PWS Amazonas 3_5_2025.docx

PERFORMANCE WORK STATEMENT

1. Introduction:

This study is funded by the Global Emerging Infections Surveillance and Response Branch (GEIS) of the Armed Forces Health Surveillance Division (AFHSD) Intramural Funding. This Performance Work Statement (PWS) defines the requirements to be performed by the contractor for conducting the Study entitled “Malaria surveillance in Amazonas - Peru”. The country where the activities will be carried out is Peru.

2. Background:

Malaria continues to pose a threat to U.S and partner military populations as well as people living in endemic areas. The US SOUTHCOM AOR includes several countries with different status of malaria transmission. Therefore, malaria surveillance in these sites is needed to provide accurate data regarding the risk to US military that are deployed as part of operations and training activities.

Peru is one of the four countries that report more than 80% of all malaria cases in South America. The region of Amazonas is a re-emerging focus of malaria with an increasing number of cases each year. This region is located near the border between the Peruvian and Ecuadorian jungle and is an area of military relevance as several Peruvian military bases are located in the area.

In order to conduct malaria surveillance, we require the services of a research institution that can collect samples from malaria suspected human subjects and conduct laboratory experiments for malaria detection on these specimens. In this regard, the institution must be able to develop and obtain all ethical and regulatory approvals for the collection of the samples.

3. General Requirements:

The requirement is for 6-month base period of performance from 01 April 2025 to 30 September 2025.

The contractor shall provide services including (but not limited to)

i) project management,

ii) write a human subject protocol,

iii) obtain the respective ethical and regulatory approvals for conducting human subject research,

iv) conduct fieldwork and collect samples and clinical and epidemiological data and v) conduct malaria screening using microscopy and molecular laboratory methods.

The contractor shall provide all supplies for sample collection, malaria microscopy screening as well as primers and probes. NAMRU SOUTH might supplement with reagents for molecular biology detection depending on funding availability.

In addition, the contractor shall provide malaria disease incidence data available from direct sources such as active human subject studies or indirectly from local health authorities.

The study sites will be located in in the Amazonas department along the Condorcanqui Province. Other sites might be opened upon coordination with NAMRU SOUTH.

4. Performance Requirements:

The Offeror is encouraged to propose a labor mix and level of effort based on their technical approach. The contractor shall provide general classes of services including (but not limited to) project management, provision of clinical samples, laboratory testing, shipment of samples, data analysis and reporting.

Laboratory molecular testing shall be performed by the contractor in response to NAMRU SOUTH requirements. In addition, the contractor shall provide demographic, clinical and laboratory test results to NAMRU SOUTH on a study database.

Monitoring activities will be conducted by NAMRU SOUTH via monthly conference calls and monitoring visits to selected field sites during the contract period. Monthly, short reports are expected during the conduction of the study. Frequent communications such as monthly teleconferences are expected during the conduction of the study.

5. DUTIES, EDUCATION, EXPERIENCE, & TRAINING

5.1 FIELD WORK ACTIVITIES

a) Obtain (IRB) approvals and regulatory permits required for enrolling human subjects and collecting human specimens in the Amazonas Department and shipping specimens to NAMRU SOUTH Parasitology.

b) Coordinate execution of malaria surveillance activities in the form of passive or active surveillance across Amazonas with local point of contacts.

c) Provide feedback on site performance, identify underperforming sites, and provide remedies which may include alternate sites.

d) Identify and open other field sites at the request of the NAMRU SOUTH.

e) Enroll, collect, and test a minimum of 150 human subjects meeting the inclusion criteria as defined by the governing human use protocol and collect clinical and epidemiological data and biological specimens from participants enrolled in these studies.

f) Packaging and local shipment of samples from field sites to a central laboratory for testing.

g) Perform one shipment of samples on each performance period as requested by NAMRU SOUTH (Shipment costs covered by the contractor).

5.2 LABORATORY ACTIVITIES

a) Perform malaria microscopy on all collected samples on each performance period.

b) Implement standardized molecular biology procedures including but not limited to DNA extraction, loop mediated isothermal amplification (LAMP) and real time PCR for malaria screening.

c) Perform DNA extraction, LAMP and/or real time PCR as required by NAMRU SOUTH on collected specimens for detection of malaria.

6 DATA SHARING

6.1 The contractor shall provide data collection information on enrollment site up to the district level, clinical symptoms and other relevant epidemiological data as requested by NAMRU SOUTH Parasitology.

6.2 At the completion of a study or when requested, the contractor shall provide all data to NAMRU SOUTH.

6.3 The contractor shall provide laboratory testing PCR as requested by NAMRU SOUTH Parasitology.

6.4 Provide input for report, scientific manuscripts, thesis and participate on authorship of resulting manuscripts.

7 EQUIPMENT, SUPPLIES AND MATERIALS

· The contractor will cover the cost of supplies and materials necessary for sample collection, transport, storage and malaria screening.

· Depending on funding availability, NAMRU SOUTH might provide DNA extraction kits, PCR primers and master mix for up to 150 subjects per performance period.

· The contractor shall provide all required equipment. No Government Furnished equipment will be provided.

8 SHIPMENTS

· The contractor shall cover the cost of one shipment of samples per year to NAMRU SOUTH Lima facilities per year upon coordination with the Department of Parasitology.

The delivery address is:

· The Contractor shall include the following into the shipments of samples:

1. Clinical samples collected as part of the study.

1. Nucleic acid material obtained from collected samples covered under this contract.

9 DELIVERABLES

9.1 The contractor shall provide data collection information on enrollment site up to the district level, clinical symptoms and other relevant epidemiological data on a monthly basis or as requested by NAMRU SOUTH Parasitology.

9.2 At the completion of a study or when requested, the contractor shall provide all data to NAMRU SOUTH.

9.3 Provide input for report and scientific manuscripts preparation.

TASK/

DELIVERABLE

ACCEPTABLE LEVEL OF PERFORMANCE (ALP)

METHOD OF SURVEILLANCE

AND RISK RELATED SCHEDULE

PERFORMANCE RATING

Performance meets all technical and functional requirements in the PWS, and contains pertinent, useful, and informative data and information.

Contractor’s technical performance meets all contract requirements.

Problems that are encountered are minor in nature, and are as follows:

· does not cause a delay in schedule;

· does not cause costs to increase;

· involves minimal effort to fix; and

· does not affect overall contractor performance

All matters shall be resolved in a satisfactory and timely manner.

100% Inspection

Are study reports complete and are they compliant with various Government regulations?

Assignment of performance rating and criteria:

Excellent: Performance meets and exceeds contract requirements. Performance delivered with no required re-performance /rework; problems encountered were minor and resolved in a highly effective manner, having no impact on schedule, costs, and overall contractor performance.

Acceptable: Performance meets most contract requirements. Performance delivered with minimal re-performance/rework; problems encountered were minor and resolved in a satisfactory manner.

Unacceptable: Performance fails to meet many contract requirements. Substantial problems were encountered and were resolved in a less than satisfactory manner causing significant impact to schedule, cost, and/or overall contractor performance. Significant re-performance or rework required.

Timeliness of Performance and Services and Product Deliverables, including Administrative aspects of Performance.

Contract requirements met with few minor and no significant problems encountered.

Performance meets all technical and functional requirements in the PWS, and provides on time pertinent, useful, and informative data and information.

Contractor’s technical performance meets all contract requirements.

Problems that are encountered are minor in nature, and are as follows:

· does not cause a delay in schedule;

· does not cause costs to increase;

· involves minimal effort to fix; and

· does not affect overall contractor performance

All matters shall be resolved in a satisfactory and timely manner.

100% Inspection

Is the contractor meeting established timeframes?

Assignment of performance rating and criteria:

Excellent: Performance meets all contract timeliness requirements. Problems that are encountered are minor and resolved in a highly effective manner, having no impact on schedule, cost, and overall contractor performance.

Acceptable: Performance meets most timeliness requirements. Performance delivered with minimal reperformance/ rework; problems encountered were minor and resolved in a satisfactory manner. Minimal impact on schedule, cost, and overall contractor performance Unacceptable: Performance fails to meet many timeliness requirements. Substantial problems were encountered and were resolved in a less than satisfactory manner causing significant impact to schedule,cost, and/or overall contractor performance.

Performance meets all technical and functional requirements in the PWS, and contains pertinent, useful, and informative data and information.

Contractor’s technical performance meets all contract requirements. Problems that are encountered are minor in nature, and are as follows:

· does not cause a delay in schedule;

· does not cause costs to increase;

· involves minimal effort to fix; and

· does not affect overall contractor performance

All matters shall be resolved in a satisfactory and timely manner.

100% Inspection

Is the contractor committed to high customer satisfaction? How proactive is the contractor? Is the contractor providing positive value to the Government?

Has the contractor communicated in a timely manner unexpected delays or issues and proposed alternative solutions to meet governments contract requirements?

Assignment of performance rating and criteria:

Excellent: Performance meets and exceeds contract requirements. Performance delivered with no required re-performance /rework; problems encountered were minor and resolved in a highly effective manner, having no impact on schedule, costs, and overall contractor performance.

Acceptable: Performance meets most contract requirements. Performance delivered with minimal re-performance/rework; problems encountered were minor and resolved in a satisfactory manner. Minimal impact on schedule, cost, and overall contractor performance.

Unacceptable: Performance fails to meet many contract requirements. Substantial problems were encountered and were resolved in a less than satisfactory manner causing significant impact to schedule, cost, and/or overall contractor performance. Significant re-performance or rework required.

Performance meets all technical and functional requirements in the PWS, and contains pertinent, useful, and informative data and information.

Contractor’s technical performance meets all contract requirements. Problems that are encountered are minor in nature, and are as follows:

· does not cause a delay in schedule;

· does not cause costs to increase;

· involves minimal effort to fix; and

· does not affect overall contractor performance

All matters shall be resolved in a satisfactory and timely manner.

Periodic Inspection

What is the Governments overall satisfaction with the contractor?

Assignment of performance rating and criteria:

Excellent: Performance meets and exceeds contract requirements. Performance delivered with no required re-performance /rework; problems encountered were minor and resolved in a highly effective manner, having no impact on schedule, costs, and overall contractor performance.

Acceptable: Performance meets most contract requirements. Performance delivered with minimal re-performance/rework; problems encountered were minor and resolved in a satisfactory manner. Minimal impact on schedule, cost, and overall contractor performance.

Unacceptable: Performance fails to meet many contract requirements. Substantial problems were encountered and were resolved in a less than satisfactory manner causing significant impact to schedule, cost, and/or overall contractor performance. Significant re-performance or rework required.