HSHQDC-09-R-00045

GEN-3 BioWatch Request for Proposals

HSHQDC-09-R-00045

U.S. Department of Homeland Security

BioWatch GEN-3

Request for Proposal

HSHQDC-09-R-00045

U.S. Dept. of Homeland Security Office of Procurement Operations PHA Acquisition Division 245 Murray Lane, SW Building 410 Washington DC 20528

SOLICITATION, OFFER AND AWARD

I

NOTE: In sealed bid solicitations "offer and "offeror mean "bid" and "bMder.

SOLICITATION

9. Sealed offers in onginai and copies for furnishing the supplies or S ~ N ~ C ~ S in the Schedule will be received at the place specified in Item 8, or if hand carned, in the

1. THIS CONTRACT IS A RATED

ORDER UNDER DPAS (15 CFR 700)

deposiiom located in until 12 00 ES local time 06/26/2009 (Hour) (Date)

CAUTION. LATE Submissions. Modincations. and Withdrawals: See Sedion L. Provision No. 52.214-7 or 52.215-1. All offers are subied to all terms and conditions contained in this soliclation.

2 CONTRACT NUMBER

RATING

11. TABLE OF CONTENTS

(XI I SEC. I DESCRIPTION IPAGEISI I (XI I SEC. I DESCRIPTION I PAGE(S)

PAGE OF PAGES

1 1 75

7. ISSUED BY CODE IDHS/OPO/PHA/OHA 18. ADDRESS OFFER TO (11 other than Item 7)

3. SOLlCiTATlON NUMBER

HSHQDC-09-R-00045

10. FOR

INFORMATION

CALL:

PART I - THE SCHEDULE I PART Ii - CONTRACT CLAUSES

I A I SOLICITATIONICONTRACT FORM 1 2 - 3 1 rn 1 I ( CONTRACT CLAUSES 135-47 I B I SUPPLIES OR SERVICES AND PRlCESlCOSTS 1 4 - 5 1 PART Ill - LIST OF DOCUMENTS. EXHIBITS AND OTHER ATTACH.

4. TYPE OF SOLICITATION

O ~ E A L E D B I D ( I F B )

NEGOTIATED (RFP)

bir::a Moorman

IA I C I DESCRIPTIONISPECS.fWORK STATEMENT 1 6- 17 I rn I J I LISTOF ATTACHMENTS 148 I D 1 PACKAGING ANDMARKING I 1 8 - 1 9 1 PART IV - REPRESENTATIONS AND INSTRUCTIONS

5. DATE ISSUED

05/27/2009

I H I SPECIAL CONTRACT REQUIREMENTS 1 2 9 - 3 4 1 I M I EVALUATION FACTORS FOR AWARD 173-75 OFFER (Must b e fullv m m o l e t e d b v offeror)

6. REQUISITIONIPURCHASE NUMBER

C E-MAIL ADDRESS

wanda.moorman@dhs.gov

B TELEPHONE (NO COLLECT CALLS)

[IP

rn

NOTE: Item 12 does not apply if the solicitation includes the provisions at 61.214-16. Minimum Bid Acceptance Period.

12. in compliance with the above, the undersigned agrees, if this o m r is accepted within calendar days (60 calendar days unless a different period 1s inseded by the offeror) rrom the date for receipt of offers specified above, to furnish any or aH items upon which prices are offered at the pl iw set opposite each item, delivered at the

AREA CODE

E

F

G

NUMBER

447-5027 designated point(s), within the time specified in the schedule

OFFEROR

EXT

INSPECTION AND ACCEPTANCE

DELIVERIES OR PERFORMANCE

CONTRACT ADMINISTRATION DATA

13. DISCOUNT FOR PROMPT PAYMENT

(See Seclion I. Clause No. 52.232.8)

14. ACKNOWLEDGEMENT OF AMENDMENTS

(The oWem acknowledges receipt of amendments to the SOLlClTATlON for oWemrs and reletad documents numbered and dated).

2 0 21-23 2 4 - 2 8

I 0 CALENDAR DAYS (%)

16. NAME AND TITLE OF PERSON AUTHORIZED TO SIGN OFFER

(Type orpint)

15A NAME

AND

I I

SUCH ADDRESS IN SCHEDULE.

AWARD (To b e completed b y government)

K

L

20 CALENDAR DAYS (%)

CODE

18. OFFER DATE

19. ACCEPTED AS TO ITEMS NUMBERED

I

22. AUTHORIN FOR USING OTHER THAN FULL AND OPEN COMPETITION:

10 U.S.C. 2304 (C) ( ) 41 U.S.C. 253 (C) ( )

24. AOMlNiSTERED BY (Ilotherfhan A m 7) CODE

26. NAME OF CONTRACTING OFFICER (Type orpnnf)

FACILITY

17. SIGNATURE

Wanda Moorman

REPRESENTATIONS. CERTIFICATIONS AND

OTHER STATEMENTS OF OFFERORS

INSTRS.. CONDS.. AND NOTICES TO OFFERORS

30 CALENDAR DAYS (%)

AMENDMENT NO.

15C. CHECK IF REMITTANCE ADDRESS

IS DIFFERENT FROM ABOVE - ENTER

158. TELEPHONE NUMBER

20. AMOUNT

23. SUBMIT INVOICES TO ADDRESS SHOWN IN

(4 copies unless othemise specitled)

25. PAYMENT WILL BE MADE BY +

(Sfgnaturn of Confracting OfKcer)

4 9-55

56-72

CALENDAR DAYS (%)

AMENDMENT NO. DATE

AREA CODE

21. ACCOUNTING AND APPROPRIATION

27. UNITED STATES OF AMERICA

IMPORTANT - Award will be made on this Form, or on Standard Form 28, or by other authorized omcial wrinen notice AUTHORIZED FOR LOCAL REPRODUCTiON STANDARD FORM 33 (Rev. 9-97) Previous ednion is unusable Prescribed by GSA - FAR (48 CFR) 53 214(c)

DATE

NUMBER IEXT.

28 AWARD DATE

NAME OF OFFEROR OR CONTRACTOR

CONTINUATlON SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED

HSHQDC- 0 9-R- 00 0 4 5

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GEN-3 BioWatch Request For Proposal

RFP NO. HSHQDC-09-R-00045

SECTION B - SUPPLIES OR SERVICES AND PRICESICOSTS

The Contractor shall provide autonomous biodetectors at a Technology Readiness Level of 6+ or greater and all other necessary equipment, consumables, and technical support to allow the Government to conduct independent testing at Government-designated sites. The Gen-3 system will be a fully autonomous network of biodetectors that will continuously monitor the air in designated locations throughout the United States for biothreat agents of public health concern.

B.l Contract Line Items (CLINs)

PRICED CLINs

Base Year Ordering Period

CLIN OPTIONS

Base Year Ordering Period

Engineering changes, Validation of Engineering Changes, Base Year - Task Order 1 : Assay Validation And Characterization Testing Base Year - Task Order 2: Field Test

B.2 Indirect Costs

The Contractor will be reimbursed for indirect costs at the following rate(s) subject to appropriate adjustment when the final rate(s) for the period are established:

COST CENTER RATE

operations and ~ainienance Ordering Period Option Year 2 - Engineering Changes, Validation of Engineering Changes, Operations and Maintenance

BASE CONTRACT YEAR

LOT

LOT

(** To be inserted at the time of contract award)

Department of Homeland Security 4

CPFF

CPFF

MOS.

TBD

TBD

GEN9 BioWatch Request For Proposal

B.3 Fixed-Fee

The fixed-fee percentage of this contract is m. The fixed-fee amount of an issued task order shall be at the same fixed fee established at the contract level. Should the cost of the order increase during performance the amount of the fee shall not change but remain fixed at the value established when the task was issued. The fixed-fee withholding provisions contained in clause

52.21 6-8, Fixed-Fee, are applicable to individual task orders. A modification or change to a task order directing additional or new work shall be fee bearing. The maximum contract value contained in the clause, Estimated Cost and Fixed Fee, has no bearing on the fixed fee amount established at the task order level.

B.6 Minimum Dollar Guarantee and Maximum Contract Limitation

The minimum value guaranteed under this contract, including options is $25,000 (Estimated cost and Fixed Fee). The Government shall issue one or more task orders for an amount not less than this minimum. There will be no further obligation on the part of the Government to issue additional orders thereafter. The maximum value of this contract across all task order contracts is $37 Million (Estimated Cost and Fixed Fee) over a three-year period for each award.

For purposes of contract estimates, the projected program budget for the DHS effort, inclusive of fee, under the proposed award is estimated at approximately $37 Million over a three-year period (base period and 2 option years) for each award. The contractor is hereby notified that due to unanticipated budget fluctuations, funding could change with little or no notice. The total amount allotted by the Government to this award for the base period is estimated to be $29.3 Million.

B.7 Adding New Labor Categories After Contract Award

The labor categories listed in the pricing tables (Attachment 5.6) represent the Contractor's best analysis of current and projected BioWatch requirements. The Government does not intend to add any labor categories to the contract after contract award. However, changes in the DHS mission, the emergence of new technologies, and other fundamental changes affecting the BioWatch requirements may necessitate the addition of new labor categories. Either annually, or at the Government's request, the contractor may propose additional labor categories/descriptions/rates to add to the contract that are necessary for performance. The Government will negotiate these rates on a case by case basis.

[End of Section B]

Department of Homeland Security 5

RFP NO. HSHQDC.09-R-00045

SECTION C - PHASE I STATEMENT OF OBJECTIVES (SOO)

C.l Introduction

The current BioWatch detection system, termed Generation-1 (Gen-1)lGeneration-2 (Gen-2), consists of aerosol collectors that contain filters that are manually retrieved for transport and subsequent analysis in a Laboratory Response Network facility. This system, while beneficial, is labor-intensive, costly, and the resultant data is significantly time-delayed.

To achieve significant improvements in these areas, the Department of Homeland Security (DHS) Office of Health Affairs (OHA), intends to procure and deploy a Generation 3 (Gen-3) BioWatch autonomous detection system. The Gen-3 detection system will be a fully autonomous network of biodetectors that will continuously monitor the air (24 hours per day, 365 days per year) in selected jurisdictions for agents of biological concern.

DHS plans a two-phase acquisition for Gen 3 with separate, competitive Requests for Proposals for each phase. During Phase I, DHS will demonstrate system performance. If Phase I1 is implemented, DHS will produce, deploy, and operate the system. Offerors for the Phase I1 solicitation are not required to participate in Phase I; however, if Phase I1 is implemented, DHS will require Phase I1 offerors to demonstrate that their proposed biodetection technology is ready for low-rate initial production.

This SO0 only applies to Phase I.

C.2 Purpose

Phase I seeks to identify and test biodetection systems through a System Performance and Demonstration contract. This requirement supports DHS plans to conduct independent field testing to demonstrate that available autonomous biodetector systems meet or exceed the performance threshold values described in Attachment J.1. The purpose of this acquisition is to acquire a limited number of autonomous biodetectors at TRL-6+ or greater and all other necessary equipment, consumables, and technical support to allow the Government to conduct independent testing at Government-designated sites. TRL 6+ is defined in Attachment 5.2. DHS anticipates that additional task orders may be issued for engineering changeslenhancements and validation in the option year(s) based on the results of testing activities described in Section C.6, below.

C.3 Scope of Contract

The contractor shall provide autonomous biodetectors and the full range of support to include consumables, data management, operations and maintenance capability, and technical personnel to support the test activities described in this SOO. The test program consists of characterization testing at laboratory locations with follow-on demonstrations of autonomous biodetectors conducted in field locations. These tests will provide the data necessary to evaluate the technical merits of each biodetector. The contractor shall provide autonomous biodetectors for field testing and characterization/live agent testing, as well as technical support during the testing period.

Department of Homeland Security 6

C.4 Background

The BioWatch Program was announced in January 2003. The program addresses the need for biodefense measures for the civilian population consistent with Homeland Security Presidential Directive 10 (HSPD- 1 O), Biodefense for the 2 1 st Century.

The BioWatch Program operates nationwide, focusing on protecting major population centers.

The program is a partnership between Federal, State, and local governments for the purpose of ensuring the protection of the nation's population against biological terrorist threats.

The current operational system is comprised of fielded aerosol collectors and teams of support personnel including field, laboratory, public health, and responders from Federal, State, and local organizations. These coordinated teams are responsible for installing the aerosol collectors (air samplers), daily sample collection and laboratory analysis, results reporting, and responding to Polymerase Chain Reaction (PCR)-verified positive signals.

To achieve significant improvements in timeliness and coverage, the Department of Homeland Security (DHS) Office of Health Affairs (OHA), will procure and deploy a Generation 3 (Gen-3) BioWatch autonomous detection system. The Gen-3 system will be based on an open systems architecture, and will be fully interoperable at the system and subsystem level. The network will be optimized to reduce cost of ownership.

Unlike the collectors currently fielded, the Gen-3 biodetectors will not only collect, but also analyze air samples autonomously. The primary functions of the proposed detection system include detection, reporting, archiving, self-assessment, failure analysis, and fault isolation.

Detection includes sample collection, preparation, analysis, and waste handling. The proposed Gen-3 system will be fully interoperable with other BioWatch system components (data repositories, reporting systems) using contractor-independent technologies. The Gen-3 system shall provide prompt notification of biological events, and provide information components to assist decision makers in determining if an event is a threat to public health.

C.5 Performance Objectives, Goals and Outcomes

Under the Phase I System Performance Demonstration contract, OHA will test mature biodetectors (TRL 6+) in laboratory settings, as well as in an operationally relevant environment, to determine the adequacy of these systems for future procurement and deployment. OHA may also issue additional task orders for engineering1 enhancements to correct and validate issues identified during testing activities described in Section C.6, below.

The Phase I1 Production and Deployment contract for the Gen-3 system will be conducted under a separate procurement. If implemented, Phase I1 activities will include (but not be limited to) Operational Test and Evaluation (OT&E) of Gen-3 production detectors, transition from OT&E to full rate production, deployment, operations, maintenance, and transition from the existing (Gen-1lGen-2) system.

Under the Phase I program, DHS requires that the contractor provide the biodetectors and all technical and operational support to enable the Government to execute its planned test program.

Objectives - DHS to test the performance of biodetectors proposed by the contractor that:

Conform to the performance specification detailed in Attachment J.1.

Department of Homeland Security 7

GEN.3 BioWatch Request For Proposal

Demonstrate a minimum system maturity level of TRL 6+ (defined in Attachment 5.2).

Contain acceptable assays and utilize reagents produced with adequate quality control procedures (see Section C.6.1, below for further definition of this objective).

Requirements - The contractor shall:

Deliver biodetectors for testing (quantities required are described in Attachment 5.3).

The items proposed must be baselined and under configuration control, and the contractor shall certify that all provided biodetectors are identical and from the same assembly line.

The quantities required by the Government do not include spare units. Rather, the contractor shall propose the number of spares required to successfully cover the entirety of the testing activities.

Operate biodetectors to support planned tests to include replenishment, consumables (including qualified reagents), and repairlmaintenance as appropriate (an independent testing organization will be responsible for ensuring that the contractor personnel do not actively participate in testing activities and that the independent nature of the test is not compromised).

Provide technical assistance to the test laboratory personnel to operate, disassemble, or reassemble their proposed equipment as required.

Restore baseline capability between tests (characterization testing only).

Establish capability within the independent testing organization and operational test jurisdiction (specifically BioWatch Lab personnel & BioWatch Action Committee) to receive, interpret, and monitor the test results to evaluate the performance of the equipment.

Collect data and provide reports (Reliability, Availability, Maintainability and Testability (RAM-T) and IT performance data.

Provide engineering and configuration support.

DHS will provide applicable test reports to the contractor, consisting of test data pertaining to that contractor's technology only. Following the receipt of the test reports, the contractor may be provided the opportunity to propose engineering changes/ modifications. If the changes are accepted and implemented, the Government will validate the changes as necessary (see Section C.6.4). In order to keep strict adherence to program schedules, DHS plans to run testing activities concurrently when feasible.

Unless otherwise specified in a task order, candidate biodetection systems will not be operated in an actionable mode during Phase I of this program. 'Actionable mode' is defined as the reliance on any signals generated by any of the candidate systems for public safety purposes, including the protection of people or property from exposure to biological agents.

Department of Homeland Security 8

C.6 Planned Testing Program And Constraints

The test program will be conducted with five distinct parts, as applicable:

validation of assay technology/characterization testing;

field testing in a jurisdiction;

engineering changes;

validation of changes and modifications/characterization; and field testing of changes/modifications.

All test assets exposed to biological threat agents, either live or killed, will be destroyed at the expense of the Government, and will not be used in subsequent test events unless otherwise specified. Test assets not exposed to biological threat agents, either live or killed, may be used in subsequent test events at the discretion of the Government. An estimate of the resources required from the contractor for the testing program is included in Attachment 5.3.

C.6.1 Task Order 1 Assay Validation

C.6.1.1 Assay Validation-The purpose of the Gen-3 System Assay Validation activity is to independently establish the assay performance in terms of sensitivity, specificity (inclusivity and exclusivity), repeatability, robustness, and reagent quality (lot-to-lot variability and reagent stability) for eventual use in its intended operational environment. DHS OHA and the Science and Technology Directorate (S&T), in coordination with the Centers for Disease Control and Prevention (CDC), will develop performance standards required for Public Health actionable assays. The validation process will use standard protocols, contractor-provided quality controlled reagents, instruments, and laboratory workers certified as proficient in the test system.

Assay validation will be conducted at independent Government designated testing facilities whose personnel have been certified as qualified to perform the protocols and procedures using the major components of the analytical subsystem in a benchtop configuration. The contractor will provide two (2) analyhcal components from the autonomous detection system for the Assay Validation effort. The contractor shall be required to provide training and certification on the operation of its analytical component to the independent laboratory personnel. The test period is expected to begin two (2) months after contract award and continue for three (3) months.

Additional information on assay validation will be available in the Gen-3 Offeror's Library. The library will contain technical documentation and information, and is available for inspection and review by prospective offerors by appointment on1 . The library of technical documentation and information is X located at 301 7 Street, SW, Washington, DC in the U.S. General Services Administration Building (see Section L.6 for instructions for accessing the offeror technical library). Prospective offerors visiting the technical library will be required to execute a DHS Non Disclosure Agreement before access to the technical library will be permitted. Prospective offerors will be allowed to review materials in the library, but copies will not be allowed, cameras (to include mobile phone cameras or other recording devices), cell phones, Department of Homeland Security 9 blackberries, laptops, etc. will not be allowed, nor can documents be removed from the library. Library materials will not be made available in electronic format.

C.6.2 Task Order 1 Characterization Testing

C.6.2.1 Characterization Testing- The contractor shall provide the required number of biodetectors and provide technical support for the duration of the test program, inclusive of all services, materials, and transportation required to ensure accomplishment of the test objectives. This activity consists of subsystem level testing, system level tests, RAM-T data collection, Information Technology (IT) verification/validation and all relevant report generation actions. The test period is expected to begin four (4) months after contract award and continue for five

(5) months.

The contractor shall be required to support all test activities to include supplying/installing all consumables (including quality-controlled reagents), providing any required preventive maintenance, and repairs in the event of a system break down during the course of the field testing. The contractor shall ensure that their system is baselined and calibrated between tests. Due to the high fidelity of the data gathered during this testing, DHS needs to ensure that each candidate system is functioning properly, and that any changes are documented to the government and have not altered the performance characteristics of the system. An independent testing organization will ensure that the contractor personnel do not actively participate in testing activities and that the independent nature of the test is not compromised.

C.6.2.1.1 Aerosol Collection Subsystem Test. The goal of this subsystem test is to measure the collection efficiency of the aerosol collection subsystem of the candidate autonomous detection systems under a variety of conditions I parameters. The aerosol collection subsystem includes all hardware involved in aerosol collection and processing steps to produce a sample for analysis. Two (2) units (or applicable subsystem(s)) of each candidate biodetector (with all necessary support equipment) will be required for the aerosol collection subsystem test (excluding spares, see Section C.5). This test will take place in a biological aerosol chamber large enough to contain the candidate autonomous detection system aerosol collection subsystems and necessary testing instrumentation. The contractor will be required to provide personnel to disassemble the unit and assist in the testing. This will take place 40 hours a week over a one (1) month period at Edgewood Chemical Biological Center (ECBC).

C.6.2.1.2 Analytical Subsystem Test 2.a. The goal of the Analytical Subsystem Test 2.a is to define the relationship between each candidate autonomous detection system analytical subsystem's detection response and concentration levels for applicable BioWatch threat agents. The analysis subsystem includes all hardware (and software) involved in the sample analysis. Four (4) units of each candidate biodetector (with all associated equipment) shall be available each test day for the Analytical Subsystem Test 2.a. (excluding spares, see Section C.5). This test will take place in a Biological Safety Level-213 (BSL-213) laboratory setting. Each

Department of Homeland Security 10 candidate autonomous detection system analytical subsystem will be tested with a variety of spiked liquid samples in a "blind" format (i.e., the system operator does not know the contents of the spiked samples). The data gathered (by the Government) during this test will enable the limit of detection to be calculated (or inferred) for each agent tested and will identify the "target concentration" (agent concentration at or slightly above the limit of detection) for each agent for subsequent testing. The contractor shall provide all consumables, equipment, and technical support to operate and have available four biodetector systems each test day over the one (1) month period of this test. The contractor shall ensure that each available biodetector system is ready to perform at a baseline level prior to the start of each test. The contractor shall not be required to enter the BSL-213 laboratory setting, rather the contractor shall direct test facility personnel to conduct required tasks in that setting. Tests are planned to be conducted five (5) days a week for the four (4) week test period at Dugway Proving Ground (DPG).

C.6.2.1.3 Analytical Subsystem Test 2.b. The goal of Analytical Subsystem Test 2.b is to determine the probability of detection for each candidate autonomous detection system analysis subsystem at the "target concentration" for each BioWatch threat agent. The target concentration will be measured during Analytical Subsystem Test 2.b. Four units of each candidate biodetector (with all associated equipment) shall be available each test day for the Analytical Subsystem Test 2.b (same systems used in Analytical Subsystem Test 2.a). This test will take place in a biological safety level (BSL) 213 laboratory setting. The data gathered during the Analytical Subsystem Test 2.b will be used to compare the candidate system's analysis subsystem response to the frequency of that response.

This will enable the probability of detection and false positive rates to be calculated (or inferred) for each agent tested at the target concentration at a given analysis subsystem response threshold. The contractor shall provide all consumables, equipment, and technical support to operate and have available four (4) biodetector systems each test day over the three (3) month period of this test. The contractor will not be required to enter the BSL-213 laboratory setting, rather the contractor shall direct test facility personnel to conduct required tasks in that setting. Tests will be conducted five (5) days a week for the twelve (12) week test period at DPG. The contractor will ensure that the biodetector system is ready to perform at a baseline level prior to the start of each test. Following completion of Analytical Subsystem tests 2.a. and 2.b., the Government will dispose of the biodetectors.

C.6.2.1.4 System Chamber Test. The goals of the System Chamber Test are to validate the findings from the previous subsystem tests and determine the ability of the candidate autonomous detection systems to detect aerosolized BioWatch Threat Agents (killed or live) and report those findings via the appropriate BioWatch communication network. This test will be conducted in a biological aerosol chamber large enough to contain the candidate autonomous detection systems and necessary test instrumentation. Two (2) units of each candidate biodetector (with all associated equipment) will be required for the systems level test (excluding

Department of Homeland Security 11 spares, see Section C.5). The candidate autonomous detection systems will be tested with a variety of biological aerosol releases. It is planned that the contractor will maintain adequate supplies, consumables and personnel to support the planned test. It is envisioned that a single test on one detector will be conducted per day, five (5) days a week for a duration of six (6) weeks. The contractor shall ensure that the detectors are ready to perform at the baseline level prior to the start of each test. Following completion of system test activities, due to exposure to BioWatch Threat Agents, the Government will dispose of the biodetectors.

C.6.3 Task Order 2 Field Test

C.6.3.1 Field Testing - Based on successful achievement of technical objectives of the activities described in Section C.6.1 (or if data from testing previously performed gives DHS reason to believe that the objectives will be met) the Government may proceed with field testing. Ten (10) units of the biodetection system (excluding spares, see Section C.5) will be required for the field test; five units will be placed in Chicago, and five will be placed in New York City (projection but may change at the Government's discretion). An additional two (2) units will be required to support reliability, availability, maintainability, and testability (RAM-T) testing and IT verification and validation. Each contractor will be responsible for providing equipment and technical support, including the operations and maintenance of their systems during the course of the field test.

This support will include supplying/replenishing all consumables, providing any required preventative maintenance, and fixing the system should it break down during the course of the field testing. Due to the high fidelity of the data gathered during this testing, DHS needs to ensure that each candidate system is functioning properly, and that any changes are documented to the government and have not altered the performance characteristics of the system. An independent testing organization will ensure that the contractor personnel do not actively participate in testing activities and that the independent nature of the test is not compromised. Required support for operational field testing includes:

C.6.3.1.1 Jurisdictional Training and Coordination. The contractor shall be required to provide equipment for signal receipt and training to the Lab personnel in the field testing jurisdiction.

C.6.3.1.2 Detector Baseline Calibration for Field Test Start. The contractor will be given approximately one (1) month to install I set-up and baseline their units at the operation testing sites identified by DHS.

At the end of the set up I baseline period, the Field Test will commence.

Each biodetector will be co-located in indoor and outdoor environments with other competitive autonomous biodetectors and a Gen-2 collector.

The Government will identify the site(s) and provide site prep and security for the biodetectors during the duration of the test. The contractor shall be responsible for the security of the system enclosure (i.e., locked door to access interior of system).

C.6.3.1.3 Operational Environment Field Testing. The autonomous detection systems will be split between indoor and outdoor locations

Department of Homeland Security 12 based upon pre-developed deployment plan. The objectives of the operational environment field testing include:

Demonstrate suitability - The candidate autonomous detection system can simultaneously monitor for all BioWatch threat agents within the applicable environment Demonstrate effectiveness - The autonomous biodetectors provide autonomous operation to include sample collection, preparation, analysis, waste handling, reporting, archiving, and self-assessment;

networked operation; full control by an operator on site or from a remote location; and interoperability with relevant IT systems Demonstrate sustainability - The autonomous biodetectors operate continuously as required.

Demonstrate IT system - The autonomous biodetector's IT systems operate as required.

Demonstrate Reliability, Availability, Maintainability and Testability (RAM-T) - During operational testing RAM-T shall evaluate and validate overall supportability of the system. The evaluation will be conducted in accordance with the TEMP and include factors that contribute to an optimum environment for developing and sustaining a stable, operational system. The system maintainability demonstration shall verify the accuracy of maintainability time estimates of individual maintenance tasks needed to repair and restore service to the biodetection system. Maintenance tasks are conducted by personnel using specified skill levels and prescribed procedures and resources and the tester records the time it takes to perform each task.

C.6.3.2 Reliability, Availability, Maintainability and Testability (RAM-T) Data Collection. The goals of the RAM-T Data Collection effort are to: 1) gather RAM-T data on each autonomous detection system in an applicable operational environment, and 2) conduct verification and validation on the proposed information technology (IT) system for each autonomous biodetector. This effort will be conducted in applicable operational environments (i.e., indoor environment, outdoor environment). RAM-T testing is expected to take place in a single indoor and outdoor location in the greater Metropolitan Washington DC area. Two (2) units of each candidate biodetector (with all associated equipment) shall be required for the RAM-T data collection effort (excluding spares, see Section C.5). Each candidate system will be co-located with a Gen-112 collector.

The contractor shall maintain supplies, consumables, and personnel adequate to keep the biodetector units operational 2417 and to provide failure analysis data for a period of four months at a single location. Failure analysis data will identify all observed problems by test unit / instrument, the sub-system at fault, the total time the system / sub-system was down and the required corrective maintenance action needed to repair the problem and restore the system /sub-system. The categories for subsystem at fault and associated subsystems will be agreed to prior to the start of testing.

C.6.3.3 IT Signal Processing V&V and Report Generation. The goal of this activity is to gather data from biodetectors to support independent verification and validation (V&V) of signal processing and report generation functions. The

Department of Homeland Security 13 contractor shall establish a capability to gather data from the two (2) units deployed to support RAM-T activities (described in C.6.3.2). The contractor shall develop and document procedures to capture and validate data content, structure and compliance with required standards and conventions. During IT testing the contractor shall generate reports that summarize device status, date and time of signal, signal content, and compliance. Regular production data verification shall be ongoing during normal detector operation. Data logs will be generated on an ongoing basis for analysis and compliance verification. IT Signal Processing V&V and Report Generation activities will support monitoring of detector functionality and analysis results, long-term reliability testing and security, and shall provide BioWatch administration personnel with assurance that system functionality is uncompromised.

C.6.4 Engineering Changes (Optional Future Task Order(s))

On completion of Task Order #2, the Government may require the contractor to address changes identified during Task Orders #1 & #2 performance. The contractor shall develop a solution and provide the Government with a data package describing the design changes and developmental testing data validating the impacts of the changes.

C.6.5 Validation of Engineering Changes (Optional Future Task Order(s))

Based on the engineering changes proposed by the contractor under C.6.3, the Government will evaluate how much regression testing is required to demonstrate effectiveness and suitability of the system. The contractor shall support the required regression testing activities, including retrofit or manufacture new test units. The contractor shall be responsible for providing equipment and technical support including the operations and maintenance of their systems during the course of testing at Government facilities or in the field. This support shall include supplying/replenishing all consumables, providing any required preventative maintenance, and fixing the system should it break down during the course of the field testing. The independent testing organization will accompany each contractor team whenever they access their systems during the course of the testing to ensure the test is not compromised. Required support may include: biodetector manufacturing, delivery, and installation, training and coordination, detector calibration, and operations and maintenance.

C.6.6 Operations and Maintenance (Optional Future Task Order(s))

DHS may elect to conduct extended field testing of Phase I biodetection systems following engineering changes. The contractor shall provide operations and maintenance of biodetection systems at designated locations. The contractor shall be responsible for providing equipment and technical support, including the operations and maintenance of their systems. This support shall include supplyinglreplenishing all consumables, providing any required preventative maintenance, and fixing the system should it break down.

C.7 Other Requirements

C.7.1 Major Program Technical Milestones - The Contractor shall meet the following three major technical milestones as follows:

Milestone #1 - The contractor shall successfully complete the I-month subsystem level testing (aerosol collection subsystem and analytical

Department of Homeland Security 14 subsystem 2.a) within the scheduled timeframe to proceed to systems level chamber test (conducted under Task Order 1);

Milestone #2 - The contractor shall successfully complete Analytical Subsystem Test 2b and Systems Level Test within the scheduled timeframe to proceed to field testing (conducted under Task Order 2);

Milestone #3 - The contractor must successfully complete field testing activities within the scheduled timeframe to proceed to optional future task orders.

Because of the cost and logistics of testing activities, if the Contractor does not successfully complete these milestones within schedule, the contractor may not receive additional funding or task orders under the Contract.

DHS will require the contractor to support major technical milestones, as well as other technical and programmatic reviews at the contractor's location or at other locations designated by the Govemment. Support may include attendance at reviews, briefing of technical and programmatic issues, and provision of hard and soft copies of technical and programmatic documentation in advance of review dates to enable independent technical analysis.

C.7.2 Technology Readiness Assessment - DHS will use Technology Readiness Assessments (TRAs) as a source of entrance criteria into the field-testing program. The contractor will provide adequate information to permit the Govemment to determine the TRL level for each candidate technology throughout the conduct of this contract. The TRL levels are described in Attachment 5.2.

C.7.3 Management Information - DHS will require the submission of Monthly Project Status Reports (MPSR) as described in Section F.lO.l of the RFP.

C.7.4 Configuration Management

C.7.4.1 DHS envisions that the contractor will wish to make minor modifications and adjustments to the biodetector equipment or manufacturing processes as a result of characterization and field testing. To ensure that the Government is fully engaged and informed about the technologies and the various options for improving them, the contractor must maintain a robust configuration management system. The contractor will be expected to submit proposed changes/modifications for approval.

C.7.4.2 DHS anticipates the need to validate selected engineering changes. If the program implements modifications or changes that will require additional characterization and system tests, the contractor will need to provide the consumables and technical support for this effort as described in Section 6, above.

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C.8 Government Test Support

C.8.1 The Government will provide secure storage and repair facilities for the duration of the characterization testing. These facilities will be located on the properties of Dugway Proving Ground and Edgewood Chemical and Biological Center.

C.8.2 The Government will provide test plans and a detailed schedule of testing no later than 30 days prior to the start of characterization or operational testing.

C.8.3 During field testing the Government will identify sites for the deployment of the detector systems. The Government will provide site preparation and security for deployed biodetectors for the duration of the test. The Government will not provide storage and/or repair facilities for contractor use in the jurisdictions during field testing.

C.8.4 No other Government Test Support should be assumed for the purpose of preparing a proposal in response to this RFP.

C.9 Open System StandardsIModularity

Phase I activities are designed to create opportunities to shape the Phase I1 acquisition. DHS has the following objectives for Phase I activities:

To the greatest extent feasible, conform to acceptable or best practice communications/data transmit requirements, including application of open systems standards at the subsystem and system levels. The approach to open systems architecture, integration, major systems interfaces, and information assurance are defined in the BioWatch Data Lnteroperability Strategy document, available in the Gen 3 Offerors Library (see Section 6.1.1).

To the greatest extent feasible, incorporate a modular design approach that optimizes maintainability resulting in a lower cost of ownership. Optimizing maintainability should provide easy access to serviceable items that are quick and easy to replace, and incorporate the use of built-in-tests to allow maintenance personnel to rapidly diagnose likely failure modes and initiate necessary maintenance action.

C.10 Schedule

DHS is committed to providing the advantages of autonomous detection to the Nation at the earliest feasible date, while ensuring that deployed technologies have been thoroughly tested prior to procurement. DHS's schedule objectives, presented in Attachment 5.8 are based on the intent that mature systems (TRL level 6+ or higher) will be selected for participation in the Phase I program. To support overall Gen-3 Program objectives, DHS seeks to complete Phase I assay, characterization, and field testing (the activities described in Sections C.6.1 and C.6.2) by the end of the Third Quarter of FYlO. Offerors are urged to examine the schedule objectives closely, and to propose a technical approach that balances schedule, technical, and cost risk to maximize Gen- 3 Program success.

C . l l Occupational Health and Safety

All deployed biodetectors must comply with occupational health and safety standards to ensure that contractor and test personnel are not exposed to undue hazards. Prior to delivery of

Department of Homeland Security 16 biodetectors, contractors shall self-certify that their biodetectors are safe to operate and that there are no known occupational safety and health concerns.

[End of Section C]

Department of Homeland Security 17

SECTION D - PACKAGING AND MARKING

D.l Markings

All deliverables submitted to the Contracting Officer, the BioWatch Program Manager, the TO Contracting Officer or the TO Contracting Officers Technical Representative (COTR) shall be accompanied by a packing list or other suitable shipping documentation that shall clearly indicate the following:

(a) Contract number;

(b) Task order number;

(c) Name and address of point of contact

Specific or unique marking requirements may be addressed in individual TOs.

D.2 Branding

The Contractor shall comply with the requirements of any DHS Branding and Marking policies.

As a matter of law, Federal criminal statutes prohibit unauthorized uses of the DHS Seal. In addition, DHS policy prohibits granting authorization for certain commercial uses of the Seal. It is permissible to reference DHS in materials if the reference is limited to true, factual statements.

The words DHS andlor Homeland Security should appear in the same color, font, and size as the rest of the text in the document. Moreover, such references shall not imply in any way an endorsement of a product, company, or technology.

Requests to use the DHS seal shall be submitted using DHS Official Seal Usage Approval, available from the COTR. The Comments section should be used to describe why use of the seal is being requested, and how it will be used. Completed forms should be sent via e-mail to the Director of Special Projects and Protocol for Public Affairs, Luigi Crespo (Luigi.Crespo@DHS.GOV) and to the Contracting Officer.

D.3 Publications and Communications Concerning Work Performed Under This Contract

All public communication referencing the work performed under this contract shall be coordinated between the contractor and the BioWatch Program Manager. The contractor will route technical communication products such as reports, journal articles, presentations, and white papers and public communication products such as brochures and fliers through the contractor's information review and release process before providing the deliverable to DHS for review and approval 30 days before any release to an external audience.

Public and technical communications shall contain the following language:

Acknowledgement

"The U.S. Department of Homeland Security (DHS) sponsored the production of this material under a contract with [insert contractor name]."

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D.4 Dissemination of Contract Information (HSAR 3052.242-71) (DEC 2003)

The Contractor shall not publish, permit to be published, or distribute for public consumption, any information, oral or written, concerning the results or conclusions made pursuant to the performance of this contract, without the prior written consent of the Contracting Officer. An electronic or printed copy of any material proposed to be published or distributed shall be submitted to the Contracting Officer.

(End of clause)

[End of Section Dl

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SECTION E - INSPECTION AND ACCEPTANCE

E.l Clauses Incorporated by Reference (FAR 52.252-2) (Feb 1998)

This contract incorporates the following clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this address:

http://www.acquisition.gov

52.246-16 1 Responsibility for Supplies (APR 1984) 1

52.246-5

52.246-9

Inspection of Services-Cost-Reimbursement (APR 1984)

Inspection of Research and Development (Short Form) (APR 1984)

E.2 Scope of Inspection

52.246-25

All deliverables will be inspected for content, completeness, accuracy and conformance to TO requirements by the TO COTR or as detailed in individual TOs. Inspection may include validation of information or software through the use of automated tools andlor testing of the deliverables, as specified in the TO. The scope and nature of this testing must be negotiated prior to TO issuance and will be sufficiently comprehensive to ensure the completeness, quality and adequacy of all deliverables. Testing by the Government is described in Section C.

Limitation of Liability-Services (FEB 1997)

The Government requires a period not to exceed thirty (30) calendar days after receipt of final deliverable items for inspection and acceptance or rejection unless otherwise specified in the TO.

[End of Section El

Department of Homeland Security 20

SECTION P - DELIVERY OR PERFORMANCE

P.l General

The DHS Contracting Officer may include additional deliveries or performance requirements in TOs, other than those enumerated in this section, such as (1) optional FAR clauses, (2) component specific clauses, and (3) task order specific clauses.

P.2 Period of Performance

The anticipated period of performance (POP) will be for 12 months from date of award with two

(2) one-year options. The term of this contract will not exceed 3 years. Task orders (TOs) will be issued with specific performance periods.

P.3 Clauses Incorporated by Reference (PAR 52.252-2) (Peb 1998)

This contract incorporates the following clause(s) by reference with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text can be accessed electronically at this Internet address:

htt~://www.acquisition.gov

P.4 Place of Performance Performance will occur at contractor facilities, Government laboratories and local Government sites in the designated jurisdiction. The Contractor will be required to provide technical support and operations and maintenance of the participating biodetectors at the designated laboratories and the operational testing locations. Limited space will be available at the DHS designated testing facilities, including Dugway Proving Ground (DPG) and Edgewood Chemical and Biological Center (ECBC), for storage and maintenance of the equipment during characterization testing. RAM-T testing is anticipated to take place in an indoor and outdoor location in Chicago.

Field testing is anticipated to take place in two jurisdictions: New York City (five (5) biodetection units) and Chicago (five (5) biodetection units). The biodetectors will be placed and operated on property designated (provided) by the jurisdiction. The contractor shall be responsible for furnishing the security, storage, and maintenance space during the operational testing.

FAR 52.242-15

P.5 Task Order Performance Period and Pricing

Stop-Work Order (AUG 1989) - Alternate I (APR 1984)

Task Orders (TOs) may be issued at any time during the POP TOs shall be priced using the pricing structure specified in the master contract that will be applicable to the TO'S anticipated period of performance.

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TOs issued in the final option year shall not extend beyond six (6) months after the POP of the final option year. At all times each order's terms shall be consistent with its funding appropriation.

F.6 Reporting Requirements

F.6.1 Technical and Progress Reporting Requirements

During the performance of this contract the contractor shall submit the following reports:

Monthly Project Status Reports (MPSR) - see Section F.8.1, below.

F.7 Notice to the Government of Delays In the event the Contractor encounters difficulty in meeting performance requirements, or when the Contractor anticipates difficulty in complying with the contract delivery schedule or completion date, or whenever the Contractor has knowledge that any…