RRP_75D301_19R_67998.doc

SOLICITATION, OFFER AND AWARD

1. THIS CONTRACT IS A RATED ORDER

UNDER DPAS (15 CFR 700)

RATING

PAGE OF

2. CONTRACT NO.

75D30119C05426

3. SOLICITATION NO.

75D301-19-R-67998

4. TYPE OF SOLICITATION

X

NEGOTIATED (RFP)

5. DATE ISSUED

06/24/2019

6. REQUISITION/PURCHASE NO.

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 3:00formtext until local time 07/22/2019 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

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 (CLINs) for Animal Services, Labware/Laundry Services, and Autoclave Operations.

3. Place of Performance

Services will be provided at CDC facilities in Atlanta and Lawrenceville, Georgia

4. Site Visit

A pre-proposal meeting/site visit is scheduled for Monday, July 8th, 2019. This event will include a tour of both the Lawrenceville and Roybal Campus Animal Care facilities, the Laboratory Supply facility and the Autoclave facility. 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 24, 2019

Solicitation Published June 27, 2019

Inquiries/Questions Due

July 1, 2019

Site Visit Notification Due

July 5, 2019

Requests for SOPs Due from Non-site Visit Attendees

July 1, 2019

Anticipated Government Response to Inquiries July 8, 2019

Site Visit

July 22, 2019

Proposals Due August 2, 2019

Discussions/Negotiations

August 28, 2019

Anticipated Award Date

September 22, 2019

Contract Performance Begins

Section B - Supplies Or Services And Prices/Costs

Animal Husbandry/Cage wash Services - Atlanta Year 1

Fixed Price, Severable Services

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

Animal Husbandry Services - Atlanta Year Glassware. Stockroom Year 1

Fixed Price, Severable Services

12 Months

Animal Husbandry Services - Atlanta Autoclave Year 1

Fixed Price, Severable Services

12 Months

Option 1 Year 2 Items:

Animal Husbandry/Cage Wash Services - Atlanta Year 2

Fixed Price, Severable Services

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

Option 2 Year 2 Items:

Animal Husbandry Services Glassware/Stock Room- Atlanta Year 2

Fixed Price, Severable Services

12 Months

Option 3 Year 2 Items:

Animal Husbandry Services - Autoclave Atlanta Year 2

Fixed Price, Severable Services

12 Months

Option 4 Year 3 Items:

Animal Husbandry/Cagewash Services - Atlanta Year 3

Fixed Price, Severable Services

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

Option 5 Year 3 Items:

Animal Husbandry Services Glassware/Stockroom - Atlanta Year 3

Fixed Price, Severable Services

12 Months

Option 6 Year 3 Items:

Animal Husbandry Services - Autoclave Atlanta Year 3

Fixed Price, Severable Services

12 Months

Option 7 Year 4 Items:

Animal Husbandry Cage/Wash Services - Atlanta Year 4

Fixed Price, Severable Services

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

Option 8 Year 4 Items:

Animal Husbandry Services Glassware - Atlanta Year 4

Fixed Price, Severable Services

12 Months

Option 9 Year 4 Items:

Animal Husbandry Autoclave Services - Atlanta Year 4

Fixed Price, Severable Services

12 Months

Option 10 Year 5 Items:

Animal Husbandry Cagewash Services - Atlanta Year 5

Fixed Price, Severable Services

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

Option 11 Year 5 Items:

Animal Husbandry Glassware/Stockroom Services - Atlanta Year 1

Fixed Price, Severable Services

12 Months

Option 12 Year 5 Items:

Animal Husbandry Autoclave Services - Atlanta Year 5

Fixed Price, Severable Services

12 Months

There are no clauses/provisions included in this section.

Section C - Description/Specification/Work Statement DSR Animal Care/Labware Contract

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 Scientific Resources (DSR).

As one of seven divisions in NCEZID, the Division of Scientific Resources (DSR) uses cutting edge technology to produce high quality products and supply services to support the public health efforts of CDC laboratorians and CDC’s laboratory emergency preparedness and response activities. The services included in this contract are provided by two of the four branches within DSR:

The Comparative Medicine Branch (CMB) provides the animal care and use program for the Roybal and Lawrenceville campuses in Atlanta and is closely aligned with CDC’s infectious disease laboratory programs. CDC’s laboratory animals are used for infectious disease biomedical research in the broad classification categories of virology, bacteriology, mycology, immunology and parasitology.

The Office of Director [DSR/OD] provides and supports Lab Waste Management and laboratories/Stockroom supplies for the Roybal and Lawrenceville campuses in Atlanta. Embedded within these functions are services that are of primary importance to OID’s research and diagnostic programs: laboratory waste decontamination and disposal services, laboratory glassware cleaning and sterilization services, laboratory supplies stockroom and distribution services, and laundry services.

C.2 Project Objectives

The primary purpose of this contract is to ensure CDC research animals are provided humane care and maintenance as set forth in Comparative Medicine Branch SOPs and all applicable federal and state laws and regulations are followed. In addition, this contract provides Labware (including stockroom inventory management and Laundry) and Laboratory Waste Decontamination and Disposal services.

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 operational personnel for the efficient performance of duties commonly termed “animal care and laboratory support services” in support of the operation of the Roybal and Lawrenceville Facilities. The services provided shall include, but are not limited to, routine animal husbandry and care, provision of appropriate housing, participation in environmental enrichment, adequate provision of feed and water, maintenance of acceptable sanitation and hygiene levels, appropriate animal handling and restraint (including non-human primates and other exotic species). Performance of the sanitation and cleaning of the animal facilities, caging, equipment and support areas must be documented and recorded. The animal care services also include technical veterinary assistance with blood collection (IV, lancet derived and prescribed methods), inoculations (IP, IM, SQ, IV and all prescribed methods. Technical staff assigned as part of this contract shall provide medical treatments as directed by the Senior Clinical Veterinarian or his/her designee. As assigned, the technical staff shall provide sample preparation, necropsy and surgical support, and support to high containment (ABSL-3 and ABSL-4) operations.

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 are included in the solicitation and will be provided to the contractor upon award. The SOPs are inclusive at the time of solicitation but the number of SOPs may be increased, decreased, updated, and/or edited. In addition to the SOPs, the contractor shall be required to comply with the provisions set forth in the Animal Welfare Acts (Public Law 89-544, 94-279 as amended), 9 CFR, Parts 1, 2 and 3 (Attachment No.1); the PHS Policy on Humane Care and Use of Laboratory Animals (Attachment No. 2), which requires adherence to the Health and Human Services Guide for the Care and Use of Laboratory Animals, HHS Pub. No. (NIH) 96-23, Revised 1985 (Attachment No. 3), in addition to other written guidance and reference documents relevant to the work performed. The Contractor shall at all times comply with AAALAC, International.

In addition, the Contractor shall provide laboratory waste management services, incinerator operation services, laboratory glassware cleaning and sterilization services, stockroom, and laundry services as stated in Section C-4 in order to ensure efficient services as required. This work will be performed at the following locations:

Roybal Campus, Atlanta, Georgia (animal care, facility sanitation and disinfection, pathology, necropsy, labware inventory management and transport, autoclaves, incinerator), protocol support services.

Lawrenceville Campus, Atlanta, Georgia (animal care and building support areas maintenance)

Site Plan

The vivarium Roybal facility, Building 23, has 2 floors for animal husbandry operations with 157 animal housing rooms covering 123,838 square feet and 117,356 square feet of support areas for a total area of 241,194 square feet included in the scope of the solicitation.

The Roybal facility, Building 18 (ABSL 3 vivarium, ABSL 3 enhanced, and ABSL 4 laboratory suites) has two floors for animal husbandry, Basement and SSB. Bldg 18 SSB area has eight animal holding rooms and an additional animal room with two cubicles. Bldg 18 Basement floor houses four enhanced Biological Safety Level (BSL) 3 suites and four BSL 4 suites. Each suite has an animal room and a necropsy room. The animal housing areas total 36, 612 square feet included in the scope of the contract.

The Lawrenceville facility has 8 buildings used to house and support laboratory animal activities; however, the majority of lab animals are housed in Building B. The other buildings, except Bldg K and the goat barn, are used infrequently. Building B has 2 floors or levels (13,429 sq ft); the upper level has 13 animal rooms and the lower level has 141 holding kennels with indoor/outdoor dog pens attached to the building and support areas. The animal housing and support areas total 352,947 square feet included in the scope of the contract.

Laboratory Support (glassware and laundry) services shall be performed in the Central Processing facility in Building 18 on the Roybal campus, which houses glassware and discard pan washing machines, clean steam and dry heat sterilizers, a laundry facility, and a stockroom for laboratory supplies. Building 17 on the Roybal campus is equipped with a satellite facility to handle discard pan washing and laboratory waste management requirements. Additionally, laboratory waste decontamination management shall be performed throughout each laboratory building (Buildings 15, 17, 18, and 23) on the Roybal campus where autoclave rooms are located on each floor.

General Requirements

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.

The four (3) main requirements for this DSR contract include:

1) Animal Care---------------------------------------Section 4.1

2) Stockroom/Lab Waste Management --------Section 4.2

3) Autoclave------------------------------------------Section 4.3

C.4 TECHNICAL REQUIREMENTS

Description of the Roybal/Lawrenceville Animal Operation The Roybal and Lawrenceville Animal Care Facilities are CDC's two Atlanta Area facilities accredited by the AAALC, International.

a) Statistical Data on Average Animal Usage The following table lists the anticipated use of 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.

b) Description of Research All CDC research involving animals is under the auspices of the Comparative Medicine Branch, which provides laboratory animal care and veterinary support to all CDC scientists producing diagnostic reagents, conducting research studies requiring animal modeling, and investigating naturally infected vertebrates.

c) Normal Operations The basic hours of operation for the Roybal and Lawrenceville Facilities are 7:00 AM - 4:30 PM Monday – Friday with essential services being provided on holidays, weekends, and during inclement weather (in accordance with D30-R-100-003-00) Personnel: Emergency, Weekend and Holiday Care). Essential services are defined as those services required to protect the health and well-being of the animals. The Contractor shall make certain that the staffing provided during the basic hours of operation during the week and on weekends is adequate to ensure compliance with the requirements of the contract.

The Federal holidays are listed in the terms and conditions. In the event there is an inclement weather closure or a holiday announced other than those recognized Federal holidays, the Contractor shall provide sufficient staff to ensure essential services are performed.

Contract staff and the Contractor’s Project Manager, Assistant Project Manager(s), or designee assigned to the Roybal and Lawrenceville Facilities shall be on-site and available for an eight-hour period during the basic hours of operation, Monday through Friday (except for holidays and facility closures).

d) Emergency Operations Occasionally, the contractor shall be required to provide staffing for emergency services performed during extended hours as requested by the COR. Extended hours include hours beyond basic hours of operation.

The Contractor’s Project Manager, Assistant Project Manager(s), or designee shall be available for emergencies occurring outside the basic hours of operation. The Manager or Assistant Manager(s) or designee shall possess a cell phone. The Manager or Assistant Manager(s) 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 one hour of the request.

The Contractor will provide support under the direction of the CDC in response to a disaster or emergency situation. Duties may include spending the night when inclement weather may require it, but are not limited to, rescuing, reclaiming, and recovering animals that have escaped or been released and coordinating logistics for animal shelter-in-place and euthanasia (as required) activities. Contractor will also support the CDC Animal Recovery and Relocation Team (ARRT) members with planning for short-and long-term activities as related to the animals.

C.4.1 ANIMAL CARE – Roybal and Lawrenceville

C.4.1.1 Receipt of Incoming Laboratory Animals

The Contractor shall receive, examine, quarantine, and cage all incoming laboratory animals in accordance with D30-R-300-007-00 and HCL-402- 404. The Government will procure laboratory animals. The Contractor will receive an ELEMENTS system notification that includes the species, strain, sex, quantity, weight, and delivery date, the name of the vendor and the name of the CDC principal investigator in accordance with D30-R-300007-00 and HCL 416. The Contractor will ensure adequate caging, spacing, equipment, and personnel are available to receive animals within 15mins of arrival.

C.4.1.2 Handling, Restraint and Common Techniques The Contractor shall be responsible for the daily handling and restraint of animals including, but not limited to, rodents, ferrets, rabbits, nonhuman primates, prairie dogs, and bats. The Government will provide equipment appropriate for handling animals.

Services required include, but are not limited to, catching, handling, and restraining nonhuman primates and other species, without using immobilizing drugs, for examination and/or treatment by a veterinarian or veterinary technician; for collection of blood samples by skin prick and/or venipuncture and for administration of intravenous and/or oral medications for research studies; administering intramuscular injections of Ketamine or other immobilizing drugs to nonhuman primates or other animal species as needed. Other procedures may include, but are not limited to, oral gavaging, oral, rectal and/or vaginal swabs, skin scrapings, and other common diagnostic procedures. Reference D30-R- Series 400- 500 and HCL series 400- 500 series.

C.4.1.3 Feeding and Watering The Contractor shall feed, water, and enrich all animals housed in the Facility in accordance with D30-R-400-009-00, 400-010-00, 500-001-00—500-025-03; D30-R-600-002-006; D30-R-600-013-01, 600-015-01. 600-016-00,-017-01 & 600-18-00 (Roybal); HCL SOP 410, 412; and L’ville SOP 506-509. The Contractor shall be responsible for maintaining records of all feeding and watering performed. The Contractor must check each lixit and watering devices daily during the AM and PM rounds, Monday-Sunday and immediately replace any lixits that are leaking or non-functioning and cage latches that are missing, bent, and/or not properly fastened. The Contractor shall be responsible for the inventory management of feed and produce in accordance with D30-R-300-004-00-00 and HCL SOP 412.

C.4.1.4 Cleaning/Sanitizing Animal Cages, Racks, Equipment, Rooms, Hallways, Service, and Support Areas

The Contractor shall check cages and rooms for cleanliness and keep the animal facilities clean and free of vermin and contaminants in accordance with D30-R-400-019-00; D30-R-400-023-00 & 024-00; D30-R-900-003-00; D30-R-900-005 & 006-00; D30-R-1100-004-00 & 005-00, and HCL SOP 420. The sanitizing procedures shall minimize the presence of vermin D30-R-400-022-00 and microbiological organisms and conditions that may adversely affect the health of all of the animals housed in the Facility. The Government, for performance of the contract, will furnish cleaning agents, disinfectants, and bedding materials.

The Contractor shall monitor the effectiveness of sanitation procedures, identify, and correct possible sources of spontaneous diseases to ensure the quality of the laboratory animals on various research projects in accordance with DRS-30-R-1100-004 & 005 & HCL SOP 1101.

The Contractor shall clean and sanitize all housing (caging, pens, etc.) equipment, animal rooms, service, and support areas in accordance with D30-R-500-001-025-03; HCL SOP 420; and L’ville SOP 506-509. Housing equipment (cages, pens, etc.) 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. Other equipment will be sanitized weekly or biweekly depending on the species with which they are associated.

All animal rooms, service, and support areas will be cleaned daily and sanitized monthly in accordance with D30-R-400-019-00 & 022-00; D30-R-500-001 thru 008-00; D30-R-500-013-00; D30-R-501-505; HCL SOP 420; and L’ville SOP 506-509. 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. Contractor will ensure that rooms, hallways, service and storage areas are kept clean and vermin free. Other equipment and facilities will be sanitized weekly or biweekly depending on the species and appropriate CMB SOP.

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 in accordance with D30-R-1100-004; D320-R-100-005-00 and HCL 1104 &1106.

At the Roybal and Lawrenceville facilities, the Contractor shall, on a quarterly basis, sanitize all animal facility hallways including walls, floors, ceilings, and support areas in accordance with D30-R-400-018-00 and D30-R-400-019-00.

C.4.1.5 Use, Cleaning, and Sanitizing Transport Vehicles (Roybal) Contractor shall supply air conditioned vehicles for the transport of animals, and vehicles for transportation of supplies, and equipment. Animals will be transported on an as needed basis, while supplies and equipment may require daily trips between Roybal and Lawrenceville campuses which is approximately 50 miles round trip. The cargo area of vehicles used to transport animals will be cleaned and sanitized by Contractor staff in accordance with D30-R-300-009-00 and HCL 302. Vehicles used to solely transport supplies and equipment intended for animal care and husbandry will be cleaned and sanitized by Contractor staff on a weekly basis.

C.4.1.6 CMB Autoclave and Incinerator Operation and Preventative Maintenance The Contractor shall operate and maintain the appropriate autoclaves and incinerators in animal facilities in accordance with D30-R-900-005-00, DSR-R-1400-009-00, and HCL SOP 910 & 911. The autoclave floor and screen will be cleaned daily to keep them free of debris in accordance with D30-R-900-005-00 and HCL SOP 910 & 911.

The Contractor will use the autoclaves to decontaminate appropriate housing, equipment, accessories, and waste in accordance with D30-R-900-001-00 and HCL SOP 910 & 911. On a monthly basis, the Contractor will perform a bacterial spore test in accordance with D300-R-1400-010-00 and HCL SOP 1106.

C.4.1.7 CMB Collection and Disposal of Hazardous Wastes and Chemicals from the Animal Facility The Contractor shall collect, contain, and dispose of wastes daily in accordance with D30-R-900-001-00 and HCL SOP 902, 903, 912, & 913. The Contractor will use the autoclaves to decontaminate appropriate housing (caging, pens, etc.) equipment, and waste in accordance with D30-R-900-001-00 and HCL SOP 906 &907. They will document completion of the task in the autoclave usage logbook immediately at the end of each run in accordance with D30-R-900-001-00 and HCL SOP 1106.

Animal carcasses and animal waste will be handled in accordance with EPA guidelines and in accordance with D30-R-900-001-00 /002-00 and HCL SOP 913. Carcasses will be maintained in a designated freezer until they can be incinerated. Each incinerator load will be documented in the incinerator logbook in accordance with HCL-913, 914, and D30-R-900-010-00.

C.4.1.8 Logbook Maintenance The Contractor shall maintain a logbook daily of the following:

Temperature Tape from rack washer and cage washer

Microbial monitoring of housing, housing areas, and accessories

Autoclave/Biological Indicator testing

Water Quality Reports

Room Husbandry Log

Cleaning/Sanitizing Transport Vehicles Log

Incinerator Log

Inventory of controlled drugs

Equipment preventative maintenance and repair logs

Non-Human Primates Live births

Mortality Log

Residual Soap Log (glassware for residual soap on glassware)

Production Count Log

Live Births (fruit bats and Guinea Pig colony)

Filter changes

The Contractor’s Quality Control procedures shall comply with D-30-R-1100-002-D30-R-005-00.

C.4.1.9 Animal Health Surveillance, Clinical Procedures, and Environmental

Enrichment Surveillance procedures shall be performed to ensure overall health and welfare of the animals. Animals shall be checked a minimum of twice daily, once before 9:00 AM and once after 2:00 PM. Surveillance, including sentinel surveillance, shall be in accordance with D30-R-400-011-00, 1100-001-00 and HCL SOP 413.

Services required also include, but are not limited to:

Assisting with surgery of all animals as required by performing the following:

Appropriate restraint of animal

Clipping and surgical preparation of animal

Intubation, if indicated

Positioning animal on exam and surgery table

Monitoring anesthesia (gas or injectable)

Preparing and maintenance of gas anesthesia machine

Scrubbing in to assist in surgery

Observing animals until recovered

Documenting observations

Performing and/or assisting with technical procedures required by performing the following:

Collection of blood, urine, fecal, and other tissues using appropriate techniques for collection, packaging and storage as required

Timed procedures such as, but not limited to, blood pressure and blood glucose monitoring

Scheduled inoculations (IM. IP, oral)

Dispensing medications

Radiographs

Documenting detailed activities on appropriate reporting forms

Inventory control of all treatment, radiograph and surgical rooms

Performing disinfectant and supply re-stocking procedures as required in the following areas:

Necropsy

Pathology Lab

Treatments rooms

Radiology Room

Surgical suites

Animal health surveillance and sentinel mice use:

Packing and transport of sentinel mice to designee

Sample collection and transportation to designated sites (serum, fecal pellets or nasal swabs)

Notification request to veterinary staff or designee of sentinel replacement needs

Rotation of housing, housing areas, housing accessories and equipment

TB testing of Non-Human Primates (NHP)

Documenting events

Ensuring environmental enrichment of all animals according to all applicable CMB SOPs and IACUC policies

C.4.1.10 Equipment Maintenance The Contractor shall maintain and perform minor repair of animal handling care housing and support equipment to ensure effective and efficient management of the Facility (e.g. repair of broken cages, carts, bedding containers, racks, including regular lubrication and replacement of casters; minor repairs on watering and flushing systems; replacing latches and lixits, and replacing valves). The Government shall provide repair parts and supplies. The Contractor shall immediately notify the COR when any equipment used in performance of the contract needs to be repaired or when additional or replacement equipment is needed. If repairs are needed, immediately notify the Facilities Maintenance and Engineering Office (FMEO) in accordance with D30-R-100-004-00.

The Government will be responsible for maintenance and repair of the air handling system, animal room drainage, cage washer, bottle washer, and all laboratory equipment.

Strick adherence to CDC policies and U.S. Department of Labor 29 CFR Part 1910 OSHA General Industry Standards and applicable local codes and national consensus standards.is required at all times. Also, to include 29 CFR Section 1910.147 Control of Hazardous Energy/ Lockout/Tagout Procedures when performing maintenance

C.4.1.11 Maintenance of Animal Care Supply Inventories To ensure an appropriate stock level of animal care supplies, the Contractor shall request, receive, and maintain an inventory of all supplies used in performance of the contract work in accordance with SOP D30-R-300-001-00. The Contractor will provide the program with item description(s) and quantity when supplies need restocking.

C.4.1.12 Cage wash Operation and Maintenance

The Contractor shall clean all housing equipment, associated equipment, and accessories, and operate the cage wash area in accordance with D30-R-900-001-00- 900-011-00 and HCL SOPs 901-914, ensuring that soiled cages and equipment are sanitized, disinfected, and washed.

C.4.2 LAB SUPPORT – (Roybal)

C.4.2.1 Glassware Wash, Inspection, and Sterilization Process

a) Decontaminated glassware received from laboratory staff is washed, inspected, and sterilized before it is inventoried for distribution upon request. The Contractor shall remove and dispose decontaminated lab waste from discard pans, separate reusable glassware, and wash all reusable laboratory glassware and discard pans in accordance with standard operating procedures (SOP).

b) The Contractor shall sort all soiled glassware received from laboratory staff located on CDC's Roybal, Chamblee, and Lawrenceville campuses according to required cleaning protocols, and sort reusable glassware according to type and size to be washed for reuse as outlined in # SOP-200B-013.

c) The Contractor shall place items requiring pre-cleaning (soaking) in an alkaline solution according to # SOP 200C-007 before washing in mechanical glassware washer.

d) The Contractor shall perform Glassware Inspection Processes.

e) The Contractor shall rewash glassware if a visual inspection reveals that the item is visibly dirty, clouded, cracked or stained.

f) The Contractor shall test glassware for residual soap in accordance with SOP-200C-008.

g) The Contractor shall sterilize laboratory supplies (autoclave, heat pack, or Ethylene Oxide sterilizers) according to # SOP-200A-024-00, SOP-200B-004-00, and SOP-CMB-R-802.

i) The Contractor shall assemble items with CDC stock numbers in the "70000" series according to standard instructions provided by CDC laboratory staff.

C.4.2.2 Stockroom Operations

Laboratory supplies (disposable and reusable) are purchased and inventoried by DSR for distribution to DDID laboratories upon request. The Contractor shall manage the inventory in DSR:

1) Verifying the quantity and correctness of supplies received from vendors that were ordered by DSR staff; (Refer to SOP#: DSR 31-031-00 Supply Receipts, Distribution and Returns).

2) Placing new disposable and clean reusable supplies in designated locations inside stockroom and other storage sites; (Refer to SOP #: DSR-31-00- Supply, Receipts Distribution and Returns).

3) Keeping stockroom clean and secure.

4) Filling orders received from DDID laboratory staff through Scireson (DSR’s Electronic Ordering System); (Refer to SOP#: DSR-031-00 Supply, Receipts Distribution and Returns)

5) Verifying the accuracy of orders received; Refer to SOP#: DSR-031-00).

6) Pulling items from the inventory and packaging inside boxes; (Refer to SOP#: DSR-

031-00).

7) Labeling boxes containing orders;

8) Following up with requesters when orders are not picked up in a timely manner. (Refer to SOP#: DSR-031-00 Supply, Receipt, Distribution and Returns).

9) Contractor shall distribute equipment or supplies to designated branch activities on the Roybal campus (Refer to SOP#: DSR-031-00 Supply, Receipt, Distribution and Returns).

10) Transfer of Supplies (Refer to SOP#: DSR-033-00).

11. Washing and Inspection Discards Pan and Lids (Refer to SOP#: D30-R-1400-

001-00).

12. Making Special Prep Items (Refer to SOP#: D30-R-1400-011-00

13. Glassware Inspection and Residual Detergent Testing (Refer to SOP D-30-R-1400-004-00).

14. Performing General Cleaning Practices (Refer to SOP#: D30-R-1400-007-00

The contractor shall perform an annual inventory (count) of laboratory supplies that are stored in the stockroom (Roybal Campus). The contractor shall also perform a spot inventory of at least 10% of supplies stored in the Roybal campus stockroom each quarter (every 3 months). The spot inventory shall be performed on a different set of supplies each quarter.

C.4.2.3 Facility Laundry Services Laundry services are required for laboratory staff who are required to wear scrubs and coveralls, and use towels in accordance with # SOP 200B-009. The Contractor shall wash, dry, and fold garments used at Roybal, Chamblee, and Lawrenceville Facilities in accordance with # SOP 200B-009.

C.4.3 Autoclave Management and Decontamination Process (ROYBAL) The Contractor shall decontaminate laboratory waste by autoclaving in accordance with the following SOPs: # OHS-0001 # 200-024-00, 200-023-00, 200-023-02, D30-R-1400-004, 200B-013, D30-R-1400-003, and D30-R-1400-007.

The services shall include:

a) Autoclaving potentially infectious laboratory waste and reusable glassware throughout the Roybal campus (31 autoclaves, 2 – 3 cycles in each autoclave per day).

b) Validating the efficiency of each autoclave cycle by certifying the appropriate cycle indicators (autoclave cycle time, temperature, and pressure) and checking the visual indicator (autoclave tape and steam sterilization indicator strips) (70 autoclaves, 2 – 3 cycles in each autoclave per day).

c) Collecting and moving decontaminated laboratory waste from autoclave rooms throughout the Roybal campus to a central location on the Roybal Campus for processing (37 autoclave rooms).

d) Assuring that autoclave records (autoclave printouts containing cycle time, temperature, and pressure information) and checklists are maintained for each autoclave cycle (70 autoclaves, 2 – 3 cycles per day) (39 of the 70 autoclaves are operated by CDC laboratory staff).

e) Maintaining autoclave room facilities by supplying discard pans and lids and Bag Pipes (37 autoclave rooms).

f) Keeping autoclave rooms clean and free of debris (42 autoclave rooms).

The Contractor shall prepare Biological Indicators (BI) (provided by the Government) according to SOP#: D30-R-1400-010 and perform quality assurance checks as required by CDC’s Autoclave Monitoring Program on all autoclaves used to decontaminate laboratory waste and sterilizer autoclaves (139 autoclaves).

The Contractor shall wear safety shoes, safety glasses/face shield, lab coat, and uniform with Contractor’s name printed on the shirt while performing these requirements.

Decontaminated lab waste is also transported from the Chamblee and Lawrenceville

Facilities by DSR staff to be processed by contractor.

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:

a) 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.

b) Quality Control Plan

A draft Quality Control Plan shall be submitted as a part of the Contract proposal. 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:

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;

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

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 as a result of the Contractor’s inspection/surveillance. These documents shall be made readily available to the Government during the term of the contract.

c) Monthly Progress Report

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

1. A narrative of the work accomplished during the reporting period, including movement of non-human primates;

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

3.

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

4.

A list of any equipment breakdowns, repairs, or concerns.

5.

A list of additional or replacement equipment needed.

C.5.2 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.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 will 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.6.2 Weather Conditions During inclement weather the Contractor shall refer and follow the following CDC policy on inclement weather: http://basis1.cdc.gov/BASIS/masompb/POLICIES/POLICIES/DDD/412

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:

A. HHS Publication No. (CDC) 21-1112 – Biosafety in Microbiological and Biomedical Laboratories, 5th edition (http://www.cdc.gov/biosafety/publications/bmbl5/index.htm)

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

1. Complete Medical and Occupational Health history forms

a. Animal Allergy Questionnaire (provided)

b. Animal Area Entry Questionnaire (provided)

c. Health queries or screening questionnaires as needed to adequately assess fitness for duty (provided)

2. Complete physical examination including:

a. Vision and color perception testing (forms provided)

b. Baseline Audiogram

c. Pulmonary function test

d. Hepatitis C titer evaluation

3. Complete the following immunizations requirements:

a. Rabies vaccine series or titer check with booster if indicated

b. Viral Hepatitis A and B

c. MMR

d. Varicella

e. IPV and Tetanus

f. Q fever titers, if indicated

g. Other vaccinations may be required pending studies

4. * Two Step skin Tuberculin test

5. Complete clinical laboratory tests including:

a. Complete blood count

b. Routine serum chemistry

c. Liver function test

d. Routine urinalysis

6. Respiratory fit test and training

C. Annually and at the contractor’s expense:

1. Complete the following preliminary examination forms:

a. Animal Area Entry Screening

b. Initial and Annual Animal Allergy

c. Hearing History

d. Interval Respirator

e. TB Quiz

2. Complete the AAA medical clearance requirements:

a. TB/Nonhuman Primate Care and Contact medical surveillance if applicable

b. 2-step TB test or TB written survey

c. Rabies, Hep A, B, & C titer evaluation

d. Pulmonary function test

e. General physical exam

f. Audiogram

D. At appropriate intervals, Contractor employees may also be required to receive other vaccines depending on assignment:

1. Smallpox vaccine, if indicated (every 10 years) [Provided by CDC]

2. Tetanus vaccine (required every 10 years)

3. Investigative New Drug Vaccines may also be required and will be provided by the CDC Occupational Health Clinic when indicated.

1) The Contractor shall assume full responsibility and Liability to ensure compliance is meet with ALL applicable regulations pertaining to the Health and Safety of all personnel during the execution of work. In the event of illness, injury, or death to contractor employees, the contractor/s shall hold the Government harmless for any action or lack of action by the Contractor, or their employees.

2) The Contractor shall provide to the Contracting Officer or Project Officer a written Comprehensive Health and Safety Plan (CHSP) for the specific work under this contract for review by the OHSO. The Contractor shall not be allowed to commence work on site until the CHSP has been approved by both OHSO and the Contracting Officer. The Contractor must receive written confirmation that OHSO has reviewed and approved the plan prior to commencing work

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 will provide Contract employees with safety glasses, face shields, and dedicated PAPR’s (portable air-purifying respirators). The Government will also provide Contract employees with expendable safety effects, such as rubber gloves, masks, disposable gowns, caps, and shoe covers.

a) The Contractor shall maintain an accurate record of, and shall report through the COR to the Contracting Officer, in such manner as the Contracting Officer may prescribe, all accidents and incidents an near misses resulting in traumatic injury, occupational disease, and/or damage to all property incident to work performed under the award. CDC Form 304 should be utilized to report all such incidents. The Contractor shall cooperate fully with CDC to investigate all incidents and to institute corrective actions where necessary.

b) When exposed to a potentially infectious agent, Contractor employees may be seen by the CDC Occupational Health Clinic. When a Contractor animal caretaker sustains a traumatic injury, which also involves a known or suspected exposure to an infectious agent, the employee will be triaged by CDC medical staff for those working at Roybal or Chamblee (when available) facilities, or triaged by Contract supervisors in consultation with CDC medical staff for those working at Lawrenceville or other locations without on-site clinic support. Initial first aid and emergency management of the exposure will be provided by the CDC Occupational Health clinics where available. After the initial management, the worker will then be referred to the Contractor’s medical provider for ongoing treatment of the injury, after appropriate first aid or other immediate intervention is rendered for the injury or exposure. If any medications for post-exposure prophylaxis are needed, the CDC Occupational Health Clinic (if available on site) will provide a small quantity and a prescription for the remaining course of medication needed.