Attachment 1 - Performance Work Statement.pdf

PERFORMANCE WORK STATEMENT (PWS)

Title: Coronavirus Analysis in Wastewater

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 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. 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 12 months from date of award

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 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 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 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 (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 (Deliverable 7). 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.

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) 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 following all established protocols for procedures, detection limits, and quality assurance/quality control.

Within two (2) calendar days of receipt of samples

6.2 4

The Contractor shall report qPCR and RT-PCR numerical analytical results 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.

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

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.

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 http://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 http://www.dtic.mil/whs/directives/corres/dir.html

a) Army Regulation 340-21, Army Privacy Program.

http://www.army.mil/usapa/epubs/340_Series_Collection_1.html

b) Army Regulation 25-2, Information Assurance.

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 340-21, Army Privacy Program

Compliance information regarding Army Privacy program may be found at:

http://www.army.mil/usapa/epubs/340_Series_Collection_1.html

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.