75D301-24-Q-77789_CDC_Fort Collins Animal Care and Associated Services.pdf

PAGES

15A. NAME

AND

ADDRESS

OF

OFFEROR

SEC. PAGE(S) SEC. PAGE(S)

(Date) (Hour)

CALENDAR DAYS

14. ACKNOWLEDGMENT OF AMENDMENTS

(The offeror acknowledges receipt of amend-ments to the SOLICITATION for offerors and related documents numbered and dated:

(Type or Print)

SOLICITATION, OFFER AND AWARD 1. THIS CONTRACT IS A RATED ORDER

UNDER DPAS (15 CFR 700)

RATING

PAGE OF

1 48

2. CONTRACT NO.

3. SOLICITATION NO.

75D301-24-Q-77789

4. TYPE OF SOLICITATION

SEALED BID (IFB)

X NEGOTIATED (RFP)

5. DATE ISSUED

07/10/2024

6. REQUISITION/PURCHASE

NO.

000HCRH1-2024-83894

7. ISSUED BY CODE 8219 8. ADDRESS OFFER TO (If other than Item 7)

Centers for Disease Control and Prevention

Chamblee Campus Building 102, MS S102-4

4770 Buford Hwy

Atlanta, GA 30341-3717

Approved as to Form and Legality: _____________________________

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

SOLICITATION

9. Digital offers in original and 1 copies for furnishing the supplies or services in the Schedule will be received at the place specified in Item 8, or if handcarried, in the depository located in email: wlv7@cdc.gov until 3 PM local time 07/30/2024

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

Nathan R. Amador

B. TELEPHONE (NO COLLECT CALLS)

AREA CODE NUMBER: EXT:

(770) 488-2690

C. E-MAIL ADDRESS

wlv7@cdc.gov

11. TABLE OF CONTENTS

(x) DESCRIPTION (x) DESCRIPTION

PART I – THE SCHEDULE PART II – CONTRACT CLAUSES

X A SOLICITATION/CONTRACT FORM 1 X I CONTRACT CLAUSES 31

X B SUPPLIES OR SERVICES AND PRICES/COSTS 2 PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.

X C DESCRIPTION/SPECS./WORK STATEMENT 3 X J LIST OF ATTACHMENTS 37

X D PACKAGING AND MARKING 16 PART IV – REPRESENTATIONS AND INSTRUCTIONS

X E INSPECTION AND ACCEPTANCE 17 REPRESENTATIONS, CERTIFICATIONS, AND

X F DELIVERIES OR PERFORMANCE 18 X K OTHER STATEMENTS OF OFFERORS 37

X G CONTRACT ADMINISTRATION DATA 21 X L INSTRS., CONDS., AND NOTICES TO OFFERORS 39

X H SPECIAL CONTRACT REQUIREMENTS 24 X M EVALUATION FACTORS FOR AWARD 45

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 calendar days (60 calendar days unless a different 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

AMENDMENT NO. DATE AMENDMENT NO. DATE

CODE FACILITY 16. NAME AND ADDRESS OF PERSON AUTHORIZED TO SIGN OFFER

15B. TELEPHONE NO.

AREA CODE NUMBER EXT.

15C. CHECK IF REMITTANCE ADDRESS

IS DIFFERENT FROM ABOVE - ENTER

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

10 U.S.C. 2304(c)( ) 41 U.S.C. 253(c)( )

23. SUBMIT INVOICES TO ADDRESS SHOWN IN

(4 copies unless otherwise specified)

ITEM

24. ADMINISTERED BY (If other than Item 7) CODE 8219 25. PAYMENT WILL BE MADE BY CODE 434

Centers for Disease Control and Prevention

Chamblee Campus Building 102, MS S102-4

4770 Buford Hwy

Atlanta, GA 30341-3717

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©

K

Section B - Supplies Or Services And Prices/Costs

Base Year Items: September 22, 2024 - September 21, 2025

ITEM SUPPLIES / SERVICES QTY / UNIT UNIT PRICE EXTENDED PRICE

0001 Animal Care Base Period Fort Collins

FFP Line Item – Severable Services

POP: 09/22/2024 – 09/21/2025

12 Month

Option Period 1 Items: September 22, 2025 - September 21, 2026

1001 Animal Care Option Year 1 Fort Collins

FFP Line Item – Severable Services

POP: 09/22/2025 – 09/21/2026

Option Period 2 Items: September 22, 2026 - September 21, 2027

2001 Animal Care Option Year 2 Fort Collins

FFP Line Item – Severable Services

POP: 09/22/2026 – 09/21/2027

Option Period 3 Items: September 22, 2027 - September 21, 2028

3001 Animal Care Option Year 3 Fort Collins

FFP Line Item – Severable Services

POP: 09/22/2027 – 09/21/2028

Option Period 4 Items: September 22, 2028 - September 21, 2029

4001 Animal Care Option Year 4 Fort Collins

FFP Line Item – Severable Services

POP: 09/22/2028 – 09/21/2029

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 11 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.

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 division of NCEZID. DVBD, located in Fort Collins, Colorado on the Colorado State University

Foothills Campus. The DVBD 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 continue to build 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, maintenance of a mosquito insectary, and glassware 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 DVBD’s laboratory animals are used for infectious disease biomedical research in the broad classification categories of virology, bacteriology, 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 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 Fort Collins (FTC) Standard

Operating Procedures (SOPs) established by the Centers for Disease Control and Prevention. FTC-SOPs shall be enforced by the Government to ensure that the services performed comply with the requirements specified. In addition to the FTC-SOPs, the Contractor shall be required to comply with the provisions set forth in the:

1. Animal Welfare Act and Animal Welfare Regulations (usda.gov)

2. 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 Guide for the Care and Use of

Laboratory Animals: Eighth Edition | The National Academies Press, Eighth Edition, 2011 (or current edition).

3. Furthermore, the Fort Collins animal care facility is accredited by the Association for Assessment and

Accreditation of Laboratory Animal Care International (AAALAC).

4. The Contractor shall always comply with all AAALAC standards and recommendations. The Contractor shall comply with the DVBD IACUC Charter, policies, and mandates, the DVBD AAALAC Program

Description and the DVBD PHS Assurance along with the DVBD-IACUC-approved protocols.

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 Technical Requirements.

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 Diseases. All animal and insect care functions shall be performed in accordance with CDC-Fort Collins developed SOPs (ex. FTC-101 Responsibility). The Contractor shall comply with the DVBD IACUC Charter, policies, and mandates, the DVBD AAALAC Program Description and the DVBD

PHS Assurance along with the DVBD-IACUC-approved protocols.

https://www.aphis.usda.gov/media/document/17164/file https://olaw.nih.gov/policies-laws/phs-policy.htm https://nap.nationalacademies.org/catalog/12910/guide-for-the-care-and-use-of-laboratory-animals-eighth https://nap.nationalacademies.org/catalog/12910/guide-for-the-care-and-use-of-laboratory-animals-eighth http://www.aaalac.org/ http://www.aaalac.org/

(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.

SPECIES APPROXIMATE

MAXIMUM

AVERAGE CAGE

CENSUS

TURNOVER

(MONTHS)

Mice 1200 450 3-12

Rabbits 8 2 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) mouse breeding colony, and the animal holding area for the experimental 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 (Ft.

Collins, Colorado is located in the Mountain time zone, Mountain Daylight Time MDT or Mountain Standard Time

MST). 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 MDT), 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 Contractor Project Manager (or designee) shall be available for emergencies occurring outside the basic hours of operation 6:30 AM - 4:00 PM MDT, Monday through Friday. The Project Manager (or designee) shall possess a cell phone (provided by the Contractor). The Project 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 shall verify that there is space available for animals to be ordered on approved protocols. The Contractor shall receive, examine, weigh, quarantine, and house incoming laboratory animals (e.g., mice, hamsters, rabbits, and birds as required). The Contractor’s animal technicians shall 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 shall verify the number, sex, and species of animals, comparing the shipping invoice to the original order and ensuring there is a current IACUC-approved protocol in place. The animal technician shall 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 shall be reviewed upon receipt of the animals.

Incoming lab animals shall be examined, and animals, by species, shall be housed in accordance with CMB-FTC-

306 and CMB-FTC-307 and the applicable IACUC-approved protocol. Rabbits shall be removed from crates and weighed within two hours of receipt. Rodents shall be removed from crates by 4 PM of the day of receipt. Gel packs may be placed in the shipping crates and 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 shall be recorded in the appropriate individual animal record or logbook. Abnormal signs observed during the health check shall be reported to the on-site Project Manager and to the Attending Veterinarian.

Technicians shall house animals in accordance with FTC-SOPs FTC-402, D30-F-400-003, FTC-404, and D30-F-

700-001 as applicable. Each animal species shall be identified, at the time of receipt, by the approved species-specified method in accordance with FTC-307.

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

In general, animals of different species shall not be housed in the same room (unless approved by the Attending

Veterinarian), and whenever possible, animals of different strains and sources/vendors shall not be housed in the same cubicle. Room assignments shall 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 shall be responsible for the daily handling and restraint of animals. Animal technicians shall be trained and adequately supervised to ensure that they use accepted humane methods of manual restraint of animals in their care. Animal handling and physical restraint by Contractor’s personnel shall be performed in accordance with FTC-D30-F-400-003. When chemical restraint is used, all animals shall be recovered according to the applicable IACUC-approved protocol, with animals being monitored every 15 minutes until they have achieved sternal recumbency, and then every 30 minutes until completely awake.

C.4.4.3 Feeding and Watering Animals

The Contractor shall 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-SOPs FTC-501, FTC- 502 and D30-F-500-

001). Animal technicians shall ensure each animal always has access to clean fresh water in accordance with FTC-

SOP D30-F-700-001.

Animal technicians shall:

i) Present animal feed in feeders, troughs and/or in a manner that precludes fecal and /or urine contamination of feed, and shall 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, water bottles, etc.), which shall also be checked daily to assess:

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

(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 shall be recorded on room husbandry logs by Contractor and any abnormalities shall be recorded on the log and reported to the Contract Project Manager. All twice daily inspections shall 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 shall also assess the presence of leaky Hydropacs, water bottles and/or flooded cages, and if bedding is excessively wet or flooded, the animals shall be transferred to a clean, dry cage, and a notation of the action shall be made on the room husbandry log.

On a quarterly basis, the Contractor shall, using sampling bottles provided by the water testing laboratory, take, and submit water samples for water quality testing in accordance with FTC-1104. Once water test results are obtained, the Contractor shall file the test report in the appropriate logbook and provide copies to the AV, IACUC office, and others as applicable.

Feed Storage in Animal Rooms – Feed bags shall be opened by Contractor in assigned animal rooms and shall 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 shall be reported immediately to the Contract Project Manager. Feed storage containers shall be marked/identified with the room number, date of acceptance and expiration, and shall not be moved from room to room to avoid cross-contamination. Feed storage containers shall 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 shall ensure that the feed being offered is fresh, and that the feeders are clean and free of any gross contamination. They shall inspect the feeders daily to assess individual or group feed consumption, and they shall report any evidence of inappetence to the Contract Project Manager, his/her designee and/or the Attending Veterinarian.

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

Feeding Rabbits –Rabbits shall be fed a designated commercial dry, high fiber rabbit chow to prevent obesity and hairballs. Alfalfa hay, greens and/or carrots may also be fed as directed. Rabbits shall 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 shall clean and sanitize all caging, equipment, animal rooms and service areas in accordance with

FTC-SOPs D30-F-900-001, D30-F-900-002 and FTC-904. Cages, bedding, water bottles, and cage lids shall be changed on a regular basis according to routine schedules for the species and type of housing involved. Waste pans for rabbits shall be changed/sanitized at least 3X/week, or more often as needed should they be excessively soiled.

Rabbit cages and racks shall be changed/sanitized at least 1X/week, and more often as needed should they be excessively soiled. Rodent cages with contact bedding shall be changed/sanitized at least 2X/week, and more often as needed should they be excessively soiled or wet. Other equipment shall be sanitized weekly or biweekly depending on the species they are associated with.

All animal rooms and service areas shall be cleaned daily and sanitized monthly in accordance with FTC-416.

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

Hallways and support areas shall be swept and mopped with a disinfectant solution just prior to the end of each workday.

The Contractor shall, 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 shall be done in accordance with FTC-904 using Hygenia ATP swabs.

Mops shall 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 shall 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 shall operate and maintain the appropriate autoclaves in accordance with FTC-805 and FTC-1105.

An autoclave usage logbook shall be maintained for each individual autoclave in accordance with FTC-1105.

Operation and maintenance activities shall be contemporaneously recorded by the operator in the appropriate/corresponding logbook. The autoclave floor and screen shall be cleaned daily to keep them free of gross debris in accordance with FTC-805.

Contractor shall use the autoclaves to decontaminate appropriate caging, equipment, and waste in accordance with

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

C.4.4.6 Collection and Disposal of Hazardous Wastes and Chemicals

The Contractor shall collect, contain, and dispose of wastes before 3:00 PM every day in accordance with FTC-416 and D30-F-900-002. As noted in Section A.4.5 above, the contractor shall use the autoclaves to decontaminate appropriate caging, equipment, and waste in accordance with FTC-SOP D30-F-900-002, and document completion of the task in the autoclave usage logbook at the end of each run-in accordance with FTC-1105.

C.4.4.7 Logbook Maintenance

The Contractors shall maintain appropriate logbooks for the animal rooms and service areas. At a minimum, the following logbooks shall be maintained: daily animal health checks, all room husbandry activities; filter changes;

inventory of controlled drugs; necropsies performed; autoclave usage and effectiveness monitoring; cage wash equipment usage logs, equipment preventative maintenance and repair logs; animals received; and live births.

Entries shall be made contemporaneously using a pen and initialed or signed.

The daily (husbandry) room checklist shall be maintained according to FTC-SOPs D30-F-400-001 and D30-F-700-

001, and upon completion at the end of the month, shall be placed in a 3-ring binder for storage in the DVBD

Animal Care office. Each room’s daily (husbandry) room checklist shall 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) shall 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 shall 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 shall daily provide Animal Health Surveillance to ensure the overall health and well-being of the animals in accordance with FTC-SOP D30-F-700-001. Contractor shall 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 shall be noted in the appropriate logbook or individual animal record and shall 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 shall be executed by the animal technicians in a timely manner in accordance with FTC-SOP D30-F-

700-001. All treatments shall be recorded in the appropriate animal record or log.

The Contractor shall 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 shall be recorded in the appropriate logbook or individual animal record by the Contractor.

The Contractor shall assist in the rodent health monitoring program in accordance with FTC-1102. This shall include use of in vitro monitoring methods such as maintaining sentinel cages in appropriate rooms, placing soiled bedding from all room cages into the sentinel cage with collection media or exhaust duct sampling. Results of rodent health monitoring tests shall be recorded in the appropriate logbook.

The Contractor shall contact the Government PI within four hours of discovery for routine communications on abnormal animal health status, illness and/or death. All carcasses shall be placed in the necropsy refrigerator when discovered in accordance with FTC-SOP D30-F-1200-001. If necropsy is not required or following completion of a necropsy, carcasses shall be disposed according to SOP and/or posted room instructions.

C.4.4.10 Environmental Monitoring (Cage and Room)

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

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

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

The Contractor shall maintain the appropriate type and level of bedding suitable for each animal species in accordance with FTC-SOP D30-F-400-002. The Project Manager or designee shall place bedding orders at least monthly (in accordance with FTC-SOPs D30-F-300-001, D30-F-300-002 and D30-F-300-003) as needed to maintain an adequate supply of bedding for use in the facility.

The Contractor shall handle and maintain feed in accordance with FTC-SOPs D30-F-300-001, D30-F-300-002 and

D30-F-300-003, shall maintain the appropriate type and level of feed suitable for each animal species in accordance with FTC-410, FTC-502 and D30-F-500-001. The Contractor shall place feed orders at least monthly (in accordance with FTC-SOPs and D30-F-500-001 as needed to maintain an adequate supply of feed for use in the facility. The

Contractor shall ensure that wasting of feed is minimized, and that feed is used before its expiration date.

Contractor shall monitor animal feed and water consumption, and shall, except for 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 shall be reported to the Attending Veterinarian.

C.4.4.11 Psychological Enrichment

Contractor shall 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 shall handle, transport, and restrain animals for special procedures, including but not limited to:

1. catching, handling, and restraining with or without using immobilizing drugs, for examination and/or treatment by a veterinarian or animal technician;

2. for collection of blood by skin prick and/or venipuncture; administration of oral medications for research studies;

3. and, administering intramuscular, subcutaneous and/or intradermal injections.

The contractor shall ensure that animals are handled to avoid injury to the animal or the handler and shall 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 shall assist with necropsy of research animals. The Contractor shall ensure that animals requiring euthanasia shall be killed in accordance with the applicable IACUC-approved protocol.

Dead and/or moribund animals shall be processed in accordance with FTC-SOP D30-F-1200-001. The Contractor shall notify appropriate study personnel, supervisor, IACUC office and the Attending Veterinarian of dead and/or dying animals. All moribund animals shall be reported to the Attending Veterinarian as soon as possible after discovery. Contractor shall properly bag and label carcasses as soon as possible after discovery in accordance with

FTC-SOP D30-F-1200-001, place the bagged carcass in the necropsy refrigerator. The Contractor shall 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 shall perform prosection, tissue collection and preservation in formalin on appropriate tissues collected on designated animals. The individual performing the prosection shall write a brief description of observations made during the prosection, prepared as directed by the Attending

Veterinarian, and the Contractor shall place the report in the appropriate animal file upon completion of the prosection. The prosector shall 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 airflow change out stations, auto water systems, and light timers) that may jeopardize animal health, programmatic compliance, and research results. The Contractor shall provide a proven, effective program of equipment preventative maintenance and minor repairs, and shall 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 shall make minor repairs to broken cages as soon as possible. The Contractor shall monitor and ensure all facility maintenance problems are promptly addressed. Facility maintenance and repair problems shall be reported to and handled by the facility maintenance and repair office. Facility maintenance and repair problems shall be reported to that office within 24 hours of identification of the problem.

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

C.4.4.15 Supply Logistics

The Contractor shall order, receive, stock, and maintain an inventory of all supplies used in performance of the contract, in accordance with FTC-301, D30-F-300-003, and FTC-306. Supplies shall be ordered within one month of estimated depletion of stock to ensure that adequate supplies of consumables are on hand. Contractor shall ensure that a one-to-three-month supply shall be always maintained. The Contractor shall 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 shall also contain the lot number (s) and/or milling dates.

The Contractor shall 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 shall 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 shall clean cages and equipment and operate the cage wash area in accordance with FTC-SOP D30-

F-900-001 and FTC-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 shall 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 shall prepare decontaminated glassware by removing tape, labels, and markings, and pre-washing, when necessary, in accordance with glassware FTC-804. The Contractor shall handle glassware marked “wash and return” separate from general use glassware and return them to the appropriate lab after processing. All glassware shall be returned to the appropriate labs within 48 hours of initial receipt.

The Contractor shall load and operate glassware washers in accordance with glassware FTC-806. They shall 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 shall discard broken and cracked glassware according to glassware SOP’s. If the items are identified as “wash and return”, the Contractor shall inform the owner of defective glassware. The Contractor shall submit orders for new glassware as needed.

C.4.4.19 Operation of Glassware Sterilizing Equipment

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

The Contractor shall 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 shall sterilize glassware according to FTC-805, FTC-806 and FTC-807. When the glassware cools to room temperature, they shall mark autoclave tape with the sterilization date. They shall 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 shall maintain an inventory of clean, sterile, general use glassware in the stockroom, ensuring that adequate supplies are available for the various laboratories. The Contractor shall submit orders for new glassware to the purchasing clerk and keep an accurate inventory of glassware washed and glassware in storage.

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

C.4.4.21 Laundry Services

The Contractor shall wash laundry on an as needed basis according to FTC-1301.

C.4.4.22 Monitoring Decontamination Autoclaves

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

C.4.4.23 Maintenance of Clean Arthropod Areas

The Contractor shall 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-421.

8) provide egg laying substrates as appropriate per species.

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

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

The Contractor shall 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-421 and the Mosquito Handbook.

The Contractor shall 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-421 and the Mosquito Handbook.

The Contractor shall assist CDC investigators by coordinating rearing of appropriate mosquito species for experimental purposes, freezing voucher specimens periodically to ensure provenance of colonies, and any other efforts to provide mosquitoes as needed to researchers.

The Contractor shall 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

FTC-416 and FTC-421.

C.4.4.24 SPF Mouse Colony Management and Maintenance

The Contractor shall breed mice for approved research protocols in accordance with FTC-501 and the IACUC-approved protocol ensuring that animals are bred in sufficient quantities to meet researchers’ needs. The husbandry provided for those animals shall be as described in the approved breeding protocols and relevant FTC-SOPs.

Appropriate bioexclusion practices shall be followed to ensure the maintenance of the SPF status of the colony.

The Contractor shall send specimens from the breeding colony for quality control testing in accordance with FTC-

1102.

The Contractor shall provide animal breeding colony management and recordkeeping services for approximately

600 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 shall be responsible to and coordinate with the federal Project Officer for the day-to-day operations of animal care.

Contractor shall provide personnel dedicated to this facility. The Contractor is required to notify the Contracting

Officer at least ten (10) workdays (M-F) in advance when making personnel changes. The Contractor shall provide justification (including qualifications of proposed substitutions) in sufficient detail to permit evaluation of the impact on the program. No change of personnel shall be made by the Contractor without written consent of the

Contracting Officer. The Contracting Officer shall ratify in writing such personnel changes, and such ratification shall constitute the consent of the Contracting Officer required by this clause.

C.4.5.1. Key Personnel – in addition to a Project Manager with IACUC credentials, offeror may propose additional

Key Personnel as deemed necessary for contract performance.

C.4.5.2. IACUC Participation

The Contractor’s Project Manager or other qualified animal care technician shall be appointed to the IACUC as a voting member. IACUC policy requires all committee members to take on-line didactive training courses. IACUC policies also require regular attendance at IACUC meetings (generally once a month).

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. Contractor’s personnel must be enrolled in an occupational health program with yearly updates and documentation provided to the Fort Collins IACUC office.

C.5.1.2 Quality Control Plan

A draft Quality Control Plan shall be submitted as a part of the Contract proposal and shall 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 shall be used, and the staff position(s) that shall 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. These records shall include the required corrective action to be taken because of the Contractor’s inspection/surveillance. These documents shall be made readily available to the Government during the term of the contract.

C.5.1.3 Monthly Progress Report

Animal Care and Lab Support monthly reports shall describe the progress of the monthly reporting period. The reports shall include:

a. A narrative of the work accomplished during the reporting period.

b. A statement of current and potential problem areas and proposed corrective action.

c. A discussion of activities to be undertaken during the next reporting period.

d. A list of additional or replacement equipment needed.

C.6 SPECIAL CONSIDERATIONS

C.6.1 Exposure to Hazardous Materials and Waste

Work performed may involve exposure to dangerous and potential lethal hazardous materials, wastes, diseases, and biological agents. Additionally, the Contractor shall be exposed to and expected to care for various animals potentially infected with diseases which may be contagious. The Contractor must take precaution to prevent injury to persons, property, and the environment from exposure to such materials, wastes, disease, and biological agents.

C.7 SAFETY AND HEALTH

C.7.1 Health Requirements

The Contractor shall take all reasonable precautions in the performance of the work under this award to protect the health and safety of all people. The Contractor shall comply, as appropriate, with the following standards:

C.7.1.1 HHS Publication No. (CDC) 300859 – Biosafety in Microbiological and Biomedical Laboratories, 6th (or current) edition Biosafety in microbiological and biomedical laboratories (cdc.gov)

C.7.1.2 Upon initial employment, and at the contractor’s expense:

C.7.1.2.1 Provide documentation that each employee is enrolled in an occupational health program specific to animal care. Yearly updates are required.

C.7.1.2.2 Respiratory fit test and training

Provide documentation that each employee has been trained in the use of respirators and that yearly fit testing is conducted by specially trained personnel.

C.7.2 Safety/Emergency Procedures

The Contractor shall ensure that all employees wear proper protective clothing while working in the Animal and

Labware facilities. The Government…