A07_-_Solicitation_W81XWH18Q0268_Final.pdf

SEE ADDENDUM

(No Collect Calls)

W81XWH18Q0268 17-Aug-2018

b. TELEPHONE NUMBER

301-619-2644

8. OFFER DUE DATE/LOCAL TIME

11:00 AM 04 Sep 2018

5. SOLICITATION NUMBER 6. SOLICITATION ISSUE DATE

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

STANDARD FORM 1449 (REV. 2/2012)

Prescribed by GSA – FAR (48 CFR) 53.212

(TYPE OR PRINT)

(SIGNATURE OF CONTRACTING OFFICER)

ADDENDA X ARE

26. TOTAL AWARD AMOUNT (For Gov t. Use Only )

23.

CODE 10. THIS ACQUISITION IS

SUCH ADDRESS IN OFFER

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT

BELOW IS CHECKED

TELEPHONE NO.

W81XWH9. ISSUED BY

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a. UNLESS BLOCK

7. FOR SOLICITATION

INFORMATION CALL:

a. NAME

ERIK J. PRZYGOCKI

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NUMBER

(TYPE OR PRINT)

30b. NAME AND TITLE OF SIGNER 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a.UNITED STATES OF AMERICA

1 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1. 52.212-4. FAR 52.212-3. 52.212-5 ARE ATTACHED.X

25. ACCOUNTING AND APPROPRIATION DATA

1. REQUISITION NUMBER

20.

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED.

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, AND 30

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

ARE NOT ATTACHED

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA ARE ARE NOT ATTACHED

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

SET FORTH HEREIN, IS ACCEPTED AS TO ITEMS:

. YOUR OFFER ON SOLICITATION

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

% FOR:SET ASIDE:UNRESTRICTED OR X

SMALL BUSINESSX

17a.CONTRACTOR/ CODE FACILITY

OFFEROR CODE

USA MED RESEARCH ACQ ACTIVITY

820 CHANDLER ST

FORT DETRICK MD 21702-5014

18a. PAYMENT WILL BE MADE BY CODE

RATED ORDER UNDER

DPAS (15 CFR 700)

13a. THIS CONTRACT IS A

13b. RATING

CODE15. DELIVER TO CODE W23MWK 16. ADMINISTERED BY

12. DISCOUNT TERMS11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

14. METHOD OF SOLICITATION

RFQ IFB RFPX

W4D7 US ARMY CTR FOR ENV HLTH

MARK W. WIDDER

568 DOUGHTEN DRIVE

FORT DETRICK MD 21702-5010

TEL: 301-619-7665 FAX:

FAX:

TEL: SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

8(A)

HUBZONE SMALL

BUSINESS

SIZE STANDARD:

1,000

NAICS:

541714

X

OFFER DATED

29. AWARD OF CONTRACT: REF.

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

EMAIL:

TEL:

31c. DATE SIGNED

SEE SCHEDULE

SCHEDULE OF SUPPLIES/ SERVICESITEM NO. QUANTITY UNIT UNIT PRICE AMOUNT

24.22.21.19.

WOMEN-OWNED SMALL BUSINESS (WOSB)

ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

32g. E-MAIL OF AUTHORIZED GOVERNMENT REPRESENTATIVE

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

(CONTINUED)

ACCEPTED, AND CONFORMS TO THE CONTRACT, EXCEPT AS NOTED: ______________________________________________________

32a. QUANTITY IN COLUMN 21 HAS BEEN

RECEIVED INSPECTED

32b. SIGNATURE OF AUTHORIZED GOVERNMENT

REPRESENTATIVE

32c. DATE 32d. PRINTED NAME AND TITLE OF AUTHORIZED GOVERNMENT

REPRESENTATIVE

32e. MAILING ADDRESS OF AUTHORIZED GOVERNMENT REPRESENTATIVE 32f . TELEPHONE NUMBER OF AUTHORIZED GOVERNMENT REPRESENTATIVE

37. CHECK NUMBER

FINALPARTIALCOMPLETE

36. PAYMENT35. AMOUNT VERIFIED

CORRECT FOR

34. VOUCHER NUMBER

FINAL

33. SHIP NUMBER

PARTIAL

38. S/R ACCOUNT NUMBER 39. S/R VOUCHER NUMBER 40. PAID BY

41a. I CERTIFY THIS ACCOUNT IS CORRECT AND PROPER FOR PAYMENT 41b. SIGNATURE AND TITLE OF CERTIFYING OFFICER 41c. DATE

42a. RECEIVED BY (Print)

42b. RECEIVED AT (Location)

42c. DATE REC'D (YY/MM/DD) 42d. TOTAL CONTAINERS

STANDARD FORM 1449 (REV. 2/2012) BACK

Prescribed by GSA – FAR (48 CFR) 53.212

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

SEE SCHEDULE

20.

SCHEDULE OF SUPPLIES/ SERVICES

21.

QUANTITY UNIT

22. 23.

UNIT PRICE

24.

AMOUNT

19.

ITEM NO.

W81XWH18Q0268

Section A - Solicitation/Contract Form

CLAUSES INCORPORATED BY REFERENCE

52.203-18 Prohibition on Contracting With Entities That Require Certain

Internal Confidentiality Agreements or Statements-- Representation

JAN 2017

52.203-19 Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements

JAN 2017

Section B - Supplies or Services and Prices

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0001 12 Months New Cell Line Testing

FFP

Work to be performed In Accordance With (IAW) Performance Work Statement (PWS) Paragraph 1.4.

Identify and test six new vertebrate cell lines that have the potential for fulfilling the requirements for ECIS testing, to include cell immortality, ability to grow in a monolayer, contact inhibited growth, optimal storage conditions and was approved by the sponsor. Potential cell lines will be investigated to determine the limits of storage time, as well as toxicity responses to test chemicals when the cells are used as an ECIS sensor. Additionally, initial work of determining cell substrates, the ability of the cells to form monolayers, and optimum culture conditions will be performed. The selected cell lines will be cultures and ECIS test parameters will be evaluated.

FOB: Destination

PSC CD: AN91

NET AMT

0002 1 Each Contractor Manpower Reporting

FFP

This is a mandatory requirement IAW Army Federal Acquisition Regulation Supplement (AFARS) 5137.91, Accounting for Contract Services. The Contractor Manpower Reporting requirements are listed in Section C.

1001 12 Months OPTION New Cell Line Testing

FFP

Work to be performed In Accordance With (IAW) Performance Work Statement (PWS) Paragraph 1.4.

Identify and test six new vertebrate cell lines that have the potential for fulfilling the requirements for ECIS testing, to include cell immortality, ability to grow in a monolayer, contact inhibited growth, optimal storage conditions and was approved by the sponsor. Potential cell lines will be investigated to determine the limits of storage time, as well as toxicity responses to test chemicals when the cells are used as an ECIS sensor. Additionally, initial work of determining cell substrates, the ability of the cells to form monolayers, and optimum culture conditions will be performed. The selected cell lines will be cultures and ECIS test parameters will be evaluated.

1002 1 Each OPTION Contractor Manpower Reporting

FFP

This is a mandatory requirement IAW Army Federal Acquisition Regulation Supplement (AFARS) 5137.91, Accounting for Contract Services. The Contractor Manpower Reporting requirements are listed in Section C.

Section C - Descriptions and Specifications

PERFORMANCE WORK STATEMENT

PERFORMANCE WORK STATEMENT (PWS)

ECIS EVALUATION OF ADDITIONAL VERTEBRATE CELL LINES FOR CHEMICAL SENSITIVITY,

TEMPERATURE TOLERANCE, AND SHELF LIFE

UNITED STATES ARMY CENTER FOR ENVIRONMENTAL HEALTH RESEARCH (USACEHR)

SECTION 1: PURPOSE

1.1. Introduction. The United States Army Center for Environmental Health and Research (USACEHR) has the lead among the United States Army Medical Research and Material Command (MRMC) laboratories to address potential health effects resulting from exposures to environmental toxicants, hazardous materials, and pollutants.

USACEHR researchers develop surveillance tools and countermeasures against adverse health effects that degrade Warfighter health and performance, to include products that assess responses to environmental toxicant/pollutant exposures.

1.2. Mission. USACEHR’s mission is to develop surveillance capabilities to detect, assess, and prevent health effects from adverse environmental, physiological, and psychological exposures.

1.3. Background. USACEHR is an outgrowth of a robust and comprehensive toxicology program that existed as part of the US Army Medical Bioengineering Research and Development Laboratory (USAMBRDL) under the US Army Medical Research and Materiel Command. USACEHR today operates as a subcommand of the US Army Medical Research Institute of Chemical Defense (USAMRICD). The USACEHR research areas include integrative systems biology, biomarkers, pulmonary health, and biomonitoring capabilities.

1.4. Scope. USACEHR is looking for additional cell lines to evaluate with electric cell-substrate impedance sensing (ECIS) technology for the detection of toxic industrial chemicals (TICs) in drinking water supplies for the military. The new cell lines should have the potential for storage on ECIS biofluidic chips without media changes for at least 30 days, but preferentially for a minimum of 9 months, with minimal loss of chemical sensitivity and impedance function. Limits of the temperature range tolerances of the cells under these conditions also needs to be evaluated. The information provided is necessary for determining cell types that may be feasible options for use in a field-portable biosensor. When each cell line evaluation is complete, a preliminary report will be provided, with a summary report of all cell lines evaluated provided at the end of the contract.

1.4.1. TASK 1 – Identify and test up to six new vertebrate cell lines that have the potential for fulfilling the requirements for ECIS testing below:

1.4.1.1. Cell line is immortal/continuous.

1.4.1.2. Cells can form a monolayer with impedance levels at 1000 ohms or greater on fluidic biochips (standard size ECIS fluidic biochips to start with the possibility of testing mini-chips if standard chips prove feasible).

1.4.1.3. Cells will be contact inhibited once the monolayer is formed.

1.4.1.4. Optimize storage conditions of cell monolayers on biochips so they can survive for at least Nine (9) months without media changes and with no loss of impedance function.

1.4.1.5. The selection of potential cell lines will be approved by USACEHR prior to beginning the TASK #2 evaluation.

1.4.2. TASK 2 – Selected cell lines will be cultured and the following ECIS test parameters will be evaluated:

1.4.2.1. Ability to form a monolayer.

1.4.2.2. Contact inhibition.

1.4.2.3. Substrate requirements for optimal performance on fluidic biochips.

1.4.2.4. Optimized media requirements and media changing protocols at 6 °C, 25 °C , and 37°C, using impedance as a measure of cell performance (minimum 30 days storage time for start of chemical testing, but will need at least 9 months storage time). Impedance measurements taken weekly as a minimum.

1.4.2.5. 96-well chip range find testing of each cell line with 6 chemicals. Selection of test chemicals will be coordinated with USAECHR personnel. Measured stocks of chemicals will be provided by USACEHR. Testing will include 6 replicates of controls and 3 concentrations of each compound per experiment and the experiment will be repeated twice.

1.4.2.6. Based on the results of 1.4.2.5., testing will be done in standard ECIS fluidic biochips (chips and readers will be supplied by USACEHR) with selected cell lines and chemicals. At least Three (3) fluidic biochips will be done for each chemical concentration of each compound.

1.4.3. TASK 3 - Provide preliminary reports to USACEHR after completing TASK #1 and TASK #2 for each cell line tested.

1.4.4. TASK 4 – Compile a final report on all cell lines with chemical test results.

1.4.1.1. Anticipated length of effort will be up to Twenty-One (21) months for research and Three (3) months for final report generation for a total of Twenty-Four (24) months from date of award to complete all Six (6) cell lines.

1.4.1.2. Estimate should include cost and man-hours per cell line evaluated.

SECTION 2: GENERAL REQUIREMENT

2.1. PERFORMANCE

2.1.1. Place of Performance: All work is performed off-site at a non-Government location

2.1.2. Period of Performance (POP). This Contract is for One (1) Twelve (12) Month Base Year, and One (1) Twelve (12) Month Option Year. The periods of performance for this contract are as follows:

24 September 2018 – 23 September 2019 – Base Year 24 September 2019 – 23 September 2020 – Option Year 1

2.1.3. Method of Delivery/Delivery Address: All deliverables shall be submitted to the Contracting Officer's Representative (COR) designated in the COR appointment letter. Electronic copies shall be delivered using Microsoft Office suite of tools (for example, MS WORD, MS EXCEL, MS POWERPOINT, MS PROJECT, or MS ACCESS format) or in Adobe PDF format, unless otherwise specified by the COR. Electronic submission shall be made via email, unless otherwise agreed to by the COR.

The Contractor shall use appropriate, validated shipping containers and templates for drug product shipments and appropriate shipping methods for all other materials, and hard copy documents. The COR must approve the selected shipping method and any exceptions to these requirements.

2.1.4. Government Acceptance Period: The COR will have Ten (10) workdays to review draft deliverables and make comments. The Contractor shall have Ten (10) workdays to make corrections. Upon receipt of the final deliverables, the COR will have Five (5) workdays for final review prior to acceptance or providing documented reasons for non-acceptance.

The COR will have the right to reject or require correction of any deficiencies found in the deliverables that are contrary to the information contained in the Contractor’s accepted proposal. In the event of a rejected deliverable, the Contractor will be notified in writing by the COR of the specific reasons for rejection. The Contractor shall have five (5) workdays to correct the rejected deliverable and return it per delivery instructions.

2.2. NON-PERSONAL SERVICES:

2.2.1. This PWS identifies services that are strictly non-personal in nature, as defined by Federal Acquisition Regulation (FAR) Part 37, Service Contracting. To ensure there is no appearance of any personal services, the Government shall neither supervise contractor personnel nor control the method by which the contractor performs the required tasks. Under no circumstances shall the Government assign tasks or prepare work schedules for individual contractor personnel. It shall be the responsibility of the contractor to manage its personnel and to guard against any actions that give the perception of personal services. If the contractor believes that any actions constitute, or are perceived to constitute personal services, it shall be the contractor's responsibility to notify the Contractor Officer (KO) immediately.

2.2.2. Contract personnel performing services under this contract shall be controlled, directed and supervised by contract management personnel only. The contractor’s management shall ensure that personnel properly comply with the performance standards outlined in the Quality Assurance Surveillance Plan (QASP). Contractor personnel will perform independent of and without the supervision of any Government official. Actions of contractor personnel may not be interpreted or implemented in any manner that results in any contractor personnel creating or modifying Federal policy, obligating the appropriated funds of the U.S. Government, overseeing the work of Federal personnel, providing direct personal services to any Federal personnel or otherwise violating the prohibitions set forth in FAR 7.5 entitled, “Inherently Government Functions” as well as in FAR 37.1, entitled, “Service Contracting.” The Government will control access to the facility and will perform the inspection and acceptance of the completed work.

2.3. CONTRACT MANAGEMENT:

2.3.1. Government Management. The Contracting Officer’s Representative (COR) and Alternate Contracting Officer’s Representative (ACOR) for this contract will be appointed by the Contracting Officer (KO). The COR will serve as the primary point of contact for all activities and issues that occur under this contract. In the event that the COR is not available, the ACOR will assume the COR’s responsibilities.

2.3.3. Subcontract Management. The Contractor shall be responsible for the management and performance of Subcontractors during this contract. Contractors may add Subcontractors to their team after notification and approval from the Procuring Contracting Officer (PCO) and COR. Cross Teaming shall be permitted.

2.4. REPORTS:

2.4.1. Reports and documents delivered by the contractor in the performance of this contract shall be considered Technical Data as defined in the applicable Federal Acquisition Regulation (FAR) clause 52.227-14, Rights in Data. All documentation shall reflect the latest version of the work product or activity, unless specifically directed otherwise by the Government. All documentation shall be prepared in accordance with (IAW) standard industry practices, ensuring electronically produced documents which reflect logical flow of material, tables of contents indexes and page numbering. Where applicable, the contractor’s attention is called to the availability of commercial, industry, federal, and military guides, instructions, and standards for many of the topics addressed in this PWS and under this contract.

2.4.1.1. Monthly Status Reports (Deliverable #1). The contractor shall provide monthly reports detailing all work completed. The report shall include, but not limited to a detailed list of all data deliveries completed during the previous month, all documentation scheduled for delivery during the next two (2) months, those items which required Government approval during the previous month, and whether approval has been given or is still pending, a list of documentation which was due and not delivered, and the status of delinquent data deliveries to include impact statements for each delinquency.

2.4.1.2. Quarterly Reports (Deliverable #2). The Contractor shall submit a quarterly report summarizing the work performed and completed throughout the quarter. The Contractor shall provide a copy of the quarterly report to the Contract Specialist, Contracting Officer, and COR no later than fifteen (15) calendar days from the end date of each quarter. Quarters run on a calendar basis (March, June, September, and December).

2.4.1.3. Final Report (Deliverable #3). The Final Report shall include, but, not be limited to: Chemical Test Results, Lessons Learned, On-going Testing, and a Synopsis of all actions taken during the Period of Performance.

2.4.1.4. Contractor Manpower Reporting (Deliverable #4). This is a mandatory requirement IAW Army Federal Acquisition Regulation Supplement (AFARS) 5137.91, Accounting for Contract Services.

The contractor shall report ALL contractor labor hours (including subcontractor labor hours) required for performance of services provided under this contract for the USACEHR via a secure data collection site. The contractor is required to completely fill in all required data fields using the following web address: http://www.ecmra.mil.

Reporting inputs will be for the labor executed during the period of performance during each Government fiscal year (FY), which runs October 1 through September 30. While inputs may be reported any time during the FY, all data shall be reported no later than October 31 of each calendar year, beginning with 2018. Contractors may direct questions to the help desk at:

http://www.ecmra.mil/.

SECTION 3: PERFORMANCE REQUIREMENTS

3.1 The contractor shall provide all necessary personnel required to perform services in support of USACEHR to complete the tasks identified in section 1.4, Scope.

3.2 PERFORMANCE REQUIREMENTS SUMMARY (PRS) MATRIX

3.2.1. The contractor shall accomplish the assigned tasks by employing and utilizing qualified personnel with appropriate combinations of education, training, and experience. The contractor shall match personnel skills to the task with a minimum of under or over employment of resources.

PERFORMANCE

REQUIREMENT

PWS

PARAGRAPH

REFERENCE

PERFORMANCE

STANDARD

ACCEPTABLE

QUALITY

LEVEL (AQL)

METHOD OF

SURVEILLANCE

Complete cell testing per tasks 1 and 2

1.4

Results will be provided in report format with pictographs and other performance graphics and metrics (impedance and toxicity testing) to verfity full evaluation of cell lines as outlined in section 1.4

100%

COMPLETE

Periodic conference calls to discuss research progress and 100% Review of individual and final reports.

3.3. Quality Assurance Surveillance Plan. Every Department of Defense (DoD) contract awarded for services in excess of $2,500.00 shall contain a Quality Assurance Surveillance Plan (QASP) as discussed in the FAR 46, Government Contract Quality Assurance. A QASP is a plan that specify the particular services the COR will inspect and the method(s) used to complete that surveillance. Each offeror shall digest the PWS in this RFP and offer a QASP associated therewith. The QASP shall be submitted as part of the offeror’s technical proposal. It will http://www.ecmra.mil/ http://www.ecmra.mil/ not be subjectively evaluated and rated. However, it may be discussed during the pre-award period for finalization prior to its inclusion in the awarded contract.

3.3.1. The COR will have an initial kick-off meeting to initiate the research phase with routine (monthly) scheduled conference calls to discuss cell line selection and on-going testing. Preliminary reports for each cell line will be reviewed and final report will also be reviewed in order to verify that all work was satisfactorily completed.

SECTION 4: SPECIAL CONTRACT REQUIREMENTS

4.1. Proprietary Information Assurance and Security. The contractor shall comply with Office of Management and Budget (OMB) Circular A-130, “Management of Federal Information Resources,” which requires Certification and Accreditation (C&A) of all federal information systems every three (3) years at a minimum or as changes that require re-accreditation occur. This C&A requirement ensures the effective safeguarding of sensitive but unclassified (SBU) data against unauthorized modification, disclosure, destruction, and denial of service, as directed by the DoD.

4.1.1. The contractor shall protect all data in the strictest confidence; prevent the unauthorized duplication, use and disclosure of information that is subject to the Privacy Act of 1974, Health Insurance Portability and Accountability Act (HIPAA) IAW applicable statutory, regulations, local policies and procedures.

4.1.2. All data received, processed, evaluated, loaded, and created as a result of this contract shall remain the sole property of the Government and shall be returned to the Government at the conclusion of the contract unless the contracting officer grants specific exception.

4.1.3. The contractor is prohibited from appropriation, disclosure, or unauthorized use of proprietary information that is acquired in the execution of this contract.

4.1.4. All products including files, software, and other information, which are created, produced or developed during the period of performance is the property of the Government and shall be returned unless the Government grants the contractor permission to retain the materials and products for continued development or publication.

4.2. Key Personnel. Key personnel for this effort include a Research Scientist who will conduct the specialized studies, as outlined in section 1.4. Essential research scientist qualifications include:

4.2.1. Expertise with handling, culturing, and experimental manipulation of multiple vertebrate cell lines.

4.2.2. Knowledge and understanding of vertebrate cell nutritional requirements and growth characteristics.

4.2.3. Expertise with electric cell-substrate impedance sensing (ECIS) technology and the use of ECIS technology for evaluation of toxic industrial chemicals, as demonstrated by experience and relevant publications in peer-reviewed journals.

4.2.4. Experience with seeding and long term maintenance of cell cultures in closed system fluidic biochips such as are used in the USACEHR Environmental Sentinel Biomonitor, on which cell line testing will be conducted.

4.2.5. Ability to prepare written reports and publications, as demonstrated by publications in the peer-reviewed literature.

SECTION 5 DELIVERABLES

5.1. The contractor shall provide the following deliverables as listed below.

ITEM PWS

REFERENCE

TITLE DISTRIBTUION ELECTRONIC

COPIES

INITIAL

1 2.4.1.1. Monthly Status Reports KO, COR 2 2 2.4.1.2. Quarterly Reports KO, COR 2 3 2.4.1.3. Final Report KO, COR 2

4 2.4.1.4. Contractor Manpower Reporting

(CMRA) KO, COR 2

SECTION 6 APPLICABLE DIRECTIVES, REGULATIONS, AND POLICIES

6.1. Environmental Requirements.

6.1.1. Mandatory Compliance. Occupational Safety and Health Act and AR 200-1, Environmental Protection and Enhancement.

6.1.2. Documents. Additional DoD and Army environmental program and regulations are available online at http://aec.army.mil.

SECTION 7 DEFINITIONS AND ACRONYMS

7.1 Definitions

7.1.1. 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.

7.1.2. Contractor Officer. A person with authority to enter into, administer, and/or terminate contracts, and make related determinations and findings on behalf of the government. The Contracting Officer is the only individual who can legally bind the government.

7.1.3. Contractor 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.

7.1.4. Defective Service. A service output that does not meet the standard of performance associated with the Performance Work Statement.

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

7.1.6. Quality Assurance. The government procedures to verify that services being performed by the contractor are performed according to acceptable standards.

7.1.7. Quality Assurance Surveillance Plan (QASP). An organized written document specifying the surveillance methodology to be used for surveillance of contractor performance.

7.1.8. Subcontractor. One that enters into a contract with a prime contractor. The Government does not have any contractual interactions with the subcontractor.

7.2. ACRONYMS

Acronym Description http://aec.army.mil/

ACOR Alternate Contracting Officer’s Representative ADP/IT Automated Data Processing/Information Management AFARS Army Federal Acquisition Regulation Supplement AFPMB Armed Forces Pest Management Board ALMS Army Learning Management System AR Army Regulation ARS Agricultural Research Service AT Anti-Terrorism ATCTS Army Training Certification Tracking System AWSNF Army Wide Network Security Focus C&A Certification and Accreditation CAC Common Access Card COR Contracting Officer’s Representative CTIP Combatting Trafficking in Persons DFARS Defense Federal Acquisition Regulation Supplement DG Decision Gate DHP Defense Health Department DoD Department Of Defense DoDDA Department of Defense and Department of the Army DTIC Defense Technical Information Center DUSD EI&E Deputy Under Secretary of Defense, Energy, Installations & Environment DWFP Deployed Warfighter Protection EEO Equal Employment Opportunity FAR Federal Acquisition Regulation FBI Federal Bureau of Investigation FDA Food and Drug Administration FPCON Force Protection Condition FY Fiscal Year HIPAA Health Insurance Portability and Accountability Act HTML Hypertext Markup Language HQDA Headquarters, Department of the Army IA/IT Information Assurance / Information Technology IASO Information Assurance Security Officer IAW In Accordance With IT Information Technology JKO Joint Knowledge Online JTR Joint Travel Regulation KO Contracting Officer KS Contract Specialist MEDCOM Medical Command NAC National Agency Check

NACI National Agency Check with Inquiries NCIC National Crime Information Center Interstate Identification Index NDS Non-Disclosure Statement NIST National Institute of Technology OCI Organization Conflict of Interest OMB Office of Management and Budget OPSEC Operations Security OSD Office of the Secretary of Defense OSHA Occupational Safety and Health Administration OTSG Office of the Surgeon General PCO Procuring Contracting Officer PDF Portable Document Format PM Program Manager POC Point Of Contact PWS Performance Work Statement QASP Quality Assurance Surveillance Plan RDT&E Research, Development, Training & Evaluation SBU Sensitive But Unclassified SHARP Sexual Harassment/Assault Response and Prevention SIPR Secure Internet Protocol Router SIPRNET Secure Internet Protocol Router Network TARP Threat Awareness and Response Program TDY Temporary Duty TSDB Terrorist Screening Database USAG United States Army Garrison USAMRAA United States Army Medical Research Acquisition Activity USAMRMC United States Medical Research and Material Command USDA United States Department of Agriculture

QASP

QUALITY ASSURANCE SURVEILLANCE PLAN

FOR

ELECTRIC CELL-SUBTRATE IMPEDANCE SENSING (ECIS) EVALUATION OF ADDITIONAL

VERTEBRATE CELL LINES FOR CHEMICAL SENSITIVITY, TEMPERATURE TOLERANCE, AND

SHELF LIFE

1. PURPOSE.

This Quality Assurance Surveillance Plan (QASP) provides a systematic method to evaluate performance for the stated contract. This QASP explains the following:

-What will be monitored?

-How monitoring will take place?

-Who will conduct the monitoring?

-How monitoring efforts and results will be documented?

This QASP does not detail how the contractor accomplishes the work. Rather, the QASP is created with the premise that the contractor is responsible for management and quality control actions to meet the terms of the contract. It is the Government’s responsibility to be objective, fair, and consistent in evaluating performance. In addition, the QASP should recognize that unforeseen and uncontrollable situations may occur.

This QASP is a “living document” and the Government may review and revise it on a regular basis. However, the Government shall coordinate changes with the contractor. Updates shall ensure that the QASP remains a valid, useful, and enforceable document. Copies of the original QASP and revisions shall be provided to the contractor and Government officials implementing surveillance activities.

2. GOVERNMENT ROLES AND RESPONSIBILITIES.

The following personnel shall oversee and coordinate surveillance activities.

a. Contracting Officer (KO) - The KO shall ensure performance of all necessary actions for effective contracting, ensure compliance with the contract terms, and shall safeguard the interests of the United States in the contractual relationship. The KO shall also assure that the contractor receives impartial, fair, and equitable treatment under this contract. The KO is ultimately responsible for the final determination of the adequacy of the contractor’s performance.

Assigned KO: Erik Przygocki Organization or Agency: US Army Medical Research Acquisition Activity Telephone: Phone: 301-619-2644 Email: erik.j.przygocki.civ@mail.mil

b. Contracting Officer’s Representative (COR) or Technical Point of Contact (TPOC) – The COR/TPOC is located at the United States Army Center for Environmental Health Research (USACEHR), Fort Detrick, MD. The COR/TPOC will be responsible for technical administration of this contract, and shall assure proper Government surveillance of the contractor’s performance. The COR/TPOC shall keep a quality assurance file. At the conclusion of the contract or when requested by the KO, the CO/TPOCR shall provide documentation to the KO. A COR/TPOC is not empowered to make any contractual commitments or to authorize any contractual changes on the Government’s behalf. The contractor shall refer any changes they deem may affect contract price, terms, or conditions to the KO for action.

Primary TPOC: Mark Widder Telephone: 301-619-7665 Email: mark.w.widder.civ@mail.mil

3. CONTRACTOR REPRESENTATIVES:

The following employee of the contractor will serve as the contractor’s Program Manager for this contract.

Program Manager: TBD Title: TBD Telephone: TBD Email: TBD

4. PERFORMANCE STANDARDS.

mailto:erik.j.przygocki.civ@mail.mil mailto:mark.w.widder.civ@mail.mil

Performance standards define desired services. The Government performs surveillance to determine if the contractor exceeds, meets or does not meet these standards.

Table 1. Performance Requirements

PERFORMANCE

REQUIREMENT

PWS

PARAGRAPH

REFERENCE

PERFORMANCE

STANDARD

ACCEPTABLE

QUALITY

LEVEL (AQL)

METHOD OF

SURVEILLANCE

Complete cell testing per tasks 1 and 2

1.4

Results will be provided in report format with pictographs and other performance graphics and metrics (impedance and toxicity testing) to verfity full evaluation of cell lines as outlined in section 1.4

100%

COMPLETE

Periodic conference calls to discuss research progress and 100% Review of individual and final reports.

5. METHODS OF QUALITY ASSURANCE SURVEILLANCE.

Various methods exist to monitor performance. The COR/TPOC shall use the surveillance methods listed below in the administration of this QASP.

-Feedback from Oversight Board -Feedback from Government Users -Feedback from Property Book Officers -Direct Observation -100% Inspection -Review of Quarterly Reports (various) -Review of Monthly Reports (various)

Regardless of the surveillance method, the COR/TPOC shall always contact the contractor's task manager or on-site representative when a defect is identified and inform the manager of the specifics of the problem. The COR/TPOC shall be responsible for monitoring the contractor’s performance in meeting a specific performance standard/AQL.

-DIRECT OBSERVATION. (Can be performed periodically or through 100% surveillance.)

-MANAGEMENT INFORMATION SYSTEMS (MIS). (Evaluates outputs through the use of management information reports. Best used for general surveillance and may need to be supplemented by periodic inspections.)

-PERIODIC INSPECTION. Uses a comprehensive evaluation of selected outputs. Inspections may be scheduled as required.

-Analysis of contractor's progress reports. (Evaluate cost, schedule, etc.)

-Performance reporting.

Surveillance results may be used as the basis for actions (to include payment deductions) against the contractor. In such cases, the Inspection of Services clause and the Inspection of Supplies clause in the Contract becomes the basis for the KO’s actions.

6. RATINGS.

Metrics and methods are designed to determine if performance exceeds, meets, or does not meet a given standard and acceptable quality level. A rating scale shall be used to determine a positive, neutral, or negative outcome. The following ratings shall be used:

Example 1:

EXCEPTIONAL: Performance significantly exceeds contract requirements to the Government’s benefit.

SATISFACTORY: Performance meets contractual requirements.

UNSATISFACTORY: Performance does not meet contractual requirements.

7. DOCUMENTING PERFORMANCE.

a. ACCEPTABLE PERFORMANCE.

The Government shall document positive performance. A report template is attached. Any report may become a part of the supporting documentation for fixed fee payments, award fee payments, or other actions.

b. UNACCEPTABLE PERFORMANCE.

When unacceptable performance occurs, the COR shall inform the contractor. This will normally be in writing unless circumstances necessitate verbal communication. In any case the COR shall document the discussion and place it in the COR file.

When the COR determines formal written communication is required, the COR shall prepare a Contract Discrepancy Report (CDR), and present it to the contractor's task manager or on-site representative. A CDR template is attached to this QASP.

The contractor shall acknowledge receipt of the CDR in writing. The CDR will specify if the contractor is required to prepare a corrective action plan to document how the contractor shall correct the unacceptable performance and avoid a recurrence. The CDR will also state how long after receipt the contractor has to present this corrective action plan to the COR. The Government shall review the contractor's corrective action plan to determine acceptability.

Any CDRs may become a part of the supporting documentation for contract payment deductions, fixed fee deductions, award fee nonpayment, or other actions deemed necessary by the KO.

8. FREQUENCY OF MEASUREMENT.

a. Frequency of Measurement. During contract/order performance, the COR shall take periodic measurements, quarterly as specified in the AQL column of the Performance Standards Summary Matrix, and shall analyze whether the negotiated frequency of measurement is appropriate for the work being performed.

b. Frequency of Performance Assessment Meetings. The COR shall meet with the contractor quarterly to assess performance and shall provide a written assessment.

PERFORMANCE REPORT

1. Contract Number: TBD

2. Prepared by: COR Name Entered At Time of Award

3. Date and time of observation:

4. Observation:

Examples of items to include in a report are:

- Method of surveillance.

- How frequently you conducted surveillance.

- Surveillance results.

- Number of observations.

Prepared by: COR/TPOC

Signature – Contracting Officer’s Representative Date

CONTRACT DISCREPANCY REPORT (CDR)

1. Contract Number: TBD

2. To: (Contractor Task Manager or on-site representative)

3. From: TBD

4. Date and time observed discrepancy:

5. Discrepancy or Problem:

Describe in detail. Identify any attachments.

6. Corrective action plan:

A written corrective action plan is / is not required.

If a written corrective action plan is required include the following. The written Corrective Action Plan will be provided to the undersigned not later than __days after receipt of this CDR.

Prepared by: COR/TPOC

Signature – Contracting Officer’s Representative Date

Received by:

Signature - Contractor Task Manager or on-site representative Date

The COR may initiate a CDR at any time, including whenever the number of monthly recorded defects for a performance standard exceeds the allowable number of defects; anytime unacceptable performance is determined critical in nature and requires formal corrective action; and whenever an unfavorable trend is detected in contractor performance.

CONTRACTOR MANPOWER REPORTING

CONTRACTOR MANPOWER REPORTING (CMR) (SEP 2017) (USAMRAA)

The contractor shall report ALL contractor labor hours (including subcontractor labor) required for performance of services provided under this contract for the USACEHR via a secure data collection site. The contractor is required to completely fill in all required data fields using the following web address: www.ecmra.mil. Reporting inputs will be for the labor executed during the period of performance during each Government fiscal year (FY), which runs October 1 through September 30. While inputs may be reported any time during the FY, all data shall be reported no later than October 31 of each calendar year, beginning with 2013.

https://www.ecmra.mil/

The four Service-specific CMRA systems have been merged into one combined application. All user accounts and system data were transferred to the new consolidated Enterprise Contractor Manpower Reporting Application (ECMRA) at www.ecmra.mil.

Contractors may direct questions to the new ECMRA Support Desk at dod.ecmra.support.desk@mail.mil or obtain detailed instructions from the CMR Contractor Manpower Reporting User Guide available on the new eCMRA website www.ecmra.mil.

The Order Data tab on the CMRA Contractor Data Entry website will ask for the “Requiring Activity Unit Identification Code” (UIC). The Unit Identification Code (UIC) of the Requiring Activity that would be performing the mission if not for the contractor. This is not necessarily the Contracting Office, Contracting Administrative Office, or Funding Source. The UIC is not the same as the Department of Defense Activity Address Code

(DODAAC).

The UIC of the Requiring Activity for this contract is W23MWK.

(End of Instruction)

CONTRACTOR IDENTIFICATION

CONTRACTOR IDENTIFICATION (June 2015) (USAMRAA)

When contractor personnel perform the services required in this contract on a Government installation they are required to possess and wear an identification badge that displays his or her name and the name of the Company.

The contractor shall ensure that contractor personnel identify themselves as contractors when attending meetings, answering Government telephones, providing any type of written correspondence, or working in situations where their actions could be construed as official Government acts.

While performing in a contractor capacity, contractor personnel shall refrain from using their retired or reserve component military rank or title in all written or verbal communications.

(End of Instruction) mailto:dod.ecmra.support.desk@mail.mil

Section E - Inspection and Acceptance

INSPECTION AND ACCEPTANCE TERMS

Supplies/services will be inspected/accepted at:

CLIN INSPECT AT INSPECT BY ACCEPT AT ACCEPT BY

0001 Destination Government Destination Government 0002 Destination Government Destination Government 1001 Destination Government Destination Government 1002 Destination Government Destination Government

Section F - Deliveries or Performance

DELIVERY INFORMATION

CLIN DELIVERY DATE QUANTITY SHIP TO ADDRESS DODAAC /

CAGE

0001 POP 24-SEP-2018 TO

23-SEP-2019

N/A W4D7 US ARMY CTR FOR ENV HLTH

MARK W. WIDDER

568 DOUGHTEN DRIVE

FORT DETRICK MD 21702-5010

301-619-7665

W23MWK

0002 POP 24-SEP-2018 TO

23-SEP-2019

N/A (SAME AS PREVIOUS LOCATION)

1001 POP 24-SEP-2019 TO

23-SEP-2020

N/A (SAME AS PREVIOUS LOCATION)

1002 POP 24-SEP-2019 TO

23-SEP-2020

N/A (SAME AS PREVIOUS LOCATION)

Section G - Contract Administration Data

CLAUSES INCORPORATED BY FULL TEXT

252.232-7006 WIDE AREA WORKFLOW PAYMENT INSTRUCTIONS (MAY 2013)

(a) Definitions. As used in this clause--

Department of Defense Activity Address Code (DoDAAC) is a six position code that uniquely identifies a unit, activity, or organization.

Document type means the type of payment request or receiving report available for creation in Wide Area WorkFlow (WAWF).

Local processing office (LPO) is the office responsible for payment certification when payment certification is done external to the entitlement system.

(b) Electronic invoicing. The WAWF system is the method to electronically process vendor payment requests and receiving reports, as authorized by DFARS 252.232-7003, Electronic Submission of Payment Requests and Receiving Reports.

(c) WAWF access. To access WAWF, the Contractor shall--

(1) Have a designated electronic business point of contact in the System for Award Management at https://www.acquisition.gov; and

(2) Be registered to use WAWF at https://wawf.eb.mil/ following the step-by-step procedures for self-registration available at this Web site.

(d) WAWF training. The Contractor should follow the training instructions of the WAWF Web-Based Training Course and use the Practice Training Site before submitting payment requests through WAWF. Both can be accessed by selecting the “Web Based Training” link on the WAWF home page at https://wawf.eb.mil/.

(e) WAWF methods of document submission. Document submissions may be via Web entry, Electronic Data Interchange, or File Transfer Protocol.

(f) WAWF payment instructions. The Contractor must use the following information when submitting payment requests and receiving reports in WAWF for this contract/order:

(1) Document type. The Contractor shall use the following document type(s).

2 in 1 invoice

(2) Inspection/acceptance location. The Contractor shall select the following inspection/acceptance location(s) in WAWF, as specified by the contracting officer.

W23MWK

(3) Document routing. The Contractor shall use the information in the Routing Data Table below only to fill in applicable fields in WAWF when creating payment requests and receiving reports in the system.

Routing Data Table*

Field Name in WAWF Data to be entered in WAWF Pay Official DoDAAC HQ0490 Issue By DoDAAC W81XWH Admin DoDAAC W81XWH Inspect By DoDAAC W23MWK Ship To Code W23MWK Ship From Code N/A Mark For Code N/A Service Approver (DoDAAC) N/A Service Acceptor (DoDAAC) W23MWK Accept at Other DoDAAC N/A LPO DoDAAC N/A DCAA Auditor DoDAAC N/A Other DoDAAC(s) N/A

(4) Payment request and supporting documentation. The Contractor shall ensure a payment request includes appropriate contract line item and subline item descriptions of the work performed or supplies delivered, unit price/cost per unit, fee (if applicable), and all relevant back-up documentation, as defined in DFARS Appendix F, (e.g. timesheets) in support of each payment request.

(5) WAWF email notifications. The Contractor shall enter the email address identified below in the “Send Additional Email Notifications” field of WAWF once a document is submitted in the system.

USACEHR: Mark Widder, mark.w.widder.civ@mail.mil

(g) WAWF point of contact. (1) The Contractor may obtain clarification regarding invoicing in WAWF from the following contracting activity's WAWF point of contact.

USAMRAA: Karian Forsha, karian.d.forsha.civ@mail.mil

(2) For technical WAWF help, contact the WAWF helpdesk at 866-618-5988.

(End of clause) mailto:karian.d.forsha.civ@mail.mil

Section I - Contract Clauses

52.202-1 Definitions NOV 2013 52.204-13 System for Award Management Maintenance OCT 2016 52.204-22 Alternative Line Item Proposal JAN 2017 52.212-4 Contract Terms and Conditions--Commercial Items JAN 2017 52.215-8 Order of Precedence--Uniform Contract Format OCT 1997 52.219-6 Notice Of Total Small Business Set-Aside NOV 2011 52.222-21 Prohibition Of Segregated Facilities APR 2015 52.222-26 Equal Opportunity SEP 2016 52.222-50 Combating Trafficking in Persons MAR 2015 52.223-5 Pollution Prevention and Right-to-Know Information MAY 2011 52.223-6 Drug-Free Workplace MAY 2001 52.223-10 Waste Reduction Program MAY 2011 52.223-18 Encouraging Contractor Policies To Ban Text Messaging

While Driving

AUG 2011

52.225-13 Restrictions on Certain Foreign Purchases JUN 2008 52.227-14 Rights in Data--General MAY 2014 52.232-1 Payments APR 1984 52.232-8 Discounts For Prompt Payment FEB 2002 52.232-11 Extras APR 1984 52.232-33 Payment by Electronic Funds Transfer--System for Award

Management

JUL 2013

52.232-39 Unenforceability of Unauthorized Obligations JUN 2013 52.232-40 Providing Accelerated Payments to Small Business

Subcontractors

DEC 2013

52.233-1 Disputes MAY 2014 52.233-4 Applicable Law for Breach of Contract Claim OCT 2004 52.239-1 Privacy or Security Safeguards AUG 1996 52.242-15 Stop-Work Order AUG 1989 52.243-1 Changes--Fixed Price AUG 1987 52.244-6 Subcontracts for Commercial Items JUL 2018 52.249-1 Termination For Convenience Of The Government (Fixed

Price) (Short Form)

APR 1984

52.249-4 Termination For Convenience Of The Government (Services) (Short Form)

APR 1984

52.253-1 Computer Generated Forms JAN 1991 252.203-7000 Requirements Relating to Compensation of Former DoD

Officials

SEP 2011

252.203-7002 Requirement to Inform Employees of Whistleblower Rights SEP 2013 252.203-7005 Representation Relating to Compensation of Former DoD

Officials

NOV 2011

252.204-7000 Disclosure Of Information OCT 2016 252.204-7003 Control Of Government Personnel Work Product APR 1992 252.204-7006 Billing Instructions OCT 2005 252.204-7008 Compliance With Safeguarding Covered Defense Information

Controls

OCT 2016

252.204-7009 Limitations on the Use or Disclosure of Third-Party Contractor Reported Cyber Incident Information

OCT 2016

252.204-7012 Safeguarding Covered Defense Information and Cyber Incident Reporting

OCT 2016

252.204-7015 Notice of Authorized Disclosure of Information for Litigation Support

MAY 2016

252.211-7003 Item Unique Identification and Valuation MAR 2016 252.211-7008 Use of Government-Assigned Serial Numbers SEP 2010 252.232-7003 Electronic Submission of Payment Requests and Receiving

Reports

JUN 2012

252.232-7010 Levies on Contract Payments DEC 2006 252.237-7010 Prohibition on Interrogation of Detainees by Contractor

Personnel

JUN 2013

252.243-7001 Pricing Of Contract Modifications DEC 1991 252.244-7000 Subcontracts for Commercial Items JUN 2013

52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR

EXECUTIVE ORDERS--COMMERCIAL ITEMS (JAN 2018)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (JAN 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L.

113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(2) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015).

(3) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553).

(4) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (Public Laws 108-77 and 108-78 (19 U.S.C. 3805 note)).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items: (Contracting Officer check as appropriate.)

___ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate I (Oct 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402).

____ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Oct 2015) (41 U.S.C. 3509).

____ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (June 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)

___ (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2016) (Pub. L. 109-

282) (31 U.S.C. 6101 note).

___ (5) [Reserved]

___ (6) 52.204-14, Service Contract Reporting Requirements (Oct 2016) (Pub. L. 111-117, section 743 of Div.

C).

___ (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Oct 2016) (Pub.

L. 111-117, section 743 of Div. C).

___ (8) 52.209-6, Protecting the Government's Interest When Subcontracting with Contractors Debarred,…