W81XWH22Q0160.pdf

W81XWH22Q0160

SOLICITATION W81XWH22Q0160

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, “Streamlined Procedures for Evaluation and Solicitation for Commercial Items,” as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; “proposals” are being requested, and a written solicitation document will not be issued.

The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2022-07.

The associated North American Industrial Classification System (NAICS) code for this procurement is 811219, with a small business size standard of $22M. This action is full and open competition.

Offeror Definition. “Offeror”, as used in this solicitation, encompasses either a single entity, or a consortium of entities including subcontractors or teaming partners, that submit a proposal in response to this solicitation. If the Offeror consists of a consortium of entities, one shall be clearly designated as the Prime Offeror.

Award without Discussions. The Government intends to evaluate proposals and award a contract without discussions with Offerors, except clarifications. The Government reserves the right to conduct discussions if the Contracting Officer later determines them to be necessary; the Contracting Officer will provide proposal revision instructions to the Offeror, as required. Therefore, the Offeror’s initial proposal should contain the Offeror’s best terms from a technical and price standpoint. All proposals shall be subject to evaluation by a team of Government personnel who will evaluate only one proposal from each prime Offeror.

PROPOSAL PREPARATION INSTRUCTIONS.

Offerors shall submit their proposal in accordance with the solicitation and attachments to provide accreditation support for the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID)’s Biodefense Reference Material Repository (BRMR) (previously known as the Unified Culture Collection (UCC)) and the USAMRIID Special Pathogens Laboratory (SPL) entities, which are a part of the Core Laboratory Services Division . Failure to submit all documents concurrently and in accordance with the instructions outlined may render a proposal ineligible for award.

Submission of Questions. Offerors are instructed to submit questions no later than 30 August 2022 at 12:00 PM EST. Questions shall be submitted electronically to Andy Shortall, Contracting Specialist, william.a.shortall.civ@health.mil. Offerors shall submit one set of questions only; multiple e-mails will not be accepted. The solicitation number, W81XWH-22-Q-0115 must be included in the subject line. Questions not submitted electronically will not be answered. Answers to all relevant and appropriate questions will be issued via amendment to the solicitation.

Submission of Proposals. Each section shall be separate and complete, so that evaluation of one may be accomplished independently of, and concurrently with, evaluation of the others. Proposal are due 4PM EST on 2 September 2022.

a. Electronic Format Submission Offerors shall provide an electronic proposal submission to Andy Shortall, Contracting Specialist, william.a.shortall.civ@health.mil. Documents shall be provided in Adobe Acrobat .pdf formats.

b. Offerors are referred to FAR 52.212-1, Instructions to Offerors, for general instructions on: submission, modification, revision and withdrawal of proposals; late proposals and revisions; offer expiration date; restrictions on disclosure and use of data; and contract award.

c. Proposals shall be valid for a minimum of 90 days.

Proposal Contents. Proposals shall be clear, specific, complete, and concise, presenting complete effective methods and approaches for satisfying the RFP’s requirements. Content shall be indexed (cross-indexed, as appropriate) and logically assembled. The Government will evaluate only one proposal from each prime Offeror.

Proposal Submission. Proposals shall contain four separate volumes as follows: Volume I – Technical Proposal, Volume II, Price proposal. Each volume shall be separate.

Proposal Format. All contract submittals shall have one inch margins and have a minimum 12 point font.

Minimum font size for graphics and tables is 8 point. All proposals shall be on 8 ½ x 11 sheets, with the exception of Engineering and Installation package drawings.

DELIVERY INFORMATION

CLIN DELIVERY DATE QUANTITY SHIP TO ADDRESS DODAAC /

CAGE

0001 POP 01-OCT-2022 TO

30-SEP-2027

N/A FORT DETRICK-USAMRIID

USAMRIID

1425 PORTER STREET

FORT DETRICK MD 21702-5011

FOB: Destination

W23MYC

1001 POP 01-OCT-2023 TO

30-SEP-2024

N/A (SAME AS PREVIOUS LOCATION)

2001 POP 01-OCT-2024 TO

30-SEP-2025

N/A (SAME AS PREVIOUS LOCATION)

3001 POP 01-OCT-2025 TO

30-SEP-2026

N/A (SAME AS PREVIOUS LOCATION)

4001 POP 01-OCT-2026 TO

30-SEP-2027

N/A (SAME AS PREVIOUS LOCATION)

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 1001 Destination Government Destination Government 2001 Destination Government Destination Government 3001 Destination Government Destination Government 4001 Destination Government Destination Government

PERFORMANCE WORK STATEMENT

SECTION 1 - PURPOSE

1.1. Introduction

This Performance Work Statement (PWS) defines the requirements to provide accreditation support for the USAMRIID’s Biodefense Reference Material Repository (BRMR) (previously known as the Unified Culture Collection (UCC)) and the USAMRIID Special Pathogens Laboratory (SPL) entities, which are a part of the Core Laboratory Services Division.

1.2. Mission

The mission of the Biodefense Reference Material Repository (BRMR) is to provide quality microbial or viral culture materials for research and development within the Department of Defense (DoD). In addition, the BRMR provides essential information about these cultures that establish their identity, purity, and expected biological characteristics. The BRMR also provides laboratory operations for accessioning, maintaining, characterizing, producing, testing, storing and shipping microbial and viral cultures.

The mission of the Special Pathogens Laboratory (SPL) is to maintain an integrated national and international network of laboratories that can quickly respond to acts of chemical or biological terrorism, emerging infectious diseases and other public health threats and emergencies. Through the development of the laboratory’s resources, including personnel, equipment and technology, the laboratory is an accredited Federal resource for the detection and identification of pathogens of special interest.

1.3. Background

The Biodefense Reference Material Repository was established as the UCC in 1999 and was accredited as a Reference Material Provider under ISO Guide 34 in December 2010. The accreditation is necessary in order for the USAMRIID to effectively achieve its mission as dictated by the Joint Program Executive Office for Chemical and Biological Defense, Chemical Biological Medical Systems (CBMS) Joint Project Management Office. The USAMRIID Special Pathogens Laboratory was derived in 2004 as the successor to the previous Special Pathogens Sample Test Laboratory (SPSTL) established in 1995 to support the Biological Weapons Convention program. In 2004, the SPSTL mission was assumed by the Department of Homeland Security and left USAMRIID with the legacy mission of providing international laboratory diagnostic reach-back support to the warfighters. As the gateway to the USAMRIID National Laboratory Response Network, the SPL provides the Commander with the primary laboratory to support the mission essential task list item of ‘rapid identification of biological threat agents.’

This critical function requires ISO 17025 accreditation for both environmental and patient sample testing in order to maintain the confidence of the supported warfighter. This PWS will satisfy the USAMRIID requirements.

1.4. Scope

Accreditation. The contractor shall provide all labor, services, equipment, tools, facilities, and parts and material to accomplish annual ISO 17034 accreditation of the USAMRIID BRMR and annual ISO 17025 accreditation of the USAMRIID SPL. USAMRIID will supply technical data, as necessary, to complete the ISO 17034 and ISO 17025 accreditation requirements. Inspections must be completed in time to allow for response, evaluation, and accreditation certification to be completed no later than 30 November of each year. Accreditations must be effective by 01 December of each year.

1.5. Organizational Conflict of Interest

The United States Army Medical Research and Development Command (USAMRDC) has categorized all service procurements into one of the following three categories as defined below, for the purpose of identifying, avoiding or mitigating Organizational Conflicts of Interest (OCI) in accordance with (IAW) Federal Acquisition Regulation (FAR) Subpart 9.5. These categories are defined as follows:

Category 1: Command Wide Internal Support: Services which, by their very nature, give the Contractor access to non-public procurement sensitive data about the contract requirements, other contractors’ proprietary information, or put the contractor 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 with subordinate directorates/Commands.

Category 2: Program Management Support: Services which assist USAMRMC in planning and managing an organization’s activities and programs. These include, for example: requirements analysis, acquisition support, budget planning and management, business process reengineering, program planning and execution support, and independent technical management support. 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.

Category 3: Product Support. Services or end items required to meet the mission requirements of the organization’s activities and programs. These include, for example: concept exploration and development, system design, system development and integration, COTS procurement and integration, internal development testing, deployment, installation, operations, and maintenance. 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.

OCI Certification. USAMRDC OCI Category 3 is applicable for this acquisition. The Contractor shall perform a thorough comparative analysis of the potential new work against all current and previous works performed in support of the USAMRIID organization and ascertain whether they have a possible conflict of interest. If there is a conflict of interest or the appearance of a conflict of interest, the Contractor shall provide a comprehensive OCI Mitigation Plan. The Contractor shall complete the OCI Certification at time of proposal submission (Deliverable 1, Exhibit 1).

1.6 Non-Disclosure Statement (NDS)

The contractor shall ensure that all contractor personnel are advised of nondisclosure policies as well as restrictions from communicating official business to media outlets. The contractor personnel shall be required to sign specific non-disclosure statements as required by the contract. The contractor shall provide signed non-disclosure statements from each personnel assigned, prior to performing any services (Deliverable 2, Exhibit 2).

SECTION 2 - GENERAL REQUIREMENT

2.1. Performance

2.1.1. Place of Performance

1425 Porter Street Fort Detrick Frederick, Maryland 21702-5011

2.1.1. Period of Performance. This contract is for one (1) twelve (12) months Base Period and four (4) twelve (12) months Option Periods. The periods of performance for this contract are as follows:

Base Year 01 OCT 2022 30 SEP 2023 Option Year One (1) 01 OCT 2023 30 SEP 2024 Option Year Two (2) 01 OCT 2024 30 SEP 2025 Option Year Three (3) 01 OCT 2025 30 SEP 2026 Option Year Four (4) 01 OCT 2026 30 SEP 2027

2.2. Non-Personal Services

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.

2.3. Contract Administration & 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.

2.3.2. Government Point of Contact (POC). The BRMR and SPL Laboratory Director will function as the Government's technical POC. The Government’s technical POC will be designated in writing to the contractor and the scope of authority will be set forth therein. The Government will provide the names and telephone numbers of any other POCs authorized to discuss service requests.

2.3.3. Contractor Point of Contact (POC). The Contractor shall provide communications (telephonic, email or internet) with the Government to discuss technical matters relating to the performance of this service. The Contractor shall provide in writing the name and telephone number of a primary and alternate individual to act as their representative for the scheduling and coordination of service calls, and to be responsible for the coordination of the contract with the Government. The Contracting Officer (KO) and Contracting Officer's Representative (COR) shall immediately be notified in writing whenever changes are made.

2.4. Contractor Personnel, Disciplines, and Specialties

2.4.1. Contractor Personnel

2.4.1.1 All contractor personnel dealing directly with Government personnel shall be English speaking. The contractor shall provide a statistician as part of the accreditation team primarily to evaluate measurement of uncertainty calculations associated with reference material characterization. Additionally, the statistician may also review any quantitative results obtained while testing accredited reference materials. The contractor shall ensure personnel are technically qualified.

2.4.1.2 Contractor personnel shall wear an identification badge on their outer garment at all times when performing services at the Government site.

2.4.1.3 The Contractor’s service personnel shall park in the appropriately designated parking areas. Violations of the Government’s site regulations and policies may result in citations answerable in the United States (Federal) District Court, not a local district, state, or municipal court.

2.5. Duty Hours.

2.5.1. Contractor personnel shall perform services during regular duty hours. Depending on the location, can range from 0800 to 1600 hours, Monday through Friday. The 8 hour regular duty day will be determined by the Depot Chief and Shop Supervisor at each location. When the services require work at other on-site Government locations, an adjustment to the regular duty hours may be necessary.

2.5.2. The contractor shall not perform services on days designated as a Federal Holiday by Federal Status, Executive Order, Presidential Proclamation or Installation Commander.

2.5.3. Federal holidays are an exception to the regular duty hours. Any of the holidays listed below falling on a Saturday will be observed on the preceding Friday; holidays falling on a Sunday will be observed on the following Monday. The following is a list of legal federal holidays that services shall not be performed:

2.5.3.1. New Year’s Day, 1 January

2.5.3.2. Martin Luther King’s Birthday, 3rd Monday in January

2.5.3.3. President’s Day, 3rd Monday in February

2.5.3.4. Memorial Day, last Monday in May

2.5.3.5. Junteenth, 19 June

2.5.3.6. Independence Day, 4 July

2.5.3.7. Labor Day, 1st Monday in September

2.5.3.8. Columbus Day, 2nd Monday in October

2.5.3.9. Veteran’s Day, 11 November

2.5.3.10. Thanksgiving Day, 4th Thursday in November

2.5.3.11. Christmas Day, 25 December

2.5.4. The contractor shall not perform services or report to work on days the Government or installation is closed due to local determinations relating to safety conditions, inclement weather conditions, national emergencies, energy conservation.

SECTION 3 - PERFORMANCE REQUIREMENTS

The contractor shall provide all necessary personnel required to perform services in the Core Laboratory Services Division. The contractor shall be responsible for execution of the requirements outlined in this PWS for accreditation. Inspection of services will be performed at least annually to ensure accreditation is completed on time. Acceptable performance of this service will be based upon the successful completion of the annual accreditation services before 30 November of each year. The following section specifies the Performance Objectives and Performance Elements for the contract.

3.1. Performance Requirements

The following section specifies the Performance Requirements for the contract.

PWS Paragraph Number Performance Requirement

3.1.1. ISO 17034 Accreditation of the USAMRIID BRMR

(Deliverable 3)

3.1.2. ISO 17025 Accreditation of the USAMRIID SPL

(Deliverable 4)

3.2. Performance Requirement Summary Matrix

Performance Objective PWS

Performance Standard

Acceptable Quality Level (AQL) Surveillance Method

ISO 17034

Accreditation of

USAMRIID BRMR

3.1.1 Based upon the

successful completion of the annual accreditation services before 30 November of each year.

100% Completion Observation of Performance and Receipt of Accreditation

ISO 17025

Accreditation of

USAMRIID SPL

3.1.2. Based upon the

successful completion of the annual accreditation services before 30 November of each year.

100% Completion Observation of Performance and Receipt of Accreditation

3.3. Quality Assurance Surveillance Plan. Every 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 specifies 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 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.

SECTION 4 - SPECIAL REQUIREMENT

4.1. Government Furnished Property

The Government will make available to the Contractor materials as required by the Contractor.

The Government will not be responsible for damage or loss due to fire, theft, accident, or other disaster of Contractor supplies, materials, or for the personal belongings brought onto Government property by the Contractor's personnel.

4.2. Contractor Furnished Property

Only the materiel referenced in section 1.4 will be furnished by the Government. All other materiel required in the performance of this contract shall be furnished by the Contractor.

4.3. Security and Safety

4.3.1. Access and General Protection/Security Policy and Procedures. The contractor and all associated subcontractors’ personnel shall comply with applicable installation, facility, and area commander installation and facility access and local security policies and procedures (provided by the Government representative). The contractor shall also provide all information required for background checks to meet installation access requirements to be accomplished by the installation Provost Marshal Office, Director of Emergency Services, or Security Office. The contractor workforce shall comply with all personal identity verification requirements (FAR clause 52.204-9, Personal Identity Verification of Contractor Personnel) as directed by DoD, HQDA, and/or local policy. In addition to the changes otherwise authorized by the changes clause of this contract, should the Force Protection Condition (FPCON) at any individual facility or installation change, the Government may require changes in contractor security matters or processes.

4.3.2. Contractors Requiring Common Access Card (CAC). Before CAC issuance, the contractor personnel requires, at a minimum, a favorably adjudicated National Agency Check with Inquiries (NACI) or an equivalent or higher investigation IAW Army Directive 2014-05, Policy and Implementation Procedures for Common Access Card Credentialing and Installation Access for Uncleared Contractors. The contractor personnel will be issued a CAC only if duties involve one of the following:

4.3.2.1. Both physical access to a DoD facility and access, via logon, to DoD networks on-site or remotely;

4.3.2.2. Remote access, via logon, to a DoD network using DoD-approved remote access procedures; or

4.3.2.3. Physical access to multiple DoD facilities or multiple non-DoD federally controlled facilities on behalf of the DoD on a recurring basis for a period of 6 months or more. At the discretion of the sponsoring activity, an initial CAC may be issued based on a favorable review of the FBI fingerprint check and a successfully scheduled NACI at the Office of Personnel Management.

4.3.3. Contractors That Do Not Require CAC, But Require Access to a DoD Facility or Installation. Contractor and all associated sub-contractors’ employees shall comply with adjudication standards and procedures using the National Crime Information Center Interstate Identification Index (NCIC-III) and Terrorist Screening Database (TSDB) (Army Directive 2014-05/AR 190-13), applicable installation, facility and area commander installation/facility access and local security policies and procedures (provided by government representative), or, at OCONUS locations, IAW status of forces agreements and other theater regulations.

4.3.4. Contractor Personnel Who Require Access to Government Information Systems.

All contractor employees with access to a government information system must be registered in the ATCTS (Army Training Certification Tracking System) at commencement of services and must successfully complete the DoD Information Assurance Awareness training prior to access to the information system and then annually thereafter.

4.3.5. Contractor Personnel Who Require Access to Government Information Systems. All contractor personnel with access to a government information system shall be registered in the ATCTS (Army Training Certification Tracking System) at commencement of services and shall successfully complete the DoD Information Assurance Awareness training prior to access to the information system and then annually thereafter.

4.3.6. Prior to commencement of services, the contractor shall provide the COR, within seven (7) calendar days in advance of the event, full names, date of birth, place of birth and Social Security numbers (or equivalent identification numbers for non-U.S. citizens) of all personnel who will be entering Army-controlled installation and facilities.

4.3.7. The contractor shall ensure that its personnel entering Army-controlled installations or facilities have obtained access badges and passes IAW facility regulations and that these badges and passes are obtained in advance so as not to delay the accomplishment of contracted services. The contractor shall contract COR or designated Government Trusted Associate Sponsorship System (TASS) Trusted Agent who is responsible to facilitate and sponsoring contractor’s registration and TASS in-processing and out-processing, to include approval, rejection and re-verification.

4.3.8. The contractor shall return all issued U.S. Government Common Access Cards, installation badges, access badges to the COR when the contract is completed or when a contractor personnel no longer requires access to the installation and facility.

4.3.9. Force Protection Condition (FPCON) impact on work levels. The contractor workforce shall comply with all personal identity verification requirements as directed by DoD, Headquarters Department of the Army (HQDA), and local policy. In addition to the changes otherwise authorized by the changes clauses of this contract, should the FPCON at any individual facility or installation change, the Government may require changes in contractor security matters or process. IAW Department of Defense Instructions (DoDI) 2000.16, DoD AT Standards, the FPCON is defined as follows:

4.3.9.1. FPCON ALPHA. This condition applies when there is a general threat of possible terrorist activity against personnel and facilities, the nature and extent of which are unpredictable, and circumstances do not justify full implementation of FPCON BRAVO measures. However, it may be necessary to implement certain measures from higher Terrorist Threat Conditions (THREATCONS) resulting from intelligence received or as a deterrent. The measures in this THREATCON must be capable of being maintained indefinitely.

4.3.9.2. FPCON BRAVO. This condition applies when an increased and more predictable threat of terrorist activity exists. The measures in this THREATCON must be capable of being maintained for weeks without causing undue hardship, affecting operational capability, and aggravating relations with local authorities.

4.3.9.3. FPCON CHARLIE. This condition applies when an incident occurs or intelligence received indicating some form of terrorist action against personnel and facilities is imminent. Implementation of measures in this THREATCON for more than a short period probably will create hardship and affect the peacetime activities of the unit and its personnel.

4.3.9.4. FPCON DELTA. This condition applies in the immediate area where a terrorist attack has occurred or when intelligence has been received that terrorist action against a specific location or person is likely. Normally, this THREATCON is declared as a localized condition. See also anti-terrorism

4.3.9.5. During FPCONs Charlie and Delta, non-essential services are discontinued. Designated essential service will resume when the FPCON level is reduced to level Bravo or lower.

4.3.9.6. When contractor personnel are considered mission essential, all contractor personnel are required to report for duty and remain on duty during declared emergencies or elevated FPCON levels unless otherwise directed by the contracting officer via the appropriate COR.

4.3.9.7. Generation, handling and storage of classified material. The contractor shall not generate, handle or store classified material for this contract.

4. 4. Security Requirements. The contractor shall not possess or store classified information at the contractor’s facility; therefore, level of safeguarding required is not applicable to this contract.

4.4.1. Unclassified Contract Security Requirements: The contractor shall ensure all personnel performing under this contract have a favorable National Agency Check with written inquires (NACI), including a favorable completion of Federal Bureau of Investigation (FBI) fingerprint check, which the ACOR will coordinate with the United States Army Garrison (USAG) Fort Detrick Security office prior to performance start date. The security requirements shall be maintained for the life of the contract, and citizenship shall be verified by presenting an original birth certificate or a U.S. passport or the original Naturalization Certificate to the USAG Fort Detrick Security office at the time of in-processing for all contract personnel assigned to the contract. In order to maintain the security requirements any derogatory information, to include law enforcement issues, mental health issues, or alcohol/drug related issues shall be reported to the COR, ACOR, and USAG Fort Detrick Security Office.

4.5. 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.

4.5.1. 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, HIPAA IAW applicable statutory, regulations, local policies and procedures.

4.5.2. 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.

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

4.5.4. 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.

4.6. Visitor Group Security Agreement. The contractor shall sign a Contractor Visitor Group Security Agreement to protect Government information involved in performance under this contract. The agreement shall outline responsibilities in the following areas: contractor security supervision; standard practice procedures; access, accountability, storage, and transmission of and other responsibilities, as required.

SECTION 5 - DELIVERABLES

5.1. Deliverables. The contractor shall provide the following deliverable as listed

Item PWS Ref Title Distribution E H Initial 1 1.5. OCI Certification KO, COR 1 1 With Proposal 2 1.6. NDS KO, COR 1 1 Upon Contract Award – The

Contractor shall submit all documents prior to performing ANY work.

3 3.1.1. ISO 17034

Accreditation of the

USAMRIID BRMR

KO, COR 1 1 No later than 30 November of each year. Accreditation must be effective 01 December of each year.

4 3.1.2. ISO 17025

Accreditation of the

USAMRIID SPL

KO, COR 1 1 No later than 30 November of each year. Accreditation must be effective 01 December of each year.

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. Non Mandatory Documents. Additional DoD and Army environmental program and regulations are available on-line at http://aec.army.mil. Error! Hyperlink reference not valid.

http://aec.army.mil/

6.3. Mandatory Compliance

The Contractor shall comply with Federal, State and Local regulations and laws applicable to the performance of this contract, and other regulations. The Contract must be accredited under the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA) Signatory under European cooperation for Accreditation (EA), the Asia Pacific Laboratory Accreditation Cooperation (APLAC) or the Inter-American Accreditation Cooperation (IAAC) as the only ILAC recognized regional cooperation bodies for accreditation of accrediting organizations.

Regulations and Policies Titles ILAC International Laboratory Accreditation Cooperation MRA Mutual Recognition Arrangement EA Signatory under European cooperation for Accreditation APLAC Asia Pacific Laboratory Accreditation Cooperation IAAC Inter-American Accreditation Cooperation

SECTION 7 - DEFINITIONS AND ACRONYMS

7.1. Definitions

7.1.1. ACCREDITATION. The act of granting credit or recognition that maintains suitable standard.

7.1.2. 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.

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

7.1.4. CONTRACTING OFFICER'S REPRESENTATIVE (COR). An employee of the U.S. Government appointed by the contracting officer to administer the contract. Such appointment shall be in writing and shall state the scope of authority and limitations. This individual has authority to provide technical direction to the contractor as long as that direction is within the scope of the contract, does not constitute a change, and has no funding implications. This individual does NOT have authority to change the terms and conditions of the contract.

7.1.5. DEFECTIVE SERVICE. A service output that does not meet the standard of performance associated with the Performance Work Statement.

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

7.1.7. KEY PERSONNEL. Contractor personnel that are evaluated in a source selection process and that may be required to be used in the performance of a contract by the Key Personnel listed in the PWS. When key personnel are used as an evaluation factor in best value procurement, an offer can be rejected if it does not have a firm commitment from the persons that are listed in the proposal.

7.1.8. PHYSICAL SECURITY. Actions that prevent the loss or damage of Government property.

7.1.9. QUALITY ASSURANCE. The government procedures to verify that services being performed by the contractor are performed according to acceptable standards.

7.1.10. QUALITY ASSURANCE SURVEILLANCE PLAN (QASP). An organized written document specifying the surveillance methodology to be used for surveillance of contractor performance.

7.1.11. QUALITY CONTROL. All necessary measures taken by the contractor to assure that the quality of an end product or service shall meet contract requirements.

7.1.12. SUBCONTRACTOR. One that enters into a contract with a prime contractor. The Government does not have privity of contract with the subcontractor.

7.1.13. WORK DAY. The number of hours per day the contractor provides services IAW the contract.

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

7.2. Acronyms

The acronyms listed below will assist in recognizing certain key words, phrases, or departments as defined in the contract, as well as any forthcoming dialogue with the contractor.

UCC Unified Culture Collection BRMR Biodefense Reference Material Repository PWS Performance Work Statement SPL Special Pathogens Laboratory SPSTL Special Pathogens Sample Test Laboratory CDC LRN Centers for Disease Control Laboratory Response Network USAMRIID US Army Medical Research Institute of Infectious Diseases

QASP

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

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.

b. Contract Specialist (CS) – The CS 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 CS shall also assure that the contractor receives impartial, fair, and equitable treatment under the contract.

c. Contracting Officer’s Representative (COR) - The COR is responsible for technical administration of the contract and shall assure proper Government surveillance of the contractor’s performance. The COR shall keep a quality assurance file. At the conclusion of the contract or when requested by the KO, the COR shall provide documentation to the KO. The COR 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.

d. Contracting Officer’s Technical Representative (COTR). A COTR is a Government employee who is authorized to monitor the contractor’s performance under the contract, serve as technical liaison between the contractor and the COR, and perform other duties specified in this document. COTRs have no authority to change any of the terms or conditions of the contract.

3. Contractor Representatives. The contractor’s identified employee shall serve as the contractor’s Program Manager and Task Manager for the contract.

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 below Performance Requirements Summary Matrix includes performance standards. The Government shall use these standards to determine contractor performance and shall compare contractor performance to the Acceptable Quality Level (AQL). If the performance standards are not met in the performance requirement summary the government will document the contractor’s past performance, and may terminate the contract in accordance with FAR Clause 52.212-4 (m), Termination For Cause.

Performance Requirement Summary Matrix

Performance Objective PWS Performance Standard

Acceptable Quality Level (AQL) Surveillance Method

ISO 17034

Accreditation of

USAMRIID BRMR

3.1.1 Based upon the

successful completion of the annual accreditation services before 30 November of each year.

100% Completion Observation of Performance and Receipt of Accreditation

ISO 17025

Accreditation of

USAMRIID SPL

3.1.2. Based upon the

successful completion of the annual accreditation services before 30 November of each year.

100% Completion Observation of Performance and Receipt of Accreditation

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0001 1 Each Base Year Inspection/Accreditation

FFP

ISO Accreditation

PSC CD: J066

NET AMT

1001 1 Each OPTION Option Period 1 Inspection/Accreditation

FFP

ISO Accreditation

2001 1 Each OPTION Option Year 2 Inspection/Accreditation

FFP

ISO Accreditation

3001 1 Each OPTION Option Year 3 Inspection/Accreditation

FFP

ISO Accreditation

4001 1 Each OPTION Option Year 4 Inspection/Accreditation

FFP

ISO Accreditation

CLAUSES INCORPORATED BY REFERENCE

52.203-3 Gratuities APR 1984 52.203-12 Limitation On Payments To Influence Certain Federal

Transactions

JUN 2020

52.204-7 System for Award Management OCT 2018 52.204-13 System for Award Management Maintenance OCT 2018 52.204-16 Commercial and Government Entity Code Reporting AUG 2020 52.204-18 Commercial and Government Entity Code Maintenance AUG 2020 52.212-4 Contract Terms and Conditions--Commercial Products and

Commercial Services

NOV 2021

52.232-40 Providing Accelerated Payments to Small Business Subcontractors

NOV 2021

52.247-34 F.O.B. Destination NOV 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

252.204-7003 Control Of Government Personnel Work Product APR 1992 252.204-7015 Notice of Authorized Disclosure of Information for Litigation

Support

MAY 2016

252.204-7018 Prohibition on the Acquisition of Covered Defense Telecommunications Equipment or Services

JAN 2021

252.209-7004 Subcontracting With Firms That Are Owned or Controlled By The Government of a Country that is a State Sponsor of Terrorism

MAY 2019

252.225-7001 Buy American And Balance Of Payments Program-- Basic JUN 2022 252.225-7012 Preference For Certain Domestic Commodities APR 2022 252.225-7048 Export-Controlled Items JUN 2013 252.225-7052 Restriction on the Acquisition of Certain Magnets, Tantalum, and Tungsten.

OCT 2020

252.225-7055 Representation Regarding Business Operations with the Maduro Regime

MAY 2022

252.225-7056 Prohibition Regarding Business Operations with the Maduro Regime

MAY 2022

252.225-7972 (Dev) Prohibition on the Procurement of Foreign-Made Unmanned Aircraft Systems (DEVIATION 2020-O0015)

MAY 2020

252.225-7973 (Dev) Prohibition on the Procurement of Foreign-Made Unmanned Aircraft Systems - Representation (DEVIATION 2020- O0015)

MAY 2020

252.225-7974 (Dev) Representation Regarding Business Operations with the Maduro Regime (DEVIATION 2020-O0005)

FEB 2020

252.226-7001 Utilization of Indian Organizations and Indian-Owned Economic Enterprises, and Native Hawaiian Small Business Concerns

APR 2019

252.232-7003 Electronic Submission of Payment Requests and Receiving Reports

DEC 2018

252.232-7010 Levies on Contract Payments DEC 2006 252.232-7017 Accelerating Payments to Small Business Subcontractors--

Prohibition on Fees and Consideration

APR 2020

252.243-7002 Requests for Equitable Adjustment DEC 2012 252.244-7000 Subcontracts for Commercial Items JAN 2021 252.246-7008 Sources of Electronic Parts MAY 2018 252.247-7023 Transportation of Supplies by Sea FEB 2019

CLAUSES INCORPORATED BY FULL TEXT

52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO

SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

The Offeror shall not complete the representation at paragraph (d)(1) of this provision if the Offeror has represented that it "does not provide covered telecommunications equipment or services as a part of its offered products or services to the Government in the performance of any contract, subcontract, or other contractual instrument" in paragraph (c)(1) in the provision at 52.204-26, Covered Telecommunications Equipment or Services-- Representation, or in paragraph (v)(2)(i) of the provision at 52.212-3, Offeror Representations and Certifications- Commercial Products and Commercial Services. The Offeror shall not complete the representation in paragraph (d)(2) of this provision if the Offeror has represented that it "does not use covered telecommunications equipment or services, or any equipment, system, or service that uses covered telecommunications equipment or services" in paragraph (c)(2) of the provision at 52.204-26, or in paragraph (v)(2)(ii) of the provision at 52.212-3.

(a) Definitions. As used in this provision-

Backhaul, covered telecommunications equipment or services, critical technology, interconnection arrangements, reasonable inquiry, roaming, and substantial or essential component have the meanings provided in the clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

(b) Prohibition.

(1) Section 889(a)(1)(A) of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (Pub. L.

115-232) prohibits the head of an executive agency on or after August 13, 2019, from procuring or obtaining, or extending or renewing a contract to procure or obtain, any equipment, system, or service that uses covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system. Nothing in the prohibition shall be construed to--

(i) Prohibit the head of an executive agency from procuring with an entity to provide a service that connects to the facilities of a third-party, such as backhaul, roaming, or interconnection arrangements; or

(ii) Cover telecommunications equipment that cannot route or redirect user data traffic or cannot permit visibility into any user data or packets that such equipment transmits or otherwise handles.

(2) Section 889(a)(1)(B) of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (Pub. L.

115-232) prohibits the head of an executive agency on or after August 13, 2020, from entering into a contract or extending or renewing a contract with an entity that uses any equipment, system, or service that uses covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system. This prohibition applies to the use of covered telecommunications equipment or services, regardless of whether that use is in performance of work under a Federal contract. Nothing in the prohibition shall be construed to--

(i) Prohibit the head of an executive agency from procuring with an entity to provide a service that connects to the facilities of a third-party, such as backhaul, roaming, or interconnection arrangements; or

(ii) Cover telecommunications equipment that cannot route or redirect user data traffic or cannot permit visibility into any user data or packets that such equipment transmits or otherwise handles.

(c) Procedures. The Offeror shall review the list of excluded parties in the System for Award Management (SAM) (https://www.sam.gov) for entities excluded from receiving federal awards for "covered telecommunications equipment or services."

(d) Representations. The Offeror represents that--

(1) It [ ___ ] will, [ ___ ] will not provide covered telecommunications equipment or services to the Government in the performance of any contract, subcontract or other contractual instrument resulting from this solicitation. The Offeror shall provide the additional disclosure information required at paragraph (e)(1) of this section if the Offeror responds "will" in paragraph (d)(1) of this section; and

(2) After conducting a reasonable inquiry, for purposes of this representation, the Offeror represents that--

It [ ___ ] does, [ ___ ] does not use covered telecommunications equipment or services, or use any equipment, system, or service that uses covered telecommunications equipment or services. The Offeror shall provide the additional disclosure information required at paragraph (e)(2) of this section if the Offeror responds "does" in paragraph (d)(2) of this section.

(e) Disclosures.

(1) Disclosure for the representation in paragraph (d)(1) of this provision. If the Offeror has responded "will" in the representation in paragraph (d)(1) of this provision, the Offeror shall provide the following information as part of the offer:

(i) For covered equipment--

(A) The entity that produced the covered telecommunications equipment (include entity name, unique entity identifier, CAGE code, and whether the entity was the original equipment manufacturer (OEM) or a distributor, if known);

(B) A description of all covered telecommunications equipment offered (include brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); and

(C) Explanation of the proposed use of covered telecommunications equipment and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(1) of this provision.

(ii) For covered services--

(A) If the service is related to item maintenance: A description of all covered telecommunications services offered (include on the item being maintained: Brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); or

(B) If not associated with maintenance, the Product Service Code (PSC) of the service being provided; and explanation of the proposed use of covered telecommunications services and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(1) of this provision.

(2) Disclosure for the representation in paragraph (d)(2) of this provision. If the Offeror has responded "does" in the representation in paragraph (d)(2) of this provision, the Offeror shall provide the following information as part of the offer:

(i) For…