTS

(x)

DESCRIPTION

(x)

DESCRIPTION

X

REPRESENTATIONS, CERTIFICATIONS, AND

OFFER (Must be fully completed by offeror)

NOTE: Item 12 does not apply if the solicitation includes the provisions at 52.214-16, Minimum Bid Acceptance Period.

12. In compliance with the above, the undersigned agrees, if this offer is accepted within period is inserted by the offeror) from the date for receipt of offers specified above, to furnish any or all items upon which prices are offered at the price set opposite each item, delivered at the designated point(s), within the time specified in the schedule.

13. DISCOUNT FOR PROMPT PAYMENT

(See Section I, Clause No. 52-232-8)

10 CALENDAR DAYS

20 CALENDAR DAYS

30 CALENDAR DAYS

CODE

FACILITY

16. NAME AND ADDRESS OF PERSON AUTHORIZED TO SIGN OFFER

15B. TELEPHONE NO.

AREA CODE NUMBER EXT.

15C. CHECK IF REMITTANCE ADDRESS

SUCH ADDRESS IN SCHEDULE.

17. SIGNATURE

18. OFFER DATE

AWARD (To be completed by Government)

19. ACCEPTED AS TO ITEMS NUMBERED

20. AMOUNT

22. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION:

21. ACCOUNTING AND APPROPRIATION

23. SUBMIT INVOICES TO ADDRESS SHOWN IN

(4 copies unless otherwise specified)

ITEM

Centers for Disease Control and Prevention (CDC)

Office of Acquisition Services (OAS)

2900 Woodcock Blvd, MS TCU-4

Atlanta, GA 30341-4004

Centers for Disease Control and Prevention (FMO)

PO Box 15580 404-718-8100

Atlanta, GA 30333-0080

26. NAME OF CONTRACTING OFFICER (Type or print)

27. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

28. AWARD DATE

IMPORTANT -- Award will be made on this form, or on Standard Form 26, or by other authorized official written notice.

AUTHORIZED FOR LOCAL REPRODUCTION

STANDARD FORM 33 (REV. 9-97)

PREVIOUS EDITION IS UNUSABLE

Prescribed by GSA

FAR (48 CFR) 53.214©

Section A – Solicitation/Contract Form (Continued)

EXECUTIVE SUMMARY

1. Description of the Item(s)/Service(s) being procured:

The Performance Work Statement (PWS) establishes the requirements for Contractor-provided services to include the necessary management and personnel required to provide care and maintenance of animals and laboratory/laundry services and autoclave services in accordance with the terms, conditions, attachments, locations, schedule, and specifications included in this solicitation and subsequent contract.

2. Type of Contract:

This is a fixed price, performance based contract, consisting of a base period of 12 months and four option period to be exercised at the discretion of the Government. This is a severable services contract with separate, optional Contract Line Item Numbers.

3. Place of Performance

Services will be provided at CDC facilities in in Fort Collins, Solorado

4. Site Visit

A pre-proposal meeting/site visit is scheduled for Wednesday, July 10, 2019. Please refer to Section L, Instructions, Conditions, and Notices to Offerors or Respondents for details of this event.

5. Period of Performance

The contract is expected to begin on or about September 22, 2019. The base and each option period will be 12 months. The expiration of performance under this contract will be 60 months after the start date, or approximately September 21, 2024.

6. Key Dates

June 30, 2019

Solicitation Published June 27, 2019

Inquiries/Questions Due

July 8, 2019

Site Visit Notification Due

July 8, 2019

Requests for SOPs Due from Non-site Visit Attendees

July 10, 2019

Anticipated Government Response to Inquiries July 10, 2019

Site Visit

July 26, 2019

Proposals Due August 8, 2019

Discussions/Negotiations

August 16, 2019

Revised Proposals Due

August 29, 2019

Anticipated Award Date

September 22, 2019

Contract Performance Begins

Section B - Supplies Or Services And Prices/Costs

Animal Care Year 1 Fort Collins

Fixed Price Line Item, Severable Services

Period of Performance 9/22/2019 * 9/21/2020 12 Months

Option 1 Year 2 Items:

Animal Care Year 2 Fort Collins

Fixed price Line Item, Severable Services

Period of Performance 9/22/2020 - 9/21/2021 12 Months

Option 2 Year 3 Items:

Animal Care Year 3 Fort Collins

Fixed price Line Item, Severable Services

Period of Performance 9/22/2021 - 9/21/2022 12 Months

Option 3 Year 4 Items:

Animal Care Year 4 Fort Collins

Fixed Price Line Item, Severable Services

Period of Performance 9/22/2022 - 9/21/2023 12 Months

Option 4 Year 5 Items:

Animal Care Year 5 Fort Collins

Fixed Price Line Item, Severable Services

Period of Performance 9/22/2023 - 9/21/2024 12 Months

There are no clauses/provisions included in this section.

Section C - Description/Specification/Work Statement Title of Project: Fort Collins Animal Care and Associated Services

C.1 Background and Need

The Centers for Disease Control and Prevention (CDC) is one of the 13 major operating components of the Department and Health and Human Services (HHS), the principal agency in the United States government for protecting the health and safety of all Americans and for providing essential human services. CDC’s mission is to promote health and quality of life by preventing and controlling disease, injury and disability.

Critical to the mission and organization of CDC is the Office of Infectious Disease (OID). OID provides national leadership in the identification, investigation, diagnosis, prevention and control of infectious diseases. As the national infectious disease laboratory of the public health service, OID conducts research in the definition, characterization, pathogenesis, and diagnosis of those infectious disease that are considered to be public health priorities. OID has developed expertise in detecting rare, exotic, or unusual diseases and is recognized for extensive capabilities in vector-borne diseases. OID also provides reference laboratory services, laboratory surveillance, technical assistance and epidemiological aid to states and nations throughout the world in the diagnosis, control and prevention of infectious diseases. OID’s internationally-recognized researchers, physician, veterinarians and others are engaged in research, training and control activities that are both national and worldwide in scope.

The CDC National Center for Emerging and Zoonotic Infectious Diseases (NCEZID) aims to prevent disease, disability, and death caused by a wide range of infectious diseases. NCEZID focuses on diseases that have been around for many years, emerging diseases (those that are new or just recently identified), and zoonotic diseases (those spread from animals to people). NCEZID’s work is guided in part by a holistic "One Health" strategy, which recognizes the vital interconnectedness of microbes and the environment. Through a comprehensive approach involving many scientific disciplines, we can attain better health for humans and animals and improve our environment.

To carry out our mission, NCEZID uses many different tactics: providing leadership in public health; conducting exemplary science; strengthening preparedness efforts; establishing public health policy; sharing vital health information with the public; and building partnerships. Each of the center's seven divisions works with partners to protect and improve the public's health in the United States and worldwide. This project supports the Division of Vector-Borne Diseases (DVBD).

CDC’s DVBD is a geographically-remote division of NCEZID, and is located in Fort Collins, Colorado on the Colorado State University Foothills Campus. The Office of the Director (OD) provides oversight for four branches in the division.

DVBD’s vision is to create a future where vector-borne diseases no longer threaten public health. Our mission is to reduce illness and death due to vector-borne diseases. To achieve this mission, DVBD has identified the following goals:

· Goal 1: Identify and detect vector-borne pathogens that cause disease in people.

· Goal 2: Understand when, where, how often, and how people are exposed to vector-borne pathogens.

· Goal 3: Prevent exposure to vector-borne pathogens and mitigate consequences of infection.

· Goal 4: Implement vector-borne disease diagnostics, surveillance, control and prevention programs developed in goals 1 through 3.

Vector-borne diseases involve complex interactions with the pathogen, host, and vector. DVBD’s scientists include a range of disciplines, including physicians, ecologists, entomologists, virologists, microbiologists, laboratory scientists, epidemiologists, behavioral scientists and statisticians that together form the unique, interdisciplinary group required to lead development efforts in this area. Scientists at the DVBD lead a sustained effort to rebuild the public health infrastructure for responding to existing and new vector-borne disease threats. Since many of the current methods for diagnosing, preventing, and controlling vector-borne diseases are largely unchanged from 40 years ago, DVBD scientists are engaged in the development of more effective diagnostic, prevention and control methods.

The purpose of this contract is to provide care, husbandry services, and maintenance of animals, and glassware and insectary services in support of research at the CDC facility in Fort Collins, Colorado. DVBD’s animal care and use program in the Fort Collins area is closely aligned with NCEZID and its divisions. The majority of CDC’s laboratory animals are used for infectious disease biomedical research in the broad classification categories of virology, bacteriology, mycology, immunology and parasitology.

C.2 Project Objective The objective of this contract is to ensure CDC research animals are provided with the best possible care and maintenance as set forth in all applicable federal and state laws and regulations.

C.3 Scope of Work

The Contractor shall, as an independent organization and not as an agent of the Government, furnish the necessary management and personnel for the efficient performance of duties commonly termed "animal care services" (to include care of the mosquitoes and other arthropods in the insectary facilities) in support of the operation of the Fort Collins, CO Animal Care Facility. The services provided shall include routine animal and insect care including, but not limited to, animal and insect health surveillance by observation, housing, environmental enrichment, feeding/watering, hygiene, animal handling and restraint and /or sanitation and cleaning of the animal and insect facilities, caging and equipment and glassware and insectary at the Fort Collins Facility.

Animal care services shall be performed as specified herein and in accordance with the Standard Operating Procedures (SOPs) established by the Centers for Disease Control and Prevention. SOPs will be enforced by the Government to ensure that the services performed comply with the requirements specified. In addition to the SOPs, the Contractor shall be required to comply with the provisions set forth in the Animal Welfare Act and Animal Welfare Regulations, the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals, 2015 which requires adherence to the National Research Council of the National Academies Guide for the Care and Use of Laboratory Animals, Eighth Edition, 2011 (or current edition). Furthermore, the Fort Collins animal care facility is accredited by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC). The Contractor shall at all times comply with all AAALAC standards and recommendations. The Contractor shall comply with DVBD IACUC Charter, Policies and mandates, the DVBD AAALAC Program Description and the DVBD PHS Assurance.

The Contractor shall fully comply with the most recent and current federal, state, and local laws and regulations, the conditions and requirements of all environmental permits, CDC directives and instructions, and other matters set forth in Section C-4.

C.4 Technical Requirements

C.4.1 Description of the Ft. Collins Animal Care Operation The Ft. Collins Animal Care Facility (hereinafter called the Ft. Collins facility) is a Colorado based facility in support of the Division of Vector Borne Infectious Diseases. All animal and insect care functions will be performed in accordance with CDC-Fort Collins developed SOPs. The Contractor shall comply with DVBD IACUC Charter, Policies and mandates, the DVBD AAALAC Program Description and the DVBD PHS Assurance.

(a) Statistical Data on Average Animal Usage

The following table lists the anticipated use of vertebrate laboratory animals by species, approximate maximum number, and approximate turnover time in months. Other species of animals may be ordered if needed to meet the requirements of the studies.

Birds

3-12

(b) Description of Research

A variety of research investigations and other conventional uses of laboratory animals and insects are conducted by the Government in this facility.

(c) Site Plan

In the Ft. Collins facility, partial sections of three (3) floors of the building, with a total area of approximately 14,500 sq. ft., houses the animal facility, the glassware operation, the clean insectary, the specific pathogen free (SPF) breeding colony, and the animal holding area for the infected insectary.

C.4.2 Hours of Operation The standard hours of operation for Contractor work are Monday to Sunday, as follows:

The basic hours of operation for the Ft. Collins facility are from 6:30 AM – 4:00 PM, Monday through Friday. The Contractor shall base the staffing needs on the requirements of work as specified in this Performance Work Statement and in the referenced SOPs. Hours of work may be based on staggered start times not to exceed a normal 8.5-hour workday (which includes 0.5 hours for lunch/break) for each of the Contractor’s employees. CDC core hours are 9-3:30, Monday through Friday. The Contractor shall make certain that the staffing provided during the basic hours during the week is adequate to ensure compliance with the requirements of the contract.

The Contractor shall be required to provide staffing for essential services performed during extended hours as requested by the Project Officer. Extended hours include hours beyond basic hours of operation (6:30 AM - 4:00 PM), Monday through Friday, weekend care to include one-time per day animal surveillance and husbandry, and on holidays and during inclement weather days.

Essential services are defined as those after-hours services determined by the Project Officer to be necessary. Essential services may include, but not be limited to, feeding, watering, transporting animals, parameter checks and daily observations.

The Contractor Project Manager assigned to the Ft. Collins facility shall be on-site and available for an eight-hour period during the basic hours of operation, Monday through Friday.

C.4.3 Emergency Services The Manager (or designee) shall be available for emergencies occurring outside the basic hours of operation 6:30 AM - 4:00 PM, Monday through Friday. The Manager (or designee) shall possess a cell phone (provided by the Contractor). The Manager (or designee) shall be available by telephone within 15 minutes for any emergency which may arise in the animal care support area and if requested, respond in person, within 30 minutes of the request.

C.4.4 Specific Tasks

C.4.4.1 Receiving, Quarantine, and Housing Animals

The on-site Project Manager or designee will verify that there is space available for animals to be ordered on approved protocols. The Contractor will receive, examine, weigh, quarantine and house incoming laboratory animals (e.g., mice, hamsters, rabbits, and birds as required). The Contractor’s animal technicians will receive and visually inspect, within 10 minutes after receipt, the condition of each shipment (e.g., shipping boxes and animals) for signs of damage or other defects. Also at the time of receipt/acceptance, the animal technician receiving the shipment will verify the number, sex, and species of animals, comparing the shipping invoice to the original order. The animal technician will record the receipt of the shipment in the appropriate receiving logbook, noting the following: purchase order number (if applicable), principal investigator (PI), species, sex, age, and number of animals received; origin of shipment or vendor name, health status, and destination (facility, floor and/or room number). Vendor quality assurance reports for shipments of incoming animals will be reviewed upon receipt of the animals.

Incoming lab animals will be examined, and animals, by species, will be housed in accordance with CMB-FTC-306 and CMB-FTC-307. Rabbits will be removed from crates and weighed within two hours of receipt. Rodents will be removed from crates by 3 PM of the day of receipt. However, if rodent shipments are received after 3 PM, Hydropacs may be placed in the shipping crates and the rodents may remain in the shipping crate and placed in assigned facility caging as soon as possible. Examination of animals shall include, but is not limited to general visual inspection of each animal for signs indicative of clinical illness. Visual observations of health status will be recorded in the appropriate individual animal record or logbook. Abnormal signs observed during the health check will be reported to the on-site Project Manager and to the Attending Veterinarian.

Technicians will house animals in accordance with FTC-CMB SOPs 402, 403, 404, and 411 as applicable. Each animal species will be identified, at the time of receipt, by the approved species-specified method in accordance with FTC-CMB SOP 307.

The Contractor will ensure that all animals are appropriately identified during their housing in DVBD facilities.

In general, animals of different species will not be housed in the same room (unless approved by the Attending Veterinarian), and whenever possible, animals of different strains and sources/vendors will not be housed in the same room. Room assignments will only be made for animals that have been appropriately procured for an IACUC-approved protocol.

C.4.4.2 Animal Handling and Restraint

The Contractor will be responsible for the daily handling and restraint of animals. Animal technicians will be trained and adequately supervised to ensure that they use accepted humane methods of manual restraint of animals in their care. Animal handling and restraint by Contractor’s personnel will be performed in accordance with FTC- CMB SOP 418. When chemical restraint is used, all animals will be recovered according to the applicable IACUC-approved protocol, with animals being monitored every 15 minutes until they have achieved sternal recumbancy, and then every 30 minutes until completely awake.

C.4.4.3 Feeding and Watering Animals The Contractor will feed and water all laboratory animals housed in the facility, ensuring that each animal is fed according to species specific guidelines (e.g., in accordance with FTC-CMB SOP 502 and 503). Animal technicians will ensure each animal has access to clean fresh water at all times in accordance with FTC-CMB SOP 411.

Animal technicians will:

i) Present animal feed in feeders, troughs and/or in a manner that precludes fecal and /or urine contamination of feed, and will inspect feeders daily to assess:

(1) feed consumption;

(2) availability of clean feed; and,

(3) feeders that need to be replaced/cleaned.

ii) Present water in watering devices (e.g., Hydropacs, lixits, buckets, troughs), which will also be checked daily to assess:

(1) water consumption, ensuring that Hydropacs are kept at least 1/2 full at all times;

(2) availability of clean/potable water, e.g., lack of debris or other contamination; and,

(3) Hydropacs that need to be replaced.

(4) water bottles are full or replaced as necessary

Documentation of daily feed and water checks will be recorded on room husbandry logs by Contractor and any abnormalities will be recorded on the log and reported to the Contract Project Manager. All twice daily inspections will be completed before 9:00 AM and after 2:00 PM each day (Monday through Friday, and at least once a day on weekends and holidays). Those inspections will also assess the presence of leaky Hydropacs, water bottles and/or flooded cages, and if bedding is excessively wet or flooded, the animals will be transferred to a clean, dry cage, and a notation of the action will be made on the room husbandry log.

On a quarterly basis, the Contractor will, using sampling bottles provided by the water testing laboratory, take and submit water samples for water quality testing in accordance with FTC-CMB SOP1104. Once water test results are obtained, the Contractor will file the test report in the appropriate logbook.

Feed Storage in Animal Rooms – Feed bags will be opened by Contractor in assigned animal rooms, and will be emptied into feed receptacles that are lined with a heavy-duty plastic liner and which have a tight fitting lid. Any abnormalities in the feed will be reported immediately to the Contract Project Manager. Feed storage containers will be marked/identified with the room number, date of acceptance and expiration, and will not be moved from room to room so as to avoid cross-contamination. Feed storage containers will be sanitized and refilled at least once a month, with completion of that task to be noted on the room log sheet.

Feed Presentation – When feeding animals, Contractor will ensure that the feed being offered is fresh, and that the feeders are clean and free of any gross contamination. They will inspect the feeders daily to assess individual or group feed consumption, and they will report any evidence of inappetence to the Contract Project Manager, his/her designee and/or the Attending Veterinarian.

Feeding Rodents –Rodents will be fed designated commercially prepared rodent diets. Rodent feeders and hoppers will be kept filled and animals will be allowed ad libitum access to the feed. Feed levels will be monitored during the twice daily room checks to ensure that adequate feed levels are present at all times.

Feeding Rabbits –Rabbits will be fed a designated commercial dry, high fiber rabbit chow in an effort to prevent obesity and hairballs. Alfalfa hay, greens and/or carrots may also be fed as directed. Rabbits will be provided with ad libitum access to feed, although limited feeding (~125g/day) may be necessary to reduce the incidence/occurrence of obesity in some rabbits.

C.4.4.4 Cleaning/Sanitizing Animal Cages, Racks, Equipment, Rooms, Hallways and Service Areas

The Contractor will clean and sanitize all caging, equipment, animal rooms and service areas in accordance with FTC-CMB SOPs 208, 901, 903, and 904. Cages, bedding, water bottles, and cage lids will be changed on a regular basis according to routine schedules for the species and type of housing involved. Waste pans for rabbits will be changed/sanitized at least 3X/week, or more often as needed should they be excessively soiled. Rabbit cages and racks will be changed/sanitized at least 1X/week, and more often as needed should they be excessively soiled. Rodent cages with contact bedding will be changed/sanitized at least 1X/week, and more often as needed should they be excessively soiled or wet. Other equipment will be sanitized weekly or biweekly depending on the species they are associated with.

All animal rooms and service areas will be cleaned daily and sanitized monthly in accordance with FTC-CMB SOP 416. Floors will be swept clean, and countertops and shelves will be wiped down with a disinfectant solution. Bagged waste will be removed and disposed of appropriately. Rack shelves in rodent rooms will be swept clean of debris using a brush. If urine spills/splashes are observed on either the floor or walls in rabbit rooms, they will be washed down/cleaned with a disinfectant solution. Cleaning equipment (squeegees, brooms, dust pans brushes, etc.) will be allocated to each room and will not be moved from room to room. Upon completion of cleaning or sanitizing the room, animal technicians will document the action(s) on the room husbandry log. Animal technicians will ensure that rooms, hallways, service and storage areas are kept clean and vermin free.

Hallways and support areas will be swept and mopped with a disinfectant solution just prior to the end of each workday. Hallway floors will be scrubbed/ buffed with a special floor detergent at least monthly, or more often as needed.

The Contractor will, on a weekly basis, perform microbial sampling of surfaces of caging, equipment, and animal room surfaces to assess the effectiveness of cleaning and sanitization procedures, and this will be done in accordance with ARB SOPs 60-61. Some facilities perform periodic bacterial swabbing/culture or RODAC plating of caging, racks, equipment, floors, walls, and ceilings to assess the presence or absence of pathogenic bacteria. Three categories of outcome of culturing include: 1) adequately sanitized - with no gram negative rods and no gram positive cocci growth on culture medium; 2) marginally sanitized - no gram negative rods, but some gram positive cocci growth on culture medium; and 3) inadequately sanitized - gram negative rod growth observed in cultures.

Mops will be sanitized at least weekly, either by soaking in a disinfectant/sanitizing solution, or by processing them through the tunnel washer.

Cleaning and sanitizing procedures will minimize the presence of vermin and microbiological organisms and conditions that may adversely affect the health of all the animals housed in the Facility.

C.4.4.5 Autoclave Operation and Preventative Maintenance The Contractor will operate and maintain the appropriate autoclaves in accordance with FTC-CMB SOP 805 and 1105. An autoclave usage logbook will be maintained for each individual autoclave in accordance with FTC-CMB SOP 1105. Operation and maintenance activities will be contemporaneously recorded by the operator in the appropriate/corresponding logbook. The autoclave floor and screen will be cleaned daily to keep them free of gross debris in accordance with FTC-CMB SOP 805.

Contractor will use the autoclaves to decontaminate appropriate caging, equipment and waste in accordance with FTC-ARB SOP 901. They will ensure that all decontamination cycles were completed, and record required information in the corresponding autoclave logbook. On a monthly basis, the Contractor will perform a bacterial spore test in accordance with FTC-ARB SOP 1105. Upon receipt of the test results (e.g., no growth or growth), the results will be entered into in the appropriate/corresponding logbook.

C.4.4.6 Collection and Disposal of Hazardous Wastes and Chemicals The Contractor will collect, contain, and dispose of wastes before 3:00 PM every day in accordance with FTC-CMB SOP 416 and 901. As noted in Section A.4.5 above, the contractor will use the autoclaves to decontaminate appropriate caging, equipment and waste in accordance with FTC-CMB SOP 901, and document completion of the task in the autoclave usage logbook at the end of each run in accordance with FTC-CMB SOP 1105.

C.4.4.7 Logbook Maintenance

The Contractors will maintain appropriate logbooks for the animal rooms and service areas. At a minimum, the following logbooks will be maintained: room husbandry activities; filter changes; inventory of controlled drugs; necropsies performed; autoclave usage and effectiveness monitoring; equipment preventative maintenance and repair logs; animals received; and live births. Entries will be made contemporaneously using a pen.

The daily (husbandry) room checklist will be maintained according to FTC- CMB SOP 411, and upon completion at the end of the month, will be placed in a 3-ring binder for storage in the DVBD Animal Care office. Each room’s daily (husbandry) room checklist will be checked daily by the Contractor to ensure that required tasks have been completed and are appropriately documented. Corrective actions (e.g., warnings, retraining, and ultimately termination) will be initiated by the Contractor if it is found that an animal technician demonstrates repeated deficiencies.

C.4.4.8 Animal Health Surveillance and Environmental Monitoring

The contractor is advised that although laboratory rodents are procured from reputable breeding facilities that conduct intensive quality assurance health testing, rodents and other animal species in a facility can become contaminated during shipment. These risk factors may necessitate scheduled gross and histopathological, parasitological, and serological examinations of a representative sample of animals within the facility.

A basic knowledge of the nature of animal models and the diseases induced in those models is important in assessing the health and well-being of animals. Contractor employees will adhere to traffic flow patterns (both by themselves and other users of the facilities), working "clean" areas and species first and "less clean" species and areas last, using appropriate personnel protective equipment, preventing cross-contamination of areas by using storage barrels and cleaning implements assigned to individual rooms, assuring that caging/equipment/facilities are adequately sanitized/disinfected, isolating clinically ill or latently infected animals from the main colony/holding room, and assuring that sentinel and environmental monitoring programs are performed as scheduled, taking corrective measures as necessary/required.

C.4.4.9 Animal Health Surveillance

The Contractor will daily provide Animal Health Surveillance to ensure the overall health and well-being of the animals in accordance with FTC-CMB SOP 411. Contractor will perform AM and PM health checks, done at the beginning of each workday and just prior to close of business each day. If abnormalities are observed, they will be noted in the appropriate logbook or individual animal record, and will then be reported to the on-duty veterinarian within 30 minutes of discovery of the problem. Any treatments posted and prescribed/directed by the veterinarian will be executed by the animal technicians in a timely manner in accordance with FTC-CMB SOP 701. All treatments will be recorded in the appropriate animal record or log.

The Contractor will collect, prepare, label, package, prepare submission forms, and submit appropriate laboratory diagnostic specimens to the appropriate diagnostic laboratory, and record results when received. As laboratory results are received, they will be recorded in the appropriate logbook or individual animal record by the Contractor.

The Contractor will assist in the Sentinel Mouse program in accordance with FTC-CMB SOP 1102. This will include ordering sentinel animals if needed, maintaining sentinel cages in appropriate rooms, placing soiled bedding from all room cages into the sentinel cage, collecting blood for serological analysis, and submitting animals for histopathological, microbiological, and parasitological assessments. Results of Sentinel animal testing will be recorded in the appropriate logbook.

The Contractor will contact the Government PI within four hours of discovery for routine communications on abnormal animal health status, illness and/or death. All carcasses will be placed in the necropsy refrigerator when discovered in accordance with FTC-CMB SOP 1201. If necropsy is not required or following completion of a necropsy, carcasses will be disposed according to SOP and/or posted room instructions.

C.4.4.10 Environmental Monitoring (Cage and Room)

The Contractor will monitor, ensure, and maintain ventilation in all animal rooms and service areas on a daily basis in accordance with FTC-CMB SOP 406, reporting problems to the Facility Maintenance immediately. The Contractor will document assessments of airflow on the daily room husbandry sheet, recording any abnormalities observed.

The Contractor will monitor, ensure, and maintain adequate lighting and light cycles in all animal rooms in accordance with FTC-CMB SOP 407. Light bulbs will be changed as necessary. Contractor will document assessments of lighting and light cycles on the daily room husbandry sheet, recording any abnormalities observed.

The Contractor will ensure noise levels are maintained at or below accepted limits in accordance with FTC-CMB SOP 407.

The Contractor will maintain the appropriate type and level of bedding suitable for each animal species in accordance with FTC-CMB SOP 408. The Project Manager or designee will place bedding orders at least monthly (in accordance with FTC-ARB SOP 301) as needed to maintain an adequate supply of bedding for use in the facility.

The Contractor will handle and maintain feed in accordance with FTC-CMB SOP 303, 304, and 305, will maintain the appropriate type and level of feed suitable for each animal species in accordance with FTC-CMB SOP 410, 502 and 503. The Contractor will place feed orders at least monthly (in accordance with FTC-CMB SOP 301 as needed to maintain an adequate supply of feed for use in the facility. The Contractor ensure that wasting of feed is minimized, and that feed is used before its expiration date.

Contractor will monitor animal feed and water consumption, and will, with the exception of rodents, weigh and record animal body weights on a regular basis, recording results on the weight sheet or in individual animal records. Extreme (acute) weight loss or chronic weight loss over time will be reported to the Attending Veterinarian.

C.4.4.11 Psychological Enrichment

Contractor will provide and document enrichment to all animals housed in the facility in accordance with SOPs and IACUC directions.

C.4.4.12 Special Procedures Assistance

Contractor will handle, transport and restrain animals for special procedures, including but not limited to: catching, handling and restraining with or without using immobilizing drugs, for examination and/or treatment by a veterinarian or animal technician: for collection of blood by skin prick and/or venipuncture; administration of oral medications for research studies; and, administering intramuscular, subcutaneous and/or intradermal injections. The contractor will ensure that animals are handled so as to avoid injury to the animal or the handler, and will provide handling and/or special procedure assistance (e.g., blood sampling and animal treatments) as requested by the Attending Veterinarian, within 10-20 minutes of the verbal request.

C.4.4.13 Necropsy / Prosection Assistance

The Contractor will assist with necropsy of research animals. The Contractor will ensure that animals requiring euthanasia will be killed in accordance with the applicable IACUC-approved protocol.

Dead and/or moribund animals shall be processed in accordance with FTC-CMB SOP 1201. The Contractor will notify appropriate study personnel, supervisor, and the Attending Veterinarian of dead and/or dying animals. All moribund animals will be reported to the Attending Veterinarian as soon as possible after discovery. Contractor will properly bag and label carcasses as soon as possible after discovery in accordance with FTC-CMB SOP 1201, place the bagged carcass in the necropsy refrigerator. The Contractor will properly bag, label, and seal carcasses and/or parts, and send them to the appropriate laboratory as directed by the Attending Veterinarian.

The Attending Veterinarian or trained designee will perform prosection, tissue collection and preservation in formalin on appropriate tissues collected on designated animals. The individual performing the prosection will write a brief description of observations made during the prosection, prepared as directed by the Attending Veterinarian, and the Contractor will place the report in the appropriate animal file upon completion of the prosection. The prosector will record animal identification, sex, weight, age, date of necropsy and date of death in the manner as directed by the Attending Veterinarian, recording that information in the appropriate necropsy report.

C.4.4.14 Maintenance and Minor Repair of Equipment

Some items of equipment are necessary for maintaining the comfort, well-being, and health of research animals while minimizing research variables (i.e., ventilated racks, laminar air-flow change out stations, auto water systems, and light timers) that may jeopardize animal health, programmatic compliance, and research results. The Contractor will provide a proven, effective program of equipment preventative maintenance and minor repairs, and will notify the government in a timely manner of equipment that needs major repairs/service. The Contractor is responsible for maintenance and minor repair of animal handling and care equipment to ensure effective and efficient management of the facility. The Contractor will make minor repairs to broken cages as soon as possible. The Contractor will monitor and ensure all facility maintenance problems are promptly addressed. Facility maintenance and repair problems will be reported to and handled by the facility maintenance and repair office. Facility maintenance and repair problems will be reported to that office within 24 hours of identification of the problem.

The Contractor will maintain a written logbook documenting all repairs to include: date, name, action taken and problem occurring. Entries will be made in the logbook within 24 hours of identification or notification of the problem.

C.4.4.15 Supply Logistics

The Contractor will order, receive, stock and maintain an inventory of all supplies used in performance of the contract, in accordance with FTC-CMB SOPs 301, 303, and 306. Supplies will be ordered within one month of estimated depletion of stock to ensure that adequate supplies of consumables are on hand. Contractor will ensure that a one-to-three month supply will be maintained at all times. The Contractor will maintain a logbook of supplies received including: date of receipt; name of vendor; type and quantity; and signature of individual accepting the shipment. Entries of feed shipments will also contain the lot number (s) and/or milling dates.

The Contractor will maintain appropriate type and quantity of feed (including fresh vegetables and hay/straw, as needed) and bedding suitable for various animal species, placing feed and bedding orders at least monthly, and ensuring that animal technicians minimize feed wastage and that feed is used prior to its expiration date.

C.4.4.16 Maintaining Equipment Certification Standards

The Contractor will ensure that certifications are met and kept current for anesthesia machines, autoclave, eye wash stations, and any other equipment utilized in the animal facility.

C.4.4.17 Cagewash Operation and Maintenance

The Contractor will clean cages and equipment, and operate the cage wash area in accordance with FTC-CMB SOP 901 and 904, ensuring that soiled cages are washed within 24 hours after receipt in the cage wash area.

C.4.4.18 Glassware Processing Operation and Maintenance

The Contractor will clean, inspect, sterilize, and stock laboratory glassware and discard containers, ensuring that all glassware is properly prepared within 24 hours of receipt in the glassware area. The Contractor will prepare decontaminated glassware by removing tape, labels, and markings, and pre-washing when necessary, in accordance with glassware FTC-CMB SOP 804. The Contractor will handle glassware marked “wash and return” separate from general use glassware, and return them to the appropriate lab after processing. All glassware will be returned to the appropriate labs within 48 hours of initial receipt.

The Contractor will load and operate glassware washers in accordance with glassware FTC-CMB SOP 806. They will perform a visual inspection of glassware for cleanliness and distortions (free of detergent residue, debris, sediment, excess water, cracks or chips), rewashing as necessary. The contractor will discard broken and cracked glassware according to glassware SOP’s. If the items are identified as “wash and return”, the Contractor will inform the owner of defective glassware. The Contractor will submit orders for new glassware as needed.

C.4.4.19 Operation of Glassware Sterilizing Equipment

The Contractor will properly operate the sterilizing equipment and monitor the performance of the decontamination autoclaves in the facility in accordance with glassware FTC-CMB SOP 805.

The Contractor will prepare glassware for steam or dry heat sterilization by capping and/or foiling the openings, placing autoclave tape across the foil, and placing glassware inside autoclave or Hot Pack. They will sterilize glassware according to FTC-CMB SOPs 805, 806 and 807. When the glassware cools to room temperature, they will mark autoclave tape with the sterilization date. They will then place sterile, dated glassware on shelves in the stockroom for reuse. All glassware is sterilized within 24 hours after receipt.

C.4.4.20 Ensuring Smooth, Efficient Glassware Operations

The Contractor will maintain an inventory of clean, sterile, general use glassware in the stockroom, ensuring that adequate supplies are available for the various laboratories. The Contractor will submit orders for new glassware to the purchasing clerk, and keep an accurate inventory of glassware washed and glassware in storage.

The Contractor will clean the glassware washing facilities daily, including equipment, counters, sinks, carts and floors.

C.4.4.21 Laundry Services

The Contractor will wash laundry on an as needed basis according to FTC – CMB SOP1301.

C.4.4.22 Monitoring Decontamination Autoclaves

The Contractor will perform monthly microbiological monitoring of all decontamination autoclaves in accordance with Glassware FTC-ARB SOP 805.

C.4.4.23 Maintenance of Clean Arthropod Areas The Contractor will maintain mosquito eggs, pans of mosquito larvae, and containers of adult mosquitoes by:

1) Hatching eggs as appropriate;

2) checking and feed larvae, maintain appropriate density in pans per species;

3) monitoring temperature, humidity and photoperiod in chambers and incubators;

4) control escapes;

5) transfer pupae to emergence cups;

6) transfer adults to cages;

7) provide sucrose to cages daily in accordance with FTC-ARB SOP 421;

8) provide egg laying substrates as appropriate per species;

9) ensure egg paper liners are maintained at proper moisture level.

Appropriate procedures will be followed to ensure that there is no loss or contamination of the colony including work on weekends and holidays as necessary.

The Contractor will blood-feed mosquito colonies weekly (or as needed per species); harvesting eggs from selected colonies; drying, labeling and storing containers of eggs; hatching eggs as needed, all in accordance with FTC-ARB SOP 421 and the Mosquito Handbook.

The Contractor will maintain the mosquito insectary by: cleaning larval pans; preparing reagents; cleaning oviposition cups; cleaning sucrose jars; cleaning emergence buckets; cleaning adult cages; constructing paper cages; ordering supplies; cleaning counters and floors, etc., all in accordance with FTC-ARB SOP 421 and the Mosquito Handbook.

The Contractor will assist the insectary manager by coordinating rearing of appropriate species for experimental purposes, freezing voucher specimens periodically to ensure provenance of colonies, and in other efforts to provide mosquitoes as needed to researchers.

The Contractor will maintain the insectary rooms by: cleaning mosquito and tick rearing equipment, feeding room and counter tops, removing/disposing trash, and maintaining caging, etc., all in accordance with applicable parts of SOP FTC-CMB 416 and 421.

The Contractor will assist with recovery of fed ticks from water in drop-off cages during tick feeds on mice.

The Contractor will maintain the flea insectary by: cleaning flea housing/rearing equipment, feeding room and counter tops, removing/disposing trash, and maintaining caging, etc., all in accordance with SOP ARB-FC (i) 03.

C.4.4.24 SPF Mouse Colony Management and Maintenance

The Contractor will breed mice for approved research protocols in accordance with FTC-CMB SOP 501 and the IACUC-approved protocol ensuring that animals are bred in sufficient quantities to meet researchers’ needs. The husbandry provided for those animals will be as described in the approved breeding protocols and relevant SOPs. Appropriate bioexclusion practices will be followed to ensure the maintenance of the SPF status of the colony.

The Contractor will send specimens from the breeding colony for quality control testing in accordance with FTC-CMB SOP 1102.

The Contractor will provide animal breeding colony management and recordkeeping services for approximately 1200 rodents in the AG129 mouse colony, maintaining the SPF status of this colony.

C.4.5 Personnel

The Contractor shall furnish fully trained managerial, supervisory, and technical personnel sufficient in number and qualifications to accomplish all work.

Contractor shall be able to speak, read, write and understand the English language, especially including unique technical, scientific and animal/insect care terminology required for the performance of duties and functions.

Contractor shall obtain and maintain in good standing all certifications, inspections, and licenses necessary or appropriate to perform all work contained in this PWS. The Contractor shall maintain the training skills and qualifications of all personnel throughout the award period. Additionally, the Contractor must provide an on-site manager who will be responsible to and coordinate with the federal Project Officer for the day to day operations of animal care.

The Contractor is required to notify the Contracting Officer five (5) work days (M-F) in advance prior to diverting any of the required individuals to other program sites. The Contractor shall provide justification (including proposed substitutions) in sufficient detail to permit evaluation of the impact on the program. No diversion of personnel shall be made by the Contractor without written consent of the Contracting Officer. The Contracting Officer may ratify in writing such diversion, and such ratification shall constitute the consent of the Contracting Officer required by this clause. The personnel required may be changed from time to time as appropriate.

C.4.5.1. IACUC Participation

The Contractor’s Project Manager or other qualified animal care technician will be appointed to the IACUC as a voting member. IACUC policy requires all committee members to participate in the IACUC 101 training course within 1 year of appointment. The Contractor is responsible for all costs associated with the appointee’s attendance at this course.

C.5 REPORTING SCHEDULE

C.5.1 Required Plan/Reports The Contractor shall submit the following reports to the COR. Detailed information on submission of reports is outlined in section F:

C.5.1.1 Occupational Safety Plan

A draft Safety Plan shall be submitted as a part of the Contractor’s proposal. An approved Safety Plan shall be finalized prior to commencing performance on the contract.

C.5.1.2 Quality Control Plan

A draft Quality Control Plan shall be submitted as a part of the Contract proposal and will be in accordance with FTC quality SOPs. An approved Quality Control Plan shall be finalized prior to commencing performance on the contract. This Plan is to be updated annually. The Quality Control Plan shall include:

C.5.1.2.1 An inspection system covering all the services stated in the Performance Work Statement. The Plan must specify areas, time of the day, and number of times to be inspected on a scheduled or unscheduled basis, the inspection procedures that will be used, and the staff position(s) that will conduct the inspections;

C.5.1.2.2 A method for identifying and preventing defects in the quality of service performed before the level of performance is unacceptable; and

C.5.1.2.3 A description of the on-site records to be utilized to record Contractor’s inspections and other surveillance of the quantity and quality of the services being performed.