12639520Q0106.pdf

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CODE 18a. PAYMENT WILL BE MADE BY

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FACILITYCODE

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER

OFFEROR

APHIS-MN-126395

MINNEAPOLIS MN 55401

SUITE410

250 MARQUETTE AVE

USDA APHIS

CODE 16. ADMINISTERED BYCODE

X

X

622110

SIZE STANDARD:

% FOR:SET ASIDE:UNRESTRICTED ORAPHIS-MN-126395

RFPIFB

10. THIS ACQUISITION ISCODE

RFQ

14. METHOD OF SOLICITATION

13b. RATING

NAICS:

SMALL BUSINESS

03/24/2020

612-336-3602KIM YEN TU

(No collect calls)

INFORMATION CALL:

FOR SOLICITATION 8. OFFER DUE DATE/LOCAL TIME

04/02/2020 1200 CT

b. TELEPHONE NUMBERa. NAME

4. ORDER NUMBER3. AWARD/ 6. SOLICITATION

12639520Q0106

5. SOLICITATION NUMBER

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS 1. REQUISITION NUMBER PAGE OF

1 1OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

TELEPHONE NO.

17a. CONTRACTOR/

15. DELIVER TO

MINNEAPOLIS MN 55401

SUITE410

250 MARQUETTE AVE

9. ISSUED BY

7.

2. CONTRACT NO.

EFFECTIVE DATE

$41.50

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW

ISSUE DATE

DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

11.

SEE SCHEDULEX

12. DISCOUNT TERMS

THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13a.

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

8(A)

USDA APHIS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

24.

AMOUNT

23.

UNIT PRICE

22.

UNIT

21.

QUANTITY

20.

SCHEDULE OF SUPPLIES/SERVICES

19.

ITEM NO.

Tax ID Number: Not Available DUNS Number: Not Available IDIQ contract for USDA Human Diagnostic and Laboratory Testing Services at National Centers for Animal Health (NCAH) and National Laboratory for Agriculture and the Environment (NLAE) at Ames, IA.

See Attachments for more details.

Period of Performance: 04/01/2020 to 03/31/2024

(Use Reverse and/or Attach Additional Sheets as Necessary)

HEREIN, IS ACCEPTED AS TO ITEMS:

DATED

PATRICIA M. SIMON

. YOUR OFFER ON SOLICITATION (BLOCK 5),

INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE SET FORTH

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DELIVER

ARE

ARE

31c. DATE SIGNED

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31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (Type or print)

ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY ADDITIONAL

SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED.

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

26. TOTAL AWARD AMOUNT (For Govt. Use Only)

OFFER

STANDARD FORM 1449 (REV. 2/2012)

Prescribed by GSA - FAR (48 CFR) 53.212

ARE NOT ATTACHED.

ARE NOT ATTACHED.

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

30b. NAME AND TITLE OF SIGNER (Type or print)

30a. SIGNATURE OF OFFEROR/CONTRACTOR

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

25. ACCOUNTING AND APPROPRIATION DATA

29. AWARD OF CONTRACT:

REF.

STATEMENT OF WORK

Task Title: USDA Human Diagnostic and Laboratory Testing Services

Synopsis: This is for the procurement of human diagnostic and laboratory services in support of worker health and safety at the National Centers for Animal Health and the National Laboratory for Agriculture and the Environment, both based in Ames, Iowa.

Contracting Officer: Kim Yen Tu 250 Marquette Ave, Suite 410 Minneapolis, MN 55401

USDA APHIS MRPBS

Phone: (612) 336-3602 Email: kimyen.n.tu@usda.gov

Contracting Officer Representative: Ricardo Franquiz-Rivera 1920 Dayton Avenue Ames, IA 50010

USDA APHIS VS DB CVB SSU

Phone: (515) 337-7257 Fax: (515) 337-7193 Email: ricardo.e.franquizrivera@usda.gov

Alternate Contracting Officer Representative: David White 1920 Dayton Avenue Ames, IA 50010

USDA APHIS VS DB CVB SSU

Phone: (515) 337-7971 Fax: (515) 337-7193 Email: david.m.white@usda.gov

Performance Period: Award Date through 5 years

Contents

1. INTRODUCTION

Organization

2. BACKGROUND

3. OBJECTIVE

4. SCOPE OF WORK

5. DESCRIPTION OF WORK

Laboratory and Personnel Requirements

Specimen Collection, Transport, Testing, Analysis, and Reporting

Rabies Rapid Fluorescent Focus Inhibition Testing (RFFIT)

Investigational New Drug (IND) Program

Serum Bank Program

6. DETAILS OF CONTRACT

Description of Agreement

Task Orders

Individuals authorized to place orders

Technical Points of Contact

Invoice Requirements

7. SECURITY REQUIREMENTS

Qualified and Properly Cleared Personnel

Contractor Key Personnel

Identification of Contractor Employees

Personnel Security Requirements

USDA Identification Badge

Disclosure of Sensitive or Proprietary Information

HIPPA, HITECH, and Privacy Act

Physical Security

Privacy Training

Records Management

8. PLACE OF PERFORMANCE

Schedule of Work

Travel

Supervision

9. GOVERNMENT FURNISHED EQUIPMENT, INFORMATION, MATERIALS AND SERVICES

10. OWNERSHIP

11. OTHER SPECIAL REQUIREMENTS

Quality Assurance

Quality Assurance Meetings

Facility Qualifications

Staff Qualifications

12. PRICE LIST - DIAGNOSTIC AND LABORATORY SERVICES

13. CLAUSES AND PROVISIONS

1. INTRODUCTION

Organization The main organization that will be managing this contract is the United States Department of Agriculture (USDA), Animal and Plant health Inspection Service (APHIS), for the National Animal Disease Center (NADC), the National Veterinary Services Laboratories (NVSL), and the Center for Veterinary Biologics (CVB), all located at the National Centers for Animal Health (NCAH) in Ames, Iowa.

National Centers for Animal Health (NCAH) 1920 Dayton Avenue Ames, Iowa 50010

National Laboratory for Agriculture and the Environment (NLAE) 1015 North University Boulevard Ames, IA 50011

Mission United States Department of Agriculture (USDA) The USDA provides leadership on food, agriculture, natural resources, and related issues based on sound public policy, the best available science, and efficient management.

Agricultural Research Services (ARS) The Agricultural Research Service (ARS) is the U.S. Department of Agriculture's chief scientific research agency. Their job is finding solutions to agricultural problems that affect Americans every day, from field to table. ARS conducts research to develop and transfer solutions to agricultural problems of high national priority and provide information access and dissemination to:

• ensure high-quality, safe food, and other agricultural products

• assess the nutritional needs of Americans

• sustain a competitive agricultural economy

• enhance the natural resource base and the environment, and

• provides economic opportunities for rural citizens, communities, and society as a whole

Animal and Plant Health Inspection Service (APHIS) The Animal and Plant Health Inspection Service (APHIS) is a multi-faceted agency with a broad mission area that includes protecting and promoting U.S. agricultural health, regulating genetically engineered organisms, administering the Animal Welfare Act and carrying out wildlife damage management activities. These efforts support the overall mission of APHIS, which is to protect and promote food, agriculture, natural resources and related issues.

National Centers for Animal Health (NCAH) The NCAH campus consolidated three USDA programs: the National Animal Disease Center (NADC), National Veterinary Services Laboratories (NVSL), and Center for Veterinary Biologics (CVB) into one facility located in Ames, Iowa. The Agricultural Research Service (ARS) conducts the NADC, while the Animal and Plant Health Inspection Service (APHIS) conducts the CVB and

NVSL.

National Animal Disease Center (NADC) The NADC conducts basic and applied research on selected diseases of economic importance to the U.S. livestock and poultry industries. The goals of the research mission are to produce knowledge and technology to:

• Reduce economic losses from infectious, genetic, and metabolic diseases to the livestock and poultry industries and the associated rural agricultural community

• Reduce or eliminate pre-harvest contamination or infection of livestock and poultry with food-borne human pathogens

• Prevent suffering and death caused by diseases in agriculturally important livestock and poultry

Center for Veterinary Biologics (CVB) The CVB implements the provisions of the Virus-Serum-Toxin Act of 1913 as amended to assure that pure, safe, potent and effective veterinary biologics are available for the diagnosis, prevention, and treatment of animal diseases. This mission mandates the use of sound scientific technology to:

• Ensure that biologics are free of disease producing agents, especially foreign animal diseases

• Develop appropriate standards and procedures for product release

• Issue licenses and permits

• Monitor and inspect products and facilities

• Control field tests and release of veterinary biologics

National Veterinary Services Laboratories (NVSL) The NVSL safeguard U.S. animal health and contribute to public health by ensuring that timely and accurate laboratory support is provided by their nationwide animal-health diagnostic system. NVSL staff accomplishes this through:

• Providing diagnostic services, reagents, and training in world-class facilities

• Responding to animal health emergencies

• Taking an active role in managing the National Animal Health Laboratory Network

(NAHLN)

• Serving as an international reference laboratory

• Maintaining a well-trained and responsive staff

National Laboratory for Agriculture and the Environment (NLAE) The National Laboratory for Agriculture and the Environment (NLAE) is multidisciplinary and focused on integrating the fundamental principles in soil, water, and air into animal, cropping and watershed systems that leads to improved environmental quality, sustainability, and enhanced agricultural system efficiency.

The mission of the lab is to generate information addressing critical problems in agriculture and watershed management to develop innovative solutions which increase the efficiency of agriculture systems and reduce environmental risk. Transdisciplinary teams address this through coordinated research in abiotic and biotic systems.

Combined Campus Services During the development of the NCAH organizational plan in 2009, it was agreed by the three entities that make up NCAH that several services could be combined to save money, time, and personnel resources. The specific service combine were:

• Administrative Unit

• Animal Resources Unit

• Facilities Engineering Unit

• Information Management Unit

• Laboratory Resources Unit

• Safety and Security Unit

Each unit was assigned under the directorate of one of the three NCAH programs. The Safety and Security Unit (SSU) is under the directorate of the APHIS CVB. SSU provides safety and security services on the NCAH campus.

2. BACKGROUND

The United States Department of Agriculture (USDA), National Centers for Animal Health (NCAH), Safety and Security Unit (SSU) provides biological, chemical, physical, radiological, and ergonomic safety and security services to almost 800 workers.

The Occupational Safety and Health Administration (OSHA), under the General Duty Clause, Section 5(a)(1) of the Occupational Safety and Health Act of 1970, requires employers to furnish to each worker employment free from recognized hazards that are causing or are likely to cause death or serious physical harm. The NCAH conducts an Occupational Medical Monitoring Program (OMMP), which provides the necessary framework to comply with the agencies’ obligation to maintain a safe workplace.

All employees and NCAH-associated personnel, including full-time and part-time workers, are encouraged to participate in the Occupational Medical Monitoring Program. The program services are provided at no cost to participants.

The Occupational Medical Monitoring Program (OMMP) is the systematic assessment of workers exposed or potentially exposed to occupational hazards. Workers are periodically assessed for evidence of unexpected exposures or overexposures, and the components and requirements of these assessments depend on the hazard. The specific components of medical monitoring will depend on the exposure effects of the hazardous agent being monitored and may include review of the worker’s medical history, review of systems, focused physical examination, laboratory studies, radiographic studies, and other specialized tests. Exposure to certain hazards are immediately disclosed by laboratory testing while others are only apparent by their effects.

The National Centers for Animal Health (NCAH) conducts a Serum Bank Program where entry and exit blood samples are obtained from certain USDA personnel and that such samples are used to determine pre-assignment serological levels as needed to establish an early and accurate diagnosis of disease(s) which constitute an occupational hazard to these workers.

In addition to medical monitoring and serum banking, the National Centers for Animal Health (NCAH) and the National Laboratory for Agriculture and the Environment (NLAE) also offers every Federal employee the opportunity to voluntarily participate in the Occupational Medical Monitoring Program.

The Wellness Screening Program consists of lab tests and test panels that measure overall health and general wellness for both men and women. These are common, routine tests ordered for health screening and offered annually at no cost to participants.

3. OBJECTIVE

The objective of this Statement of Work (SOW) is to obtain a services contract with a qualified Vendor for the provision of human diagnostic and laboratory services for the United States Department of Agriculture (USDA), National Animal Disease Center (NADC), National Veterinary Services Laboratories (NVSL), and Center for Veterinary Biologics (CVB) at the National Centers for Animal Health (NCAH) in Ames, Iowa.

4. SCOPE OF WORK

The Vendor shall provide human diagnostic and laboratory services as requested by the USDA for workers based in Ames, Iowa that are potentially exposed to hazardous agents in the course of their assigned duties or that want to complete routine laboratory testing as part of the voluntary wellness program.

The USDA estimates approximately 400-450 employees per fiscal year will require the services detailed under this Statement of Work.

5. DESCRIPTION OF WORK

The Vendor shall provide diagnostic and laboratory services to support the NCAH and NLAE at Ames, Iowa:

• Laboratory and Personnel Requirements

• Specimen Collection, Transport, Testing, Analysis, and Reporting

• Rabies Rapid Fluorescent Focus Inhibition Testing (RFFIT)

• Investigational New Drug (IND) Program

The USDA Contracting Officer (CO) is the point of contact for clarifying contract issues or changes. The USDA Contracting Officer’s Representative (COR), is the point-of-contact for the daily operations and administrative issues with this Statement of Work.

After award of the contract, the Vendor shall meet with the USDA Contracting Officer’s Representative (COR), to discuss timing, contacts, documentation, and other pertinent information. This kick-off meeting will take place either on-site or by teleconference at the discretion of the COR after award of the contract.

Laboratory and Personnel Requirements

• The Vendor shall have availability to perform diagnostic and laboratory services 7 days a week, 24 hours a day (see section 10.3 for facility requirements). The Vendor shall have an off-site diagnostic and laboratory testing facility available for USDA personnel to go and complete specimen collection and testing as indicated under Section 11 USDA personnel must be able to access the Vendor’s diagnostic and laboratory testing facility during all work shifts. The Vendor’s diagnostic and laboratory testing facility shall have and maintain Clinical Laboratory Improvement Act (CLIA) certification. The Vendor shall ensure compliance with all applicable safety and security regulations, and all laboratory operation requirements for handling of human samples and specimens.

• The Vendor employees shall possess the necessary qualifications and expertise for human specimen collection, testing, and analysis, and must adhere to strict procedures governing the collection, preservation, and transportation of human specimens to assure specimen stability and integrity. The Vendor shall adhere to 42 CFR 493.1242 (Medicare, Medicaid, and CLIA Programs; Laboratory Requirements Relating to Quality Systems and Certain Personnel Qualifications) standards.

• The Vendor shall adhere to Health Insurance Portability and Accountability Act (HIPAA), Health

Information Technology for Economic and Clinical Health (HITECH) Act, and Privacy Act of 1974 standards and requirements.

• The Vendor shall provide supervision of their personnel and perform all Vendor-related administrative functions. The USDA will not supervise the day-to-day activities of assigned Vendor personnel. The Vendor will provide total task management and supervision of contracting personnel. The Vendor shall communicate all task-related requests through the

USDA COR.

Specimen Collection, Transport, Testing, Analysis, and Reporting

• The Vendor shall coordinate the dates and times for specimen collection with the USDA COR throughout the course of the year. The Vendor shall not complete any service(s) stated under this Statement of Work unless provided with written authorization by the USDA COR. The Vendor shall accept verbal authorization to perform services only in cases where providing a written authorization is unfeasible or impractical, and the verbal authorization must be provided by the USDA COR or their designated representative.

• The Vendor shall have available personnel to provide on-site specimen collection services at the

NCAH for six (6) months each fiscal year, twice per month for three (3) hours each visit, at the address specified in Section 7. The Vendor shall have available personnel to provide on-site specimen collection services at the NLAE for one (1) three- (3) hour visit at the address specified in Section 7. The dates and times for these visits will be coordinated and scheduled during the post-award kick-off meeting between the Vendor and USDA COR or their designated representative. The USDA reserves the right to reschedule Vendor visits for any reason. The Vendor shall be responsible for providing all supplies and materials necessary to perform the requested services. The Vendor shall be responsible for providing the necessary means of transportation to and from the NCAH and NLAE to perform specimen collection as well as to transport samples to the laboratory in a manner that ensures specimen integrity.

• The Vendor shall perform the diagnostic and laboratory services listed in section 11 of this

Statement of Work. The USDA reserves the right to have all or some Government personnel from both NCAH and NLAE travel to the Vendor’s diagnostic and laboratory testing facility for specimen collection, testing, and analysis.

• The Vendor shall deliver test results and/or reports to the USDA COR via encrypted electronic mail or fax within 14 days of specimen collection.

• In certain identified instances, the USDA will request that the Vendor obtain blood samples from USDA personnel. The Vendor shall centrifuge these identified samples and store the serum in a temperature-monitored, medical-grade, commercial freezer. The USDA COR or their designated representative will acquire the sample on a biweekly basis on dates and times mutually agreed between the Vendor and the USDA during the post-award kick-off meeting. The Vendor shall not test these samples without the explicit written consent of the USDA COR or their designated representative. The USDA reserves the right to reschedule pick-up dates and/or times for any reason.

Rabies Rapid Fluorescent Focus Inhibition Testing (RFFIT) In certain identified instances, the USDA will request that the Vendor obtain specimen samples from USDA personnel to test for anti-rabies virus antibody levels using the Rapid Fluorescent Focus Inhibition Test (RFFIT) method. There are only two commercially available laboratories that conduct this test. In accordance with this Statement of Work, the Vendor shall collect and send these samples to the laboratory under contract with the USDA. Information about this laboratory, including name and address, will be provided by the USDA during the post-award kick-off meeting between the Vendor and the USDA COR or their designated representative.

Investigational New Drug (IND) Program In certain identified instances, the USDA will request that the Vendor obtain specimen samples from USDA personnel which have been administered an Investigational New Drug (IND) to test for antibody levels and/or other pertinent biological indicators. In accordance with this Statement of Work, the Vendor shall collect and send these samples to the laboratory under contract and/or in affiliation with the USDA. Pertinent information about this laboratory, including name and address, will be provided by the USDA during the post-award kick-off meeting between the Vendor and the USDA COR or their designated representative.

Serum Bank Program In certain identified instances, the USDA will request that the Vendor obtain blood samples from USDA personnel for inclusion into the Serum Bank Program. The sample obtained for this purpose will be centrifuged, transferred to a plastic transport tube, frozen, and delivered to the COR.

Specimen integrity must be maintained during the entire process. In accordance with this Statement of Work, the Vendor shall collect and send these samples to the COR on a periodic basis which will be determined and agreed upon during the post-award kick-off meeting between the Vendor and the USDA COR or their designated representative.

6. DETAILS OF CONTRACT

Description This is a single award, fixed price, Indefinite Delivery Indefinite Quantity (IDIQ) type contract. Period of performance is 4 years (base and 3 option years). The contractor shall provide Diagnostic and Laboratory Testing Services in accordance with the specifications.

This IDIQ consists of the following periods:

Base Period : 04/01/2020 – 03/31/2021 Option Period 1: 04/01/2021 – 03/31/2022 Option Period 2: 04/01/2022 – 03/31/2023 Option Period 3: 04/01/2023 – 03/31/2024 Option Period 4: 04/01/2024 – 03/31/2025

Task Orders

Delivery orders will be made 1-2 times annually. Orders will be issued via email. All sample collection will be coordinated with the Contracting Officer Representative and/or NCAH Occupational Health Clinic Nurse. The COR is responsible for tracking all coordination.

Individuals authorized to place orders Any USDA APHIS Contracting Officer may issue orders under this contract.

Technical Points of Contact The Contracting Officer is the point of contact for clarifying contract issues or changes. The COR is the point-of-contact for the daily operations and administrative issues with orders.

Contact information for the Contracting Officer, Contracting Officer Representative, and Alternate Contracting Officer Representative for this contract are listed in the cover sheet of this Statement of Work.

Invoice Requirements Invoices shall be submitted on a monthly basis. The vendor will submit invoices using the IPP.gov website. All invoices shall be submitted through the IPP.gov system with the appropriate details of service in the invoice. The Vendor shall be paid after meeting the performance standards of the deliverables. If the COR determines that the Vendor does not meet the performance standards, the COR is required to notify the Contracting Officer and the Vendor for resolution.

Additionally, the Vendor will submit a copy of the invoice submitted through IPP.gov system to the COR for review by sending an invoice hardcopy on a monthly basis on the first of each month to the following address:

ATTN: Occupational Health Nurse National Centers for Animal Health 1920 Dayton Avenue, Ames, IA 50010

The invoice submitted to the COR will contain a summary of charges and a separate list of individuals detailing the amount and description of services rendered. The Vendor will send invoices via secure fax and/or email upon request by the COR.

7. SECURITY REQUIREMENTS

Any information made available in any format shall be used only for carrying out the provisions of this agreement. Such information shall not be divulged or made known in any manner to any unauthorized person. The Vendor shall immediately notify the USDA CO and COR upon discovery of any inadvertent disclosures of information, including Personally Identifiable Information (PII) and Protected Health Information (PHI). All information arising from this task, both hard copy and electronic, shall be returned to the government at task conclusion.

Qualified and Properly Cleared Personnel

The Vendor shall provide only fully qualified and properly cleared personnel for the work to be performed under this task order. The Vendor will ensure compliance with all applicable security regulations, and all program security operations requirements for facility access and handling of materials (if necessary). Vendor personnel must show a valid, government-issued photo identification in order to gain access to USDA facilities. The Government reserves the right to deny, withhold, or terminate access for cause.

Contractor Key Personnel The contractor shall identify key personnel in the technical proposal regardless of the type of task.

NOTE: key personnel may not be removed from a task without the express approval of the COR.

The contractor shall provide a Project/Program Manager who shall be responsible for the performance of the work. The name of this person and an alternate who shall act for the contractor when the manager is absent shall be designated in writing to the contracting officer. The Project/Program Manager or alternate shall have full authority to act for the contractor on all contract matters relating to daily operation of this contract.

Identification of Contractor Employees All contract personnel attending meetings, answering Government telephones, and working in other situations where their contractor status is not obvious to third parties are required to identify themselves as such to avoid creating an impression in the minds of members of the public that they are Government officials. They must also ensure that all documents or reports produced by contractors are suitably marked as contractor products or that contractor participation is appropriately disclosed.

Personnel Security Requirements Vendor personnel shall comply with USDA Homeland Security Presidential Directive (HSPD-12), Policy for a Common Identification Standard for Federal Employees and Contractors, Federal Information Processing Standards Publication (FIPS PUB) 201, Personal Identity Verification (PIV) of Federal Employees and Contractors, and USDA security policy and procedures.

USDA Identification Badge Vendor employees completing on-site work under this Statement of Work must present a valid, government-issued photo identification (e.g., driver’s license, passport card or book) to gain site access. Vendor employees will then be provided with temporary visitor identification badges upon entry to the premises. USDA requires government-issued identification badges and display of them at all times while on the premises. The Vendor shall ensure that all Vendor employee USDA visitor identification badges are returned to the USDA immediately after completion of on-site services as the Vendor employee exits the premises. The Government will have and exercise full and complete control over granting or denying of visitor identification cards or other required security identification badges. It shall be the Vendor’s responsibility to account for all identification cards/badges issued to Vendor personnel. Final Vendor payment will be withheld until all identification cards and security identification badges as well as keys or other Government assigned items have been accounted for.

Disclosure of Sensitive or Proprietary Information

The Vendor shall not disclose sensitive or proprietary information of, or in the possession of, the USDA or any of its operating units, Vendors, or business partners to unauthorized persons. The Vendor will be subject to any penalties imposed by law for unlawful disclosure of Department information. Vendor employees will be required to sign Non-Disclosure Statements

HIPPA, HITECH, and Privacy Act Work on this Statement of Work may require that personnel have access to Privacy Information. The Vendor shall adhere to the Privacy Act, Title 5 of the U. S. Code, Section 552a – as amended and applicable agency rules and regulations. The Vendor shall ensure that all contract personnel take the required USDA Privacy training. The Vendor shall protect the privacy, security, and integrity of Personally Identifiable Information (PII) and Protected Health Information (PHI) from unauthorized access and shall comply with the Health Insurance Portability and Accountability Act of 1996 (HIPAA), Health Information Technology for Economic and Clinic Health Act of 2009 (HITECH), and Privacy Act of 1974 -- as amended. The Vendor shall not use or disclose PII/PHI, except as permitted by law and in accordance with the individual’s rights as required under the HIPAA regulations.

Physical Security Custody of sensitive information must be protected under The Privacy Act of 1974, 5 U.S.C. § 552a --as amended. The Contractor/Service Provider shall be responsible for safeguarding Personally Identifiable Information (PII) and Protected Health Information (PHI) data against unauthorized disclosure, dissemination or modification in accordance with the requirements, law and USDA PII policy and regulations. This shall include, but is not limited to: Privacy and PII data located in IT Systems, software, research data / information, personnel (institutional knowledge) and buildings/offices.

Privacy Training All Contractor employees under this contract are required to complete Privacy Training annually.

The contractor may provide its own training or use the training of another agency. Privacy training shall address the key elements necessary for ensuring the safeguarding of personally identifiable information or a system of records. The training shall be role-based, provide foundational as well as more advanced levels of training, and have measures in place to test the knowledge level of users.

At a minimum, the privacy training shall cover--

(1) The provisions of the Privacy Act of 1974 (5 U.S.C. 552a), including penalties for violations of the Act;

(2) The appropriate handling and safeguarding of personally identifiable information;

(3) The authorized and official use of a system of records or any other personally identifiable information;

(4) The restriction on the use of unauthorized equipment to create, collect, use, process, store, maintain, disseminate, disclose, dispose, or otherwise access personally identifiable information;

(5) The prohibition against the unauthorized use of a system of records or unauthorized disclosure, access, handling, or use of personally identifiable information; and

(6) Procedures to be followed in the event of a suspected or confirmed breach of a system of records or unauthorized disclosure, access, handling, or use of personally identifiable information (see Office of Management and Budget guidance for Preparing for and Responding to a Breach of Personally Identifiable Information).

Records Management

a. Contractor must adhere to 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228.

b. Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.

c. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records.

d. Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act.

e. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract.

f. The Government Agency owns the rights to all data/records produced as part of this contract.

g. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as 6 part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.

h. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974.

These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.].

i. No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules

8. PLACE OF PERFORMANCE

Where tasks do not require direct involvement of USDA personnel, work may be performed at the Vendor location. Performance of such tasks will be coordinated with the USDA COR. The Vendor shall furnish its employees with the equipment required to provide secure remote support, if needed.

If any work is performed on-site, the majority of work shall be performed at:

• National Centers for Animal Health (NCAH) 1920 Dayton Avenue Ames, IA 50010

• National Laboratory for Agriculture and the Environment (NLAE) 1015 North University Boulevard Ames, IA 50011

Schedule of Work The Vendor shall have availability to receive human specimens 7 days a week, 24 hours a day. If the Vendor is unable to immediately test the specimen(s) after receipt, the Vendor shall ensure specimen integrity and stability until such testing is possible. The Vendor at all times must maintain an adequate workforce for the uninterrupted performance of all tasks defined within this Statement of Work. When hiring personnel, the Vendor shall keep in mind that the stability and continuity of the USDA workforce are essential.

Travel All travel shall be identified and coordinated in advance with the USDA COR to ensure proper access controls are in place to prevent any delays in the performance of work. Travel costs should be included in proposal price item 37 – Onsite specimen collection.

Supervision The Vendor shall provide supervision of their personnel and perform all Vendor related administrative functions. USDA will not supervise the day-to-day activities of assigned Vendor personnel. The Vendor will provide total task management and supervision of contractor personnel.

The Vendor shall communicate all task-related requests through the USDA COR or their designated representative.

The Vendor will ensure compliance with all applicable safety and security regulations, and all program security operations requirements, for facility access and handling of materials. Vendor personnel must show a photo ID in order to gain access to USDA facilities. The Government reserves the right to deny, withhold, or terminate access for cause.

9. GOVERNMENT FURNISHED EQUIPMENT, INFORMATION, MATERIALS AND SERVICES

No Government Furnished Equipment is necessary for this contract.

The Government will make meeting, consultation, or specimen collection rooms available when required. The Vendor shall specify in the response to this Statement of Work any other requirements needed to perform successfully on this task. Unless otherwise agreed by the parties, Government-furnished resources will be provided only during normal business hours at the designated work sites.

The Vendor shall be expected to provide all requisite hardware and software necessary to perform all tasks.

10. OWNERSHIP

The Vendor shall not divulge any data obtained through the execution of this contract to any third parties without explicit written consent from the USDA Contracting Officer or COR. The Vendor shall not have ownership, nor use and/or test any specimens acquired from USDA personnel without explicit authorization by the USDA COR or their designated representative

11. OTHER SPECIAL REQUIREMENTS

Quality Assurance The Vendor shall be solely responsible for the supervision, management, and inspection of its employees under this Statement of Work. The Vendor will monitor and ensure its employees meet the requirements of this Statement of Work. The Vendor shall provide and maintain an inspection system acceptable to the Government covering services provided under this Statement of Work.

Task quality level will be assessed by the USDA COR or their designated representative. The Government will periodically evaluate the Vendor performance in accordance with the performance goals and objectives of this Statement of Work.

Government surveillance of tasks not listed or by methods other than those listed may occur during the performance period of the contract. Such surveillance will be accomplished according to standard inspection procedures or the applicable provisions of the task order. Any action taken by the USDA Contracting Officer as a result of surveillance will be in accordance with the terms of the task order.

General measures of quality for each contract line item performance will meet the following:

• On-time delivery of the CLIN as mutually agreed upon in the project plan and schedules

• Customer satisfaction

• Innovative approaches to problem solving

Quality Assurance Meetings The USDA CO/COR may require the Vendor program or project manager to meet with USDA officials, and other government personnel as necessary. The Vendor may request a meeting with the USDA CO/COR or their designated representative whenever the Vendor’s technical or administrative personnel believe such a meeting is necessary. The Vendor shall prepare and provide written minutes of any such meetings to the USDA CO/COR or their designated representative for signature by the USDA CO/COR. If the USDA CO/COR or their designated representative does not concur with any portion of the minutes, notice of such non-concurrence will be provided to the Vendor program or project manager and task orders representative within five business working calendar days following receipt of the minutes. The Vendor shall acknowledge or resolve all disputes and resubmit the minutes to the USDA CO/COR within five (5) business days of receipt of the USDA non-concurrence.

Facility Qualifications The Vendor shall have an off-site location within 20 miles of the addresses listed in Section 7 for NCAH personnel to visit and complete laboratory services in a timely manner. The Vendor’s diagnostic and laboratory testing facility shall acquire and maintain Clinical Laboratory Improvement Act (CLIA) certification.

Staff Qualifications

Experienced staff with specialized education and training is required to meet the established performance period. The Vendor shall ensure and certify that their staff satisfies all of the professional and ethical requirements of diagnostic and laboratory workers in the United States, as well as the following:

a) Must be proficient in written and spoken English.

b) Must complete CLIA competency- and performance-based training with periodic up-to-date training in accordance with current CLIA standards.

c) Must possess at least 6 months of specialized experience directly related to competently completing laboratory support work, performing laboratory testing, and preparing laboratory report of findings.

d) Must submit qualifications for approval by the Government.

12. PRICE LIST - DIAGNOSTIC AND LABORATORY SERVICES

Pricing for the various diagnostic and lab services shall include phlebotomy Services. Quantities are estimates only and are not guaranteed.

CLIN Services Annual Estimated Quantities

$/ Sample Base Yr

$/Sample Option Yr 1

$ /Sample Option Yr 2

$ /Sample Option Yr 3

$ /Sample Option Yr 4

Acetylcholinesterase, Erythrocytes, Blood

Brucella Antibody Screen, IgG and IgM, Serum

Brucella Total Antibody Confirmation, Agglutination, Serum

Complete Blood Count (CBC) w/o Differential, Blood

• Red Blood Cell (RBC) Count

• Hemoglobin

• Hematocrit

• Mean Corpuscular

Volume (MCV)

• Mean Corpuscular

Hemoglobin (MCH)

• Mean Corpuscular

Hemoglobin Concentration (MCHC)

• Red Cell Distribution Width (RDW)

• White Blood Cell (WBC) Count

• Platelet Count

Complete Blood Count (CBC) w/ Differential, Blood

• Red Blood Cell (RBC) Count

• Hemoglobin

• Hematocrit

• Mean Corpuscular Volume (MCV)

• Mean Corpuscular Hemoglobin (MCH)

• Mean Corpuscular Hemoglobin Concentration (MCHC)

• Red Cell Distribution Width (RDW)

• White Blood Cell (WBC) Count

• WBC Absolute and Percentage Differential Counts

• Platelet Count

Chlamydia psittaci Antibody Screen, IgG and IgM, Serum

Comprehensive Metabolic Panel, Serum

• Glucose

• Calcium

• Sodium

• Potassium

• Chloride

• Bicarbonate

• Anion Gap

• Blood Urea Nitrogen

(BUN)

• Creatinine

• Estimated Glomerular

Filtration Rate (eGFR)

• Total Protein

• Albumin

• Aspartate

Aminotransferase (AST)

• Alanine

Aminotransferase (ALT)

• Alkaline Phosphatase

(ALP)

• Total Bilirubin

8 Creatine Kinase (CK), Serum 20

Eastern Equine Encephalitis Antibody, IgG and IgM, Serum

Francisella Tularensis Antibody, Hepatic Function Panel, Serum

• Total Bilirubin

• Direct Bilirubin

• Aspartate

Aminotransferase (AST)

• Alanine

Aminotransferase (ALT)

• Alkaline Phosphatase

(ALP)

• Albumin

• Total Protein

Hepatitis B Core Total Antibodies, Hepatitis B Surface Antibody, Quantitative, Serum

Hepatitis B Surface Antigen, Hepatitis C Antibody Screen, Hepatitis C Virus (HCV) RNA Detection and Quantification by Real-Time Reverse Transcription- PCR (RT-PCR), Serum

HIV-1/2 Antigen and Antibody Screen (4th Generation) w/ P24 Antigen Screen

HIV-1/2 Rapid Antibody Screening

Investigational New Drug (Sample Processing) See section 5.4

20 Leptospira, IgM, Serum 70

Lipid Panel, Serum

• Total Cholesterol

• Triglycerides

• High-Density Lipoprotein

(HDL) Cholesterol

• Low-Density Lipoprotein

(LDL) Cholesterol

• Very Low-Density

Lipoprotein (VLDL) Cholesterol

• Non-HDL Cholesterol

Prostate-Specific Antigen (PSA) Screen, Serum

Prothrombin Time (PT/INR), Plasma

Pseudocholinesterase, Total, Q Fever Antibody, IgG and IgM, QuantiFERON-TB Gold Plus, Blood

Renal Function Panel, Serum

• Glucose

• Calcium

• Sodium

• Potassium

• Chloride

• Bicarbonate

• Anion Gap

• Blood Urea Nitrogen

(BUN)

• Creatinine

• Estimated Glomerular

Filtration Rate (eGFR)

• Albumin

• Phosphorus

Rabies Rapid Fluorescent Focus Inhibition Test (Sample Processing) See section 5.3

Serum Banking (Sample Processing) See section 5.5

Thyroid-Stimulating Hormone (TSH), Serum

Urinalysis w/o Microscopy, Urine

• Color

• Appearance

• Specific Gravity

• pH

• Bilirubin

• Urobilinogen

• Protein

• Glucose

• Ketones

• Occult Blood

• Leukocyte Esterase

• Nitrite

Urinalysis w/ Microscopy, Urine

• Color

• Appearance

• Specific Gravity

• pH

• Bilirubin

• Urobilinogen

• Protein

• Glucose

• Ketones

• Occult Blood

• Leukocyte Esterase

• Nitrite

• Red Blood Cells (RBC)

• White Blood Cells (WBC)

• Epithelial Cells

• Bacteria, Yeast, Parasites

• Casts

• Crystals

Wellness Profile

• Complete Blood Count w/o Differential

• Comprehensive Metabolic Panel

• Urinalysis w/o Microscopy

• Lipid Panel

• Thyroid Stimulating

Hormone

West Nile Virus Antibody, IgG and IgM, Serum

Western Equine Encephalitis Antibody, IgG and IgM, Serum

36 Miscellaneous Test (as needed) 2

Unit $/per visit

Onsite specimen collection services at the NCAH and NLAE (see section 5.2)

• Fixed-price per onsite collection.

13 onsite collections

13. CLAUSES AND PROVISIONS

52.252-2 Clauses Incorporated by Reference (Feb 1998) This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es): http://farsite.hill.af.mil 52.204-21 Basic safeguarding of covered CIS 52.204-13, System for Award Management Maintenance (OCT 2018) 52.204-18 Commercial and Government Entity Code Maintenance (Jul 2016) 52.212-4 Contract Terms and Conditions -- Commercial Items (Oct 2018) 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (Dec 2013)

52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders -- Commercial Items (Jan 2020)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(2) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L. 115-91).

(3) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (Aug 2019) (Section 889(a)(1)(A) of Pub. L. 115-232).

(4) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015).

(5) 52.233-3, Protest After Award (Aug 1996) (31 U.S.C. 3553).

(6) 52.233-4, Applicable Law for Breach of Contract Claim (Oct 2004) (Public Laws 108-77 and 108- 78 (19 U.S.C. 3805 note)).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

[Contracting Officer check as appropriate.] _X_ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate I (Oct 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402).

__ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Oct 2015) (41 U.S.C. 3509)).

__ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (June 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)

_X_ (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2018) (Pub. L. 109-282) (31 U.S.C. 6101 note).

__ (5)[Reserved].

__ (6) 52.204-14, Service Contract Reporting Requirements (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

__ (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

_X_ (8) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Oct 2015) (31 U.S.C. 6101 note).

__ (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Oct 2018) (41 U.S.C. 2313).

__ (10)[Reserved].

__ (11) (i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Nov 2011) (15 U.S.C.657a).

__ (ii) Alternate I (Nov 2011) of 52.219-3.

__ (12) (i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Oct 2014) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

__ (ii) Alternate I (Jan 2011) of 52.219-4.

__ (13)[Reserved] __ (14) (i) 52.219-6, Notice of Total Small Business Set-Aside (Nov 2011) (15 U.S.C.644).

__ (ii) Alternate I (Nov 2011).

__ (iii) Alternate II (Nov 2011).

__ (15) (i) 52.219-7, Notice of Partial Small Business Set-Aside (June 2003) (15 U.S.C. 644).

__ (ii) Alternate I (Oct 1995) of 52.219-7.

__ (iii) Alternate II (Mar 2004) of 52.219-7.

_X_ (16) 52.219-8, Utilization of Small Business Concerns (Oct 2018) (15 U.S.C. 637(d)(2) and (3)).

__ (17) (i) 52.219-9, Small Business Subcontracting Plan (Aug 2018) (15 U.S.C. 637(d)(4)) __ (ii) Alternate I (Nov 2016) of 52.219-9.

__ (iii) Alternate II (Nov 2016) of 52.219-9.

__ (iv) Alternate III (Nov 2016) of 52.219-9.

__ (v) Alternate IV (Aug 2018) of 52.219-9 __ (18) 52.219-13, Notice of Set-Aside of Orders (Nov 2011) (15 U.S.C. 644(r)).

__ (19) 52.219-14, Limitations on Subcontracting (Jan 2017) (15 U.S.C.637(a)(14)).

__ (20) 52.219-16, Liquidated Damages-Subcontracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)).

__ (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Oct 2019) (15 U.S.C. 657f).

_X_ (22) 52.219-28, Post Award Small Business Program Rerepresentation (Jul 2013) (15 U.S.C.

632(a)(2)).

__ (23) 52.219-29, Notice of Set-Aside for, or Sole Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (Dec 2015) (15 U.S.C. 637(m)).

__ (24) 52.219-30, Notice of Set-Aside for, or Sole Source Award to, Women-Owned Small Business Concerns Eligible Under the Women-Owned Small Business Program (Dec 2015) (15 U.S.C.

637(m)).

_X_ (25) 52.222-3, Convict Labor (June 2003) (E.O.11755).

_X_ (26) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Jan 2020) (E.O.13126).

_X_ (27) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

_X_ (28) (i) 52.222-26, Equal Opportunity (Sept 2016) (E.O.11246).

__ (ii) Alternate I (Feb 1999) of 52.222-26.

_X_ (29) (i) 52.222-35, Equal Opportunity for Veterans (Oct 2015) (38 U.S.C. 4212).

__…