1.03 PWS, QASP, Attachments.pdf

PERFORMANCE WORK STATEMENT (PWS)

Species Identification and Pathogen Detection in Field-Collected Ticks in Kosovo

Part 1

General Information

1. GENERAL: This is a non-personnel services contract to provide vector surveillance. The Government shall 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.

1.1 Description of Services/Introduction: The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items and non-personal services necessary to perform vector surveillance as defined in this Performance Work Statement except for those items specified as government furnished property and services. The contractor shall perform to the standards in this contract.

1.2 Background: U.S. Naval Medical Research Unit EURAFCENT (NAMRU-EAC) is an infectious disease research institute of the United States Navy located in Sigonella, Italy. NAMRU-EAC conducts scientific research and public health initiatives throughout the Middle East, Eastern Europe, Central and Southeast Asia, North and West Africa. Tick-borne disease is a major threat to force health protection, particularly in Europe where endemic tick species are known to transmit Borrelia, Crimean Congo Hemorrhagic Fever Virus (CCHFV), and Tick-Borne Encephalitis Virus (TBEV). Military installations in Europe typically have perimeter fencing which precludes the migration of large mammals. These mammals are the typical host for many tick species, including Ixodes ricinus, one of the primary tick-borne disease vectors in Europe. This species is found throughout much of Europe, including Kosovo. There is limited information on how the exclusion of large mammal hosts impacts tick abundance, species distribution, and pathogen infection rates. Therefore, to fill these knowledge gaps and assess the risk to personnel deployed in Kosovo, we plan in this study to: (1) establish the circulation rates of tick-borne pathogens in Kosovo by assessing the prevalence of infection in natural populations of tick species with Borrelia, CCHV, and TBEV; (2) tick abundance and species composition onboard secure military facilities and in their vicinity

(3) investigating potential differences in infection rates and species composition between on-base and off-base tick populations.

1.3 Objectives: Specific objectives: The goal of these studies is to fill in this information gap by conducting entomological research to determine relative health risks associated with the presence of vector species and/or vector-borne diseases.

1.4 Scope: Under this task order, the contractor will conduct analysis of provided tick specimens to include identification to species and determining infection status for Borrelia, CCHV, and TBEV.

Laboratory analysis will be conducted at the contracted facility using equipment already present. This contract will allow for the purchase of consumable materials and labor for the contracted facility.

1.5 Period of Performance: The period of performance shall be for one (1) Base Year of 12 months and one (1) 12-month option years. The Period of Performance reads as follows:

Base Year: 30 September 2026-29 September 2027 Option Year 1: 30 September 2027-29 September 2028

1.6 General Information:

1.6.1 Quality Control: N/A

1.6.2 Quality Assurance: The government shall evaluate the contractor’s performance under this contract in acTPOCdance with the Quality Assurance Surveillance Plan. This plan is primarily focused on what the Government must do to ensure that the contractor has performed in acTPOCdance with the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and the minimum acceptable defect rate(s).

1.6.3 Recognized Holidays: The contractor is not required to work on the designated Kosovo public holidays observed by the organization where the work is performed as per the schedule below:

New Year’s Day Orthodox Christmas Catholic Christmas Independence Day Constitution Day Catholic Easter Orthodox Easter International Labor Day Europe Day Eid Al Fitr Eid Al Adha

1.6.4 Hours of Operation: N/A

1.6.5 Safeguarding of Biological Samples and Equipment: The contractor shall safeguard all biological samples required under this contract. Samples shall be properly secured inside the contractor’s facility. The contractor shall safeguard and observe the function of necessary supplies and equipment including, but not limited to, refrigerators, freezers, or incubators, to ensure that biological samples and isolates are properly stored acTPOCding to conditions as stated in the SOPs provided by NAMRU-EAC.

1.6.6 Place of Performance: The work to be performed under this contract will be performed at the University of Pristina.

1.6.7 Type of Contract: The government will award a (Type of contract to be determined by CCE and the customer).

1.6.8 Security Requirements: N/A

1.6.8.1 PHYSICAL Security: The contractor shall be responsible for safeguarding all government equipment, information and property provided for contractor use. At the close of each work period, government facilities, equipment, and materials shall be secured.

1.6.8.2 Key Control: N/A

1.6.8.3 Identification of Contractor Employees: N/A

1.6.8.4 Lock Combinations: N/A

1.6.9 Special Qualifications: N/A

1.6.10 Contractor Travel: The contractor will be required to travel within Kosovo during the performance of this contract to provide technical assistance at field sites. The contractor may be required to travel to off-site training locations and carry or ship training materials. Contractor will be authorized travel expenses consistent with the substantive provisions of the Joint Travel Regulations (JTR) and the limitation of funds specified in this contract. All travel requires Government approval/authorization and notification to the

TPOC.

1.6.11 Data Rights: The Government has unlimited rights to all documents/material produced under this contract. All documents and materials, to include the source codes of any software, produced under this contract shall be Government owned and are the property of the Government with all rights and privileges of ownership/copyright belonging exclusively to the Government. These documents and materials may not be used or sold by the contractor without written permission from the Contracting Officer. All materials supplied to the Government shall be the sole property of the Government and may not be used for any other purpose. This right does not abrogate any other Government rights.

1.6.12 Post Award Conference/Periodic Progress Meetings: N/A

1.6.13 Other Direct Costs: There may be ODCs required to perform this PWS and will be defined on as needed basis in writing (e.g., e-mail) by the TPOC for this contract. ODCs will typically include (but are not limited to) contractor-procured supplies, equipment, disposable and non-disposable items, and subcontractor and consultant services incidental to performance. All ODCs shall be approved by the TPOC in writing (e.g., email) if within scope and budget. Otherwise, a modification to the contract will be required.

1.6.14 Activity Point of Contact (APOC): The APOC monitors all technical aspects of the contract and assists in contract administration. The APOC is authorized to perform the following functions: assure that the Contractor performs the technical requirements of the contract: perform inspections necessary in connection with contract performance: maintain written and oral communications with the Contractor concerning technical aspects of the contract: issue written interpretations of technical requirements, including Government drawings, designs, specifications: monitor Contractor's performance and notifies both the Contracting Officer and Contractor of any deficiencies; coordinate availability of government furnished property, and provide site entry of Contractor personnel. The APOC is not authorized to change any of the terms and conditions of the resulting order.

1.6.15 Technical Point of Contact (TPOC) The TPOC is identified below in paragraph 1.6.19. The TPOC monitors all technical aspects of the contract and assists in contract administration. The TPOC is authorized to perform the following functions: assure that the Contractor performs the technical requirements of the contract: perform inspections necessary in connection with contract performance: maintain written and oral communications with the Contractor concerning technical aspects of the contract: issue written interpretations of technical requirements, including Government drawings, designs, specifications: monitor Contractor's performance and notifies both the Contracting Officer and Contractor of any deficiencies;

coordinate availability of government furnished property, and provide site entry of Contractor personnel. A letter of designation issued to the TPOC, a copy of which is sent to the Contractor, states the responsibilities and limitations of the TPOC, especially with regard to changes in cost or price, estimates or changes in delivery dates. The TPOC is not authorized to change any of the terms and conditions of the resulting order.

1.6.16 Key Personnel: N/A

1.6.17 Organizational Conflict of Interest: Contractor and subcontractor personnel performing work under this contract may receive, have access to or participate in the development of proprietary or source selection information (e.g., cost or pricing information, budget information or analyses, specifications, or work statements, etc.) or perform evaluation services which may create a current or subsequent Organizational Conflict of Interests (OCI) as defined in FAR Subpart 9.5. The Contractor shall notify the Contracting Officer immediately whenever it becomes aware that such access or participation may result in any actual or potential OCI and shall promptly submit a plan to the Contracting Officer to avoid or mitigate any such OCI. The Contractor’s mitigation plan will be determined to be acceptable solely at the discretion of the Contracting Officer and in the event the Contracting Officer unilaterally determines that any such OCI cannot be satisfactorily avoided or mitigated, the Contracting Officer may affect other remedies as he or she deems necessary, including prohibiting the Contractor from participation in subsequent contracted requirements which may be affected by the OCI.

1.6.18 PHASE IN /PHASE OUT PERIOD: N/A

1.6.19 TPOC:

HM1 Michael J. Scaife Email: michael.j.scaife.mil@health.mil

PART 2

DEFINITIONS & ACRONYMS

2.0 DEFINITIONS AND ACRONYMS:

2.1. DEFINITIONS:

2.1.1. CONTRACTOR. A supplier or vendor awarded a contract to provide specific supplies or service to the government. The term used in this contract refers to the prime.

2.1.2. CONTRACTING OFFICER. A person with authority to enter into, administer, and or terminate contracts, and make related determinations and findings on behalf of the government. Note: The only individual who can legally bind the government.

2.1.3. TECHNICAL POINT OF CONTACT (TPOC). An employee of the U.S. Government appointed by the contracting officer to administer the contract. Such appointment shall be in writing and shall state the scope of authority and limitations. This individual has authority to provide technical direction to the Contractor as long as that direction is within the scope of the contract, does not constitute a change, and has no funding implications. This individual does NOT have authority to change the terms and conditions of the contract.

2.1.4. DEFECTIVE SERVICE. A service output that does not meet the standard of performance associated with the Performance Work Statement.

2.1.5. DELIVERABLE. Anything that can be physically delivered, but may include non-manufactured things such as meeting minutes or reports.

2.1.6. KEY PERSONNEL. Contractor personnel that are evaluated in a source selection process and that may be required to be used in the performance of a contract by the Key Personnel listed in the PWS. When key personnel are used as an evaluation factor in best value procurement, an offer can be rejected if it does not have a firm commitment from the persons that are listed in the proposal.

2.1.7. PHYSICAL SECURITY. Actions that prevent the loss or damage of Government property.

2.1.8. QUALITY ASSURANCE. The government procedures to verify that services being performed by the Contractor are performed according to acceptable standards.

2.1.9. QUALITY ASSURANCE Surveillance Plan (QASP). An organized written document specifying the surveillance methodology to be used for surveillance of contractor performance.

2.1.10. QUALITY CONTROL. All necessary measures taken by the Contractor to assure that the quality of an end product or service shall meet contract requirements.

2.1.11. SUBCONTRACTOR. One that enters into a contract with a prime contractor. The Government does not have privity of contract with the subcontractor.

2.1.12. WORK DAY. The number of hours per day the Contractor provides services in accordance with the contract.

mailto:michael.j.scaife.mil@health.mil

2.1.12. WORK WEEK. Monday through Friday, unless specified otherwise.

2.2. ACRONYMS:

ATPOC Alternate Contracting Officer's Representative AFARS Army Federal Acquisition Regulation Supplement AR Army Regulation CCE Contracting Center of Excellence CCHV Crimean Congo Hemorrhagic Fever Virus CFR Code of Federal Regulations CONUS Continental United States (excludes Alaska and Hawaii) COTS Commercial-Off-the-Shelf DA Department of the Army DD250 Department of Defense Form 250 (Receiving Report) DD254 Department of Defense Contract Security Requirement List DFARS Defense Federal Acquisition Regulation Supplement DMDC Defense Manpower Data Center DOD Department of Defense FAR Federal Acquisition Regulation GDDRP Global Disease Detection and Response Program HIPAA Health Insurance Portability and Accountability Act of 1996 KO Contracting Officer MOH Ministry of Health NAMRU EAC US Naval Medical Research Unit EURAFCENT OCI Organizational Conflict of Interest OCONUS Outside Continental United States (includes Alaska and Hawaii) ODC Other Direct Costs PIPO Phase In/Phase Out POC Point of Contact PRS Performance Requirements Summary PWS Performance Work Statement QA Quality Assurance QAP Quality Assurance Program QASP Quality Assurance Surveillance Plan QC Quality Control QCP Quality Control Program TBEV Tick-Borne Encephalitis Virus TE Technical Exhibit TPOC Technical Point of Contact WHO EMRO World Health Organization Eastern Mediterranean Office

PART 3

GOVERNMENT FURNISHED PROPERTY, EQUIPMENT, AND SERVICES

3. GOVERNMENT FURNISHED ITEMS AND SERVICES:

3.1. Services: N/A

3.2 Facilities: N/A

3.3 Utilities: N/A

3.4 Equipment: N/A

3.5 Materials: The government will provide all tick specimens for species and identification and pathogen detection.

PART 4

CONTRACTOR FURNISHED ITEMS AND SERVICES

4. CONTRACTOR FURNISHED ITEMS AND RESPONSIBILITIES:

4.1 General: The Contractor shall furnish all supplies, equipment, facilities, and services required to perform work under this contract and this PWS.

4.2 Secret Facility Clearance: N/A

4.3. Materials: The Contractor shall provide sample collection material, as well as testing reagents and supply molecular diagnostic reagents. Consumables will be procured by the contractor using ODC funds.

4.4. Equipment: Contactor shall utilize equipment for laboratory testing of samples in their facility and inform the Government of any changes in equipment or deviations from methods due to equipment availability.

PART 5

SPECIFIC TASKS

5.0 Specific Tasks:

5.1. Basic Services. The contractor shall provide services for identification and pathogen infection status of tick specimens delivered by the government.

5.1.1. The contractor will identify the species of provided adult and nymphal tick specimens using morphological keys.

5.1.2. The contractor will test for pathogens (Borrelia, CCHV, and TBEV) in up to 250 pools of field collected ticks. Pools shall be composed of up to ten individual ticks of the same species, life stage, and collection location and time. Tick pools will be furnished by the government. For RNA detection, tick pools with extraction Lysis buffer and specific beads will be homogenized by shaking in Mini-Beadbeater- 96 (BioSpec, Bartlesville, OK, USA). Nucleic acids will then be extracted following QIAamp kits (Qiagen, Valencia, CA) protocol. Reverse transcription (RT) PCR will be performed using SuperScript® One-Step RT-PCR System with Platinum® Taq DNA Polymerase (Invitrogen, Carlsbad, CA, USA).

5.2. Task Heading: N/A

5.3. CONTRACTOR MANAGEMENT REPORTING (CMR) : N/A

PART 6

APPLICABLE PUBLICATIONS

6.0. APPLICABLE PUBLICATIONS (CURRENT EDITIONS):

6.1. The generated data under this contract should not be published or submitted to any scientific conferences without preapproval from NAMRU-EAC authority.

6.2. The Contractor must abide by all applicable regulations, publications, manuals, and local policies and procedures, as in the Declaration of Helsinki, the Code of Federal Regulation, GCP and the research ethics guideline of NAMRU-3. (http://www.gpo.gov/, http://www.ich.org/home.html) (Revised Common Rule found at https://www.hhs.gov/ohrp/regulations-and-policy/regulations/finalized-revisions-commonrule/ index.html), the study protocol and NAMRU-EAC Standard Operating procedures written and provided by

NAMRU-EAC.

PART 7

7.0. Enterprise-wide Contractor Manpower Reporting Application (ECMRA). The contractor shall report contractor labor hours (including subcontractor labor hours) required for performance of services provided under this contract for the [NAMED COMPONENT] via a secure data collection site. Contracted services excluded from reporting are based on Product Service Codes (PSCs). The excluded PSCs are:

(1) W, Lease/Rental of Equipment;

(2) X, Lease/Rental of Facilities;

(3) Y, Construction of Structures and Facilities;

(4) D, Automatic Data Processing and Telecommunications, IT and Telecom- Telecommunications Transmission (D304) and Internet (D322) ONLY;

(5) S, Utilities ONLY;

(6) V, Freight and Shipping ONLY.

The contractor is required to completely fill in all required data fields using the following web address:

https://www.ecmra.mil.

Reporting inputs will be for the labor executed during the period of performance during each Government fiscal year (FY), which runs October 1 through September 30. While inputs may be reported any time during the FY, all data shall be reported no later than October 31 of each calendar year. Contractors may direct questions to the help desk, linked at https://www.ecmra.mil

PART 8

ATTACHMENT/TECHNICAL EXHIBIT LISTING

8. Attachment/Technical Exhibit List:

8.1. Attachment 1/Technical Exhibit 1 – Performance Requirements Summary

8.2. Attachment 2/Technical Exhibit 2 – Deliverables Schedule

8.3. Attachment 3/Technical Exhibit 3 – Estimated Workload Data

8.4. Attachment 4/Technical Exhibit 4 – Special Licensing Agreement

TECHNICAL EXHIBIT 1

Performance Requirements Summary

Quality Assurance Surveillance Plan (QASP) The contractor service requirements are summarized into performance objectives that relate directly to mission essential items. The performance threshold briefly describes the minimum acceptable levels of service required for each requirement. These thresholds are critical to mission success.

1. Purpose: To ensure that the Government has an effective and systematic method of surveillance for the services in the PWS. The QASP will be used primarily as a tool to verify that the contractor is performing all services required by the PWS in a timely, accurate and complete fashion.

2. Performance Standards:

a. Schedule - The due dates for deliverables and the actual accomplishment of the schedule will be assessed against original due dates and milestones established for the contract or task order(s).

b. Deliverables – The deliverables required to be submitted will be assessed against the specifications for the deliverables detailed in the PWS for the required content, quality, timeliness, and accuracy.

c. Past Performance - The Government will assess the contractor’s record of conforming to contract requirements and to standards of good workmanship, the contractor’s adherence to contract schedules including the administrative aspects of performance, the contractor’s history of reasonable and cooperative behavior and commitment to customer satisfaction, and the contractor’s business-like concern for the interest of the customer.

3. Performance Requirements Summary:

The contractor service requirements are summarized into performance objectives that relate directly to mission essential items. The performance threshold briefly describes the minimum acceptable levels of service required for each requirement. These thresholds are critical to mission success.

4. Incentives/Disincentives:

The TPOC makes an annual report on Contractor Performance. The contractor’s failure to achieve satisfactory performance under the contract/task order, reflected in the TPOC’s annual report, may result in the loss of future Government contracts/task orders.

For each item that does not meet acceptable levels, the Government may issue a Contract Discrepancy Report (CDR). CDRs will be forwarded to the Contracting Officer with a copy sent to the contractor. The contractor must reply in writing within 5 days of receipt identifying how future occurrences of the problem will be prevented. Based upon the contractor’s past performance and plan to solve the problem, the Contracting Officer will determine if any further action will be taken.

In accordance with the inspection of services provisions of the contract, the contractor will be incentivized to provide quality products in a timely manner since the Government can require the Contractor, at no additional cost, to replace or correct work that fails to meet contract requirements.

Performance Objective (The Service required—usually a shall statement)

Standard Performance Threshold (This is the maximum error rate. It could possibly be “Zero deviation from standard”)

Method of Surveillance

PRS # 1.

The contractor shall provide identification to species of all furnished nymphal and adult tick specimens and provide the data to TPOC

Maintain detailed spreadsheet for species identification data, listing the location, date, and species of each specimen furnished.

Reported no later than 45 days after receipt of each specimen.

95% Review and Feedback.

Lab visits to observe identification procedures.

PRS # 2

Shall Detect pathogens (Borrelia, CCHV, and TBEV) in furnished tick specimens of up to 250 pools.

Contractor will provide monthly report on the number of positive and negative tick pools tested for each pathogen based on location, species, and date they were collected. The number of ticks tested in each pool will be reported, as will the laboratory methods used to test the samples. This report will be received no later than 60 days after receipt of each specimen.

95% Review and feedback

Lab visits to observe testing procedures.

TECHNICAL EXHIBIT 2

DELIVERABLES SCHEDULE

Deliverable Frequency # of Copies Medium/Format Submit To Report of the species identification of all provided adult and nymphal tick specimens.

Within 45 days of specimen delivery.

The report should be submitted electronically in an excel format that is created by

NAMRU EAC PI.

Methods used and summary of findings will be provided in a word document to supplement raw data file.

Review by POC:

HM1 Michael J.

Scaife michael.j.scaife.mil @health.mil

Report of the pathogen infection status for the first 250 tick pools provided by the government over the course of one year.

Within 60 days of specimen delivery.

1 The report should be submitted electronically in an excel format that is created by

NAMRU EAC PI.

Methods used and summary of findings will be provided in a word document to supplement raw data file.

Review by POC:

HM1 Michael J.

Scaife michael.j.scaife.mil @health.mil

TECHNICAL EXHIBIT 3

ESTIMATED WORKLOAD DATA

ITEM

NAME

ESTIMATED QUANTITY

1 Project Manager (Scientist) 1 520 hours

TECHNICAL EXHIBIT 4

Special License Agreement

Data Rights: The Government has unlimited rights to all documents/material produced under this contract.

All documents and materials, to include the source codes of any software, produced under this contract shall be Government owned and are the property of the Government with all rights and privileges of ownership/copyright belonging exclusively to the Government. These documents and materials may not be used or sold by the contractor without written permission from the Contracting Officer. All materials supplied to the Government shall be the sole property of the Government and may not be used for any other purpose. This right does not abrogate any other Government rights.

MAIL INVOICE INFORMATION

INVOICES AND PAYMENTS

Technical POC:

HM1 Michael J. Scaife Email: michael.j.scaife.mil@health.mil

Courtesy copy to:

Sherine Wahba E-mail: sherine.k.wahba.ln@health.mil

DoDAAC Code: N40358

ADDRESS: NAMRU-EAC

USAID building - Takseem Laselki Maadi, Cairo, Egypt

The contractor shall submit their own manually created invoice to the TPOC listed above. The TPOC will then review, prepare and submit the invoice package and send it to the payment office identified in block 18a.

Vendor's invoice should be provided with following information for proper invoice:

- Invoice Number

- Invoice Date

- Contract Line Item Number(s)

- Service/Material Receipt Date

- Service/Material Acceptance Date mailto:sherine.k.wahba.ln@health.mil

Invoices will be handled in acTPOCdance with the Prompt Payment Act (31U.S.C. 3903) and Office of Management and Budget (OMB) Prompt