SA_Solic.pdf

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Attached to: South America Clinical Research
Solicitation number: w81xwh18q0109
Issued by: Department of the Army Medical Command

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SEE ADDENDUM

(No Collect Calls)

W81XWH18Q0109 16-Jul-2018

b. TELEPHONE NUMBER

(301) 619-2359

8. OFFER DUE DATE/LOCAL TIME

09:00 AM 31 Jul 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 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

JORGENSEN, RYAN

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

0 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1. 52.212-4. FAR 52.212-3. 52.212-5 ARE ATTACHED.

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 ORX

SMALL BUSINESS

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 W23MYC 16. ADMINISTERED BY

12. DISCOUNT TERMS11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

14. METHOD OF SOLICITATION

RFQ IFB RFPX

USA MED RESEARCH INST OF INFECTIOUS DISE

BEVERLY FOGTMAN

1425 PORTER STREET

FORT DETRICK MD 21702-5011

TEL: 301-619-4641 FAX:

FAX:

TEL: SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

8(A)

HUBZONE SMALL

BUSINESS

SIZE STANDARD:

1,000

NAICS:

541714

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)

PAGE 2 OF73

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.

Section SF 30 - BLOCK 14 CONTINUATION PAGE

PERFORMANCE WORK STATEMENT

ATTACHMENT 1: PERFORMANCE WORK STATEMENT (PWS)

Title: LOGISITICAL SUPPORT FOR CLINICAL RESEARCH SITE Requiring Activity/Agency Name: US Army Medical Research Institute of Infectious Diseases (USAMRIID), Division of Medicine (DoM) Program Name: Division of Medicine, Clinical Immunology

1.0 Scope: This award provides for services to assist in management of international clinical research efforts. The recipient would assess and report on the changing epidemiological situation in regions of interest; provide expertise on clinical protocol development and approvals, such as import and export permits, ethics board approvals ; provide expertise on establishment of international agreements with local hospitals and research institutions; procure consumables required for research activities; provide logistical support for clinical observational trials, such as patient enrollment, communication, sample and collection; and provide shipping and packaging expertise for clinical specimens. This award is for performance of non- personal external services. This award is not a vehicle for acquiring in-house support contractors. This award identifies services that are severable in nature.

2.0 Background:

The U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) at Fort Detrick, Maryland conducts basic and applied research to develop products, information, procedures, strategies, and training programs for medical defense against biological threats and naturally occurring infectious diseases of military significance that require bio-containment.

The Division of Medicine conducts on‐site clinical research in Bio‐Defense (BD) and Infectious Diseases (ID) of military significance. The division provides a critical component to employee safety through its Special Immunizations Program and conducts a variety of educational programs on BD. The SIP manages the program for administering licensed and investigational new drug (IND) vaccines to employees who work in the institute’s laboratories as well as to off‐site agencies. The Department of Clinical Research is a state‐of‐the‐art program staffed and resourced at USAMRIID to conduct intramural and extramural clinical research with a focus on issues pertaining to human vaccines against biological weapons. The Division of Medicine is currently developing enhanced clinical research efforts in South America to enhance our ability to study and respond to emerging pathogens in this region which have the potential to put service members and the civilian population at risk of infection.

The goal of the program is to identify and characterize emerging pathogens before they become a threat to public and military health. Researchers have established collaborative ties to clinical research sites in Colombia. Through IRB approved research protocols, samples have been collected and shared with USAMRIID researchers with the aim of characterizing emerging pathogens proactively investigating causes of severe illness in the region. This effort is complicated by the difficulties associated with procurement of supplies at the local sites; language barriers to communicating with physicians and medical staff; and overarching awareness of epidemiological events that might be established on a local but not on an international level. In order to position USAMRIID ahead of the outbreak response, it is imperative that improved communications and procurement pathways are established to ease collaboration in the region.

3.0 Purpose and Objective:

The purpose of this procurement is to identify an entity to assist in management of international clinical research activities.

The objective is to ensure that processes and procedures required for advancement of international research efforts are in place to enable cutting edge research efforts on emerging pathogens in South America.

4.0 General Information:

4.1 Period of Performance:

The estimated period of performance for this task order is:

Base Period – 10 August 2018 – 09August 2019 Option Period 1 – 10 August 2019– 09 August 2020 Option Period 2 –10 August 2020– 09 August 2021 Option Period 3 –10 August 2021 – 09- Auguster 2022 Option Period 4 – 10 August 2022– 09- August 2023.

4.2 Contracting Officer’s Representative (COR): This task order will have a COR assigned that is separate from the base contract COR. Contact information will be provided upon award.

5.0 Performance Requirements:

The Contractor shall furnish the necessary personnel, equipment, supplies and support, to complete the performance of the work outlined below at a standard enabling investigators in the Division of Medicine to achieve the following:

establishment of collaborative sample collection protocols for research purposes; procurement of supplies required to execute clinical research protocols; facilitation of sample shipping from international sites to USAMRIID.

Task 5.1 Clinical Development/Clinical Study Support

Subtask 5.1.1: Clinical Site Selection and Preparation. Provide scientific/technical and administrative support to assist the task order COR (or designee) in the selection, assessment, preparation/remediation of clinical site(s)/facilities to support clinical research and development efforts. The contractor shall:

Evaluate/assess candidate sites for clinical research worldwide with a focus on South America.

The Contractor shall select candidate sites meeting the requirements specified in user test plans (clinical development plans and protocols).

Provide detailed analysis of potential candidate sites in terms of ability to meet the clinical development plan’s requirements. The communication shall include, at a minimum, strengths and weaknesses of each site in relation to requirements, necessary equipment and or infrastructure costs, analysis of staffing and Principal Investigator (PI) qualifications, cost of remediation activities and materials, and a recommendation for selection.

Provide scientific/technical and administrative support to remediate clinical site deficiencies to meet the requirements defined by the clinical development plan and clinical protocol. Activities include, but are not limited to performing and/or contracting for activities to remediate compliance issues (FDA/ICH and/or resident country regulations), activities required to train study site personnel in duties/responsibilities related to conduct of the study, activities related to remediation of any technical issues (e.g.: shipment, installation, qualification and maintenance of required equipment, and costs associated with facility/space rental).

Subtask 5.1.2: Perform study and site management activities. Provide and/or contract for clinical site/facilities and/or associated personnel capable of adequately performing clinical studies in accordance with clinical research protocols and FDA and resident country regulations, if applicable. The contractor shall:

Prepare and/or assist in the preparation of procedures (e.g.: Standard Operating Procedures (SOPs) or Site Specific Procedures (SSPs)) necessary for the conduct of the study.

Ensure adequate staffing and engagement at clinical site for successful execution of the research protocol in the time frame requested.

Subtask 5.1.3: Clinical Supplies and Equipment. Obtain supplies and equipment essential to the mission of conducting research in a cost effective and timely manner, as requested and funded.

Subtask 5.1.4: Clinical Protocol Review Support. Support coordination of scientific and human use review of all clinical study protocols by the Institutional Review Board (IRB) of record and provide coordination of any other host country review requirements.

Subtask 5.1.5: Clinical Recruitment Support. Provide scientific/technical and administrative support for the recruitment of study volunteers. Work in this task includes, but is not limited to: developing recruitment strategy (ies), developing informed consent forms, and developing marketing materials (e.g.: advertisements, fliers, commercials, etc.) as needed to achieve the recruitment goals of the study. All recruitment material must be approved by the local IRB and the ORP, prior to executing.

6.0 Place of Performance:

The government anticipates performance of this contract in the following regions: Central and South America, including, but not limited to, Colombia, Venezuela, and Brazil.

The contractor shall be responsible for the safety and security of its employees.

7.0 Contract Management and Administration

7.1 Contract Management: The contractor shall provide a contract manager who shall be responsible for the performance of the work. The name of this person and an alternate who shall act for the contractor when the manager is absent shall be designated in writing to the contracting officer. The contract manager or alternate shall have full authority to act for the contractor on all contract matters relating to daily operation of this contract. The contract manager or alternate shall be available between 8:00 am and 4:00 pm, Monday through Friday except Federal holidays or when the government facility is closed for administrative reasons.

7.7 Meetings: The Contractor shall schedule and conduct a kick-off meeting in coordination with the Government within 28 business days after task order award. A teleconference is acceptable. The Contractor shall meet with the Government to present an overview of their approach and established schedules, procedures, and points of contact necessary to conduct the required tasks. This meeting shall not exceed 2 hours in length.

Key points of contact (Government and Contractor) Temporary work locations (alternate office spaces, telework, virtual offices, etc.)

Means of communication available under the circumstances (e.g. email, webmail, telephone, FAX, courier, etc.)

Essential work products expected to continue production by priority

The Contractor Task Manager, in coordination with the COR, shall make use of the resources and tools available to continue contracted functions to the maximum extent possible under emergency circumstances. The Contractor shall obtain approval from the COR and Contracting Officer prior to incurring costs over and above those allowed for under the terms of this contract. Regardless of contract type, and of work location, Contractors performing work in support of authorized tasks within the scope of their contract shall charge those hours accurately in accordance with the terms of this contract.

7.9 Organizational Conflict of Interest: The FAR Part 9.5 provides guidance for Contracting Activities with regards to Organizational conflict of Interest (OCI). OCI is characterized by a) biased judgment on the part of the Offeror or b) unfair competitive advantage in procurement. The FAR encourages mitigation of a conflict if at all possible. The Contracting Officer has significant discretion as to the acceptability of any mitigation plan offered.

The work to be performed under this requirement has a significant potential for OCI.

Offerors are required to present their best strategy for mitigation of any potential OCI under this requirement. This mitigation plan shall be updated as necessary throughout the life of the task order.

United States Army Medical Research Materiel Command (USAMRMC) has categorized its requirements into three broad categories, as defined below, for purposes of identifying, avoiding or mitigating against OCIs in accordance with FAR Subpart 9.5. Offeror s may submit a proposal for task orders in any of the OCI categories. These categories are defined as follows:

Category 1: Internal Support: Where services which, by their very nature, give the Offeror access to non-public procurement sensitive data about the contract requirements, Offerors’ proprietary information, or put the Offeror in a position to influence the award decision on a contract in which they are participating.

Services would be characterized as having access to Command Wide procurement sensitive information, or work that could likely have an influence over follow-on awards or contracts within subordinate directorates/Commands.

Mitigation strategies may include: avoidance (non-participation), firewalls between existing personnel and new requirement.

Category 2: Program and/or Administrative Support: Services which assist in planning and managing an organization’s activities and programs.

Services would be characterized as having access to only Directorate or Subordinate Command level procurement sensitive information or work that would have little influence on follow-on requirements or requirements of other directorates/Subordinate Commands.

Mitigation Strategies: Within the requirements office – avoidance or firewalls; in other directorates/Subordinate Commands – acceptable mitigation plan or self-certification that no OCI (real or apparent) exists.

Category 3: Product Support. Services or end items required to meet the mission requirements of the organization’s activities and programs.

Services can be characterized as having little or no access to procurement sensitive information other than the immediate requirement and little chances of follow-on work that can be influenced by the immediate requirement.

Mitigation Strategies: Offeror can provide a mitigation plan or acceptable self-certification that no OCI exists.

The work required under this task order has been determined by USAMRMC to be:

Category 2: Program and/or Administrative Support

The Offeror shall perform a comparative analysis of the potential new work against all current and previous work performed in support of USAMRMC in any category other than that of the new work being offered. The comparative analysis must be included in the proposal for this task order, and must include a statement certifying whether the Offeror believes that its performance of the proposed task order would create a real or apparent OCI.

The Offeror shall sign and submit the USAMRMC Organizational Conflict of Interest certification statement (Attachment 3). Failure to adhere to this statement may constitute default on the part of the Offeror.

The Offeror shall also obtain a similar certification of OCI status from all subcontractors, teaming partners or consultants prior to taking any such party under this contract. The Offeror shall appropriately modify and include this Paragraph, in all consulting agreements and subcontracts of any tier to preserve the rights of the Government.

For breach of any of the above restrictions or for nondisclosure or misrepresentation of any relevant facts required to be disclosed concerning this contract, the Government may terminate this contract, disqualify the Offeror from subsequent related contractual efforts, and pursue any remedies as may be permitted by law or this contract.

7.10 Contractor Manpower Reporting (CMR) – 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 via a secure data collection site. The contractor is required to completely fill in all required data fields using the following web address: https://cmra.army.mil/Login.aspx .

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. Contractors may direct questions to the applicable help desk at: https://cmra.army.mil/Login.aspx.

The contractor shall provide verification of CMR submission to the COR (Deliverable 6).

7.11 Security Requirements: Not Applicable

7.12 Travel and Other Direct Costs (ODCs): ODCs shall be billed on a cost reimbursable basis. ODCs are defined as purchase price of materials or services plus applicable indirect costs and tax (if applicable), fee will not be paid on ODCs or travel.

Worldwide contractor travel will be required for some tasks. Contractor will be authorized travel expenses consistent with the substantive provisions of the JTR and the limitation of funds specified in this contract. All travel requires Government prior approval/authorization by the COR.

Arrangements for and costs of all travel, transportation, meals, lodging, and incidentals are the responsibility of the Contractor. Contractor shall submit travel requests with estimated costs to the COR NLT 15 days prior to travel.

Travel costs shall be incurred and billed in accordance with Federal Acquisition Regulation Part 31. Costs for these expenses will be reviewed and approved by the COR. All travel and transportation shall utilize commercial sources and carriers provided the method used for the appropriate geographical area that results in reasonable charges to the government. The Government will not pay for economy plus, business class or first-class travel.

7.13 Key Personnel: Substitutions of proposed Key Personnel are allowed. Any substitution or replacement Key Personnel shall have qualification equal to or greater than the individuals proposed.

7.15 Personally Identifiable Information (PII) and Protected Health Information (PHI): The Contractor shall establish appropriate administrative, technical, and physical safeguards to protect any and all Government data. The Contractor shall also ensure the confidentiality, integrity, and availability of Government data in compliance with all applicable laws and regulations, including data breach reporting and response requirements, in accordance with Defense Federal Acquisition Regulation Supplement Subpart 224.1 (Protection of Individual Privacy), which incorporates by reference DoD Directive 5400.11, “DoD Privacy Program,” May 8, 2007, and DoD 5400.11-R, “DoD Privacy Program,” May 14, 2007. The contractor shall also comply with federal laws relating to freedom of information and records management. The Contractor shall comply with all requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) (Pub. L. 104-191), as implemented by the HIPAA Privacy and Security Rules codified at 45 CFR Parts 160 and 164, and as further implemented within the Military Health System (MHS) by DoD 6025.18-R, "DoD Health Information Privacy Regulation," January 24, 2003, and DoD 8580.02-R, “DoD Health Information Security Regulation, July 12, 2007.

7.16 Research Involving Human Subjects: The Contractor shall oversee the execution of the research to ensure compliance with this clause. The Contractor shall comply fully with 32 CFR Part 219 and DoD Directive 3216.02, applicable DoD component policies, 10 USC 980 and when applicable, FDA policies and regulations.

The Contractor shall not commence performance of research involving human subjects that is covered under 32 CFR Part 219 or that meets exemption criteria under 32 CFR 219.101(b), or expend funding on such effort, until and unless the conditions of either the following paragraph (c)(1) or (c)(2) have been met:

The Contractor furnishes to the ORP, with a copy to the KO, an assurance of compliance and IRB approval and receives notification from the KO that the ORP has approved the assurance as appropriate for the research under the Statement of Work and also that the ORP has reviewed the protocol and accepted the IRB approval for compliance with the DoD component policies. The Contractor shall furnish evidence of an existing assurance of compliance for acceptance by the ORP, if an appropriate assurance has been approved in connection with previous research. The Contractor shall notify the KO immediately of any suspensions or terminations of the assurance.

The Contractor furnishes to the ORP, with a copy to the KO, a determination that the human research proposed meets exemption criteria in 32 CFR 219.101(b) and receives written notification from the KO that the exemption is determined acceptable. The determination shall include citation of the exemption category under 32 CFR 219.101(b) and a rationale statement. In the event of a disagreement regarding the Contractor’s furnished exemption determination, the ORP retains final judgment on what research activities or classes of research are covered or are exempt under the contract.

8.0 Deliverables

8.1 Delivery Address: All deliverables shall be submitted to the COR designated in the COR appointment letter.

8.2 Method of Delivery: 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.

8.3 Shipping: The Contractor shall use appropriate, refrigerated shipping carriers for shipments (FedEx, World Courier, or similar, as agreed to by the COR), and appropriate shipping methods for all other materials, equipment, and hard copy documents. In the United States, the contractor shall use the US Postal Service standard delivery for delivery of all such shipments. The COR must approve the selected shipping method and any exceptions to these requirements.

8.4 Government Acceptance Period: The COR will have ten (10) business days to review draft deliverables and make comments. The Contractor shall have five (5) business days to make corrections. Upon receipt of the final deliverables, the COR will have two (2) workdays for final review prior to acceptance or providing documented reasons for non-acceptance. Should the Government fail to complete the review within the review period the deliverable will become acceptable by default, unless prior to the expiration of the ten (10) business days the Government notifies the Contractor in writing to the contrary. The final submission should be deemed approved if the Government has not rejected it in 30 calendar days.

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 shall be notified in writing by the COR of the specific reasons for rejection. The Contractor shall have five (5) business days to correct the rejected deliverable and return it per delivery instructions.

8.5 Deliverable/Delivery Schedule:

A summary of deliverables follows. Copies are to be provided to the Government officials indicated in electronic file (E) unless otherwise stated.

Item

PWS

Ref

Title Distribute

To Initial Subsequent Comments

Deliverable 1 7.2 Quarterly Task Status Report

COR

NLT 45 days after task order award

NLT 15th of each month

Deliverable 2 – Reserved for Base Contract Deliverable

Deliverable 2 7.10 Verification of Contractor Manpower Reporting Submission

COR NLT 31 Oct Annually, NLT 31 Oct

9.0 Inspection and Acceptance:

The COR is a Government official who has been delegated specific technical, functional and oversight responsibilities for this task order. The COR is designated in the COR appointment letter, issued by the Contracting Officer, and is responsible for inspection and acceptance of all services, incoming shipments, and documents.

9.1 Contractor Payment Processing: The Contractor is responsible for properly preparing and forwarding to the appropriate Government official, the invoice and receiving report for payment. The Contractor shall invoice in accordance with the Contract Line Item Structure in Section B of the task order. The Contractor shall attach back up information to receiving reports for ODCs. Backup information for ODCs shall list all elements of costs. When the Wide Area Workflow (WAWF) – Receipt and Acceptance application is able to be used, it is the preferred method of submission.

Advanced Payments for work performed under this task order will be considered.

10.0 Quality Assurance

10.1 Quality Assurance Surveillance Plan: The Government intends to utilize a Quality Assurance Surveillance Plan (QASP) to monitor the quality of the Contractor’s performance. The oversight provided for in the task order and in the QASP will help to ensure that service levels reach and maintain the required levels throughout the task order period of performance. Further, the QASP provides the COR with a proactive way to avoid unacceptable or deficient performance, and provides verifiable input for the required Past Performance Information Assessments.

The QASP will be finalized immediately following award and a copy provided to the Contractor after award. The QASP (Attachment 2) is a living document and may be updated by the Government as necessary.

10.2 Performance Requirements Summary Matrix: By monitoring the Contractor, the COR will determine whether the performance levels set forth in the order have been attained. Performance standards are specified in the following Performance Requirements Summary Matrix in the Standard and Acceptable Quality Level columns.

PWS

Reference

Deliverable Indicator Standard Acceptable

Quality Level

Method of Surveillance

Incentive

7.2 1 Monthly Task Status Report

Includes status on all open task orders

100% 100% Inspection

Positive Past Performance Rating

7.10 6 Verification of

CMR

submission

Reported annually by 31 Oct

100% 100% Inspection

Positive Past Performance Rating

10.3 Contractor Performance Assessment Reporting The Contractor Performance Assessment Reporting System (CPARS) will be used to electronically capture assessment data and manage the performance evaluation process.

Refer to task order instruction “Contractor Performance Assessment Reporting System (CPARS) (June 2015) (USAMRAA)” for additional information.

11.0 Contractor Employees

11.1 Contractor Identification: 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.

11.2 Attendance at Meetings: Contractor personnel may be required to attend meetings or otherwise communicate with Government and/or other contract representatives to meet the requirements of this order. Contractor personnel shall make their Contractor status known during introductions.

11.3 Use of Military Rank by Contractor Personnel: Contractor personnel, while performing in a Contractor capacity, are prohibited from using their retired or reserve component military rank or title in all written or verbal communications associated with the task order under which they provide services.

11.4 Conduct: The Contactor shall not supervise, direct, or control the activities of Government personnel or the employee of any other Contractor under the contract and the Government will not exercise any supervision or control over the Contractor in the performance of contractual services under this task order. The Contractor is accountable to the Government for the actions of its personnel. The Contactor shall ensure that all of its employees, including Subcontractor employees, working under this task order are informed of the substance of this Section. If the Contractor believes any action or communication has been given that would create a personal services relationship between the Government and any Contractor employee or any other potential supervision or duty violation, the Contractor must notify the KO immediately of this communication or action.

The Contactor shall not discuss with unauthorized persons any information obtained in the performance of work under MPRD; conduct business not directly related to this contract on Government premises; use Government computer systems and/or other Government facilities for company or personal business; recruit on Government premises; or otherwise act to disrupt official Government business. The Contactor shall ensure that all of its employees, including Subcontractor employees, working under this task order are informed of the substance of this Section. If the Contractor believes any action or communication has been given that would create a business ethic or conduct violation, the Contractor must notify the KO immediately of this communication or action.

PWS Acronyms:

AR Army Regulation

BD Bio Defense

CFR Code of Federal Regulations

CMR Contractor Manpower Reporting

COR Contracting Officer’s Representative

DA Department of the Army

DoD Department of Defense

DoM Division of Medicine

FAR Federal Acquisition Regulation

FDA Food and Drug Administration

HIPAA Health Insurance Portability and Accountability Act

ID Infectious Diseases

IDIQ Indefinite Delivery Indefinite Quantity

IND Investigational New Drug

IRB Institutional Review Board, ensures research is conducted safely and ethically

KO Contracting Officer

MS Micro Soft

NLT No Later Than

OCI Organizational Conflict of Interest

OCONUS Outside the Continental United States

ODC Other Direct Cost

OPSEC Operations Security

PHI Protected Health Information

PI Principal Investigator

PII Personally Identifiable Information

PWS Performance Work Statement

QA Quality Assurance

QASP Quality Assurance Surveillance Plan

SOPs Standard Operating Procedures

SSP Site Specific Procedures

USAMRIID U.S. Army Medical Research Institute of Infectious Diseases

USAMRMC US Army Medical Research and Materiel Command

WAWF Wide Area Workflow

(End of PWS)

QUALITY SURVALIENCE PLAN

QUALITY ASSURANCE SURVEILLANCE PLAN OR QUALITY CONTOL PLAN (QASP)

FOR

LOGISITICAL SUPPORT FOR CLINICAL RESEARCH SITE

1. PURPOSE.

This Quality Assurance Surveillance Plan (QASP) provides a systematic quality control program to ensure services are performed in accordance with the contract. Specifically, it is the means by which its work complies with the requirement of the contract and to evaluate performance for the 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 or performance work statement (PWS). 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.

FAR 52.246‐4 Inspection of Services – Fixed‐Price, applies to this effort

2. GOVERNMENT ROLES AND RESPONSIBILITIES.

The following personnel shall oversee and coordinate surveillance activities.

Contracting Officer’s Technical Representatives (COTRs) – The COTR is responsible for assisting the COR in technical administration of the contract, and shall assist the COR in assuring proper Government surveillance of the contractor’s performance. The COTR shall provide input and documentation for the COR’s quality assurance file. A COTR 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.

Assigned COTR: Beverly D. Fogtman Title: Contracting Officer’s Technical Representatives (COTRs) Telephone: 301‐619‐4641 Fax: 301‐619‐2312 Email: Beverly.d.Fogtman.civ@mail.mil

3. CONTRACTOR REPRESENTATIVES:

The following employee of the contractor will serve as the Program Manager for this contract. This will be determined once the contract has been awarded.

4. PERFORMANCE STANDARDS.

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

The PWS for this contract has been submitted separately. The PWS specifies each performance requirement/objective, performance standards and performance thresholds, as well as surveillance method for each such performance requirement/objective.

The Government shall use the standards set forth in the PWS to determine the contractor’s performance and shall compare the contractor’s performance to the Acceptable Quality Level (AQL).

5. METHODS OF QA SURVEILLANCE.

Various methods exist to monitor performance and each method aligns specifically with each performance requirement/objective. These are more fully detailed in the PWS. The COTR shall use the surveillance methods listed below in the administration of this QASP, which methods are specified for each related performance requirement/objective.

Direct monitoring of progress and quality of deliverables

Direct monitoring of overall project

Review of deliverables by users and other USAMRIID personnel

Direct monitoring of response time by KO and COR

Matching of proposed deliverable timelines to Integrated Master Schedule (IMS)

In‐Process Review Meetings

Review of Monthly Reports

Regardless of the surveillance method, the COR 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 shall be responsible for monitoring the contractor’s performance in meeting a specific performance standard.

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.

6.2 Surveillance Matrix

6.2.1. The Surveillance Matrix Table 1 is the list of performance objectives and standards that must be performed by the contractor. This matrix details the method of surveillance the COR will use to validate and inspect these performance elements. Inspection of each element will be documented in the COR file.

6.2.3. Performance objectives define the desired outcomes. Performance Standards define the level of service required under the contract to successfully meet the performance objective. The inspection methodology defines how, when, and what will be assessed in measuring performance. The Government performs surveillance, using this QASP, to determine the quality of the contractor's performance as it relates to the performance element standards. The matrix should be used to form the foundation of the COR's inspection checklist. In evaluating the quality of contractor’s performance, the following performance ratings may be used.

Performance Rating

Criteria

Exceptional Performance meets contractual requirements and exceeds many to the Government’s benefit. The element being assessed was accomplished with few minor problems for which corrective actions taken by the contractor were highly effective.

Very Good Performance meets contractual requirements and exceeds some to the Government’s benefit. The element being assessed was accomplished with some minor problems for which corrective actions taken by the contractor were effective.

Satisfactory Performance meets contractual requirements. The element being assessed contains some minor problems for which corrective actions taken by the contractor appear or were satisfactory.

Marginal Performance does not meet some contractual requirements. The element being assessed reflects a serious problem for which the contractor has not yet identified corrective actions.

Unsatisfactory Performance does not meet most contractual requirements and recovery is not likely in a timely manner. The element being assessed contains a serious problem(s) for which the contractor’s corrective actions appear or were ineffective.

Table 1 - Surveillance Matrix

Performance Requirement Performance Standard

Acceptable Quality Level

Method of Surveillance

Provide scientific/technical and administrative support in the selection, assessment, preparation/remediation of clinical site(s)/facilities to support clinical research and development efforts.

Exceptional or Very Good