RFP2008-N-09689.doc

SOLICITATION, OFFER AND AWARD

1. THIS CONTRACT IS A RATED ORDER

UNDER DPAS (15 CFR 700)

RATING

PAGE OF

2. CONTRACT NO.

3. SOLICITATION NO.

2008-N-09689

4. TYPE OF SOLICITATION

X

NEGOTIATED (RFP)

5. DATE ISSUED

01/22/2008

6. REQUISITION/PURCHASE NO.

Centers for Disease Control and Prevention (CDC)

Procurement and Grants Office (PGO)

Acquisition & Assistance, Branch II, Team I

2920 Brandywine Road

Atlanta, GA 30341-5539

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 3 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 address in block 7., Mailroom 1110 until

3:30PM

local time 02/26/2008 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

Jeff Miller

B. TELEPHONE (NO COLLECT CALLS)

AREA CODE NUMBER: EXT:

(770) 488-2651

C. E-MAIL ADDRESS

Afx2@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

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 in accordance with the terms, conditions, attachments, locations, schedule, and specifications included in this solicitation and subsequent contract.

2. Type of Contract:

Performance based, Indefinite Delivery/Indefinite Quantity (IDIQ) contract that is the best value to the Government. Task Orders will consist of period of coverage for specific facilities (CLINs) in accordance with contact pricing (Firm Fixed Price) as listed in Section B. The Contractor is guaranteed a minimum purchase of twelve (12) months of CLIN 0001, 0003, 0004, and 0005 for the first year (base year) of the contract. The maximum services that can be purchased are sixty (60) months of CLINs 0001-0005.

3. Format of the Contract:

An initial one (1) year contract with five (5), one (1) year options – each Task Order issued will include period of coverage within the specific year of the contract, i.e., base year, option year I, option year II, etc.

4. The North American Industry Classification System (NAICS):

The NAICS code for this acquisition is 541940. The small business size standard is $5.0 million.

5. Unusual /Specific Aspects of the Acquisition:

Some of the requirements included in this solicitation and subsequent contract are subject to possible A-76 Competition. Consequently, during the possible sixty (60) month coverage of the contract it is very likely that these requirements, due to A-76 competition, will not be included in any task orders issued against this contract.

6. Contract Administration – NOTE: The Contracting Officer who is administering this requirement (Jeff Miller) is going to be out of the office from January 25th through February 7th. Mr. Miller will be back in the office on February 8th. Please hold all questions concerning this procurement for Mr. Miller when he returns. Please submit any and all questions in writing to afx2@cdc.gov. All questions submitted by contractors will be discussed at the preproposal conference and then written answers will be posted on FedBizOpps.

Section B - Supplies Or Services And Prices/Costs

B.1 DESCRIPTION OF SERVICES

The contractor shall, as an independent organization, furnish the necessary management and personnel required to provide care and maintenance of animals in accordance with the terms, conditions, attachments, locations, schedule, and specifications included in this solicitation and subsequent contract.

BASE YEAR (YEAR I OF THE CONTRACT) 5-1-08 THROUGH 4-30-2009

Months

TOTAL PRICE – BASE YEAR $_______________

OPTION YEAR I (YEAR II OF THE CONTRACT) 5-1-09 THROUGH 4-30-2010

TOTAL PRICE – OPTION YEAR I $_______________

OPTION YEAR II (YEAR III OF THE CONTRACT) 5-1-2010 THROUGH 4-30-2011

TOTAL PRICE – OPTION YEAR II $_______________

OPTION YEAR III (YEAR IV OF THE CONTRACT) 5-1-2011 THROUGH 4-30-2012

TOTAL PRICE – OPTION YEAR III $_______________

OPTION YEAR IV (YEAR V OF THE CONTRACT) 5-1-2012 THROUGH 4-30-2013

TOTAL PRICE – OPTION YEAR IV $_______________

AGGREGATE TOTAL (BASE AND ALL OPTION YEARS)………………$_______________

Section C - Description/Specification/Work Statement

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. Overall, CDC includes 4 coordinating centers, 11 centers, 1 institute, 2 coordinating offices and the Agency for Toxic Substances and Disease Registry. Approximately 9,300 personnel are employed at CDC.

Critical to the mission and organization of CDC is the Coordinating Center for Infectious Disease (CCID). CCID 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, CCID conducts research in the definition, characterization, pathogenesis, and diagnosis of those infectious disease that are considered to be public health priorities. CCID has developed expertise in detecting rare, exotic, or unusual diseases and is recognized for extensive capabilities in vector-borne diseases. CCID 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. CCID’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 animal care and use program in the Atlanta and Fort Collins area is closely aligned with CCID and its divisions. The majority of CDC’s laboratory animals are used for infectious disease biomedical research in the broad classification categories of virology, bacteriology, mycology, immunology and parasitology.

The purpose of this contract is to provide care and maintenance of animals in support of research for four (4) CDC animal facilities (three (3) in Atlanta, Georgia and one (1) in Ft. Collins, Colorado) and glassware and insectory at the Fort Collins facility.

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 – Definition: An overall, non-technical description of the work to be performed. It expands on the projected objectives, but does not attempt to detail all of the work required. It must be consistent with the detailed requirements.

The SP 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" in support of the operation of the Chamblee, GA., Lawrenceville, GA., Roybal. GA., and Fort Collins, CO., Animal Care Facilities. The services provided shall include routine animal care including, but not limited to, animal health surveillance by observation, housing, environmental enrichment, feeding/watering, hygiene, animal handling and restraint (including non-human primates and other exotic species) and /or sanitation and cleaning of the animal facilities, caging and equipment and glassware and insectory at the Fort Collins Facility.

Animal care services shall be performed as specified herein and in accordance with the Standard Operating Procedures (SOPs) established by the Centers for Disease Control and Prevention. SOPs will be enforced by the Government to ensure that the services performed comply with the requirements specified. In addition to the SOPs, the Service Provider (SP) shall be required to comply with the provisions set forth in the Animal Welfare Acts (Public Law 89-544, 95-279) 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). Furthermore, the Atlanta area Animal Care facilities, Chamblee, Lawrenceville and Roybal, are accredited by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) The SP shall at all times comply with all AAALAC standards and recommendations.

General Requirements

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

C.4 Technical Requirements -

C.4.1 Description of the Chamblee Animal Care Operation

The Chamblee Animal Care Facility (hereinafter called the Chamblee Facility) is one of CDC's three Atlanta area facilities, which are all accredited by the Association for the Assessment and Accreditation of Laboratory Animal Care International, Inc. (AAALAC).

(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 A variety of research investigations and other conventional uses of laboratory animals are conducted in this Facility. Generally, rabbits are used for antibody production and/or blood meals for mosquitoes. The Division of Parasitic Diseases and Malaria Branch, National Center for Zoonotic, Vector-Borne, and Enteric Diseases, uses a wide variety of animals for malaria, helminth and protozoal studies. Diseases studied include, but are not limited to, Trichinosis, Leishmaniasis, Shistosomiasis, Babesiosis, Cryptosporidiosis, Microsporidia, Malaria and Giardiasis. Two rooms at the Facility (Room 1211 and Room 1215), equipped with an adjoining autoclave and airlock, are available for Biosafety Level 3 and/or other work requiring special containment.

(c) Site Plan The Chamblee Facility has a total area of 12,000 sq. ft. on one level and is further defined below:

Twenty-two animal rooms (each 9'8" x 22', 213 sq. ft.), two large animal rooms (19'2" x 22', 422 sq. ft.) and one small animal room (9'x10', 90 sq. ft.) are available for housing animals. An investigator workroom (Room 1202), a surgery suite (Room 1204-B), treatment room (Room 1204-A), necropsy (Room 1208), soiled cage staging area (Room l0l0-A), clean cage area (Room 1503), feed and bedding storage area (Room 1505), walk-in cooler (Room 1405) and connecting corridors are included in the building. One 90 sq. ft. room (Room 1013) is available for additional storage and as an office/workroom area some of which may be assigned to the SP. The Facility is equipped with men and women's washrooms and a single lunchroom area. The Facility includes loading docks.

C.4.2 Hours of Operation The basic hours of operation for the Chamblee Facility are from 6:30 AM - 4:00 PM, seven (7) days a week. The SP 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 .5 hours for lunch/break) for each contract employee. CDC core hours are 9-11 and 1-3:30. Each employee is expected to be onsite during core hours. While the Facility’s basic hours of operation include weekends, only essential services will be performed on the weekends during the basic hours of operation. The SP 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.

Occasionally, the SP shall be required to provide staffing for essential services performed during extended hours as requested by the Project Officer. Extended hours include hours beyond basic hours of operation (6:30 AM - 4:00 PM), Monday through Sunday, 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 are not limited to, assisting in treatments or emergency surgeries, making malaria slides, feeding, watering, transporting animals, parameter checks and daily observations.

The Federal holidays are Columbus Day, Veterans Day, and Thanksgiving Day, Christmas Day, New Year’s Day, Martin Luther King’s Day, President’s Day, Memorial Day, Independence Day and Labor Day. In the event there is an inclement weather closure or a holiday announced other than those recognized Federal holidays, the SP shall provide services with sufficient staff to provide essential services as identified above.

The Contract Manager or Assistant Contract Manager assigned to the Chamblee 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 and Disaster Response The Manager or Assistant Manager or designee shall be available for emergencies occurring outside the basic hours of operation 6:30 AM - 4:00 PM, Monday through Sunday and during the basic hours of operation on Saturday and Sunday. The Manager or Assistant Manager or designee shall possess a cell phone. The Manager or Assistant 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 one hour of the request.

The Animal Disaster Response Plan (ADRP) establishes responsibility, authority, and direction for veterinary and animal care resources to protect the animals and provide for their welfare during emergencies at CDC’s Chamblee Campus by addressing preparedness, response, recovery, and mitigation activities. Every effort is made to ensure the safety and well-being of the animals at the CDC at all times. However, human life and safety is CDC’s top priority when responding to any emergency.

Roles and responsibilities for each of the Emergency Response Team (ERT) members are discussed in detail in the Chamblee Emergency Response Plan (ERP). It is vitally important that all members of the EACT be familiar with CDC’s Chamblee Emergency Response Plan in addition to the ADRP.

Animal Treatment Team (ATT) Responsibilities

The ATT consists primarily of veterinarians assisted by Laboratory Animal Technicians (refer to Annex A, Notification Lists of the Chamblee ERP) who can rapidly provide specialized veterinary medical support to injured or sick animals as required. Members of the ATT are responsible for triage, treatment, or euthanasia of animals affected by an incident.

Animal Recovery and Relocation Team (ARRT) Responsibilities

ARRT members consist primarily of animal care and handling personnel and other facility personnel. ARRT members are responsible for rescuing, reclaiming, or recovering animals that have escaped or been released; and coordinating logistics for animal shelter-in-place and euthanasia (as required) activities. ARRT members will also be responsible for planning for short-and long-term activities as related to the animals.

After Hours Medical Care for Contract Animal Technicians The SP shall provide after hours medical care for contract animal technicians who sustain traumatic injuries, which also involves a known or suspected exposure to an infectious agent or a biological agent in accordance with Section H.16 (e).

C.4.4 Specific Tasks

(a) Receipt of Incoming Laboratory Animals The SP shall receive, examine, quarantine and cage all incoming laboratory animals in accordance with ARB SOP 22. The Government will procure laboratory animals. The SP will be given advance written notice that a request for animal procurement has been placed. The SP will ensure adequate caging, spacing, equipment and personnel are available. The GRANITE system notification will contain the species, strain, sex, quantity, weight, delivery date(s), the name of the vendor and the name of the CDC principal investigator in accordance with ARB SOP 20.

(b) Handling, Restraint and Common Techniques The SP shall be responsible for the daily handling and restraint of animals including, but not limited to, rodents, rabbits and nonhuman primates. The Government will provide equipment appropriate for handling animals.

Services required include, but are not limited to, catching, handling and restraining small nonhuman primates, without using immobilizing drugs, for examination and/or treatment by a veterinarian or animal 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; assisting to properly restrain the nonhuman primates on portable tables; and making malaria slides on all specified animals. Malaria slides shall be started no later than 8:30 am every morning, including weekends, unless previous arrangements have been made. Other procedures may include, but are not limited to, oral gavaging, oral, rectal and/or vaginal swabs, skin scrapings, and other common diagnostic procedures.

(c) Feeding and Watering The SP shall feed and water all animals housed in the Facility in accordance with ARB SOPs 35 - 37. The SP shall be responsible for maintaining records of all feeding and watering performed. The contract manager and/or assistant project manager must check each lixit daily M-F during PM rounds. The SP shall be responsible for maintaining an appropriate inventory of feed and produce in accordance with SOP 16.

(d) Sanitation and Cleaning The SP shall check cages and rooms for cleanliness and keep the animal facilities clean and free of vermin and contaminants in accordance with ARB SOPs 41 - 47. The 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. The Government, for performance of the contract, will furnish cleaning agents, disinfectants, and bedding materials. The SP shall monitor the effectiveness of sanitation procedures and identify and correct possible sources of spontaneous diseases to ensure the quality of the laboratory animals on various research projects in accordance with ARB SOP 56-61.

The transport vehicle shall be cleaned and sanitized after each use in accordance with ARB SOP 21.

The SP shall wash and dry all cloth uniforms, scrub suits, towels, drapes, and other materials used by the SP or Project Officer in caring for animals at the Chamblee Facility. A washer and dryer, located in Room 1501, provided by the Government, shall be used to perform these tasks in accordance with ARB SOP 090.

The SP shall maintain a logbook of the following:

· Temperature Tape from rack washer and cage washer

· Microbial monitoring of cages and accessories

· Autoclave/Biological Indicator testing

· Water Quality Reports

· Chemical dilution checks

The SP’s Quality control procedures shall comply with ARB SOPs 56 - 61.

(e) Animal Health Surveillance, required clinical procedures and environmental enrichment Surveillance procedures shall be performed to ensure overall health and welfare of the animals. Animals shall be checked, at a minimum, twice daily, before 9:00 am every morning and after 2:30 pm each afternoon, including weekends. Surveillance shall be in accordance with ARB SOPs 31-33, and 38-40. Services required also include, but are not limited to:

i. 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 table

· Monitoring anesthesia (gas or injectable)

· Preparing and maintenance of gas anesthesia machine

· Scrubbing in to assist in surgery

· Observing animals until recovered

ii. Animal Health Monitoring and Surveillance

· Sample collection (serology, feces, urine, etc.)

· Notification request to pathologist of reorder needs

· Rotating of caging

· TB testing of NHP’s

iii. Assisting in necropsy or performing prosection and tissue collection to include:

· Recording identification of animal, sex, weight, age, date of necropsy, date of death

· Making observations of tissues for gross pathology

· Weighing all major organs

· Taking samples of all tissues and preserving in formalin

· Being prepared to remove the brain if requested

· Writing a brief description of observations

iv. Ensuring psychological enrichment according to ARB-SOP 75-84 and IACUC policies.

iv. Updating animal records on a daily basis

a. Maintain a logbook/database of the following

· Animal locations

· Animal births

· Animal deaths

· Daily Air Flow Checks

· Room Temperatures

· Abnormal Conditions Found

· Weekly Relative Humidity Checks

· Filter Changes

· Water Quality Reports

· Psychological Enrichment log

(f) Equipment Maintenance The SP shall maintain and perform minor repair of animal handling and care equipment to ensure effective and efficient management of the Facility (e.g. repair of broken cages, carts, bedding containers, racks, including periodic lubrication of casters; minor repairs on watering and flushing systems; replacing valves and broken sections of supply tubing). The SP is responsible for the care and maintenance of all ventilated caging system according to ARB SOP 087. The Government shall provide repair parts and supplies. The SP shall immediately notify the Project Officer when other 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 Engineering Services Office Dispatcher in accordance with ARB SOP 62.

The Government will be responsible for repair of the air handling system, animal room drainage, cage washer, bottle washer, and all laboratory equipment. The SP shall maintain a written record to document all repairs, including date(s), name(s), action(s) taken and problem(s) occurring.

(g) Maintenance of Supply Inventories To ensure a 1-3 month stock of supplies are available at all times, the SP shall order, receive and maintain an inventory of all supplies used in performance of the contract work. The SP shall also supply, when requested, up to 3 price quotes of requested items. The Government will procure all supplies and furnish the SP with a copy of each purchase order in accordance with ARB SOP16-17. Purchase orders will include item description(s), quantity, and vendor and delivery date.

C.4.5 Personnel

(a) The following positions have been designated as key and/or essential personnel at the Chamblee Facility:

Project Manager (Key Personnel)

Assistant Project Manager (Key Personnel)

Quality Assurance Technician (Key Personnel)

Lead Animal Care Technician (Key Personnel)

Animal Health Technicians (Essential Personnel)

Lead Cage Washing Attendant/Truck Driver (Essential Personnel)

The on-site Project Manager or, in his/her absence, the Assistant Project Manager shall have full authority to act for the SP in all matters relating to the daily operations of the Facility. The Project Manager/Assistant Project Manager shall provide competent on-site supervision to ensure that all functions of the contract are carried out in an efficient and professional manner and shall ensure that the policies and procedures specified are followed.

(a) The SP shall provide sufficient personnel to perform all the services required and within the time frames specified.

C.4.6 Description of the Ft. Collins Animal Care Operation The Ft. Collins Animal Care Facility (hereinafter called the Ft. Collins facility) is a Colorado based facility in support of the Division of Vector Borne Infectious Diseases. All animal care functions will be performed in accordance with CDC developed SOPs.

(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.

A variety of research investigations and other conventional uses of laboratory animals will be conducted in this Facility.

(c) Site Plan

· In the new Ft. Collins facility, 3 floors of the building with a total area of approximately 14,500sq. ft. will house the animal facility, the glassware operation, the clean insectary, the SPF breeding colony, and the animal holding area for the infected insectary.

C.4.7 Hours of Operation The standard hours of operation for SP 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, seven days a week. The SP shall base the staffing needs on the requirements of work as specified in the 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 .5 hours for lunch/break) for each SP employee. CDC core hours are 9-11 and 1-3:30. Each employee is expected to be onsite during core hours. The SP 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.

Occasionally, the SP shall be required to provide staffing for essential services performed during extended hours as requested by the Project Officer. Extended hours include hours beyond basic hours of operation (6:30 AM - 4:00 PM), Monday through Sunday, 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, assisting in emergency surgeries and treatments, feeding, watering, transporting animals, parameter checks and daily observations.

The Federal holidays are Columbus Day, Veterans Day, Thanksgiving Day, Christmas Day, New Year’s Day, Martin Luther King’s Day President’s Day, Memorial Day, Independence Day and Labor Day. In the event there is an inclement weather closure or a holiday announced other than those recognized Federal holidays, the SP shall provide services with sufficient staff to provide essential services.

The SP 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.4.8 Emergency Services The Manager or designee shall be available for emergencies occurring outside the basic hours of operation 6:30 AM - 4:00 PM, Monday through Sunday. The Manager or designee shall possess a cell phone. The Manager or designee shall be available by telephone within 15 minutes for any emergency which may arise in the animal care support area and if requested, respond in person, within one hour of the request.

After Hours Medical Care for Contract Animal Technicians

The animal technician SP is responsible for providing access to after-hours medical care. For Service Provider animal technicians or technicians who sustain traumatic injuries which also involves a known or suspected exposure to an infectious agent or for biological agent exposures which occur outside of CDC’s clinic hours, the SP’s employee will report to the local emergency room as designated by CDC. The designated emergency room will also be available to animal technicians who develop the signs or symptoms of a work-related infectious disease outside of CDC normal clinic hours. The SP shall ensure that the employee contacts his/her supervisor who will contact CDC. If an infectious agent exposure has occurred, the employee will first be referred to the designated emergency room and then to the SP’s medical provider for further treatment, if deemed necessary. If any medications for post-exposure prophylaxis are required, a prescription shall be provided to the employee by the designated emergency room personnel.

C.4.9 Specific Tasks

(a) Ordering, Receiving, Quarantine, and Housing Animals The Service Provider (SP) will order, receive, examine, weigh, quarantine and house incoming laboratory animals (e.g., mice, rats, guinea pigs, hamsters, rabbits, birds, and exotic species as required). The on-site Project Manager or designee will order animals for approved protocols, placing orders within 2 days of the PI’s request. The SP’s animal technicians will receive and visually inspect, within 10 minutes after receipt, the condition of each shipment (e.g., shipping boxes and animals) for signs of damage or other defects. Also at the time of receipt/acceptance, the animal technician receiving the shipment will verify the number and species of animals, comparing the shipping invoice to the original order. The animal technician will contemporaneously (or at least within 24 hours) record the receipt of the shipment in the appropriate receiving logbook, noting the following: purchase order number (if applicable), PI, species, sex, age, and number of animals received; origin of shipment or Vendor name, health status, and destination (facility, floor and/or room number). Vendor quality assurance reports for shipments of incoming animals will be reviewed upon receipt of the animals.

Incoming lab animals will be examined, most species will be weighed, and animals, by species, will be quarantined and housed in accordance with ARB SOP 22-25 and ARB SOP 28. Exotic animals will be removed from crates and weighed within 20 minute of receipt, and will not be kept in those crates for more than 1 hour after receipt. Rabbits will be removed from crates and weighed within 2 hours of receipt, and will not be kept in those crates for more than 3 hours after receipt. Rodents will be removed from crates by 3 PM of the day of receipt. However, if rodent shipments are received after 3 PM, water bottles may be placed on the shipping crates and the rodents may remain in the shipping crate until 9:00 AM the following day. Examination of animals shall include, but is not limited to general visual inspection of each animal for signs indicative of clinical illness. Animal body weights and visual observations of health status will be recorded in the appropriate individual animal record or logbook. Abnormal signs observed during the health check will be reported to the supervisor and to the Attending Veterinarian.

Incoming animals will be quarantined by SP animal technicians according the time period specified for that species in accordance with ARB SOP 22-25 and ARB SOP 28. Technicians will house animals in accordance with ARB SOP 23, 24, 26 and 51 as applicable. Each animal species will be identified, at the time of receipt, by the approved species-specified method in accordance with ARB SOP 48. Animals will remain in the quarantine room until they are released by the Attending Veterinarian. Rooms housing quarantine animals will be serviced last, after husbandry and other related duties are completed in other animal holding rooms.

The SP staff will ensure that all animals are appropriately identified during/prior to release from quarantine and during their housing in DVBID facilities.

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

(b) Animal Handling and Restraint

The SP’s contract animal care staff will be responsible for the daily handling and restraint of animals. Animal technicians will be trained and adequately supervised to ensure that they use accepted humane methods of manual restraint of animals in their care. Animal handling and restraint by SP’s contract personnel will be performed in accordance with ARB SOP's 15. When chemical restraint is used, all animals will be recovered according to ARB SOP 52, with animals being monitored every 15 minutes until they have achieved sternal recumbancy, and then every 30 minutes until completely awake.

(c) Feeding and Watering Animals The SP’s contract personnel will feed and water all laboratory animals housed in the facility, ensuring that each animal is fed according to species specific guidelines (e.g., in accordance with ARB SOP 35-36). Animal technicians will ensure each animal has access to clean fresh water at all times in accordance with ARB SOP 35-36. Animal technicians will present animal feed in feeders, troughs and/or in a manner that precludes fecal and /or urine contamination of feed, and will inspect feeders daily to assess: (1) feed consumption; (2) availability of clean feed; and, (3) feeders that need to be replaced/cleaned. Watering devices (e.g., bottles, lixits, buckets, troughs) will also be checked daily to assess: (1) water consumption, ensuring that water bottles are kept at least 1/2 full at all times; (2) availability of clean/potable water, e.g., lack of debris or other contamination; and, (3) waterers that need to be replaced/cleaned. Documentation of daily feed and water checks will be recorded on room husbandry logs by animal technicians and any abnormalities will be recorded on the log and reported to the supervisor (Lead Animal Technician). All twice daily inspections will be completed before 8:30 AM and after 2:30 PM each day (Monday through Friday, and at least once a day on weekends and holidays). Those inspections will also assess the presence of leaky water bottles and/or flooded cages, and if bedding is excessively wet or flooded, the animals will be transferred to a clean, dry cage, and a notation of the action will be made on the room husbandry log.

On a quarterly basis, the Project Manager or Lead Animal Technician will, using sampling bottles provided by the water testing laboratory, take and submit water samples for water quality testing in accordance with ARB SOP 58. Once water test results are obtained, the Project Manager or Lead Animal Technician will file the test report in the appropriate logbook.

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

Feed Presentation – When feeding animals in their care, Animal Technicians will ensure that the feed being offered is fresh, and that the feeders are clean and free of any gross contamination. They will inspect the feeders daily to assess individual or group feed consumption, and they will report any evidence of inappetence to the Lead Animal Technician or designee and/or the Attending Veterinarian.

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

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

(d) Cleaning/Sanitizing Animal Cages, Racks, Equipment, Rooms, Hallways and Service Areas

The SP’s contract personnel will clean and sanitize all caging, equipment, animal rooms and service areas in accordance with ARB SOPs 41, 44, 45-47. Cages, bedding, water bottles, and cage lids will be changed on a regular basis according to routine schedules for the species and type of housing involved. Waste pans for rabbits will be changed/sanitized at least 3X/week, or more often as needed should they be excessively soiled. Guinea pig and rabbit cages and racks will be changed/sanitized at least 1X/week, and more often as needed should they be excessively soiled. Rodent cages with contact bedding will be changed/sanitized at least 2X/week, and more often as needed should they be excessively soiled or wet. Other equipment will be sanitized weekly or biweekly depending on the species they are associated with.

All animal rooms and service areas will be cleaned daily and sanitized monthly in accordance with ARB SOPs 41, 44, 45-47. Floors will be swept clean, and countertops and shelves will be wiped down with a disinfectant solution. Bagged waste will be removed and disposed of appropriately. Rack shelves in rodent rooms will be swept clean of debris using a brush. If urine spills/splashes are observed on either the floor or walls in rabbit rooms, they will be washed down/cleaned with a disinfectant solution. Cleaning equipment (squeegees, brooms, dust pans brushes, etc) will be allocated to each room and will not be moved from room to room. Upon completion of cleaning or sanitizing the room, animal technicians will document the action(s) on the room husbandry log. Animal technicians will ensure that rooms, hallways, service and storage areas are kept clean and vermin free in accordance with ARB SOP 46.

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

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

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

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

(e) Cleaning/Sanitizing Transport Vehicles After each use, the cargo area of the transport truck will be cleaned and sanitized by SP staff in accordance with ARB SOP 21. The individual performing this task will, upon completion, document in the appropriate logbook that the task has been performed, and will ensure that the Project Manager or Lead Animal Technician also countersigns to entry for confirmation of completion of the task.

(f) Autoclave Operation and Preventative Maintenance The SP’s contract personnel will operate and maintain the appropriate autoclaves in accordance with ARB SOP 59. An autoclave usage logbook will be maintained for each individual autoclave in accordance with ARB SOP 59. Operation and maintenance activities will be contemporaneously recorded by the operator in the appropriate/corresponding logbook. The autoclave floor and screen will be cleaned daily to keep them free of gross debris in accordance with ARB SOP 59.

Animal technicians will use the autoclaves to decontaminate appropriate caging, equipment and waste in accordance with ARB SOP 44. They will ensure that all decontamination cycles were completed, and record required information in the corresponding autoclave logbook. On a monthly basis, the Lead Animal Technician, or designee, will perform a bacterial spore test in accordance with ARB SOP 59. Upon receipt of the test results (e.g., no growth or growth), the results will be entered into in the appropriate/corresponding logbook.

There are three major methods for assessing the adequacy of sterilization/disinfection: physical methods, chemical methods, and microbiological methods. The first two methods are used primarily for assessing effectiveness of sterilization procedures in autoclaves. Physical methods include time/temperature chart recorders or computer printouts, documenting that the appropriate temperature was achieved and for how long. However, this still does not address concerns for achievement of adequate temperatures within central packs. Chemical methods involve the use of autoclave tape and sterilometer strips, the former being on the outside of packs, and the later placed within the pack itself. In both cases, the physicochemical process resulting in color change of the strips merely indicates that the appropriate temperature was achieved, but gives no indication whether it was maintained for a sufficient period of time. The most accurate method is the microbiological method, using impregnated paper strips or capsules containing the spores of Bacillus stearothermophilus. Following processing, the strips or capsules are sent for culture and observation, with negative growth indicating successful sterilization. With mechanical washers, modern machines have built-in computer printouts of time and temperature, but previously expressed concerns for loading and organic contamination must be taken into account. Physicochemical strips and capsules which change color can be placed at various sites within the load to assess effectiveness. Use of spore capsules is also an effective method for assessing disinfection.

(g) Collection and Disposal of Hazardous Wastes and Chemicals The SP’s contract personnel will collect, contain, and dispose of wastes before 3:00 PM every day in accordance with ARB SOP 47. As noted in Section A.4.6 above, contract staff will use the autoclaves to decontaminate appropriate caging, equipment and waste in accordance with ARB SOP 44. They will document completion of the task in the autoclave usage logbook immediately at the end of each run in accordance with ARB SOP 59.

Animal carcasses and animal waste will be incinerated in accordance with EPA guidelines and in accordance with ARB SOP 45. Carcasses will be maintained in a –20 degree freezer until they can be incinerated. Each incinerator load will be documented in the incinerator logbook.

(h) Logbook Maintenance

The SP’s contract personnel will maintain appropriate logbooks for the animal rooms and service areas. At a minimum, the following logbooks will be maintained: room husbandry activities; filter changes; inventory of controlled drugs; necropsies performed; autoclave usage and effectiveness monitoring; equipment preventative maintenance and repair logs; animals received; and live births. Entries will be made contemporaneously using a pen, and any corrections required will be made according to GLP practices.

The daily (husbandry) room checklist will be maintained according to ARB SOP 31-35, and upon completion at the end of the month, will be placed in a 3-ring binder for storage in the Project Manager’s office. Each room’s daily (husbandry) room checklist will be checked daily by the Project Manager or Lead Animal Technician to ensure that required tasks have been completed and are appropriately documented.