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Animal Care and Research Laboratory Glassware Services - Atlanta
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Atlanta Area Animal Care Solicitation

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SOLICITATION, OFFER AND AWARDPAGES

1. THIS CONTRACT IS A RATED ORDER

UNDER DPAS (15 CFR 700)

RATING

PAGE OF
162

2. CONTRACT NO.

3. SOLICITATION NO.

2014-N-15769

4. TYPE OF SOLICITATION
SEALED BID (IFB)
XNEGOTIATED (RFP)
5. DATE ISSUED

12/6/2013

6. REQUISITION/PURCHASE NO.

000HCVLH-2014-63950

7. ISSUED BY
CODE
2543
8. ADDRESS OFFER TO (If other than Item 7)

Centers for Disease Control and Prevention (PGO) Procurement and Grants Office 2920 Brandywine Rd, RM 3000 Atlanta, GA 30341-5539

Gordon D. Barritt, Contracting Officer CDC, Procurement and Grants Office, MS E09, 2920 Brandywine Road, Atlanta GA 30341-5539 email ins4@cdc.gov

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 2 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 inuntil2:00plocal time01/15/2014(Date)

(Hour)

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)SEC.

PAGE(S)

PAGE(S)

SEC.

DESCRIPTION

(X)

DESCRIPTION

PART I – THE SCHEDULE
PART II – CONTRACT CLAUSES
X
A
SOLICITATION/CONTRACT FORM
1
X
I
CONTRACT CLAUSES
42
X
B
SUPPLIES OR SERVICES AND PRICES/COSTS
2
PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.
X
C
DESCRIPTION/SPECS./WORK STATEMENT
4
X
J
LIST OF ATTACHMENTS
46
X
D
PACKAGING AND MARKING
17
PART IV - REPRESENTATIONS AND INSTRUCTIONS

XK

E
INSPECTION AND ACCEPTANCE
19

REPRESENTATIONS, CERTIFICATIONS, AND

X
F
DELIVERIES OR PERFORMANCE
20
X
K
OTHER STATEMENTS OF OFFERORS
X
G
CONTRACT ADMINISTRATION DATA
23
X
L
INSTRS., CONDS., AND NOTICES TO OFFERORS
X
H
SPECIAL CONTRACT REQUIREMENTS
29
X
M
EVALUATION FACTORS FOR AWARD

OFFER (Must be fully completed by offeror)

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

12. In compliance with the above, the undersigned agrees, if this offer is accepted within calendar days (60 calendar days unless a differentCALENDAR DAYS

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 PAYMENT14. ACKNOWLEDGMENT OF AMENDMENTS
(The offeror acknowledges receipt of amend-
ments to the SOLICITATION for offerors and
related documents numbered and dated:
(See Section I, Clause No. 52-232-8)
10 CALENDAR DAYS
%
20 CALENDAR DAYS
%
30 CALENDAR DAYS
%
%
AMENDMENT NO.
DATE
AMENDMENT NO.
DATE
15A.NAME
AND
ADDRESS
OF
OFFEROR

(Type or Print)

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

15B. TELEPHONE NO.

AREA CODE NUMBER EXT.

15C. CHECK IF REMITTANCE ADDRESS
IS DIFFERENT FROM ABOVE - ENTER
SUCH ADDRESS IN SCHEDULE.
17. SIGNATURE

18. OFFER DATE

AWARD (To be completed by Government)

19. ACCEPTED AS TO ITEMS NUMBERED 20. AMOUNT

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

21. ACCOUNTING AND APPROPRIATION

10 U.S.C. 2304(c)( )41 U.S.C. 253(c)( )
23. SUBMIT INVOICES TO ADDRESS SHOWN IN
(4 copies unless otherwise specified)
ITEM
I
24. ADMINISTERED BY (If other than Item 7)
CODE
2543
25. PAYMENT WILL BE MADE BY
CODE
434

Centers for Disease Control and Prevention (PGO) Procurement and Grants Office 2920 Brandywine Rd, RM 3000 Atlanta, GA 30341-5539

Centers for Disease Control and Prevention (FMO) PO Box 15580 404-718-8100

Atlanta, GA 30333-0080

26. NAME OF CONTRACTING OFFICER (Type or print)

27. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

28. AWARD DATE

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

AUTHORIZED FOR LOCAL REPRODUCTIONSTANDARD FORM 33 (REV. 9-97)
PREVIOUS EDITION IS UNUSABLEPrescribed 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 descretion 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 Thursday, December 12, 2013. This event will include a tour of both the Lawrencevill 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 March 15, 2014. 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 March 15, 2019.

6. Key Dates

December 6, 2013Solicitation Published
December 9, 2013Site Visit Notification Due
December 12, 2013Site Visit
December 12, 2013Requests for SOPs Due from Non-site Visit Attendees
December 16, 2013Inquiries Due
December 19, 2013Anticipated Government Response to Inquiries
January 15, 2014Proposals Due
March 1, 2014Anticipated Award Date
March 15, 2014Contract Performance Begins

Section B - Supplies Or Services and Prices/Costs

ITEM
SUPPLIES / SERVICES
QTY / UNIT
UNIT PRICE
EXTENDED PRICE
0001
Base Year

This is to establish the Base year services for this contract.

Period of Performance: 4/15/2014 – 4/14/2015

000101
Roybal/Lawrenceville

Base year of the contract for animal husbandry and cage wash services for the Atlanta (Roybal) and the Lawrenceville campuses.

12 Months

000102
Labware/Laundry Services

This is the CLIN for the base year for the labware and laundry services for the Atlanta area CDC campuses

12 Months

000103
Autoclave

This CLIN is for the autoclave potion for the base year of the contract.

12 Months

Total Price Base Year

0002
Option Year 1

This is for option Year 1 of the contract Period of Performance: 4/15/2015 – 4/14/2016

000201
Roybal/Lawrenceville Animal Care Services

CLIN for option period 1

12 Months

000202
Labware/Laundry

This is the CLIN for labware laundry services on option year 1

12 Months

000203
Autoclave

This CLIN is for the Autoclave function under option year 1

12 Months

Total Price Option Year 1

0003
Option Year 2

This is for option Year 2 of the contract Period of Performance: 4/15/2016 – 4/14/2017

000301
Roybal/Lawrenceville Animal Care Services

CLIN for option Year 2

12 Months

000302
Labware/Laundry

This is the CLIN for labware laundry services on option year 2

12 Months

000303
Autoclave

This CLIN is for the Autoclave function under option year 2

12 Months

Total Price Option Year 2

ITEM
SUPPLIES / SERVICES
QTY / UNIT
UNIT PRICE
EXTENDED PRICE
0004
Option Year 3

This is for option year 3 of the contract Period of Performance: 4/15/2017 – 4/14/2018

000401
Roybal/Lawrenceville Animal Care Services

CLIN for option Year 3

12 Each

000402
Labware/Laundry

This is the CLIN for labware/laundry services on option year 3

12 Months

000403
Autoclave

This CLIN is for the Autoclave function under option year 3

12 Months

Total Price Option Year 3

0005
Option Year 4

This is for option year 4 of the contract Period of Performance: 4/15/2018 – 4/14/2019

000501
Roybal/Lawrenceville Animal Care Services

CLIN for option period 4

12 Months

000502
Labware/Laundry

This is the CLIN for labware laundry services on option year 4

12 Months

000503
Autoclave

This CLIN is for the Autoclave function under option year 4

12 Months

Total Price Option Year 4

Total Price Base Plus All Options

This is a Severable Services Contract. Services for each line item must be completed not later than 12 months after the beginning of the start of the performance period.

Section C - Description/Specification/Work Statement

PERFORMANCE WORK STATEMENT

Title of Project: Atlanta Area Animal Cares Services and Autoclave Operations

C.1 Background and Need

The Centers for Disease Control and Prevention (CDC) is one of the 13 major operating components of the Department of 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 9 centers, 1 institute, 12 offices and the Agency for Toxic Substances and Disease Registry. Approximately 15,000 personnel are employed at CDC.

Critical to the mission and organization of CDC is the National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), one of three National Centers that comprises the Office of Infectious Diseases (OID). NCEZID provides national leadership in the identification, investigation, diagnosis, prevention and control of infectious diseases. NCEZID conducts research in the definition, characterization, pathogenesis, and diagnosis of those infectious diseases that are considered to be public health priorities. NCEZID has developed expertise in detecting rare, exotic, or unusual diseases and is recognized for extensive capabilities in vector-borne diseases. NCEZID 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. NCEZID’s internationally-recognized researchers, physicians, veterinarians and others are engaged in research, training, and control activities that are both national and worldwide in scope.

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 Animal Resources Branch (ARB) 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 Scientific Products and Support Branch (SPSB) supports daily laboratory functions, develops, maintains and evaluates in-vitro diagnostic products, and supports emergency response and continuity of operation functions for CDC’s laboratories.

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 care and maintenance as set forth in Animal Resources Branch Standard Operating Procedures (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 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 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 sanitation and cleaning of the animal facilities, caging, and equipment. The animal care services also include technical assistance with blood collection (IP, IM, SQ & IV), inoculations (IP, IM, SQ & IV), and medical treatments as determined by the Attending Veterinarian.

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 provided at the site visit and as requested in Section J of this solicitation, and will be provided to the contractor upon award. 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 all Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) and the International Animal Care & Use Committee (IACUC) recommendations.

In addition, the Contractor shall provide laboratory waste management 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, labware, autoclave) Lawrenceville Campus, Atlanta, Georgia (animal care)

C.3.1 Site Plan

The 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, ABSL 3 enhanced, and ABSL 4) 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 (16,667 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 29,517 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.

C.3.2 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 three (3) main requirements for this DSR contract include:

1) Animal Care--------Section C.4.5
2) Lab Support--------Section C.4.6
3) Autoclave-----------Section C.4.7

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 Association for the Assessment and Accreditation of Laboratory Animal Care, International, Inc. (AAALAC).

C.4.1 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.

SPECIES
APPROXIMATE
TURNOVER (MONTHS)
Non-human primates, Aotus
119
60-120
Non-human primates, Cyno
32
60-120
Non-human primates, Pigtail
139
60-120
Non-human primates, Rhesus
150
60-120
Non-human primates, Squirrels
16
60-120
Guinea Pigs
30
Ferrets
256
3-24
Hamsters
400
3-12
Rabbits
65
3-12
Mice
5000
3-12
Rats
20
3-12
Gerbils
0
3-5
Prairie Dogs
300
60-100
Bats
200
10-20
Dogs
30
5-10
Goats
17
0
Calf
1
1
Fox
0
2-3
Raccoons
0
5-10

C.4.2 Description of Research

All CDC research involving animals is under the auspices of the Animal Resource 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.4.3 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 ARB SOP- 104 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 term 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.

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.

C.4.4 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, 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 Animal Recovery and Relocation Team (ARRT) members with planning for short-and long-term activities as related to the animals.

C.4.5 ANIMAL CARE – Roybal and Lawrenceville

C.4.5.1 Receipt of Incoming Laboratory Animals The Contractor shall receive, examine, quarantine, and cage all incoming laboratory animals in accordance with ARB SOP- 307 and HCL-402- 404. The Government will procure laboratory animals. The Contractor will receive a GRANITE 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 ARB SOP-307 and HCL 416. The Contractor will ensure adequate caging, spacing, equipment, and personnel are available.

C.4.5.2 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 new world 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. 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 ARB SOPs Series 400- 500 and HCL series 400- 500 series.

C.4.5.3 Feeding and Watering

The Contractor shall feed and water all animals housed in the Facility in accordance with ARB SOP 409, 410, 501-505 (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 daily during the AM and PM rounds, Monday-Sunday. The Contractor shall be responsible for the inventory management of feed and produce in accordance with ARB SOP- 303 and HCL SOP 412.

C.4.5.4 Cleaning/Sanitizing Animal Cages, Racks, Equipment, Rooms, Hallways, and Service 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 ARB SOPs 418 & 421 and HCL SOP 420. 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 Contractor 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- 1103, 1108, & 1108.1; and HCL SOP 1101.

The Contractor shall clean and sanitize all caging, equipment, animal rooms, and service areas in accordance with ARB SOPs 418, 501-505; HCL SOP 420; and L’ville SOP 506-509. 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. Other equipment will be sanitized weekly or biweekly depending on the species with which they are associated.

All animal rooms and service areas will be cleaned daily and sanitized monthly in accordance with ARB SOPs 418, 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.

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 ARB & L’ville SOP 1108 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, and ceilings in accordance with SOP ARB- 418.

C.4.5.5 Use, Cleaning, and Sanitizing Transport Vehicles (Roybal) Contractor shall supply air conditioned panel vans for the transport of animals, supplies, and equipment. The Contractor will use a separate vehicle for the transport of live animals. Animals will be transported on an as needed basis, while supplies and equipment may require daily trips between Roybal and Lawrenceville campuses. The cargo area of vehicles used to transport animals will be cleaned and sanitized by Contractor staff in accordance with ARB SOP-308 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.4.5.6 ARB Autoclave Operation and Preventative Maintenance The Contractor shall operate and maintain the appropriate autoclaves in animal facilities in accordance with ARB SOP 1106 and HCL SOP 910 & 911. The autoclave floor and screen will be cleaned daily to keep them free of debris in accordance with ARB SOP 905 and HCL SOP 910 & 911.

The Contractor will use the autoclaves to decontaminate appropriate caging, equipment, and waste in accordance with ARB SOP 901 and HCL SOP 910 & 911. On a monthly basis, the Contractor will perform a bacterial spore test in accordance with ARB SOP 1106 and HCL SOP 1106.

C.4.5.7 ARB 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 ARB SOP-901 and HCL SOP 902, 903, 912, & 913. The Contractor will use the autoclaves/incinerator to decontaminate appropriate caging, equipment, and waste in accordance with ARB SOP-901 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 ARB SOP-901 and HCL SOP 1106.

Animal carcasses and animal waste will be handled in accordance with EPA guidelines and in accordance with ARB SOP-901 & 906 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.

C.4.5.8 Logbook Maintenance

The Contractor shall maintain a logbook daily of the following:

Temperature Tape from rack washer and cage washer Microbial monitoring of cages 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 Production Count Log Live Births Filter changes

The Contractor’s Quality Control procedures shall comply with ARB SOPs 1103-1108.1.

C.4.5.9 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, excluding weekends and holidays. Surveillance, including sentinel surveillance, shall be in accordance with ARB SOP 411 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 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

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 pathologist or designee of sentinel replacement needs Rotation of caging

TB testing of Non-Human Primates (NHP) Documenting events Ensuring environmental enrichment of all animals according to all applicable ARB SOPs and IACUC policies

C.4.5.10 Equipment Maintenance

The Contractor 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 regular lubrication of casters; minor repairs on watering and flushing systems; and, replacing valves). The Government shall provide repair parts and supplies. The Contractor 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 Facilities Maintenance and Engineering Office (FMEO) in accordance with ARB SOP-105-905.

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.

C.4.5.11 Maintenance of Animal Care Supply Inventories

To ensure an appropriate stock level of animal care and supplies, the Contractor shall request, receive, and maintain an inventory of all supplies used in performance of the contract work. The Contractor will provide the program with item description(s) and quantity when supplies need restocking.

C.4.5.12 Cagewash Operation and Maintenance The Contractor shall clean cages and equipment, and operate the cage wash area in accordance with ARB SOP- 901-908 and HCL SOPs 901-914, ensuring that soiled cages and equipment are sanitized, disinfected, and washed.

C.4.6 LAB SUPPORT – (Roybal)

C.4.6.1 Glassware Wash, Inspection, and Sterilization Process

C.4.6.1.1 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).

C.4.6.1.2 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.4.6.1.3 The Contractor shall place items requiring pre-cleaning (soaking) in an alkaline solution according to # SOP 200C-007 before washing in mechanical glassware washer.

C.4.6.1.4 The Contractor shall perform Glassware Inspection Processes as outlined in SOP-200B-013.

C.4.6.1.5 The Contractor shall rewash glassware if a visual inspection reveals that the item is visibly dirty, clouded, cracked or stained.

C.4.6.1.6 The Contractor shall test glassware for residual soap in accordance with SOP-200C-008.

C.4.6.1.7 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-ARB-R-802.

C.4.6.1.8 The Contractor shall assemble items with CDC stock numbers in the "70000" series according to standard instructions provided by CDC laboratory staff.

C.4.6.2 Stockroom Operations

Laboratory supplies (disposable and reusable) are purchased and inventoried by DSR for distribution to OID 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; 2) placing new disposable and clean reusable supplies in designated locations inside stockroom and other storage sites; 3) keeping stockroom clean and secure; 4) filling orders received from OID laboratory staff through Scireson (DSR’s Electronic Ordering System); 5) verifying the accuracy of orders received; 6) pulling items from the inventory and packaging inside boxes; 7) labeling boxes containing orders; and 8) following up with requesters when orders are not picked up in a timely manner. In addition, Contractor shall distribute equipment or supplies to designated branch activities on the Roybal campus.

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.4.6.3 Facility Laundry Services Laundry services are required for laboratory staff that are required to wear cloth wearing apparel (laboratory coats, smocks, etc.) and use towels in accordance with # SOP 200B-009. Dirty laundry is picked up daily, or as required, from decontamination (autoclave) rooms. Clean lab coats will be picked up by laboratory staff from the stockroom. The Contractor shall wash, dry, fold, and hang garments used at Roybal, Chamblee, and Lawrenceville Facilities in accordance with # SOP 200B-009.

C.4.7 Autoclave Management and Decontamination Process (ROYBAL) Note: This is an optional task to be exercised at the sole discretion of the Government.

The Contractor shall decontaminate laboratory waste by autoclaving in accordance with the following SOPs: # SOP-OHS-0001 (replaces SOP-0HS (1), # SOPs-200A-024-00, 200-023-00, 200B-011, 200A-014, 200B-013, 200B-006-00 and 200GEN.010.

The services shall include:

C.4.7.1Autoclaving potentially infectious laboratory waste and reusable glassware throughout the Roybal campus (31 autoclaves, 2 – 3 cycles in each autoclave per day).

C.4.7.2Validating the efficiency of each autoclave cycle by certifying the appropriate cycle indicators (autoclave cycle time, temperature, and pressure) (31 autoclaves, 2 – 3 cycles in each autoclave per day).

C.4.7.3 Collecting and moving decontaminated laboratory waste from autoclave rooms throughout the Roybal campus to a central location on the Roybal Campus for processing (42 autoclave rooms).

C.4.7.4Assuring that autoclave records (autoclave printouts containing cycle time, temperature, and pressure information) are maintained for each autoclave cycle (84 autoclaves, 2 – 3 cycles per day) (53 of the 84 autoclaves are operated by CDC laboratory staff).

C.4.7.5Maintaining autoclave room facilities by supplying discard pans and lids (42 autoclave rooms).

C.4.7.6Keeping autoclave rooms clean and free of debris (42 autoclave rooms).

The Contractor shall prepare Biological Indicators (BI) (provided by the Government) according to #SOP 200B-005 and perform quality assurance checks on all autoclaves used to decontaminate laboratory waste as required by CDC’s Autoclave Monitoring Program (84 autoclaves).

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

C.5 REPORTING SCHEDULE

C.5.1 Required Plan/Reports

The Contractor shall submit the following reports to the COR. Detailed information on submission of reports is outlined in section F:

C.5.1.1 Occupational Safety Plan

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

C.5.1.2 Quality Control Plan

A draft Quality Control Plan shall be submitted as a part of the Contract proposal. An approved Quality Control Plan shall be finalized prior to commencing performance on the contract. This Plan is to be updated annually.

The Quality Control Plan shall include:

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

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

C.5.1.2.3 A description of the on-site records to be utilized to record Contractor’s inspections and other surveillance of the quantity and quality of the services being performed. 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.5.1.3 Monthly Progress Report

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

a.A narrative of the work accomplished during the reporting period;
b.A statement of current and potential problem areas and proposed corrective action;
c.A discussion of activities to be undertaken during the next reporting period;
d.A list of additional or replacement equipment needed.

C.6 SPECIAL CONSIDERATIONS

C.6.1 Exposure to Hazardous Materials and Waste

Work performed may involve exposure to dangerous and potential lethal hazardous materials, wastes, diseases, and biological agents. Additionally, the Contractor 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:

C.7.1.1HHS Publication No. (CDC) 21-1112 – Biosafety in Microbiological and Biomedical Laboratories, 5th edition (http://www.cdc.gov/biosafety/publications/bmbl5/index.htm)

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

C.7.1.2.1 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)

C.7.1.2.2 Complete physical examination including:

a. Vision and color perception testing (forms provided)

b. Baseline Audiogram

c. Pulmonary function test

d. Hepatitis C titer evaluation

C.7.1.2.3 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

C.7.1.2.4* Step skin Tuberculin test

C.7.1.2.5 Complete clinical laboratory tests including:

a. Complete blood count

b. Routine serum chemistry

c. Liver function test

d. Routine urinalysis

C.7.1.2.6 Respiratory fit test and training

C.7.1.3 Annually and at the contractor’s expense:

C.7.1.3.1 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

C.7.1.3.2 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

C.7.1.4 At appropriate intervals, Contractor employees may also be required to receive other vaccines depending on assignment:

a. Smallpox vaccine, if indicated (every 10 years)

b. Tetanus vaccine (required every 10 years)

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

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.

C.7.2.1 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 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.

C.7.2.2 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. Treatment by the CDC Occupational Health Clinics will be available between 8:00 am and 4:30 pm, Monday through Friday, excluding federal holidays. The CDC Occupational Health Clinics will assist with any medical documentation needed for Worker’s Compensation purposes as requested.

C.7.2.3 The Contractor is responsible for providing after hours medical care to its employees when needed. However, for Contractor employees who sustain injuries which also involve a known or suspected exposure to an infectious agent or for biological agent exposures which occur outside of CDC’s clinic hours, the Contractor’s employee may have access to the CDC Occupational Health Clinics’ physician on call at 404-639-4444. The physician on call will provide advice, guidance and referral as needed. The Contractor shall ensure that the employee contacts his/her supervisor who will help manage the care of the injury/illness in consultation with CDC’s supervisory or clinical staff as needed. If a specialist is needed, the CDC Occupational Health Clinics will be available to assist with these referrals. The Contractor is fully responsible for any costs related to the specialty services provided. The Contractor is fully responsible for the cost of any medications needed to provide prophylaxis or treatment of any Contractor worker for any illness or exposure.

C.7.2.4 The Contractor shall provide a copy of all occupational health records delineating the services provided above, both initially and on an ongoing basis, for each Contractor worker to the CDC Occupational Health Clinics. The Contractor will assist the CDC clinic in obtaining additional health records from the Contractor’s medical provider when the records are needed.

C.7.2.5 All costs associated with medical treatment subsequent to the initial diagnostic consultation/treatment provided by the CDC Occupational Health Clinics shall be the responsibility of the Contractor or Worker’s Compensation, whichever is applicable. The Government assumes no responsibility for costs associated with any other treatment provided after the initial visit/consultation conducted by the CDC Occupational Health Clinic.

C.8 Government Furnished Property-

C.8.1 The Government will provide the facilities, equipment, materials, supplies and services listed below for the Contractor’s use in performing the required services under the Contract.

a) Office/work space as needed for contract performance

b) IT equipment/access as needed for contract performance

c) Expendable safety items, such as rubber gloves, masks, disposable gowns, caps, and shoe covers.

d) Supplies and equipment necessary for the operation of the facilities, such as animal feed, cleaning agents, cages, bedding, laboratory supplies, and absorbents.

C.8.2 The Contractor shall supply the following:

a) Uniforms The Contractor shall provide uniforms for all personnel assigned to the CDC project pursuant to this contract. Uniforms shall be worn by the staff at all times while engaged in the performance of duties set forth in the contract. All Contractor personnel shall wear the same color and style of uniform. The color and style shall be different from the uniforms worn by the security guard force contract employees, staff of the CDC’s Engineering Services Office and contract employees assigned to the CDC Mail Facility. All personnel shall have a nametag and distinctive uniform patch present on the uniform that is lettered to indicate the identity of the Contractor. The Contractor shall launder uniforms using the washer and dryer provided by the Government inside the Facility. Employees shall wear clean coveralls over surgical scrub uniforms outside of the Facility.

Animal Care staff: surgical scrubs for inside and coverall, jackets/coats and raingear for outside wear are required.

Labware: steel toe shoes are required.

C.9 References

C.9.1 Animal Care and Laboratory Standard Operating Procedures will be distributed to potential offerors at the site visit on December 12, 2013. Potential Offerors not attending the site visit may request a copy of the Standard Operating Procedures by submitting a request to Gordon D. Barritt at gbarritt@cdc.gov by December 12, 2013.

C.9.2 Biosafety and Microbiological an Biomedical Laboratories, HHS Publication (CDC) 21-1112 can be accessed at: http://www.cdc.gov/od/ohs/biosfty/bmbl4/bmbl4toc.htm

Section D - Packaging And Marking

Contractor will comply with packaging/marking instructions found in applicable Standard Operating Procedures.

Section E - Inspection And Acceptance

The Contractor is responsible for quality assurance in accordance with the Government approved Contractor Quality Assurance Plan.

The Government will assess the effectiveness and compliance of the Contractor’s quality assurance in accordance with the Government’s Quality Assurance Surveillance Plan.

E.1 Inspection and Acceptance (Jul 1999)

Inspection and acceptance of the articles, services, and documentation called for herein shall be accomplished by the Contracting Officer, or his duly authorized representative (who for the purposes of this contract shall be the Project Officer) at the destination of the articles, services or documentation.

(End of Clause)

E.2 Inspections of Services 52.246-4 Inspection of Services—Fixed-Price.

As prescribed in 46.304, insert the following clause:

INSPECTION OF SERVICES—FIXED-PRICE (AUG 1996)

(a) Definition. “Services,” as used in this clause, includes services performed, workmanship, and material furnished or utilized in the performance of services.

(b) The Contractor shall provide and maintain an inspection system acceptable to the Government covering the services under this contract. Complete records of all inspection work performed by the Contractor shall be maintained and made available to the Government during contract performance and for as long afterwards as the contract requires.

(c) The Government has the right to inspect and test all services called for by the contract, to the extent practicable at all times and places during the term of the contract. The Government shall perform inspections and tests in a manner that will not unduly delay the work.

(d) If the Government performs inspections or tests on the premises of the Contractor or a subcontractor, the Contractor shall furnish, and shall require subcontractors to furnish, at no increase in contract price, all reasonable facilities and assistance for the safe and convenient performance of these duties.

(e) If any of the services do not conform with contract requirements, the Government may require the Contractor to perform the services again in conformity with contract requirements, at no increase in contract amount. When the defects in services cannot be corrected by reperformance, the Government may—

(1) Require the Contractor to take necessary action to ensure that future performance conforms to contract requirements; and

(2) Reduce the contract price to reflect the reduced value of the services performed.

(f) If the Contractor fails to…

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