Attachment 2 - Statement of Work (SOW).pdf

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 in Ames, Iowa.

Contracting Officer: Stephen Tees 250 Marquette Ave, Suite 410 Minneapolis, MN 55401

USDA APHIS MRPBS AAMD

Email: stephen.tees@usda.gov

Contracting Officer Representative: (Redacted; information is provided at time of award)

Performance Period: IDIQ with five ordering periods

Contents

1. INTRODUCTION

Organization

Mission

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

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. DIAGNOSTIC AND LABORATORY SERVICES REQUIRED

1. INTRODUCTION

Organization The 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

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.

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

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 combined 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 approximately 600 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) 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 to participants.

3. OBJECTIVE

The objective of this Statement of Work (SOW) is to obtain a services contract with a qualified provider 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 Contractor shall provide human diagnostic and laboratory services as requested by the USDA for workers based in Ames, Iowa as part of the Occupational Medical Monitoring Program and routine laboratory testing as part of the voluntary wellness screening program.

The USDA estimates approximately 250-350 employees per fiscal year will require the services detailed under this Statement of Work.

5. DESCRIPTION OF WORK

The Contractor must provide diagnostic and laboratory services to support the NCAH 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), or their designated representative, is the point-of-contact for the daily operations and administrative issues with this Statement of Work.

After award of the contract, the Contractor 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 Contractor must have availability to perform diagnostic and laboratory services 7 days a week, 24 hours a day. The Contractor must have an off-site diagnostic and laboratory testing facility available for USDA personnel to go and complete specimen collection and testing.

USDA personnel must be able to access the Contractor’s specimen collection facility during all work shifts. The Contractor’s diagnostic and laboratory testing facility must have and maintain Clinical Laboratory Improvement Act (CLIA) certification. The Contractor must ensure compliance with all applicable safety and security regulations, and all laboratory operation requirements for handling of human samples and specimens. A copy of the current CLIA certification must be provided to the Contracting Officers Representative (COR).

The Contractor employees must 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 Contractor shall adhere to 42 CFR 493.1242 (Medicare, Medicaid, and CLIA Programs; Laboratory Requirements Relating to Quality Systems and Certain Personnel Qualifications) standards.

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

Specimen Collection, Transport, Testing, Analysis, and Reporting

The Contractor shall coordinate the dates and times for specimen collection with the USDA COR throughout the course of the year. The Contractor shall not complete any service(s) stated under this Statement of Work unless authorized by a delivery order and with written authorization provided by the USDA COR. The Contractor 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.

The Contractor must have available personnel to provide on-site specimen collection services at the NCAH for five (5) months each contract period of performance, twice per month for three

(3) hours each visit. The dates and times for these visits will be coordinated and scheduled during the post-award kick-off meeting between the Contractor and USDA COR. The USDA reserves the right to reschedule Contractor visits for any reason. The Contractor must be responsible for providing all supplies and materials necessary to perform the requested services. The Contractor is responsible for providing the necessary means of transportation to and from the NCAH to perform specimen collection as well as to transport samples to the laboratory in a manner that ensures specimen integrity.

The Contractor must perform the diagnostic and laboratory services listed in this Statement of Work. The USDA reserves the right to have all or some Government personnel from the NCAH travel to the Contractor’s diagnostic and laboratory testing facility for specimen collection, testing, and analysis.

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

The USDA will periodically require that the Contractor obtain blood samples from USDA personnel. The Contractor must centrifuge these identified samples and store the serum in a temperature-monitored, medical-grade, commercial freezer until transfer to the USDA. The USDA COR will schedule the sample transfer on a monthly basis at dates and times mutually agreed between the Contractor and the USDA COR during the post-award kick-off meeting. The Contractor must not test these samples without the explicit written consent of the USDA COR.

The USDA reserves the right to reschedule pick-up dates and/or times for any reason.

Rabies Rapid Fluorescent Focus Inhibition Testing (RFFIT)

The USDA will require that the Contractor obtain specimen samples from USDA personnel to test for anti-rabies virus antibody levels using the Rapid Fluorescent Focus Inhibition Test (RFFIT) method.

Investigational New Drug (IND) Program In certain identified instances, the USDA will request that the Contractor 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 Contractor must 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 Contractor and the USDA COR.

Serum Bank Program The USDA will require that the Contractor obtain blood samples from USDA personnel for inclusion into the NCAH Serum Bank Program. The sample obtained for this purpose will be centrifuged, transferred to a plastic transport tube and frozen. Specimen integrity must be maintained during the entire process. In accordance with this Statement of Work, the Contractor must collect and coordinate transportation of 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 Contractor and the USDA

COR.

6. DETAILS OF CONTRACT

Orders It is anticipated delivery orders will be issued 1-2 times annually. Orders will be issued via email. All sample collection will be coordinated with the Contracting Officer Representative (COR). The COR is responsible for tracking all coordination.

Individuals authorized to place orders USDA APHIS Contracting Officers may place orders up to their warrant and within the limits of the contract Min/Max as established in the contract clauses.

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

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

Additionally, the Contractor must email a copy of the invoice submitted through IPP.gov system to the COR for review on a monthly basis before the seventh (7th) day of each month to the following email address:

(Redacted; information is provided at time of award)

The invoice submitted to the COR must contain a summary of charges and a separate list of the USDA personnel detailing the amount and description of services rendered. The Contractor must send invoices via 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 must not be divulged or made known in any manner to any unauthorized person. The Contractor must 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, must be returned to the government at task conclusion.

Qualified and Properly Cleared Personnel

The Contractor must provide only fully qualified and properly cleared personnel for the work to be performed under this contract. The Contractor must ensure compliance with all applicable security regulations, and all program security operations requirements for facility access and handling of materials (if necessary). Contractor 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 to USDA facilities.

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

NOTE: key personnel may not be removed from a task without prior notification to the COR.

At a minimum, 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 Contractor 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

Contractor personnel 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. Contractor 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 Contractor must ensure that all contractor personnel issued USDA visitor identification badges are returned to the USDA immediately after completion of on-site services as the contractor personnel 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 Contractor’s responsibility to account for all identification cards/badges issued to contractor personnel. Final Contractor payment may 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 Contractor must not disclose sensitive or proprietary information of, or in the possession of, the USDA or any of its operating units, Contractors, or business partners to unauthorized persons. The Contractor will be subject to any penalties imposed by law for unlawful disclosure of Department information. Contractor 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 Contractor must adhere to the Privacy Act, Title 5 of the U. S. Code, Section 552a – as amended and applicable agency rules and regulations. The Contractor must ensure that all contract personnel take the required USDA Privacy training. The Contractor must 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 Contractor 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 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 must address the key elements necessary for ensuring the safeguarding of personally identifiable information or a system of records. The training must 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 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

Contractor’s location. Performance of such tasks will be coordinated with the USDA COR. The Contractor must furnish its employees with the equipment required to provide secure remote support, if needed.

When work is performed on-site, work shall be performed at:

1920 Dayton Avenue Ames, IA 50010

Schedule of Work

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

Travel All travel must 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 and administrative costs must be included in the item quote prices.

Supervision

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

The Contractor must ensure compliance with all applicable safety and security regulations, and all program security operations requirements, for facility access and handling of materials. Contractor 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 to USDA facilities for cause.

9. GOVERNMENT FURNISHED EQUIPMENT, INFORMATION, MATERIALS AND SERVICES

The Government will make meeting, consultation, or specimen collection rooms available when required. The Contractor 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 may be provided only during normal business hours at the designated work sites. The Contractor must provide all requisite hardware and software necessary to perform all tasks.

No other Government furnished equipment or materials will be provided.

10. OWNERSHIP

The Contractor 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 Contractor shall not have ownership, nor use and/or test any specimens acquired from USDA personnel without explicit authorization by the USDA COR.

11. OTHER SPECIAL REQUIREMENTS

Quality Assurance The Contractor is solely responsible for the supervision, management, and inspection of its employees under this Statement of Work. The Contractor will monitor and ensure its employees meet the requirements of this Statement of Work. The Contractor must 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. The Government will periodically evaluate the

Contractor 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 specimen collection and testing 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 Contractor program or project manager to meet with USDA officials, and other government personnel as necessary. The Contractor may request a meeting with the USDA CO/COR whenever the Contractor’s technical or administrative personnel believe such a meeting is necessary. The Contractor must prepare and provide written minutes of any such meetings to the USDA CO/COR 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 Contractor program or project manager and task orders representative within five (5) business working calendar days following receipt of the minutes. The Contractor must 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 Contractor must have an off-site location within 20 miles of the NCAH address listed in this statement of work for NCAH personnel to visit and complete laboratory services in a timely manner.

The Contractor’s diagnostic and laboratory testing facility must acquire and maintain Clinical Laboratory Improvement Act (CLIA) certification. A current copy of the CLIA certification must be provided to the COR.

Staff Qualifications

Experienced staff with specialized education and training is required to meet the established performance standards. The Contractor must ensure and certify that their staff satisfies all of the professional and ethical requirements of diagnostic and laboratory workers in the United States, as required for CLIA certification.

12. DIAGNOSTIC AND LABORATORY SERVICES REQUIRED

Pricing for the various diagnostic and lab services must include phlebotomy Services.

Quantities are estimates only and are not guaranteed. Supplies and services will be ordered through the issuance of individual Delivery Orders as the requirements of the U.S. Department of Agriculture (USDA) are defined. The quantities listed are not intended to convey a minimum or maximum quantity that will be ordered by the Government.

Item Service Estimated Quantity / Year

1 Brucella Antibody Screen, IgG and IgM, Serum 125 - 150

2 Brucella Total Antibody Confirmation, Agglutination, Serum 5 - 15 3 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

10 -20

4 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

10 - 20

5 Chemical Profile

• Complete Blood Count w/o Differential

• Comprehensive Metabolic Panel

• Urinalysis w/o Microscopy

125-150

6 Chlamydia psittaci Antibody Screen, IgG and IgM, Serum 5 - 15

7 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

10 - 20

8 Creatine Kinase (CK), Serum 5 - 10

9 Eastern Equine Encephalitis Antibody, IgG and IgM, Serum 5 - 10 10 Francisella Tularensis Antibody, Serum 5 - 10

11 Hepatic Function Panel, Serum

• Total Bilirubin

• Direct Bilirubin

• Aspartate Aminotransferase (AST)

• Alanine Aminotransferase (ALT)

• Alkaline Phosphatase (ALP)

• Albumin

• Total Protein

5 - 10

12 Hepatitis B Core Total Antibodies, Serum 5 - 10

13 Hepatitis B Surface Antibody, Quantitative, Serum 10 - 50

14 Hepatitis B Surface Antigen, Serum 5 - 10

15 Hepatitis C Antibody Screen, Serum 5 - 10

16 Hepatitis C Virus (HCV) RNA Detection and Quantification by Real-Time Reverse Transcription-PCR (RT-PCR), Serum

5 - 10

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

5 - 10

18 HIV-1/2 Rapid Antibody Screening 5 - 10

19 Leptospira, IgM, Serum 40 - 60

20 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

5 - 15

21 Prostate-Specific Antigen (PSA) Screen, Serum 5 - 10

22 Prothrombin Time (PT/INR), Plasma 5 - 10

23 Pseudocholinesterase, Total, Serum 5 - 10

24 Q Fever Antibody, IgG and IgM, Serum 5 - 15

25 QuantiFERON-TB Gold Plus, Blood 50 - 100

26 Renal Function Panel, Serum

• Glucose

• Calcium

• Sodium

• Potassium

• Chloride

• Bicarbonate

• Anion Gap

• Blood Urea Nitrogen (BUN)

• Creatinine

• Estimated Glomerular Filtration Rate (eGFR)

• Albumin

• Phosphorus

5 - 10

27 Rabies Rapid Fluorescent Focus Inhibition Test (Sample Processing), Blood

100 - 150

28 Rabies Rapid Fluorescent Focus Inhibition Test (Results) 100 - 150

29 Serum Banking (Sample Processing) 25 - 75

30 Thyroid-Stimulating Hormone (TSH), Serum 5 - 15

31 Urinalysis w/o Microscopy, Urine

• Color

• Appearance

• Specific Gravity

• pH

• Bilirubin

• Urobilinogen

• Protein

• Glucose

• Ketones

• Occult Blood

• Leukocyte Esterase

• Nitrite

5 - 10

32 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

5 - 10

Wellness Profile

• Complete Blood Count w/o Differential

• Comprehensive Metabolic Panel

• Urinalysis w/o Microscopy

• Lipid Panel

• Thyroid Stimulating Hormone

50 - 150

34 West Nile Virus Antibody, IgG and IgM, Serum 5 - 10

35 Western Equine Encephalitis Antibody, IgG and IgM, Serum 5 - 10

36 On-site specimen collection 10