PWS - NAMRU Ghana.pdf

PERFORMANCE WORK STATEMENT (PWS)

Naval Medical Research Unit Europe, Africa, Central (NAMRU EURAFCENT)

Clinical evaluation of the Xpert® tropical fever test on the Genexpert® Edge X system using venous and capillary whole blood specimens and University of Ghana Medical Centre [UMGC]

PART 1

GENERAL INFORMATION

1. GENERAL: This is a non-personnel services contract to provide sample collection and testing for protocol 258C2: Clinical evaluation of the Xpert® tropical fever test on the Genexpert® Edge X system using venous and capillary whole blood specimens. 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 sample collection and testing for protocol 258C2 as defined in this Performance Work Statement except for those items specified as government furnished property and services. The contractor shall meet the standards in this contract.

1.2 Background: STATEMENT OF WORK (SOW) BETWEEN NAVAL HEALTH RESEARCH CENTER

[NHRC] & NAVY MEDICAL RESEARCH UNIT - EURAFCENT [NAMRU EURAFCENT] FOR 258C2:

Clinical evaluation of the Xpert® tropical fever test on the Genexpert® Edge X system using venous and capillary whole blood specimens is approved to conduct research at University of Ghana Medical Centre (UMGC). The Xpert Tropical Fever test, performed on the GeneXpert Instrument Systems, is an automated, multiplex real-time PCR assay intended for the qualitative in vitro identification of nucleic acids from multiple fever-causing pathogens: Plasmodium species (including differentiation and reporting of P. falciparum), Dengue virus, Zika virus, Chikungunya virus, and Leptospira species. The Xpert Tropical Fever test uses ethylenediaminetetraacetic acid (EDTA) VWB and CWB specimens collected by fingerstick capillary or venous blood draw from patients who are symptomatic for AFI without localizing signs. The test is intended as an aid in the diagnosis of parasitic, viral, or bacterial infections that cause AFI and results should be used in conjunction with clinical and laboratory findings, in addition to epidemiological risk factors such as patient travel history.

1.3 Objectives: Evaluate the clinical performance of the Xpert Tropical Fever test using venous whole blood (VWB) and capillary whole blood (CWB) when performed in an environment representative of a Clinical Laboratory Improvement Amendment (CLIA)-waiver (CW) by untrained users on the GeneXpert Edge X System.

1.4 Scope: Collect capillary and venous blood samples from approximately 100 patients presenting with clinical suspicion of one of the fever causing pathogens for Tropical Fever (Malaria, Dengue, Zika, Chikungunya, and/or Leptospira) and history or residence in/or travel to a geographic region within the last 3 months in which Tropical Fever transmission occurs.

i. 250 uL CWB collected in EDTA coated micro-collection device.

ii. 2.0 mL VWB collected in EDTA coated blood collection tube.2.0 mL.

iii. VWB collected in EDTA coated blood collection tube.

Test capillary blood on-site on the Edge X and GXDX.

Perform laboratory analysis on Edge X, GXDX on-site on a portion of the venous blood and perform Biofire Global Fever Panel comparator testing and Discrepant analysis with use of bi-directional sequencing at sites performing lab (NMIMR)

1.5 Period of Performance: The period of performance shall be for one (1) Base Year of 12 months and one (1) 6-months option period.

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 accordance 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 accordance 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 U.S. Federal Government holidays listed below or on the U.S. Embassy designated Egyptian holidays.

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

1.6.4 Hours of Operation: The contractor is responsible for conducting business, between the hours of 0800-1700, Monday thru Friday, except official Government holidays or when the facility is closed due to local or national emergencies, administrative closings, or similar Government directed facility closings. Each assigned role is expected to contribute approximately five (5) hours per week to the project, as outlined in the accompanying Cepheid Tropical Fever Ghana Sites Budget Combined FY26. For other than firm fixed price contracts, the contractor will not be reimbursed when the government facility is closed for the above reasons. The Contractor shall at all times maintain an adequate workforce for the uninterrupted performance of all tasks defined within this PWS when the Government facility is not closed for the above reasons. When hiring personnel, the Contractor shall keep in mind that the stability and continuity of the workforce are essential.

1.6.5 Place of Performance: The work to be performed under this contract will be performed at the University of Ghana Medical Centre in Ghana.

1.6.6 Type of Contract: The government will award a (Type of contract to be determined by

CCE and the customer).

1.6.7 Security Requirements: Contractor personnel performing work under this contract and working at University of Ghana Medical Centre in Ghana possess a basic security clearance

(for U.S. citizens), a valid host country permit (third country nationals), or obtain U.S.

Embassy clearance (Ghanaian Nationals) at time of the proposal submission, and shall maintain the level of security required for the life of the contract.

1.6.7.1 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.

1.6.7.2 Key Control: The Contractor shall establish and implement methods of making sure all keys/key cards issued to the Contractor by the Government are not lost or misplaced and are not used by unauthorized persons. NOTE: All references to keys include key cards. No keys issued to the Contractor by the Government shall be duplicated. The Contractor shall develop procedures covering key control that shall be included in the Quality Control Plan. Such procedures shall include turn-in of any issued keys by personnel who no longer require access to locked areas. The Contractor shall immediately report any occurrences of lost or duplicate keys/key cards to the Contracting Officer.

1.6.7.2.1 In the event keys, other than master keys, are lost or duplicated, the Contractor shall, upon direction of the Contracting Officer, re-key or replace the affected lock or locks; however, the Government, at its option, may replace the affected lock or locks or perform re-keying. When the replacement of locks or re-keying is performed by the Government, the total cost of re-keying or the replacement of the lock or locks shall be deducted from the monthly payment due the Contractor. In the event a master key is lost or duplicated, all locks and keys for that system shall be replaced by the Government and the total cost deducted from the monthly payment due the Contractor.

1.6.7.2.2 The Contractor shall prohibit the use of Government issued keys/key cards by any persons other than the Contractor’s employees. The Contractor shall prohibit the opening of locked areas by Contractor employees to permit entrance of persons other than Contractor employees engaged in the performance of assigned work in those areas, or personnel authorized entrance by the Contracting Officer.

1.6.7.2.3 Lock Combinations: N/A

1.6.8 Special Qualifications: N/A

1.6.9 Post Award Conference/Periodic Progress MeetingS: The Contractor agrees to attend any post award conference convened by the contracting activity or contract administration office in accordance with Federal Acquisition Regulation Subpart 42.5. The contracting officer, Contracting Officers Representative (COR), and other Government personnel, as appropriate, may meet periodically with the contractor to review the contractor's performance. At these meetings the performance and the contractor will apprise the Government of problems, if any, being experienced. Appropriate action shall be taken to resolve outstanding issues. These meetings shall be at no additional cost to the government.

1.6.10 Contracting Officer Representative (COR): The (COR) will be identified by separate letter.

The COR monitors all technical aspects of the contract and assists in contract administration The COR 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 COR, a copy of which is sent to the Contractor, states the responsibilities and limitations of the COR, especially with regard to changes in cost or price, estimates or changes in delivery dates. The COR is not authorized to change any of the terms and conditions of the resulting order.

1.6.11 Key Personnel: N/A

1.6.12 Identification of Contractor Employees: N/A

1.6.13 Contractor Travel: N/A

1.6.14 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.

1.6.15 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.

1.6.16 PHASE IN /PHASE OUT PERIOD: N/A

PART 2

DEFINITIONS & ACRONYMS

2. 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 CONTRACTING OFFICER'S REPRESENTATIVE (COR). 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.

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

2.0 ACRONYMS:

ACOR Alternate Contracting Officer's Representative AFARS Army Federal Acquisition Regulation Supplement AR Army Regulation CCE Contracting Center of Excellence CFR Code of Federal Regulations CONUS Continental United States (excludes Alaska and Hawaii) COR Contracting Officer Representative COTR Contracting Officer's Technical Representative 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 EURAFCENT US Naval Medical Research Unit Europe, Africa, Central Command NMIMR Noguchi Medical Institute of Medical Research OCI Organizational Conflict of Interest OCONUS Outside Continental United States (includes Alaska and Hawaii) ODC Other Direct Costs PI Principal Investigator 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 TE Technical Exhibit UMGC University of Ghana Medical Centre 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: Shipping/ Handling, Participant compensation; Ethics/ Regulatory approval (including amendment, renewals); Site initiation and study closeout; Data access; Stationery and printing;

Team, training, meetings and coordination; Storage of samples; Community Entry Fees;

Administration and logistics.

3.2 Facilities: N/A

3.3 Utilities: N/A

3.4 Equipment: Through the Government, Cepheid will be providing the GenXPert machine, pouches to run on the GenXPert, and assorted supplies for collecting patient samples, running on the instrument, and shipping to Noguchi for further testing. See attachment 7.

3.5 Materials: Through the Government Cepheid will provide the necessary materials for the contractor staff to provide the support outlined in the Protocol 258C2 and PWS for the work to be performed in the UMGC clinical area. Stationery and printing, Personal Protective Equipment (PPE), will also be funded/ supplied. See attachment 7

PART 4

CONTRACTOR FURNISHED ITEMS AND SERVICES

4. CONTRACTOR FURNISHED ITEMS AND RESPONSIBILITIES:

4.1 General: Lab space

4.2 Secret Facility Clearance: N/A

4.3 Materials:

Collected capillary and venous blood samples from approximately 100 patients presenting with clinical suspicion of one of the fever causing pathogens for Tropical Fever (Malaria, Dengue, Zika, Chikungunya, and/or Leptospira) and history or residence in/or travel to a geographic region within the last 3 months in which Tropical Fever transmission occurs.

i. 250 uL CWB collected in EDTA coated micro-collection device.

ii. 2.0 mL VWB collected in EDTA coated blood collection tube.2.0 mL.

iii. VWB collected in EDTA coated blood collection tube.

4.4 Equipment: N/A

PART 5

SPECIFIC TASKS

5. Specific Tasks:

5.1 Basic Services. The contractor shall provide services for:

5.1.1 Conduct study procedures as described on protocol 258C2 (refer to attachments).

5.1.2 Obtain Institutional Review Board (IRB) approval for protocol & Informed Consent Form

(ICF), prior to study initiation and submit protocol amendments/deviations, progress reports, special reports to IRB.

5.1.3 Performing site IRBs will review and approve documentation, according to country specific regulations prior to trial initiation. Documentation reviewed may include but is not limited to: protocol, principal investigators, informed consents, recruitment procedures, all printed information given to subjects, and information and/or statements regarding compensation.

5.1.4 Performing site will be responsible for the proper conduct of the trial and should be familiar with the appropriate use of Good Clinical Practice (GCP) and applicable regulations.

5.1.5 Ensure adequate delegation of responsibilities and Cepheid led training occurs for all persons assisting with the trial on the protocol, the investigational product and their trial-related duties and functions.

5.1.6 Ensure all privacy and confidentiality safeguards are in place prior to study initiation, and throughout the study, as approved by the IRB.

5.1.7 Create and maintain a regulatory binder. The regulatory binder will stay at the performer site for the duration of the study; however, the study coordinator will update documents (i.e. protocol modifications, IRB-stamped documents, training certificates, written correspondence) as applicable.

5.1.8 Consent and enroll patients according to the IRB-approved protocol and following all privacy and confidentiality safeguards.

5.1.9 Prepare samples for device testing according to package insert instructions. Operate the GeneXpert and Edge X following manufacturer instructions.

5.1.10 Maintain laboratory and laboratory study equipment in conjunction with Safe Laboratory Practice (SLP) guidelines.

5.1.11 Perform Biofire Global Fever Panel comparator testing and discrepant analysis with use of bi-directional Sanger sequencing at the performing lab.

5.1.12 Communicate with NAMRU EURAFCENT regarding study specifics of their concern.

5.1.13 Provide reports to NAMRU EURAFCENT per deliverables to maintain project records (as appropriate), decisions and periodic status project progress through:

i. Periodic/regular teleconferences with NAMRU EURAFCENT and UMGC.

ii. Monthly site status reports.

iii. Site visit reports to be submitted subsequent to each site visit.

iv. Copies of all IRB protocols, amendments and associated documents and their English translations (if applicable).

v. Collection and testing of samples and data entry and reports provided to study monitor as instructed per protocol.

Provide reports to NAMRU EURAFCENT per deliverables to maintain project records (as appropriate), decisions and periodic status of project progress through:

i. Periodic/regular teleconferences with NAMRU EURAFCENT and UMGC.

ii. Monthly site status reports.

iii. Site visit reports to be submitted subsequent to each site visit.

iv. Copies of all IRB protocols, amendments and associated documents and their English translations (if applicable).

v. Collection and testing of samples and data entry and reports provided to study monitor as instructed per protocol.

The following roles and activities are expected to support the facilitation of the protocol

i. Principal Investigator (PI) oversight during the twelve month study window

ii. Co-PI 1 oversight during the twelve month study window

iii. Co-PI 2 oversight during the twelve month study window

iv. Site Administrator will spend an average of five hours per week for the study duration

v. Phlebotomist for sampling (phlebotomy and finger pricking) of both adult and pediatric patients. Four personnel allows for continuous coverage.

vi. Consenter to be split between adult (2) and pediatric (2) participants

vii. Medical Screener to be split between adult (2) and pediatric (2) participants

viii. BioFire Operators, Two to ensure continuity

ix. Data entry personnel, Two data entry personnel at 100% FTE each, one for primary data entry, another for quality assurance

x. Research Assistants to assist with sample processing, storage and retrieval

5.2. Task Heading: N/A

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

PART 6

APPLICABLE PUBLICATIONS

6. APPLICABLE PUBLICATIONS (CURRENT EDITIONS; N/A

6.1. The Contractor shall abide by all applicable regulations, publications, manuals, and local policies and procedures.

6.2 The Contractor shall abide by all procedures defined in Protocol 258C2: Clinical Evaluation of the Xpert® Tropical Fever Test on the Genexpert® Edge X System Using Venous And Capillary Whole Blood Specimens.

PART 7

ATTACHMENT/TECHNICAL EXHIBIT LISTING

7. Attachment/Technical Exhibit List:

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

7.2. Attachment 2/Technical Exhibit 2 – Deliverables Schedule

7.3 Attachment 3/Technical Exhibit 3 – Estimated Workload Data

7.4 Protocol 258C2: Clinical Evaluation of the Xpert® Tropical Fever Test on the Genexpert® Edge X

System Using Venous and Capillary Whole Blood Specimens.

7.5 Statement of Work Between Naval Health Research Center [NHRC] and Naval Medical Research Unit

– EURAFCENT [NAMRU EURAFCENT] for 258C2: Clinical evaluation of the Xpert® tropical fever test on the Genexpert® Edge X system using venous and capillary whole blood specimens

7.6 Cepheid Tropical Fever Ghana Sites Budget Combined FY26

7.7 258C2_Site 605_Packing List_Cepheid to University of Ghana Medical Centre Equipment furnished by government

TECHNICAL EXHIBIT 1

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.

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 Conduct study procedures as described on protocol 258C2

Conduct study in accordance with signed Statement of Investigator, study protocol, Good Clinical Practices, Good Laboratory Practices, Safe Laboratory Practice (SLP) guidelines, and other applicable FDA and/or country specific regulations, regulatory requirements, the Belmont Report, and the Declaration of Helsinki

Compliance shall be maintained at a rate of not less than 98%, as verified through periodic reviews or audits.

Periodic Surveillance as defined by protocol 258C2

PRS # 2

The contractor shall attend Cepheid led training for all people assisting with the trial on the protocol, the investigational product and their trial-related duties and functions.

The contractor shall ensure that all technical staff maintain current training and competency certifications required from Cepheid as defined in protocol 258C2

100% training compliance for all Cepheid investigators and technicians

Periodic Surveillance

PRS # 3

The contractor shall Ensure all privacy and confidentiality safeguards are in place prior to study initiation, and throughout the study.

approved by the IRB.

Zero deviation from the approved IRB standard

100% at the beginning of the study

PRS # 4

The contractor shall Create and maintain a regulatory binder at each study site.

Defined documentation found in protocol 258C2. The study coordinator will update documents (i.e. protocol modifications, IRB-stamped documents, training certificates, written correspondence) as applicable.

Compliance shall be maintained at a rate of not less than 98%, as verified through periodic reviews or audits

Periodic Surveillance

PRS # 5

The contractor shall obtain Consent and enroll patients according to the IRB-approved protocol and follow all privacy and confidentiality safeguards.

100% Compliance Periodic Surveillance

PRS # 6

The contractor shall Collect and Prepare samples for device testing

Operate the GeneXpert and Edge X following manufacturer instructions.

95% success rate (valid results with no instrument/ operational errors) with 100% trained operator compliance

Periodic Surveillance

PRS # 7

The contractor shall Maintain laboratory study equipment

In accordance with Safe Laboratory Practice (SLP) guidelines. Notify NAMRU EURAFCENT in equipment malfunctions, errors, damage.

>98% operational uptime and 100% adherence to safe laboratory use

Periodic Surveillance

PRS # 8

The contractor shall

(See example provided in PRS 1.)

(See example provided in

PRS 1.)

(See example provided in

PRS 1.)

TECHNICAL EXHIBIT 2

DELIVERABLES SCHEDULE

(This technical exhibit lists any reports or documentation that is required as a deliverable to include the frequency, # of copies, medium/format and who/where it is to be submitted. A deliverable is anything that can be physically delivered but may include non-physical things such as meeting minutes. Note: All PWS deliverables should be included in this exhibit.)

Deliverable Frequency # of Copies Medium/Format Submit To

Obtain Institutional Review Board (IRB) approval for protocol & Informed Consent Form (ICF), and submit protocol amendments/devi ations, progress reports, special reports to IRB prior to study initiation

1 printed copy to be filed in regulatory binder 1 electronic copy.

1 printed copy to be filed in regulatory binder.

1 electronic copy.

IRB, NAMRU

EURAFCENT

Principal Investigator Required for Cepheid Review

Collect capillary and venous blood samples from approximately 100 patients presenting with clinical suspicion of one of the fever causing pathogens for Tropical Fever (Malaria, Dengue, Zika, Chikungunya, and/or Leptospira) and history or residence in/or travel to a geographic region within the last 3 months in which Tropical Fever transmission occurs.

For the duration of the 12-month study collection period appx 100 samples i.250 uL CWB collected in EDTA coated micro-collection device.

ii. 2.0 mL VWB collected in EDTA coated blood collection tube.2.0 mL.

iii. VWB collected in EDTA coated blood collection tube.

Noguchi Memorial Institute of Medical Research

(NMIMR)

Test samples collected on side using GenXPert

For the duration of the 12-month study collection period

Appx. 100 samples Aliquot Noguchi for further advanced testing (sequencing).

TECHNICAL EXHIBIT 3

ESTIMATED WORKLOAD DATA

(This technical exhibit lists the historical workload data, i.e., the hours previously performed under the PWS by labor category. This workload data should be used to prepare the Independent Government Cost Estimate (IGCE), if available. Note: Based on the PWS, historical workload data can be provided in other formats, i.e., the volume of tasks order issued over a five year period, the number of users by locations requiring Information Technology Support, etc.)

ITEM

NAME

ESTIMATED QUANTITY

1 Principal Investigator 1 12 months

2 Co- PI 1 1 12 months

3 Co PI 2 1 12 months

4 Site Administrator 1 12 months

5 Phlebotomist 4 1 hour per

(100) patients

6 Consenter

4 1 hour per

(100) patients

7 Medical Screener

4 1 hour per

(100) patient

8 BioFire Operators

2 2 hours per patient

9 Data entry personnel

2 12 months

10 Research Assistants

2 12 months