2010 SOW Attachment 3.pdf

Attachment 3

STATEMENT OF WORK

Project Title: “Provision of Barrier Reared and Maintained Rabbits, Rats, Mice, Hamsters, Gerbils, and Guinea Pigs”

I. Statement of Work

a. Background Information

The Division of Veterinary Resources (DVR), Animal Procurement Unit (APU), is responsible for the centralized ordering of rodents and rabbits for the National Institutes of Health (NIH). The APU maintains contracts with commercial vendors of laboratory animals to support the research requirements of investigators within the NIH intramural research program.

This centralized purchasing mechanism is used for the following functions:

C To provide monitoring and oversight of the genetic quality and health status of research animals introduced into the NIH animal facilities;

C To maintain compliance with various federal laws and NIH regulations affecting the use of laboratory animals;

C To assure that IC laboratory animal programs have authorized placement of individual animal orders, and;

C To provide an efficient and cost effective centralized purchasing mechanism that can maintain uninterrupted support of the research animal needs of intramural investigators.

b. Objectives

The objective of this contract is to provide quality laboratory rodents and rabbits to the NIH intramural research program in a rapid manner at fair and reasonable prices.

II. Services to be Performed

a. General Requirements

Independently, and not as an agent of the Government, the Contractor shall furnish the following:

MANDATORY:

C various strains and stocks of barrier reared and maintained rats, cotton rats, mice, hamsters, gerbils, guinea pigs and rabbits from commercial catalogs that meet specific species, strain, health status, sex, age, weight, and/or pregnancy requirements;

ADDITIONAL/OPTIONAL:

C tissues, organs, blood and other biological specimens; including germplasm

C surgical and technical procedures such as embryo cryopreservation and rederivation, quarantine services, and other services such as vasectomies, cannulations, implants, and telemetry.

C empty shipping crates and containers

C other services such as model generation, breeding colony management, if available.

The requirement includes presentations by the Contractor’s professional and technical staff of an overview of their products, services, animal health surveillance program and technical capabilities to the NIH Veterinary and research staff. This Contractor presentation shall be required, at minimum, one time within the first two years of performance. Conference room space at the NIH and audiovisual equipment will be made available by the Government at no cost to the Contractor.

The Contractor shall be regularly engaged in the breeding, raising, and shipping of the species covered under this solicitation. The animals, tissues, organs, and blood or serum supplied under this contract shall be maintained and collected in the Contractor’s facilities.

The Contractor shall operate any and all proposed facilities for services related to rederivation of animal models for the elimination of the vertical and horizontal transfer of pathogens, parasites and other undesired organisms, and the cryopreservation of mouse and/or rat embryos. However, with the Government’s approval, some or all of the long-term storage of cryopreserved embryos (repository functions) may be subcontracted.

The Contractor shall be accredited by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC). In addition, the Contractor shall comply with all applicable laws, regulations and standards governing animal welfare while performing under this contract. All facilities, practices and procedures of husbandry, care and maintenance of animals used in the performance of this contract shall be in accordance with the latest issue in effect of the Guide for the Care and Use of Laboratory Animals.

b. Disease Prevention and Health Status

The Contractor shall have a health surveillance and disease control program that meet or exceed NIH requirements (see Attachment 12, Agent Lists). The Contractor shall be responsible for the cost of the testing. Oversight of these programs shall be developed, administered, and directed by a veterinarian who is board certified or eligible for certification by the American College of Laboratory Animal Medicine.

The microorganisms that shall be monitored, and the frequency, are outlined by species in Attachment 12, Agent Lists. The organisms and tests outlined in each table represent a minimal characterization of the colony. The contractor shall adapt testing strategies to incorporate the testing of “emerging” diseases/organisms that affect, are suspected of affecting, or have the potential to affect the health of laboratory animals.

If requested animals need to be reconstituted from cryopreserved germplasm, they shall be housed and tested to preclude contamination with the agents listed in Attachment 1, Agents List. Health status testing of the offspring will adhere to the requirements set forth in this SOW.

The Contractor shall, using trained staff under the direction of the veterinarian, examine sick and dead animals and collect appropriate specimens from these animals for further study by the veterinarian or other designated qualified individuals.

All health surveillance test results shall be clearly identified with:

1) Date of report;

2) Type of specimen collected;

2) Date specimen collected;

3) Number of animals examined;

4) Species and strain or stock examined;

5) Age or date of birth;

6) Source of animal or specimen (e.g., building and room number, if available, include the cage or pen number), and;

7) Agent tested for and test used.

8) Test results

The required testing specified herein shall be performed by a diagnostic laboratory, approved by the Project Officer or their designee. The diagnostic laboratory staff shall be qualified by training and/or experience and shall have demonstrated the capability to perform the required tests. The diagnostic laboratory may be owned and operated independently of the Contractor, or it may be owned and operated by the Contractor.

The Project Officer shall have the right to require confirmatory testing at a lab of their specification and at the Contractor’s expense. Results of the required tests shall be made available to the Project Officer or their designee.

The Contractor shall notify the Project Officer and their designees within twenty-four hours of receiving any confirmation of a pathogen within the colony. Whenever test results are positive for any of the disease entities listed in Attachment 12, Agent Lists, the Contractor shall conduct confirmatory testing within 72 hours. During this period animals from the suspected room(s) shall not shipped to NIH facilities. Following the 72 hour period the Project Officer and their designees shall be notified if the original results are confirmed as positive or if the confirmatory tests are still pending. Notification shall be made by E-Mail or telephone with a written notice to follow. The Government retains the right to order or reject animals from the Contractor’s colonies that have tested positive for any of the disease entities listed in Attachment 12, Agent Lists, or to receive a credit or replacement for these animals.

Additional Rejection Considerations

Any physical event which, either potentially or directly, could adversely influence the health status of animals in the production colonies shall be reported to the Project Officer within 24 hours of the occurrence. Examples of such events include, but are not limited to, problems with environmental control equipment or transportation of animals, extremes in weather conditions and contamination of feed or water.

All animals shall be delivered in physically sound and healthy condition (except those animal models that exhibit clinical signs appropriate to their genetic makeup) and shall be free of wounds (except those related to requested surgical modifications), scars, and clinical signs of disease. Physically mature male animals which are prone to fighting shall be physically separated. Breeding pairs and other animals purchased for breeding shall not have any conditions that would impair breeding performance.

Animals provided under this contract shall not have been subject to previous experimental use of any type or kind. They shall not have been reared, housed, or transported in contact with animals of a different health status.

Animals provided under this contract shall not have been treated with any medication without prior approval from the Project Officer or their designee. If medication of the animals is agreed to, monthly reports concerning such use shall be submitted to the Project Officer.

Genetic Integrity

Breeding schemes shall be designed to assure the homozygosity of inbred strains and the heterogeneity of outbred stocks. The structure of the colony shall be detailed, and no more than five (5) generations should elapse between the foundation and production colonies.

The Contractor shall have a documented genetic quality control program to assure the homozygosity and genetic uniformity of inbred animal models. Testing shall be conducted at least semi-annually and results of the testing from the genetic quality control program shall be available if requested by the Project Officer. Evidence of any genetic contamination shall be reported to the Project Officer within two (2) business days and additional testing shall be conducted to determine the cause and source of the contamination. Results of the testing and a plan for correction shall be provided to the Project Officer.

The Contractor shall have a qualified animal geneticist review the management of the colonies at least once per annum. This individual shall have a Ph.D. degree in animal genetics or a related field and have at least two years professional experience with rodent species.

c. Optional/Additional Services to be Provided by the Contractor:

1. Surgery Services:

As required, the Contractor shall provide surgically modified animals. All surgery performed under this contract shall be performed according to the standards described in the Guide for the Care and Use of Laboratory Animals.

2. Services to Eliminate the Transmission of Specific Pathogens, Parasites and Organisms specified on the contract agent lists:

As required, the Contractor shall provide rederivation services for the purpose of eliminating the transmission of specified pathologic agents.

The Contractor shall establish and maintain records as specified in the specific agreements established for these services. This may include the number, sex, and genotype of all animals, any treatments (e.g. superovulation, health, etc.), number of embryos/pups recovered, number of embyos transplanted, number of litters and pups successfully weaned, and any other information requested by the individual order. Upon request, the contractor shall provide copies of their SOPs for rederivation procedures for review.

3. Cryopreservation and Banking Services for Germplasm (sperm, ovaries, embryos, etc.)

As required, the Contractor shall provide services to establish a bank of cryopreserved germplasm or establish living offspring from banked germplasm to include ovary or oviduct removal, embryo or sperm collection and cryopreservation, storage of cryopreserved germplasm, thawing, and rederivation of Specific Pathogen Free (SPF) offspring from banked germplasm.

The Contractor shall have the capability of long term storage of cryopreserved germplasm to include:

C the distribution of banked germplasm in two or more liquid nitrogen freezers;

C the storage of banked germplasm at a remote site to protect against local disaster at the primary storage site;

C an inventory control system;

C equipment and procedures to ensure continuous low temperatures when banked germplasm is shipped;

C alarms to monitor continuous low temperatures and physical security of storage refrigerators, and;

C a documented plan of action to safeguard the cryopreserved germplasm in the event of a storage freezer failure.

The Contractor shall establish and maintain the following records, which shall be made available to the Government upon request.

C Physical conditions of each cryopreservation run, including the protocol used for cryopreserving the germplasm and the results of random viability tests carried out to confirm success;

C Genetic identification of banked germplasm. The strain, genotype and pedigreed number(s) of donor(s). For any germplasm cryopreserved from a pedigreed stock, information shall be recorded to enable its ancestry to be traced to the colony from which it was derived;

C Storage location of banked germplasm. Identification of the container in which the germplasm are contained and the precise location in the liquid nitrogen refrigerators shall be recorded along with the amount of germplasm and an indication of whether embryos were obtained by gonadotropin-induction or spontaneous ovulation of the donor female, and;

C Thawing and recovery data for banked germplasm. Provide the number of containers and embryos thawed and success of each step in the process including quality control procedures used to rederive live-born mice.

4. Quarantine Services

As required, the Contractor shall receive, house, breed, and monitor the health of specified incoming laboratory animals (rodents and rabbits) designated by the Government which are harboring organisms on the contract agent list, or if their disease status is unknown.

The Contractor shall evaluate the animals for organisms specified prior to shipping animals to NIH colonies or designated delivery points outside the NIH.

Disposition of such quarantined animals shall require clearance by the Project Officer or designee and the appropriate Institute Rodent Import Officer (IC RIO).

Any procedure and/or manipulation of the animals shall be anticipated, discussed with, and approved by the requestor prior to the shipment of animals to the Contractor.

The Contractor shall positively identify animals entering or born within the facility using a reliable identification system. For each shipment of animals received, the Contractor will maintain a record that includes the requestors name, shipment arrival date, room destination, number of animals, strain, sex, and date of birth. Additionally, each record will contain an isolation clearance form that summarizes all pertinent information to include special handling, technical requests received, and testing results. This record shall be updated as each procedure is completed and results are received.

5. Model Generation

The contractor shall provide services to produce genetically modified mouse models utilizing gene targeting technologies to include targeted gene mutation, targeted gene replacement and reversible RNA inhibition systems to allow for specific gene modifications in vivo. Genetic material shall be provided by the Government.

6. In Vitro Fertilization

The contractor shall provide breeding services via in vitro fertilization to produce age matched cohorts of specific and opportunistic pathogen free mice

7. Genotyping

The contractor shall provide genotyping for quality control purposes.

c. Additional Contractor Requirements:

1. Feed and Bedding

The Contractor shall have a documented quality assurance program for laboratory animal feed and bedding. The quality assurance program shall include, at minimum, a nutrient and contaminant analyses of representative feed samples on a quarterly basis. Upon request, the Contractor shall submit copies of the analyses or samples of feed and bedding to the Project Officer.

The quality assurance program shall include, but not be limited to Standard Operating Procedures for the following feed and bedding operations:

a) Dietary regimens for each animal species;

b) Receipt and storage of feed and bedding;

c) Maintenance of storage areas; storage of bagged feed and bedding in the warehouse;

d) Pest Control Procedures

Upon request, the Contractor shall provide the Project Officer with the supplier name, product name, ingredient list, and nutrient concentrations of the diets fed to animals purchased by the NIH. Upon request, the Contractor shall provide the Project Officer with the supplier name and product name of the bedding used in and under the cages of the animals purchased by the NIH. The Contractor shall notify the Project Officer in writing before there is a change in feed or bedding used for animals purchased by the NIH.

The Contractor shall notify the NIH Project Officer within 24 hours if it is determined that the feed is deficient or toxic in any nutrient or contaminated by pathogens or any chemical compounds known to be undesirable. The Contractor shall notify the NIH Project Officer within 24 hours if it is determined that the bedding used for animals purchased by the NIH is contaminated by pathogens or any toxic compounds at levels known to be undesirable.

2. Water Quality:

Animals shall have continuous access to fresh, potable, uncontaminated drinking water.

The Contractor shall have a documented water and watering devices quality assurance program. The quality assurance program shall include monitoring water for pH, hardness, and microbial and chemical contamination on a quarterly basis. The Contractor shall submit copies of the analyses to the Project Officer upon request.

The Contractor shall notify the NIH Project Officer within 24 hours if it is determined that the water and /or the watering devices used for animals provided under this contract is contaminated by pathogens or any toxic compounds at levels known to be undesirable.

RFP Attachment: 12. Agent Lists

SECTION D - PACKAGING AND MARKING

ARTICLE D.1 Packing/Marking

Animals shall be delivered in properly ventilated, filtered, escape proof containers furnished by the Contractor. If the container is constructed with cardboard, the cardboard should be of sufficient strength to withstand 50 lbs pressure without damaging the integrity of the container. Each order shall be boxed separately. Containers should be divided into compartments to reduce the number of animals that can congregate at ventilation openings and to separate animals from fighting. Windowed crates shall be used for international shipments.

At a minimum, the packing slip accompanying the shipment shall contain the following information:

C Request for Animal Delivery (RAD) # C Species C Strain

• Sex

• Quantity

• Building & Room of origin C Date of Birth (if applicable) C Weight range (if applicable) C Delivery location

ARTICLE D.2 Shipping

The Contractor shall follow all applicable federal, state and local laws and regulations affecting the transportation of animals and comply with the most recent edition of The Guide for the Care and Use of Laboratory Animals, the PHS Policy on Humane Care and Use of Laboratory Animals, the Institute of Laboratory Animal Resources (ILAR) Guidelines, and the International Air Transport Association (IATA) Regulations.

Each shipping container shall be provided with a transport water kit or moisture/nutrient gel with appropriate moisture content to meet the needs of the species transported. The Contractor shall be responsible for meeting all requirements associated with the shipment of laboratory animals to the NIH. It is recognized that breeders and suppliers of laboratory animals have no direct control or jurisdiction over public carriers used for transporting animals. However, they shall maintain close liaison with carrier personnel in order to assure their cooperation for proper care of animals during transit.

The Contractor should ensure that the secondary enclosure (delivery vehicle) is loaded on a last in/first out basis (according to the delivery schedule) to avoid the unnecessary movement out of animals within or outside of the vehicle. Animal shipping cartons shall not be placed outside of the vehicle (street, sidewalk, or concrete loading dock surface, etc.) while sorting through the containers to identify those to be delivered at the designated building.

All vehicles used in transporting animals under this requirement shall be heated / air-conditioned as needed to provide an ambient temperature between 68o and 78o F. The Contractor may authorize an agent or delivery agency to make deliveries to air carriers if the vehicle and drivers meet the specifications stated herein.

The period during loading and unloading when an animal’s environment is not controlled shall be held to a minimum.

In hot weather (greater than 78o F), floor space per animal shall be increased by up to 50% by reducing the number of animals in each shipping container.

Each driver or assistant shall be trained and qualified to handle and care for the species of laboratory animals being transported and to provide needed service in emergencies.

(a) Animals shall be delivered by the Contractor, or his designee, to the designated destination detailed on each order. Animals shall be delivered no earlier than 7:00 a.m. and no later than 2:00 p.m. on the date specified.

(b) This delivery service may involve (1) truck or van delivery from the Contractor's premises to the consignee or (2) air freight shipment to a local airport plus an approved local delivery service to NIH or (3) the service of an acceptable air freight forwarding company. Temperature-controlled and disease-free facilities for proper storage of animals received after hours shall be available if air freight shipment is used.

(c) The Contractor is responsible for ensuring that the animals are delivered to the building designated by the order form, or to the designated animal receiving location for that facility.

(d) Each animal delivery shall be made to the representative of the designated facility who is required to sign the Contractor's delivery receipt or log sheet.

SECTION E - INSPECTION AND ACCEPTANCE

Article E.1 Inspection/Acceptance

A. The Contracting Officer or the duly authorized representative will perform inspection and acceptance of the supplies and services to be provided.

B. For the purpose of this Article, the Government Project Officer is responsible for inspection and acceptance of all supplies and services to be provided under this contract.

C. Inspection and acceptance will be performed at:

National Institutes of Health Office of Research Services (ORS) Division of Veterinary Resources Animal Procurement Unit, Building 14G, Room 102 9000 Rockville Pike Rockville, Maryland 20892

Contacts: John Chick/Scott Green Telephone: 301-594-3569 / 301-435-4444

D. All defective shipment claims and claims for replacement of animals will be submitted to the

Contractor. The Contractor shall address the request within five (5) business days, make a determination as to the accuracy of the claim, and inform the NIH in writing of their response. In instances in which the Contractor disputes the claim for defective shipment, the procedures described in the disputes clause shall be followed.

Article E.2 52.252-2 Clauses Incorporated by Reference

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES

FAR CLAUSE NO. TITLE AND DATE

52.246-02 Inspection of Supplies - Fixed-Price (AUG 1996) 52.246-16 Responsibility for Supplies (Apr 1984)

SECTION G - CONTRACT ADMINISTRATION DATA

ARTICLE G.1 PROJECT OFFICERS

The following Project Officers will represent the Government for the purpose of this contract:

Project Officer: John Chick Alt Project Officer: Scott Green

The Project Officers are responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the Statement of Work and any other technical performance requirements;

(3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance. The Alternate Project Officer shall act in the absence of the Project Officer.

The Contracting Officer is the only person with the authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the Statement of Work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor any costs incurred during the performance of this contract (5) otherwise change any terms and conditions of this contract.

The Government may unilaterally change its Project Officer designation.

ARTICLE G.2 ORDERING PROCEDURES

1) The DVR animal procurement unit receives Requests for Animal Delivery (RAD) from NIH IC’s for submission to Contractors. At a minimum the RAD includes the following information:

a. Species

b. Strain

c. Vendor model number (if applicable)

d. Sex of animals

e. Number of animals

f. Weight or age

g. Requested delivery date

h. Delivery location (building designation)

i. Surgical procedures, gestation day, age of pups (if applicable)

j. RAD Number

2) Ordering Officials will contact individual Contractors to determine availability. If the Contractor is able to meet the requirements of the RAD, , an order is placed at which time the Contractor shall provide the Ordering Official with confirmation of the order. This confirmation shall include the date of delivery and all applicable pricing information. The Contractor shall provide the estimated cost which includes the item cost, shipping cost, container charge, and any other applicable charges (surgical modification) for each order at the time it is confirmed (before the order is shipped).

3) If the Contractor is unable to meet the requirements of the RAD, they may submit a counteroffer detailing which parameters they are unable to meet, and what they could provide as an alternative. The Contractor shall hold the counteroffer for 24 hours before releasing the animals.

Any differences in the handling, housing, and health status of the counter offered animals from the requirements of this SOW will be clearly delineated in the offer.

4) If the Government accepts the counteroffer an order is placed and the Contractor shall provide a confirmation as in #2, above.

5) No orders shall be shipped to the NIH prior to communication of a confirmed delivery date to the

Ordering Official.

6) Request for Animal Delivery (RAD) Number

a) The unique RAD number, given at the time each order is placed, will remain the same for each shipment delivered against a standing order. The delivery date shall be present on the delivery slip and invoice for each order and shipment.

b) The unique RAD number, given at the time each order is placed, shall remain the same for each shipment delivered against a partial order. The delivery date shall present on the delivery slip and invoice for each order and shipment.

7) The Contractor shall obtain delivery confirmation with signatures from personnel receiving the animals for each order at the time of delivery.

8) The following individuals are designated as Ordering Officials and are authorized to place and receive orders:

a. The cognizant Project Officer and Alternate Project Officer.

b The cognizant Contracting Officer.

c. The cognizant Contract Specialist.

d. Mr. Tony Adderly

e. Mr. Robert Hines

f. Mr. Walter Southerland

g. Arthur Johnson

GOVERNMENT PURCHASE CARD PROCEDURES

1) Government Ordering Officials may elect to place orders using Government Purchase Card (Purchase Card) procedures. If Purchase Card procedures are used, a Purchase Card order number shall be given to the Contractor by the Government Ordering Official at the time the order is placed. The Contractor is cautioned not to accept an order unless a Purchase Card order number is issued.

2) Contractor Responsibilities:

Each delivery shall be accompanied by a packing slip citing the Order Confirmation Number.

Invoices shall be submitted to the purchase card bank. Purchase card bank surcharge costs shall not be invoiced to the Government. At minimum, all invoices shall cite the RAD or order # provided to the Contractor at the time each order is placed, the delivery date of the animal shipment and invoice date. Note: The Government anticipates that the Purchase Card order number will not exceed 9 bytes of space.

3) Government Responsibilities:

For all purchase card orders, the purchase card number, purchase card order number and name of the ordering official will be provided to the Contractor at the time the order is placed.

4) When processing the purchase card transaction, the vendor shall include all information detailed in #2, above.

ARTICLE G.3 CREDITS OR REPLACEMENT INVOICES

1) Requests for order credit or replacement will be submitted to the Contractor by an authorized Ordering Official. See Article G.2 for authorized Ordering Officials.

2) Contractors shall review the request for credit or replacement, provide a written response indicating that credit or replacement will, or will not be issued, and why. Credit invoices referencing the appropriate order number will be submitted through the same invoicing procedure as used for the original order.

3) Disputes will be handled in accordance with the disputes clause.

ARTICLE G.4 FEDERAL ACQUISITION, RECYCLING, AND WASTE PREVENTION

The Contractors shall participate in established NIH recycle programs. Furthermore, contractors shall recycle uniforms, i.e. reuse uniforms from terminated employees and redistribute to new employees. Contractors shall also recycle full face respirators. Even though they are custom fit to the face of an employee, they can be retrofitted and reused.

Contract deliverables such as reports and other documents shall be printed on both sides of at least 30 percent post consumer paper.

Contractors are encouraged to use reusable shipping containers whenever the safety and health of the animals and handlers allow.

The Contractor shall comply with NIH Waste Management Guidelines.