Combined Synopsis-Solicitation W91ZLK-22-R-0005 Coronavirus Analysis in Wastewater Including Variants.pdf

COMBINED SYNOPSIS/SOLICITATION

W91ZLK-22-R-0005

Coronavirus Analysis in Wastewater Including Variants

This combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subpart

12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. Incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2022-01, effective 4 November 2021. The solicitation number for this request for proposal (RFP) is W91ZLK-22-R-0005 for a base period of 12 month plus two option years.

This requirement is under the associated North American Industry Classification System (NAICS) Code 541380, Testing Laboratories, and the Small Business Size Standard $16.5M. This is a 100% Small Business set aside. The

Government contemplates award of a Firm-Fixed Price purchase order in accordance with FAR 13, Simplified

Acquisition Procedures. This procurement will be evaluated as lowest price technically acceptable, for the procurement of the following services/materials.

The Contractor shall provide Ribonucleaic Acid (RNA) virus detection using quantitative polymerase chain reaction (qPCR) and Reverse Transcriptase polymerase chain reaction (RT-PCR) laboratory techniques by collecting and analyzing wastewater samples, and providing data on the presence and concentration of alternative forms of the virus, also known as variants.

52.212-1 Instruction to Offeror’s Commercial Items

This clause applies in its entirety and there are currently no addenda to the provision.

Proposals shall be submitted in two (2) separate volumes:

Volume I: Coronavirus Analysis in Wastewater Including Variants - W91ZLK-22-R-0005: PRICE Proposal

Volume II: Coronavirus Analysis in Wastewater Including Variants - W91ZLK-22-R-0005 TECHNICAL

Proposal

ALL PROPOSALS SHALL BE SUBMITTED VIA EMAIL WITH THE SUBJECT LINE:

W91ZLK-22-R-0005 PROPOSAL FROM (INSERT COMPANY NAME)

Proposal Format:

Volume I: Detailed Price Proposal to include the following elements:

1. Header Page Company Name, DUNS, CAGE, Business Type/Size, ETN# and point of contact information to include: Name, title, email address, and telephone number including extension.

2. INCLUDE ALL Information Below:

Base Year: 2 Mar 2022 – 1Mar 2023

Option Year 1: 2 Mar 2023 – 1 Mar 2024

Option Year 2: 2 Mar 2024 – 1 Mar 2025

Volume II: Detail Technical Proposal shall be evaluated based on the following factor:

Technical: The contractor shall provide Ribonucleaic Acid (RNA) virus detection using quantitative polymerase chain reaction (qPCR) and Reverse Transcriptase polymerase chain reaction (RT-PCR) laboratory techniques by collecting and analyzing wastewater samples, and providing data on the presence and concentration of alternative forms of the virus, also known as variants.

PLEASE COMPLETE AND RETURN: 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment.

NOTE: Contractor shall achieve technically acceptable rating on all technical factors to be considered technically acceptable.

52.212-2, Evaluation Commercial Items

The contract will be awarded to the Lowest Price Technically Acceptable (LPTA) offeror. The technical evaluation will be a determination based on information furnished by the vendor. The Government is not responsible for locating or securing any information which is not identified in the offer. The Government reserves the right to make an award without discussions.

52.212-3 Offeror Representations and Certifications -- Commercial Items.

All quotations from responsible sources will be fully considered. Vendors, who are not registered in the System for Award Management (SAM), prior to award, will not be considered.

Vendors may register with SAM by going to www.sam.gov.

52.212-4 Contract Terms and Conditions Commercial Items

This clause applies in its entirety and there are currently no addenda to the provision.

52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders -- Commercial Items.

This clause applies, and the following clauses are incorporated by reference.

The following provisions and clauses will be incorporated by reference, and the full text of the references may be accessed electronically at this address: http://farsite.hill.af.mil:

(a)

(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).

http://www.sam.gov/ http://farsite.hill.af.mil/

(4) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (Public Laws 108-77, 108-78 (19

U.S.C. 3805 note)).

(b)

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).

52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (July 2013) (31 U.S.C. 6101 note).

52.219-6, Notice of Total Small Business Aside (Nov 2011) (15 U.S.C. 644).

(ii) 52.219-8, Utilization of Small Business Concerns (Jul 2013) (15 U.S.C. 637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds $650,000 ($1.5 million for construction of any public facility), the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.

52.219-14, Limitations on Subcontracting (Jan 2017) (15 U.S.C. 637(a)(14)).

52.222-3, Convict Labor (June 2003) (E.O. 11755).

52.222-19, Child Labor—Cooperation with Authorities and Remedies (Oct 2016) (E.O. 13126).

52.222-21, Prohibition of Segregated Facilities (Apr 2015).

52.222-26, Equal Opportunity (Sep 2016) (E.O. 11246).

52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793).

(vii) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (DEC 2010) (E.O.

13496). Flow down required in accordance with paragraph (f) of FAR clause 52.222-40.

52.222-41, Service Contract Act of 1965 (Nov 2007) (41 U.S.C. 351, et seq.).

52.222-43, Fair Labor Standards Act and Service Contract Act—Price Adjustment (Multiple Year and

Option Contracts) (Sep 2009) (29 U.S.C. 206 and 41 U.S.C. 351, et seq.).

52.222-50, Combating Trafficking in Persons (Mar 2015) (22 U.S.C. chapter 78 and E.O. 13627).

52.222-51, Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment--Requirements (Nov 2007) (41 U.S.C. 351, et seq.)

52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (Jun

2016) (E.O.13693).

52.223-13, Acquisition of EPEAT® -Registered Imaging Equipment (Jun 2014) (E.O.s 13423 and 13514

52.223-18, Encouraging Contractor Policies to Ban Text Messaging while Driving (Aug 2011) (E.O.

13513).

52.224-3, Privacy Training (Jan 2017) (5 U.S.C. 552a).

52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 4505), 10 U.S.C.

2307(f)).

52.232-33, Payment by Electronic Funds Transfer— System for Award Management (Jul 2013) (31 U.S.C.

3332).

52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).

52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or

Equipment.

As prescribed in 4.2105(a), insert the following provision:

REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT

(AUG 2020)

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 the provision at 52.204-26, Covered Telecommunications Equipment or Services—Representation, or in paragraph (v) of the provision at 52.212-3, Offeror Representations and Certifications-Commercial Items.

(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 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 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)(2) 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 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)(2) of this provision.

(End of provision)

52.217-8 Option to Extend Services (Nov 1999)

The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor at least 30 days before the contract expires.

52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor within 30 days;

provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least

45 days before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed 42 mths.

252.223-7999 Ensuring Adequate COVID-19 Safety Protocols for Federal Contractors (Deviation 2021-O0009)

As prescribed in Class Deviation 2021-O0009, Ensuring Adequate COVID-19 Safety Protocols for Federal

Contractors, use the following clause:

ENSURING ADEQUATE COVID-19 SAFETY PROTOCOLS FOR FEDERAL CONTRACTORS (DEVIATION

2021-O0009) (OCT 2021)

(a) Definition. As used in this clause –

United States or its outlying areas means—

(1) The fifty States;

(2) The District of Columbia;

(3) The commonwealths of Puerto Rico and the Northern Mariana Islands;

(4) The territories of American Samoa, Guam, and the United States Virgin

Islands; and

(5) The minor outlying islands of Baker Island, Howland Island, Jarvis Island, Johnston Atoll, Kingman Reef, Midway Islands, Navassa Island, Palmyra Atoll, and Wake Atoll.

(b) Authority. This clause implements Executive Order 14042, Ensuring Adequate COVID Safety Protocols for

Federal Contractors, dated September 9, 2021 (published in the Federal Register on September 14, 2021, 86

FR 50985).

(c) Compliance. The Contractor shall comply with all guidance, including guidance conveyed through Frequently

Asked Questions, as amended during the performance of this contract, for contractor or subcontractor workplace locations published by the Safer Federal Workforce Task Force (Task Force Guidance) at https:/www.saferfederalworkforce.gov/contractors/.

(d) Subcontracts. The Contractor shall include the substance of this clause, including this paragraph (d), in subcontracts at any tier that exceed the simplified acquisition threshold, as defined in Federal Acquisition

Regulation 2.101 on the date of subcontract award, and are for services, including construction, performed in whole or in part within the United States or its outlying areas.

(End of provision)

(c)

SUBMISSION PROCEDURES:

All questions regarding this solicitation must be submitted to the Contracting Office via email no later than 10:00 a.m. EST, 24 Jan 2022. Please submit questions to Peggy Pennie at Peggy.Y.Pennie.civ@army.mil. The responses will be posted to sam.gov.

Firm Fixed Price (FFP) proposals must be signed, dated, and received by 10:00 a.m. EST, 4 Feb 2022, via email to

Peggy Pennie at Peggy.Y.Pennie.civ@army.mil

All quotations from responsible sources will be considered. Vendors who are not registered in the System for Award

Management (SAM) database prior to award will not be considered. Vendors may register with SAM by calling 1-

866-606-8220 or online at https://www.sam.gov.

Offerors shall include a completed copy of the provision at FAR 52.212-3, Offeror Representations and

Certifications- Commercial Items, with its offer.

NO TELEPHONE REQUESTS WILL BE HONORED.

PERFORMANCE WORK STATEMENT (PWS)

Title: Coronavirus Analysis in Wastewater Including Variants

Requiring Activity Name: U.S. Army Public Health Center (APHC)

1. INTRODUCTION

The U.S. Army Public Health Center (APHC) is part of the U.S. Army Medical Command (MEDCOM) and focuses on epidemiology, laboratory sciences, occupational health sciences, public health information and toxicology to enhance Army readiness and assure the quality and effectiveness of Army’s Public Health Enterprise.

2. PURPOSE AND BACKGROUND

The mission of the APHC is to “Enhance Army readiness by identifying and assessing current and emerging health threats; developing and communicating public health solutions; and assuring the quality and effectiveness of the Army’s

Public Health Enterprise.”

3. SCOPE

The APHC is using wastewater analysis for public health surveillance of the novel coronavirus (SARS-COV-2) that causes the disease known as COVID-19. The data provided by this analysis will allow Army senior leaders to evaluate mailto:Peggy.Y.Pennie.civ@army.mil mailto:Peggy.Y.Pennie.civ@army.mil https://www.sam.gov/ current conditions for coronavirus and determine appropriate policies to prevent and control virus spread. Contractor will provide Ribonucleaic Acid (RNA) virus detection using quantitative polymerase chain reaction (qPCR) and

Reverse Transcriptase polymerase chain reaction (RT-PCR) laboratory techniques. Further, the contractor will analyze the samples and provide data on the presence and concentration of alternative forms of the virus, also known as variants.

This analysis technique is not unique, but performing this technique on wastewater samples is. There are special preparation steps that must be taken to analyze the extremely low levels of virus RNA that might be in wastewater.

Many laboratories test for coronavirus in samples taken directly from human patients, but required contractor lab will perform this test on wastewater samples.

4. PERIOD OF PERFORMANCE

The period of performance for this contract are as follows:

Base Period 3/02/2022 – 3/01/2023

Option Year 1 3/02/2023 – 3/01/2024

Option Year 2 3/02/2024 – 3/01/2025

5. WORK SCHEDULE AND LOCATION

5.1. Work Location

The work locations for this requirement will be performed at the Contractor’s laboratory. There is no onsite support for this requirement.

6. PERFORMANCE REQUIREMENTS

6.1. Objectives

Objective 1– Provide APHC EHSE monthly with sample analysis bottles. These bottles will be used to collect wastewater samples and return ship to contractor laboratory. Bottles must be large enough to provide sufficient volume for analysis plus quality assurance / quality control (QA/QC) processes. Bottles must be shipped in packaging that ensures no breakage. The material of bottle shall not adversely affect the analysis of the sample either in minimum detection level or in other quantitative or qualitative ways. Bottles must be cleaned to a standard such that the analysis of the sample will not be adversely affected, such as (but not limited to) by: contamination, false positives, or microbial action consuming the target RNA.

Objective 2 – Perform two (2) weekly sample analysis within two (2) calendar days of receipt of samples following established protocols for RT-qPCR analysis of wastewater including variant analysis, ensuring no contamination of/by samples due to samples potentially containing pathogenic organisms. Notes and records of procedures, results, conclusions, and QA/QC must be kept.

Objective 3 – Report weekly analysis results, including variant analysis and full lab reports, to APHC EHSE within

(2) calendar days of completion of sample analysis. Interpretations/notes/conclusions/comments are to be included where appropriate. Any deviations from established protocols (and response to those deviations) must be described, explained, and included in weekly lab reports.

6.2. Specific Tasks / Requirements

Key Task 1 – The Contractor shall provide nine (9) sample bottles (total of 108) the 1st Monday of every month for

12 consecutive months that meet the contractor’s laboratory’s standards (size, shape, material, cleanliness, etc.) for sample collection. (Deliverable 1)

U.S. Army Public Health Center (APHC)

8242 Blackhawk Road

Building E-5165

APG, MD 21010-5403

Key Task 2 – The Contractor shall provide paid express return shipping labels and instruction to return sample bottles to the laboratory. (Deliverable 2)

Key Task 3 – The Contractor shall perform qPCR and RT-PCR analysis, including variant analysis, following all established protocols for procedures, detection limits, and QA/QC. (Deliverable 3)

Key Task 4 – The Contractor shall report qPCR and RT-PCR numerical analytical results, including variant analysis, (no more than four (4) calendar days following sample return receipt). Results shall be sent electronically to:

kevin.r.russell1.civ@mail.mil; wendy.b.mervine.civ@mail.mil; and melissa.a.torralbes.civ@mail.mil. (Deliverable

4)

Key Task 5 – Full lab reports (which are in addition to the numerical analytical results) shall include at a minimum:

summary table of results; sample identification information (sample #, delivery date, collection point, etc.); key for terminology/abbreviations; narrative (including any variations from established protocols/procedures); any comments, conclusions, or notes as appropriate; and QA/QC data (as described in established protocols/procedures).

(Deliverable 5)

Key Task 6 – Contractor shall be available during regular business hours (Monday through Friday 0700 to 1700, not including Federal Holidays) to answer questions/inquiries and address comments on laboratory analysis, results, and reporting. Answers/responses shall be provided NLT the next business day. (Deliverable 6)

6.3 Quality Control Plan

The contractor shall provide a draft Quality Control Plan (QCP) no later than 15 calendar days after contract award.

The contractor shall prepare and adhere to a QCP describing how the contractor intends to manage the contract to achieve the established standards set forth in the Performance Standards Summary Matrix and the contractor’s QCP.

At a minimum, the QCP must include a self- inspection plan, an internal staffing plan, and an outline of the procedures the Contractor shall use to maintain quality, timeliness, responsiveness and customer satisfaction.

(Deliverable 7)

7. DELIVERABLES

The contractor shall complete and submit deliverables in accordance with the “Deliverables Table” below. Unless specified in the PWS within the description of the deliverable, all deliverables will be made to the COR electronically.

DELIVERABLES TABLE

PWS Ref. Number Title/Description Due

6.2 1

The Contractor shall provide 9 sample bottles

(total of 108 each year of contract) the 1st

Monday of every month for 12 consecutive months that meet the contractor’s laboratory’s standards.

First shipment received

NLT 30 calendar days after contract award.

6.2 2

The Contractor shall provide paid express return delivery shipping labels and instruction to return sample bottles to the laboratory.

NLT 30 calendar days after contract award.

6.2 3 The Contractor shall perform qPCR and RT-PCR analysis, including variant analysis, following all

Within two (2) calendar days of receipt of

PWS Ref. Number Title/Description Due established protocols for procedures, detection limits, and quality assurance/quality control.

samples

6.2 4

The Contractor shall report qPCR and RT-PCR numerical analytical results, including variant analysis, weekly. Results shall be sent electronically to: kevin.r.russell1.civ@mail.mil;

wendy.b.mervine.civ@mail.mil; and melissa.a.torralbes.civ@mail.mil

Within two (2) calendar days of sample analysis.

6.2 5

Full lab reports shall include at a minimum:

summary table of results; sample identification information (sample #, delivery date, collection point, etc.); key for terminology/abbreviations;

narrative (including any variations from established protocols/procedures); any comments, conclusions, or notes as appropriate; and quality assurance/quality control data (as described in established protocols/procedures).

No later than seven (7) calendar days after sample return receipt.

6.2 6

Contractor shall be available during regular business hours to answer questions/inquiries and address comments on laboratory analysis, results, and reporting. Answers/responses must be given by the next business day.

As requested by APHC.

6.3 7

Quality Control Plan - how the contractor intends to manage the contract to achieve the established standards set forth in the Performance Standards

Summary Matrix and the contractor’s QCP. At a minimum, the QCP must include a self- inspection plan, an internal staffing plan, and an outline of the procedures the Contractor shall use to maintain quality, timeliness, responsiveness and customer satisfaction.

No later than 15 calendar days after contract award

7.1. Reports and Documents

Reports and documents delivered by the contractor in the performance of this contract shall be considered

Technical 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.

7.2. Inspection and Acceptance

The COR delegated oversight of specific technical, functional and oversight responsiblities is responsible for inspection and acceptance of all services, incoming shipments, documents, and services.

mailto:kevin.r.russell1.civ@mail.mil mailto:wendy.b.mervine.civ@mail.mil mailto:melissa.a.torralbes.civ@mail.mil

Certification by the Government of satisfactory services provided is contingent upon the Contractor performing in accordance with the performance standards contained in the Performance Work Statement and all terms and conditions of this order, including all modifications.

7.3. COR Information

TBD

8. Contract Management

8.1. Government Management

The Contracting Officer’s Representative (COR) 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.

Only the KO has the authority to enact changes to this award. COMPLIANCE DOCUMENTS

8.2. General Compliance

8.2.1. Federal Law

The services provided under this contract must be conducted in accordance with all Federal law, Department of Defense (DOD), Department of the Army (DA) and Medical Command (MEDCOM) laws and command laws, regulations, policies, and procedures that govern the conduct of regulated research.

Federal regulations governing regulations for human subject’s protection are found in 45 CFR 46. The

International Convention on Harmonization Guidelines for Good Clinical Practice is the standard governing the conduct of research trials. References for military regulations and policies governing regulated research may be found at https://mrmc.amedd.army.mil/rodorphrpo.asp.

8.2.2. Occupational Safety and Health Administration

The contractor shall comply with Occupational Safety and health Administration Standard Number 1904.32.

The contractor shall deliver the 300A by February 1 of each year (Deliverable XX).

8.2.3. DoD Compliance Documents

A complete list of Department of Defense compliance documents providing specifications, standards, or guidelines can be found at https://www.dtic.mil/whs/directives/corres/dir.html

A complete list of Department of Defense compliance documents providing specifications, standards, or guidelines can be found at https://www.dtic.mil/whs/directives/corres/dir.html

a) Army Regulation 340-22, Army Privacy Program.

https://armypubs.army.mil/ProductMaps/PubForm/Details.aspx?PUB_ID=1001059

b) Army Regulation 25-2, Army Cybersecurity.

https://armypubs.army.mil/ProductMaps/PubForm/Details.aspx?PUB_ID=1002626

c) Title 21, CFR Part 11 Electronic Records: Electronic Signature.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11

8.3. Medical and Laboratory Compliance

8.3.1. Army Regulation 340-22, Army Privacy Program

Compliance information regarding Army Privacy program may be found at:

https://armypubs.army.mil/ProductMaps/PubForm/Details.aspx?PUB_ID=1001059ml

8.4. Organizational Conflict of Interest

U.S. Army Public Health Center (APHC) 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 APHC 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.

13.5.1 OCI Certification. APHC 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 APHC 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.

8.5. Invoices

The contractor shall submit invoices monthly to Wide Area Work Flow (WAWF) with sufficient documentation to provide certification of invoice.

The contractor is responsible for properly preparing and forwarding to the appropriate Government official, the invoice and receiving report for payment. Equipment purchases are not authorized under this contract.

The Wide Area Workflow – Receipt and Acceptance application is the required method of submission.

8.6. Dissemination of Information/Publishing

There shall be no dissemination or publication, except within and between the Contractor and any Sub

Contractors or specified Integrated Product/Process Team (IPT) members who have a need to know, of information developed under this order or contained in the reports to be furnished pursuant to this order without prior written approval of the COR or the Contracting Officer.

8.7. Data Rights

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 KO grants a specific exception.

8.8. Anti-Terrorism and Operational Security

There is no on-site support for this requirement.

QUALITY ASSURANCE SURVEILLANCE PLAN

US Army Public Health Center (APHC)

Coronavirus Wastewater Surveillance

1. Vision

The U.S. Army Public Health Center (APHC) focuses on epidemiology, laboratory sciences, occupational health sciences, public health information and toxicology to enhance Army readiness and assure the quality and effectiveness of Army’s Public Health Enterprise.

2. Mission

The mission of the APHC is to “Enhance Army readiness by identifying and assessing current and emerging health threats; developing and communicating public health solutions; and assuring the quality and effectiveness of the

Army’s Public Health Enterprise.”

3. Purpose

3.1. This Quality Assurance Surveillance Plan (QASP) is a government-developed document used to determine if the contractor's performance meets the performance standards contained in the contract. The QASP establishes procedures on how this assessment/inspection process will be conducted. It provides the detailed process for a continuous oversight process:

3.1.1. The Government will use the QASP which provides a systematic method to evaluate the services that the

Contractor is required to furnish, but not the details of how the Contractor accomplishes the work.

3.1.2. The Contracting Officer’s Representative (COR) will use direct observation techniques for monitoring all service actions to ensure quality standards have been met on time and are technically complete.

3.1.3. The COR will document the monitoring on the monthly COR report.

3.2. The contractor is responsible for implementing and delivering performance that meets contract standards using its Quality Control Plan. The QASP provides the structure for the government's surveillance of the contractor's performance to assure that it meets contract standards. It is the government's responsibility to be objective, fair and consistent in evaluating contractor performance.

3.3. The QASP is not part of the contract nor is it intended to duplicate the contractor's quality control plan. This

QASP is a living document. Flexibility in the QASP is required to allow for an increase or decrease in the level of surveillance necessary based on contractor performance.

3.4. The government may provide a copy of the QASP to the contractor to facilitate open communication. In addition, the QASP should recognize that unforeseen or uncontrollable circumstances might occur that are outside the control of the contractor.

Bottom line, the QASP should ensure early identification and resolution of performance issues to minimize impact on mission performance.

4 Authority

Authority for issuance of this QASP is provided under Part 46 of the Federal Acquisition Regulation, Inspection of

Services clauses, which provide for inspection, acceptance and documentation of the service called for in the contract or order. This acceptance is to be executed by the contracting officer or a duly authorized representative.

5 Roles and Responsibilities

The following personnel shall oversee and coordinate surveillance activities.

5.1 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 ensure that the contractor receives impartial, fair, and equitable treatment under this contract. Determine and document the final assessment of the contractor's performance in the governments past performance tracking system.

5.2 Contracting Officer's Representative (COR)

The COR is responsible for providing continuous technical oversight of the contractor's performance. The COR uses the QASP to conduct the oversight/surveillance process. The COR shall keep a Quality Assurance file that accurately documents the contractor's actual performance. The purpose is to ensure that the contractor meets the performance standards contained in the contract. The COR is responsible for reporting early identification of performance problems to the KO. The COR is required to provide an annual performance assessment to the KO which will be used in documenting past performance. The QASP is the primary tool for documenting contractor performance. The COR is not empowered to many any contractual commitments or to authorize any contractual change on the Government's behalf.

Assigned COR: This section is to be completed at time of award

Organization or Agency:

Telephone:

Email:

6 Performance Requirements and Method of Surveillance

This section describes the special requirements for this effort. The following sub-sections provide details of various considerations on this effort.

6.1 Contract Surveillance

The goal of the QASP is to ensure that contractor performance is effectively monitored and documented. The COR's contribution is their professional, non-adversarial relationships with the KO, PM and the contractor, which enables positive, open and timely communications. The foundation of this relationship is built upon objective, fair, and consistent COR evaluations of contractor performance against contract requirements. The COR uses the methods contained in this QASP to ensure the contractor is in compliance with contract requirements. The COR function is responsible for a wide range of surveillance requirements that effectively measure and evaluate the contractor's performance. Additionally, this QASP is based on the premise that the contractor, not the government, is responsible for management and QC/QA actions to successfully meet the terms of the contract.

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 Target Method of

Surveillance

Method of Inspection

The contractor must provide sample bottles appropriate for collection and analysis of wastewater samples delivered to

APHC weekly prior to each sampling event.

Appropriate sample bottles received weekly.

COR receives delivery receipt or confirmation from

APHC that appropriate bottles have arrived.

Review of delivery receipts (and/or confirmations) by

COR and APHC

Quality Manager.

Contractor will conduct real time Polymerase Chain

Reaction (rt PCR) analysis of wastewater samples conforming to all the requirements of established lab procedures/protocols.

100% of analyses are conducted following established procedures/protocols.

APHC Quality

Manager and COR should receive lab reports of procedures/protocols.

Review procedures/protocols upon receipt by

APHC Quality

Manager and COR.

Contractor will weekly provide full lab reports of results from rt PCR to include quality assurance and quality control

(QA/QC) information.

100% of analyses are conducted within established QA/QC requirements. 100% of analyses reported weekly.

APHC Quality

Manager and COR should receive lab reports of results and

QA/QC.

Review results and

QA/QC upon receipt by APHC Quality

Manager and COR.

CORRECTIVE ACTION REPORT (CAR)

(If more space is needed, use reverse and identify by number)

1. CONTRACTOR

2. CONTRACT NUMBER

3. TYPE OF SERVICES

4. FUNCTIONAL AREA

5. SUSPENSE DATE

6.

CONTROL

NUMBER

7. DEFICIENCY MAJOR MINOR

FINDING:

FINDING IMPACT:

Please respond with a written corrective action plan that details the corrective action of the cited deficiency, the cause of the deficiency, and actions taken to prevent recurrence by Suspense Date in Block 5. If date was not entered in Block 5, the contractor is not required to provide a response.

8. QUALITY ASSURANCE PERSONNEL (COR)

TYPED NAME AND GRADE

SIGNATURE AND DATE

9. ISSUING AUTHORITY

TYPED NAME AND GRADE

SIGNATURE AND DATE

10. COR RESPONSE TO CONTRACTOR CORRECTIVE ACTION AND ACTION TAKEN TO PREVENT

RECURRENCE

11. COR DETERMINATION

ACCEPTED REJECTED

12. CLOSE DATE

CUSTOMER COMPLAINT RECORD

DATE/TIME OF

COMPLAINT

SOURCE OF COMPLAINT

ORGANIZATION

BUILDING

INDIVIDUAL

PHONE

NATURE OF COMPLAINT

CONTRACT REFERENCE

VALIDATION

DATE/TIME CONTRACTOR INFORMED OF COMPLAINT

ACTION TAKEN BY CONTRACTOR

RECEIVED/VALIDATED BY

PERFORMANCE ASSESSMENT REPORT (PAR)

(If more space is needed, use reverse and identify by number)

1. CONTRACT/TASK ORDER

NUMBER

2. CONTRACTOR 3. TYPE OF SERVICES

4. QUALITY ASSURANCE PERSONNEL (COR) SIGNATURE AND

DATE

5. COR PHONE 6.

SUSPENSE

DATE

I. PERFORMANCE

7. DEFICIENCY (CHECK ALL BOXES THAT

APPLY)

NEW

REPEAT

NO DEFICIENCY NOTED

8. SERVICES SUMMARY or PWS

PARAGRAPH ITEM REVIEWED

9. BRIEF DESCRIPTION OF DEFICIENCY (IF

DEFICIENCY BOX WAS CHECKED)

10. DETAILED PERFORMANCE

ASSESSMENT

II. CONTRACTOR VALIDATION

11. CONTRACTOR REPRESENTATIVE CONCUR

NON-CONCUR

12. CORRECTIVE ACTION ESTIMATED

COMPLETION DATE

13. CONTRACTOR REPRESENTATIVE CORRECTIVE ACTION AND PREVENTION OF RECURRENCE

OR REASON FOR NON-CONCURRENCE OF COR CITED DEFICIENCY

III. ACTION CORRECTED

14. CONCUR NON-CONCUR COR SIGNATURE AND DATE

15. COR REMARKS (REQUIRED)

16. CONTRACTOR REPRESENTATIVE REMARKS