12639523Q0147 mod 1.pdf

(x)

12639523Q0147 x x copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted ; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGEMENT TO BE

RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR

OFFER. If by virtue of this amendment you desire to change an offer already submitted , such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

x

APHIS-MN-126395

MINNEAPOLIS MN 55401

SUITE410

250 MARQUETTE AVE

USDA APHIS

05/09/20230001

13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

12. ACCOUNTING AND APPROPRIATION DATA (If required) is not extended.is extended, Items 8 and 15, and returning

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended , by one of the following methods: (a) By completing

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

FACILITY CODE CODE

10B. DATED (SEE ITEM 13)

10A. MODIFICATION OF CONTRACT/ORDER NO.

9B. DATED (SEE ITEM 11)

9A. AMENDMENT OF SOLICITATION NO.

CODE

8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code)

7. ADMINISTERED BY (If other than Item 6)CODE 6. ISSUED BY

PAGE OF PAGES

4. REQUISITION/PURCHASE REQ. NO.3. EFFECTIVE DATE2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO. (If applicable)

1. CONTRACT ID CODE

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

04/26/2023

CHECK ONE A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority) appropriation data, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

E. IMPORTANT: Contractor is not is required to sign this document and return __________________ copies to the issuing office.

ORDER NO. IN ITEM 10A.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

Tax ID Number: Not Available

DUNS Number: Not Available

The purpose of this Amendment is to:

1 Revise the specifications for Current lab testing turnaround times (see page 14)

2. Incorporate the attached Responses to Questions.

3. Change the required response date and time to May 15, 2023 by 12:00 p.m. EST

Continued ...

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)15A. NAME AND TITLE OF SIGNER (Type or print)

15C. DATE SIGNED 16B. UNITED STATES OF AMERICA 15B. CONTRACTOR/OFFEROR 16C. DATE SIGNED

(Signature of person authorized to sign) (Signature of Contracting Officer)

LATISHA A. HOLLMAN

STANDARD FORM 30 (REV. 11/2016)

Prescribed by GSA FAR (48 CFR) 53.243

Previous edition unusable

Except as provided herein, all terms and conditions of the document referenced in Item 9 A or 10A, as heretofore changed, remains unchanged and in full force and effect .

NBAF Occupational Health Clinic National Bio and Agro-Defense Facility (NBAF) 1980 Denson Ave Manhattan, KS 66502

Vendor:

Address:

UeiSAM:

Telephone No.:

ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

NAME OF OFFEROR OR CONTRACTOR

2 71

CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF

(A) (B) (C) (D) (E) (F)

12639523Q0147/0001

NSN 7540-01-152-8067 OPTIONAL FORM 336 (4-86)

Sponsored by GSA

FAR (48 CFR) 53.110

1. INSTRUCTIONS TO QUOTERS:

1. Submit quotes to Latisha Hollman at Latisha.A.Hollman@usda.gov by the time specified in the solicitation.

A COMPLETE QUOTE SHALL INCLUDE THE FOLLOWING INFORMATION:

☐ a. Cover page or Standard Form (SF) 1449. Reference the solicitation number and include name, address, point of contact information, and Unique Entity Identifier (SAM.gov) of the Quoter.

☐ b. Acknowledgement of Solicitation Amendments (if applicable)

☐ c. Completed Pricing Schedule and Turnaround Time (ATTACHMENT 1). Alternate Pricing Schedules will not be considered. A vendor must provide a price on all items in this solicitation to be eligible for award. Provide a Turnaround Time for each test specified.

☐ d. Technical Capability Information:

☐ 1. MANAGEMENT PLAN

Quoters shall Include a narrative description to explain how the contractor plans to staff and manage the project. The Management Plan shall, at minimum, address the following:

a. A clear and detailed description of the personnel and resources that will be used to complete the requirements of this contract to include lines of authority and evidence of CLIA certification.

b. Quoter shall provide a narrative description as to how it intends to address the mechanism and turn-around times that the offeror will utilize to notify the Government when testing and/or accreditation issues arise:

Routine Specimen Pickup through Results Delivery. Quoter provides descriptive evidence demonstrating knowledge and ability to meet specimen transportation requirements to include daily transport services as defined in Section 2.2.2.1. Include a step-by-step description of performance, detailing the following:

1) Notification by ordering activity

2) Proposed carrier

3) Pickup of specimens

4) Specimen tracking protocol for specimen transportation, including sample record and shipping method

5) Analysis protocol

6) Delivery of results (i.e. method, notification process, etc.)

7) Contractor Lab Published Turn Around Times (TAT)

Irreplaceable Specimen Pickup through Results Delivery. Quoter provides descriptive evidence demonstrating knowledge and ability to meet irreplaceable specimen transportation requirements services as defined in Section 2.2.2.2.

Include a step-by-step description of performance, detailing the following:

1) Notification by ordering activity

2) Proposed carrier

3) Pickup of irreplaceable specimen(s) shall be delivered directly by medical courier ground vehicle from NBAF to the contractor’s laboratory facility staff within that same day.

4) Specimen tracking protocol for irreplaceable specimen transportation, including sample record and shipping method

5) Special labeling requirements to identify the specimen as an irreplaceable sample

6) Steps taken to preserve the integrity of samples during every stage of transport

7) Analysis protocol

8) Delivery of results (i.e. method, notification process, etc.)

9) Contractor Lab Published Turn Around Times (TAT)

☐ 2. Relevant Experience. Provide a list of at least two (2) no more than five (5) of the most relevant contracts performed for Federal agencies and/or commercial customers within the past ten (10) years.

Relevant experience is defined as human specimen transport, testing, analysis, and reporting.

Project examples shall be provided for the quoter (prime) and/or subcontractor(s) that will perform the work. A letter of commitment is required for a subcontractor’s experience to be evaluated

☐ 3. Past Performance.

In addition to the relevant experience information specified, quoters shall disclose the following past performance information:

Provide all malpractice and lawsuit information with laboratory related content within the last 3 years (quoter and proposed subcontractor(s))

List the number of incidents in the last three (3) years where the quoter or a proposed subcontractor failed to meet the requirements of CFR 49, the CDC, DOT, and IATA when packing, shipping, or transportation of biological, infectious, or hazardous substances.

☐ e. Representations and Certifications. Quoters must complete annual representations and certifications electronically in the System for Award Management (beta.SAM.gov) no later than the solicitation response date. Complete the representations specified in Section 6.0 Solicitation Provisions.

2. All questions must be submitted in writing to Latisha Hollman at Latisha.A.Hollman.usda.gov. Submit questions no later than three (3) business days prior to the response deadline to ensure adequate mailto:lisa.a.draves@aphis.usda.gov time is available to respond and amend the solicitation if necessary. Telephone inquiries will not be honored.

3. A prospective contractor may be requested to provide additional information to assist the Government in making a responsibility determination (FAR Subpart 9.1).

4. The U.S. Department of Agriculture (USDA) is an agency of the Federal Government and is tax exempt (Tax ID # 41-069271).

TABLE OF CONTENTS

1. INSTRUCTIONS TO QUOTERS:

Performance Work Statement

1.0 General

1.1 Objective

1.2 Place of Performance

1.3 Contract Type

1.4 Period of Performance

1.5 Mission

1.6 Background

2.0 Scope of Work

2.1 Laboratory and Personnel Requirements

2.1.1 Laboratory Requirements

2.2 Materials and Supplies for Government Specimen Collection, Transport Services, Testing, Analysis, and Reporting

2.2.1 Materials and Supplies for Government Specimen Collection

2.2.1.1 Government Specimen Collection

2.2.2 Transport Services

2.2.2.3 Medical Courier Requirements

2.2.3 Testing, Analysis, and Reporting

2.2.4 Deliverables

3.0 Other Requirements

3.1 Recognized Federal Holidays

3.2 Identification of Contractor Employees

3.3 Contracting Officer’s Representative (COR)

3.4 Post Award Meeting

3.5 Technical Direction

3.6 Government Contacts

3.7 Invoice Requirements

3.8 Security Requirements

3.9 Disclosure of sensitive or proprietary

3.11 Records Management

3.12 Ownership

4.0 OTHER SPECIAL REQUIREMENTS

4.1 Quality Assurance

4.2 Quality Assurance Meetings

4.3 Performance Measurements

Appendix A: Labs

Note: Estimated annual quantities are not guaranteed and subject to change

5.0 Contract Clauses

6.0 Solicitation Provisions

Performance Work Statement

NBAF Occupational Medical Services

1.0 General

1.1 Objective

The objective of this acquisition is to obtain human diagnostic and laboratory services from a qualified Contractor to support the National Bio and Agro- Defense Facility (NBAF) in meeting its health, safety, wellness, operational, and regulatory needs. Services shall include specimen transport, testing, analysis, and reporting as specified.

1.2 Place of Performance

Services shall be performed at the Contractor’s facility. Specimen transportation services shall be provided from the NBAF Occupational Health Clinic to the Contractor’s facility.

NBAF Occupational Health Clinic National Bio and Agro-Defense Facility (NBAF) 1980 Denison Ave Manhattan, Kansas 66502

1.3 Contract Type

This is a firm-fixed-price Indefinite-Delivery Indefinite-Quantity (IDIQ) type contract. Services will be ordered through the issuance of individual task orders. (See clause 52.216-22 Indefinite Quantity.)

Laboratory Services shall be ordered quarterly based on quantities estimated at time of order (See Appendix A, “Labs (Estimated Annual Quantity)”. The Government may issue task orders for additional services/quantities on an as-needed basis in accordance with the terms of this contract. Daily transport Service shall be ordered annually for continuous service.

Task order prices will be in accordance with the fixed unit prices established in the Pricing Schedule. The unit price shall include all costs associated with furnishing and delivering all materials and for performing all work under the contract in a complete and acceptable manner.

The unit price that will be paid for any line item will not be changed based on the quantity actually ordered by the Government.

Contract and Task Order minimum and maximum amounts are specified in the following clauses:

52.216-19 “Order Limitations” and 452.216-73 “Minimum and Maximum Contract Amounts”.

The ultimate contract price for any given contract period will be the sum of the task orders issued during that period.

1.4 Period of Performance

The period of performance for this contract shall include a base period of 12 months and four option periods, each 12 months in duration. The estimated date for contract award is May 2023.

The Contractor shall begin performance within 30 days following contract award in coordination with the COR.

1.5 Mission

The mission of the United States Department of Agriculture (USDA) is to provide leadership on food, agriculture, natural resources, and related issues based on sound public policy, the best available science, and efficient management. This acquisition will provide nonpersonal health care services to support the occupational health care program at the USDA National Bio and Agro-Defense Facility (NBAF), a new state-of-the-art biosafety level (BSL) 3 and 4 facility, located in Manhattan, KS.

1.5.1 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

1.5.2 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.

1.5.3 National Bio and Agro-Defense Facility (NBAF)

The NBAF is operated by two USDA agencies (APHIS and ARS) and houses USDA programs focused on the diagnosis and research into foreign and emerging animal diseases, including two programs previously housed at the Plum Island Animal Disease Center: the APHIS Foreign Animal Disease Diagnostic Laboratory and the ARS Foreign Animal Disease Research Unit (FADRU).

1.5.4 NBAF ARS Animal Disease Research Units

At NBAF, ARS Animal Disease Research Units conduct basic and applied research on selected diseases of economic importance to the U.S. livestock and poultry industries and include the Foreign Animal Disease Research Unit (FADRU), Zoonotic and Emerging Disease Research Unit (ZEDRU) and the Foreign Arthropod Borne Animal Disease Research Unit (FABADRU).

The goals of the research mission are to produce knowledge and technology to:

Reduce economic losses from emerging and foreign animal diseases to the livestock industries and associated rural agricultural communities

Prevent suffering and death caused by diseases in agriculturally important livestock.

1.6 Background

The United States Department of Agriculture (USDA), National Bio and Agro-Defense Facility (NBAF), Safety, Health, and Environmental Management Unit (SHEM) provides biological, chemical, physical, radiological, and ergonomic safety and environmental services including, but not limited to convenient, efficient, and comprehensive occupational health services to nearly 450 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 NBAF conducts an occupational health program which provides the necessary framework to comply with the agencies’ obligation to maintain a safe workplace. All employees and NBAF-associated personnel, including full-time and part-time workers, are either required or encouraged to participate in the occupational health program.

The program services are provided at no cost to participants.

The Centers for Disease Control and Prevention (CDC) encourages employers to provide their employees with preventive services, training and tools, and an environment to support healthy behaviors. The NBAF acknowledges the impact that health promotion and wellness policies, programs, practices, and strategies can have in the workplace. The NBAF strives to reduce worker health risks and improve the quality of life of its employees by supporting sensible wellness initiatives.

2.0 Scope of Work

The Contractor shall provide human diagnostic and laboratory services to support the NBAF facility employees. Services shall include specimen transport, testing, analysis, and reporting as specified.

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

This is a non-personal services requirement. The Government will not exercise any supervision or control over the contract service providers performing the services herein.

Such contract service providers shall be accountable solely to the Contractor who, in turn is responsible to the Government.

2.1 Laboratory and Personnel Requirements

2.1.1 Laboratory Requirements

The contractor’s diagnostic and laboratory testing facility shall be certified to perform testing on human specimens under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). The contractor shall comply with all Federal, state, and municipal laws, codes, and regulations applicable to the performance of this work, including applicable safety and security regulations, and all laboratory operation requirements for handling of human samples and specimens.

Under no circumstances shall the Contractor allow any patient information or lab testing samples to be sent outside the confines of the internationally recognized borders of the United States of America. Contractor referrals to a secondary (Subcontractor) laboratory shall be kept to a minimum for control and uniformity purposes. Subcontractors shall be held to the same quality standards as specified in the contract.

The Contractor shall maintain current accreditation and notify the Contracting Officer of all lapses in state license, Clinical Laboratory Improvement Amendments (CLIA)certification, or clinical pathology certification. The Contractor shall provide a copy of the renewed licenses/certificates to the Contracting Officer before expiration

2.1.2 Personnel Requirements

Contractor personnel shall possess the necessary qualifications and expertise for human specimen, testing, and analysis, and must adhere to strict procedures governing the 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 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.

2.2 Materials and Supplies for Government Specimen Collection, Transport Services, Testing, Analysis, and Reporting

USDA shall collect, prepare, and package laboratory specimens in accordance with the requirements defined in the Contractor's laboratory user’s manual and Contractor’s guidance.

The Contractor shall provide an adequate supply of requisition forms, specimen collection materials and kits, dry ice and appropriate transport container, special preservatives, or transport media required for specimen preservation, any special instructions, and a current list of tests with reference ranges and specimen requirements. These requirements shall be defined in the laboratory user manual that will be made available to the Contracting Officer’s Representative (COR) at start of service and within 7 days of any updates.

2.2.1 Materials and Supplies for Government Specimen Collection

2.2.1.1 Government Specimen Collection

USDA NBAF Occupational Health Nurses will collect specimens onsite at the NBAF Occupational Health Clinic for Contractor pick up, analysis, and reporting on an as needed basis. The Government will perform specimen collection for 100% of total tests ordered

2.2.1.2 Materials and Supplies

The contractor shall provide all supplies and materials necessary to perform the services specified in the contract. Materials and supplies are not separately priced.

Contractor will ensure that all supplies furnished to the Government, including specimen collection tube/containers and requisition forms supplied are up to date and adequate inventory is delivered onsite. Contractor will provide NBAF Occupational Health Clinic with urine drug testing kits, chain of custody forms, and transport containers in compliance with state and federal regulations.

a. Specimen collection supplies.

The contractor shall furnish appropriate specimen collection tubes/containers and supplies for 100% of the estimated quantity of applicable tests ordered plus 20%. Supplies shall be delivered to the NBAF Occupational Health Clinic within 7 days following issuance of a task order.

b. Urine drug testing kits The contractor shall furnish appropriate urine drug testing kits for 100% of the estimated quantity of applicable tests ordered plus 20%.

Supplies shall be delivered to the NBAF Occupational Health Clinic within 7 days following issuance of a task order.

c. Transport Containers and Materials The contractor shall furnish containers and materials to safely and appropriately transport lab specimens to include appropriate container, special preservatives, or transport media required for specimen preservation for 100% of the estimated quantity of tests ordered plus 20%. Supplies shall be delivered to the NBAF Occupational Health Clinic within 7 days following issuance of a task order. Dry ice shall be provided for transport as needed via courier at scheduled pick up time.

d. Transport Labels The contractor shall furnish appropriate labels required by IATA/DOT dangerous goods labels for transport. Transport labels shall be supplied for 100% of the estimated quantity of tests ordered plus 20%.

Supplies shall be delivered to the NBAF Occupational Health Clinic within 7 days following issuance of a task order.

e. Chain of Custody/Requisition Forms.

f. The Contractor shall furnish chain of custody/requisition (test request/order) forms to document specimen transfer and provide for extended specimen storage. A written record of specimen transfer, from patient, to analyst, to storage and disposal, is maintained on all specimens covered by chain-of-custody.

g. The contractor shall provide Information and materials via laboratory manual to guide NBAF Occupational Health Clinic collection, including appropriate specimen collection tubes, containers, media, and necessary sample processing (e.g. serum separation). Details regarding appropriate specimen collection tubes and necessary sample storage prior to and during transport must also be provided by the contractor, including information on storage for when samples are collected after drop-off deadlines for a given day.

2.2.2 Transport Services

The Contractor shall transport NBAF lab specimens collected onsite from NBAF to the contractor’s laboratory facility.

2.2.2.1 Daily Transport Service

The Contractor shall provide daily transport of routine specimens not identified as irreplaceable from NBAF to the contractor’s laboratory. Services shall be performed once daily, Monday – Friday, between 8:00 a.m. and 4:00 p.m. excluding Federal Holidays. The daily routine pick-up time shall be coordinated in advance with the COR or designee.

Services shall be coordinated via secured portal, email, fax, and or phone.

The Government will order Daily Transport Services on an annual basis. Payment for Daily Transport Service shall be made on a per day basis at the firm-fixed unit price established in the contract. USDA reserves the right to cancel daily pick up without charge or penalty with 24 hours advance written notice to the Contractor.

2.2.2.2 Irreplaceable Specimen Transport Services

The contractor shall provide expedited irreplaceable specimen transport services from NBAF to the contractor’s laboratory upon request and on an as-needed basis.

Contractor must provide the option to USDA to select irreplaceable specimen transport for those specimens that cannot be redrawn or replaced. USDA will notify the lab at time of irreplaceable specimen collection by telephone followed by written record via email or portal. To ensure minimal risk during transport, the contractor must provide an identifier to represent that the specimen is irreplaceable and have tracking capability.

Irreplaceable specimen shall remain with Contractor’s receiving and delivering personnel at all times. Irreplaceable specimen shall be delivered directly by medical courier ground vehicle from NBAF to the contractor’s laboratory facility staff within that same day. The responsibility for the proper transportation time and conditions is the responsibility of the Contractor. The contractor shall take steps to preserve the integrity of samples during every stage of transport. This includes transport from the collection site to the laboratory, as well as transport within the laboratory. Other sensitive specimens, such as blood samples, may be damaged by agitation, exposure to daylight and other physical factors. Proper transportation time and conditions is the responsibility of the Contractor.

Irreplaceable Specimen Transport Services will be ordered, and funded based on estimated quantities that the Government anticipates but does not guarantee will be needed/scheduled during the task order period of performance (approximately quarterly). Payment for Irreplaceable Specimen Transport Services shall be made per each scheduled transport at the firm-fixed unit prices established in the contract.

The Government may schedule Irreplaceable Specimen Transport services Monday- Friday between 8:00 a.m. and 4:00 p.m., excluding Federal Holidays. Services shall not be scheduled more frequently than once daily. Same day pick-up and delivery must be available that day for Irreplaceable Specimen transport.

2.2.2.3 Medical Courier Requirements

Contractor or Subcontractors that transport, or ship biological, infectious, and hazardous substances shall comply with all laws, regulations, and policies of Federal, State, and Local governments, the Centers for Disease Control (CDC), Department of Transportation (DOT), International Air Transport Association (IATA), and the USDA.

Contractor or Subcontractors transporting or shipping hazardous materials (hazmat) must be aware of the potential use of hazmat for acts of terrorism and are required to have documented transportation security awareness training. As many biological specimens are now classified as hazmat, it is important for all personnel that are involved in the packing and shipping of laboratory specimens to have hazmat training. The Contractor shall ensure that all personnel who deal with specimen transportation and shipment have the training and certification required by law and regulation. Failure to maintain compliance shall be reason for the Government to terminate the contract.

The Contractor shall be responsible for transporting in such a manner as to ensure the integrity of the specimen to include proper temperature monitoring.

Contractor shall provide a contingency plan for failure of cold storage. The

Contractor shall have procedures and materials for employees to clean up spilled diagnostic specimens and infectious substances.

Contractor shall provide a contingency plan in the event of a delay due to an auto accident, severe weather, auto failure, major traffic jams, or road closures.

Contractor drivers shall be licensed and insured. Contractor employees shall follow chain of custody procedures and provide their signature on the requisition form upon receipt of solicitation specimens.

Contractor shall ensure secure storage of specimens, which may include overnight storage in a lock box (or equivalent) on Contractor property as long as specimen integrity is maintained and ensured.

Courier shall provide their signature upon release of the specimens to authorized laboratory personnel and testify in court on the delivery of the specimens, if necessary.

Contractor shall provide documentation to support compliance requested by USDA.

Samples may be transported to the contract lab via NBAF staff if needed in special circumstances and as mutually agreed upon by both parties.

2.2.3 Testing, Analysis, and Reporting

The contractor shall receive, process, and analyze the samples in a manner that preserves their integrity. Types of lab tests conducted are limited to those specified in Appendix A, “Labs (Estimated Annual Quantity)”. The scope of this contract includes adding or removing laboratory tests as mutually agreed upon (52.212-4).

Laboratory tests will be ordered and funded on the basis of estimated quantities that the Government anticipates but does not guarantee. Payment for laboratory services shall be made per each individual laboratory analysis report at the firm-fixed unit prices established in the contract. The contractor shall invoice only for actual services and quantities rendered. Payment shall not exceed the total funded amount, and the Contractor shall not continue performance if doing so would exceed the funded task order amount.

A laboratory analysis report is defined as a final copy of laboratory testing results.

Lab Analysis Report:

The contractor shall submit one (1) one laboratory analysis report per individual for each lab test conducted to include the following information:

Patient's name and identification code (this may include multiple identifiers) Physician's name (if supplied) Facility Name Patient's location (if supplied) Date/time specimen received in Reference Lab Test ordered Date/time of specimen collection Date test completed Test result Flag abnormal values and critical values Reference range Toxic and therapeutic range where applicable Testing laboratory specimen number Name and address of testing laboratory (Contractor and Subcontractor) Type of specimen All additional comments related to test provided by submitting labs.

All other information the laboratory has that may indicate the questionable validity of test results Unsatisfactory specimen shall be reported with reason of unsuitability for testing If results were previously telephoned, the report must include the Name of the individual notified of the results

Critical Values: The Contractor shall immediately telephone the COR or USDA NBAF Occupational Health Nurse when results of certain tests fall within established alert or critical ranges. This report shall also be immediately communicated via secure portal, encrypted electronic email, or fax.

Current lab testing turnaround times:

Services shall be performed in accordance with the turnaround times (TAT) incorporated into the contract. TAT is defined as the time interval between when the specimen is picked up to the time the results have been delivered to NBAF.

The Contractor shall deliver test results and/or reports to the USDA COR or designated authority via secure portal, encrypted electronic email, or fax within 24 hours from the turnaround times (TAT) established in the contract for that test, Monday through Friday.

The Contractor shall provide an alternate route of transmission (i.e. telephone, or certified confidential courier service) for test results to be provided to the Government in the case of a failure of the primary method of transmission of test results. Specific information regarding when and how the alternate route of transmission will be used will be provided to the assigned COR. The alternate route of transmission is required to comply with all response times required by the contract.

Replacement Samples & Re-Analysis: Replacement samples will be collected by NBAF staff and analyzed by the laboratory in the event that problems occur with shipping or testing or in the event that analytical results are invalidated due to unacceptable QA/QC or rejected by NBAF.

NBAF reserves the right to review data deliverables and reject any analytical result. Rejection will be based on sound technical review of the data deliverables by NBAF or its representatives.

NBAF also reserves the right to reject any analytical result if contractual requirements are not adhered to. Replacement samples needed due to contractor error shall be analyzed by the laboratory at no additional cost. On occasion NBAF may request that a sample be retested to confirm an unexpected or questionable result. If the result of the reanalyzed sample is significantly different from the original value reported, the laboratory will be expected to retest the sample at least one additional time to determine the most accurate value for reporting purposes and there will be no additional cost to NBAF for these re-analyzed samples.

Service and Maintenance:

The Contractor shall provide telephone number(s) and contact person plus an alternate contact to be used by the Government to make specimen problem inquiries. The Contractor shall include names and telephone numbers of technical directors and pathologists available for consultation.

Contractor shall advise the Government of any changes in methodology, procedure, reference ranges and all new tests. In the event that the Contractor changes the assay procedure or a critically important component of an assay (e.g., antibody, purified antigen, etc.), the Contractor shall notify the CO and assigned COR prior to the intended change

2.2.4 Deliverables

Timely submission of deliverables and reports is essential to successfully completing contract requirements.

Contractor shall provide a laboratory user manual that will be made available to the Contracting Officer’s Representative (COR) at start of service and within 7 days of any updates.

Contractor shall provide a copy of its policy concerning corrected or amended reports within 7 calendar days of time of award or any changes made thereafter.

3.0 Other Requirements

3.1 Recognized Federal Holidays

The contractor is not required to perform services on Federal holidays. If the holiday falls on a Saturday, the Friday immediately before is the recognized legal holiday. If a holiday falls on a Sunday, the following Monday is the recognized legal holiday.

New Year’s Day Labor Day Martin Luther King Jr.’s Birthday Columbus Day President’s Day Veteran’s Day Memorial Day Thanksgiving Day Juneteenth Christmas Day Independence Day

3.2 Identification of Contractor Employees

(a) In all situations where contractor personnel status is not obvious, all contractor personnel are required to identify themselves to avoid creating an impression that such contractor personnel are Government officials. This can occur during meeting attendance, through written (letter or email) correspondence or verbal discussions (in person or telephonic), when making presentations, or in other situations where their contractor status is not obvious to third parties. Contractor employee(s) shall: (1) Not by word or deed give the impression or appearance of being a Government employee; (2) Wear appropriate badges visible above the waist that identify them as contractor employees when in Government spaces, at a Government-sponsored event, or an event outside normal workspaces in support of the contract/order; (3) Clearly identify themselves as contractor employees in telephone conversations and in all formal and informal written and electronic correspondence. Identification shall include the name of the company for whom they work;

(4) Identify themselves by name, their company name, if they are a subcontractor the name of the prime contractor their company is supporting, as well as the Government office they are supporting when participating in meetings, conferences, and other interactions in which all parties are not in daily contact with the individual contractor employee; and (5) Be able to provide, when asked, the full number of the contract/order under which they are performing, and the name of the Contracting Officer’s Representative.

(b) If wearing a badge is a risk to safety and/or security, then an alternative means of identification maybe utilized if endorsed by the Contracting Officer’s Representative and approved by the Contracting Officer.

(c) The Contracting Officer will make final determination of compliance with regulations with regard to proper identification of contractor employees.

3.3 Contracting Officer’s Representative (COR)

The Contracting Officer will designate in writing a Contracting Officer’s Representative (COR) to assist in monitoring the work under this contract. The COR is responsible for the technical administration of the contract and technical liaison with the Contractor. The COR is not authorized to change the scope of work or specifications as stated in the contract, to make any commitments or otherwise obligate the Government or authorize any changes which affect the contract price, delivery schedule, period of performance, or other terms or conditions. The Contractor will receive a copy of the COR Appointment Letter outlining the roles and responsibilities of the COR.

3.4 Post Award Meeting

After award of the contract, the contractor shall meet with the USDA Contracting Officer’s Representative (COR) and designee, to discuss timing, contacts, documentation, and other pertinent information. This kick-off meeting, which will be chaired by the COR, will take place via teleconference at a time mutually agreed upon and within seven (7) days after award of the contract.

3.5 Technical Direction

Performance of the work under this contract shall be subject to the technical direction of the COR or designee. The term “technical direction” is defined to include, without limitation:

Providing direction to the contractor that redirects contract effort, shift work emphasis between work areas or tasks, require pursuit of certain lines of inquiry, fill in details, or otherwise serve to accomplish the contractual performance work statement.

Providing written information to the contractor that assists in interpreting specifications or technical portions of the work description.

Reviewing and, where required by the contract, approving technical information to be delivered by the contractor to the Government.

Technical direction must be within the scope of work. It is the contractor’s responsibility to contact the Contracting Officer immediately in writing if there is even the appearance of any technical direction that is or may be outside the scope of the contract. Upon receiving the notification from the contractor, the Contracting Officer will promptly advise the contractor that

(1) technical direction is within the scope of the contract and does not constitute a change; (2) the Government will issue a written modification; or (3) advise the contractor not to proceed with the instruction or direction by the COR.

A failure of the contractor and Contracting Officer either to agree that the technical direction is within the scope of the contract or to agree upon the contract action to be taken with respect to the technical direction will be subject to the provisions of clause 52.212-4 (d), Contract Terms and Conditions – Commercial Items.

3.6 Government Contacts

Contact information for the Contracting Officer, Contracting Officer Representative, and Alternate Contracting Officer Representative for this contract are as follows:

Contracting Officer: Latisha Hollman

USDA APHIS MRPBS

Phone: (612) 336-3364 Email: Latisha.A.Hollman@usda.gov

Contracting Officer Representative: Indira Klotzer

1980 Denison Ave.

Manhattan, Kansas 66502 USDA APHIS NBAF Environmental Protection Specialist

Alternate Contracting Officer Representative: (TBD)

1980 Denison Ave.

Manhattan, Kansas 66502 USDA APHIS NBAF Management and Programs Analyst Phone: (758) 477-2165 Email:

Although the COR shall be the contractor’s main point of contact for coordinating services under this contract, other NBAF Veterinary Services personnel from the medical services division may be assisting in coordinating services under this contract. Their names will be provided after the award during the kickoff meeting. If other VS personnel have contact with the contractor for the purpose of coordinating services, they must include the COR in their communications or advise the COR of any communications with the contractor.

3.7 Invoice Requirements

The Government will make payment in accordance with clause 52.212-4(i) and the Prompt Payment Act (31 U.S.C. 3902). The Contractor may invoice only for services and quantities actually rendered. The USDA, APHIS uses the Invoice Processing Platform (IPP) for electronic submission and tracking of invoices and payment information to its suppliers of goods and services. Invoices shall be submitted electronically to the IPP invoicing system (ipp.gov) against the task order. Invoices shall be prepared monthly in accordance with FAR 52.212-4 (g) and include at minimum:

Name and address of the contractor Invoice date and number mailto:Email:lisa.a.draves@usda.gov

Contract number, task order number, line item number(s), line item description, quantity, unit of measure, unit price and extended price of items delivered The invoice description must include a detailed list of individual laboratory analysis reports being invoiced, test date, test type, unit price, and employee ID.

3.8 Security Requirements

Any information made available in any format shall be used only for carrying out the requirements of this contract. Such information shall not be divulged or made known in any manner to any unauthorized person. The Contractor 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.

A. The Contractor will ensure compliance with all applicable security regulations, and all program security operations requirements, for facility access, and handling of materials. Contractor personnel must show a photo ID to gain access to USDA facilities. The Government reserves the right to deny, withhold, or terminate access for cause. All personnel and vehicles entering NBAF property will be subject to search. This includes but is not limited to all vehicles, passengers, items being transported, etc. per 41 CFR Part 102-74.370.

The contractor shall not employ persons for work on this contract if such employee is considered by the USDA to be a potential threat to health, safety, general well-being or operational mission of USDA and its employees and property. If the USDA finds a prospective employee to be unsuitable for his or her assigned duties, the contractor will be advised immediately that such employee cannot continue to work or be assigned to work under the contract.

3.9 Disclosure of sensitive or proprietary

The Contractor shall 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.

3.10 HIPPA, HITECH, and Privacy Act

Work on this SOW may require that personnel have access to Privacy Information. Personnel shall adhere to the Privacy Act, Title 5 of the U. S. Code, Section 552a – as amended and applicable agency rules and regulations. The Contractor shall ensure that all contract personnel take the required Privacy training. The Contractor shall protect the privacy, security, and integrity of protected health information (PHI) and personally identifiable information (PII) 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 PHI, except as permitted by law and in accordance with the individual’s rights as required under the

HIPAA regulations. Upon termination of this contract, the Contractor shall provide the Government with the PII/PHI date created and amended during contracted service in the form of a common-use electronic format that is readable and accessible by mainstream database or spreadsheet software.

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) 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.

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—

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

b. The appropriate handling and safeguarding of personally identifiable information;

c. The authorized and official use of a system of records or any other personally identifiable information;

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

e. The prohibition against the unauthorized use of a system of records or unauthorized disclosure;

f. Access, handling, or use of personally identifiable information; and

g. 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).

3.11 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.

i. 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.].

j. No disposition of documents will be allowed without the prior written consent of the Contracting Officer.

k. 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.

3.12 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 or their designated representative.

4.0 OTHER SPECIAL REQUIREMENTS

4.1 Quality Assurance

The Contractor shall be solely responsible for the…