HT942524Q0030 0002.pdf

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print)

30-105-04EXCEPTION TO SF 30

APPROVED BY OIRM 11-84

STANDARD FORM 30 (Rev. 10-83) Prescribed by GSA

FAR (48 CFR) 53.243

Amendment 0002 includes a revised Performance Work Statement (PWS) and Attachment 4, Final Reporting Requirements. Additionally, the quote due date has been extended to 11:00 AM, 26 March 2024.

1. CONTRACT ID CODE PAGE OF PAGES

J 1 21

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

16C. DATE SIGNED

BY 15-Mar-2024

16B. UNITED STATES OF AMERICA15C. DATE SIGNED15B. CONTRACTOR/OFFEROR

(Signature of Contracting Officer)(Signature of person authorized to sign)

8. NAME AND ADDRESS OF CONTRACTOR (No., Street, County, State and Zip Code) X HT942524Q0030

X 9B. DATED (SEE ITEM 11)

06-Feb-2024

10B. DATED (SEE ITEM 13)

9A. AMENDMENT OF SOLICITATION NO.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

X The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offer X is extended, is not extended.

Offer must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended by one of the following methods:

(a) By completing Items 8 and 15, and returning 1 copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN

REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS.

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE

CONTRACT ORDER NO. IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(B).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor is not, is required to sign this document and return copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

10A. MOD. OF CONTRACT/ORDER NO.

2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO.(If applicable)

6. ISSUED BY

3. EFFECTIVE DATE

15-Mar-2024

CODE

ARMY MED RES ACQ ACTIVITY

808 SCHREIDER ST

FORT DETRICK MD 21702

HT9425 7. ADMINISTERED BY (If other than item 6)

4. REQUISITION/PURCHASE REQ. NO.

CODE

See Item 6

FACILITY CODECODE

EMAIL:TEL:

HT942524Q0030

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 1449 - CONTINUATION SHEET

SOLICITATION/CONTRACT FORM

The required response date/time has changed from 07-Mar-2024 11:00 AM to 26-Mar-2024 11:00 AM.

The following have been modified:

PWS

PERFORMANCE WORK

STATEMENT (PWS)

PWS Revision 1: PWS Section 6.2.1.6. has been revised to allow a grace period opportunity for liquidated damages. All revisions are highlighted yellow.

Title: Lab Industrial Hygiene (IH) Sample Analysis Contract

Requiring Activity Name: Defense Centers for Public Health – Aberdeen (DCPH-A) (Formerly known as the US Army Public Health Center – APHC)

1. INTRODUCTION

The Defense Centers for Public Health – Aberdeen (DCPH-A) is part of the Defense Health Agency (DHA) and focuses on epidemiology, laboratory sciences, occupational health sciences, public health information and toxicology to enhance military readiness and assure the quality and effectiveness of the Public Health Enterprise. Ensuring high-quality services is an imperative of the DCPH-A as it strives to become a high-reliability organization (HRO).

2. PURPOSE AND BACKGROUND

The mission of the DCPH-A is to “Enhance Military readiness by identifying and assessing current and emerging health threats; developing and communicating public health solutions; and assuring the quality and effectiveness of the Public Health Enterprise.” As part of the DCPH-A mission, the Lab Sciences Directorate performs Industrial Hygiene Sample Analysis in support of the Military operating environments and military bases to ensure the safety and security of all who work there.

The Lab Sciences (LS) Directorate currently analyzes industrial hygiene and occupational samples for various parameters in support of the DCPH-A mission. However, the LS does not currently have the analytical capability and/or capacity to perform all industrial hygiene analyses required including analyses from various worldwide locations and from natural or man-made disaster locations.

3. SCOPE

The DCPH-A requires analyses on Industrial Hygiene and Occupational Health samples and results of various compounds in each sample.

The data obtained under this contract shall be used by the DHA to comply with Federal and State requirements of the Occupational Safety and Health Administration (OSHA).

Procedures specified in Attachment 3 - Limits of Quantitation and Attachment 4 - Final Reporting Requirements, shall be used in the analyses on Industrial Hygiene and Occupational Health samples.

If the referenced standard procedures have been modified in any way (sample preparation, analysis, types and number of Quality Control (QC) samples employed, QC acceptance criteria, etc.), these modifications must be clearly explained in the laboratory Standard Operating Procedures (SOPs) and provided to DCPH-A prior to contract award for approval. Contractor shall employ safe handling techniques and quality assurance/quality control protocol. In addition, strict adherence to chain-of-custody and quality control procedures is required at all times.

Procedures specified in Attachment 3 - Limits of Quantitation and Attachment 4 - Final Reporting Requirements, shall be used in the analyses on Industrial Hygiene and Occupational Health samples.

If the referenced standard procedures have been modified in any way (sample preparation, analysis, types and number of Quality Control (QC) samples employed, QC acceptance criteria, etc.), these modifications must be clearly explained in the laboratory Standard Operating Procedures (SOPs) and provided to DCPH-A prior to contract award for approval. Contractor shall employ safe handling techniques and quality assurance/quality control protocol. In addition, strict adherence to chain-of-custody and quality control procedures is required at all times.

4. PERIOD OF PERFORMANCE

This contract is for one (1) twelve (12) month Base Period and four (4) twelve (12) month option periods.

Base Year 1 April 2024 – 31 March 2025 Option Year 1 1 April 2025 – 31 March 2026 Option Year 2 1 April 2026 – 31 March 2027 Option Year 3 1 April 2027 – 31 March 2028 Option Year 4 1 April 2028 – 31 March 2029

5. WORK SCHEDULE AND LOCATION

5.1. Work Location

The work location is at the Contractor’s or Sub-Contractor’s laboratory facility.

6. PERFORMANCE REQUIREMENTS

6.1. Objectives

To provide Industrial Hygiene sample analysis in accordance with the parameters identified with various types of samples.

6.2. Specific Tasks / Requirements

6.2.1. Objective 1 – The Contractor shall perform analysis on Industrial Hygiene samples provided by the Government. The Contractor shall follow Chain-Of-Custody (COC) procedures as defined in the contractor’s COC Standard Operating Procedure (SOP).

6.2.1.1. Key Task 1 – Receipt and Storage of Samples prior to analysis. The Government will send samples for analysis to the Contractor facility. Each container contains specific parameters for which the sample must be analyzed. The Contractor is responsible for storing and handling the samples in accordance with the analytical method specifications.

Samples will be provided to the Contractor either through from DCPH-A or shipment directly from the field.

6.2.1.1.1 Sample Shipment Protocol from the DCPH-A lab. If applicable, DCPH-A shall pay the shipping costs for transportation of the samples. The Contractor shall store samples in accordance with the preservation guidelines as noted in the analytical method until samples are analyzed, and thereafter until results are approved by the COR.

6.2.1.1.2 Direct shipment of samples from the field to the contractor. If holding times are of concern, there may be a necessity to ship the samples to the contract lab directly from the field following collection. The DCPH-A sample submitter will ship the samples and a corresponding field Chain-of- Custody (COC) document to the contract lab.

6.2.1.1.3 When the contract lab receives the samples and corresponding field COC forms, the Contractor shall sign the COC forms documenting receipt of samples and immediately (within the same business day of receipt) forward the field COC to the COR for review, accountability and LIMS login at the DCPH-A (Deliverable 1). The contractor’s project manager will also report to the COR the condition of the samples upon receipt (to include receipt temperature) in the contractor lab. The DCPH-A COR shall use project planning information and the information on the COC form to generate an Outsource Document containing all applicable information (i.e.

DCPH-A lab ID, DCPH-A field ID, analyses requested, matrix, points-of-contact, etc.). The generated Outsource Document will be forwarded electronically to the contract laboratory. The contractor shall then begin sample analysis. The Contractor shall assure that the contract laboratory analyzes the sample within holding times specified in applicable methodology. If paperwork from the COR is pending, the contract lab should obtain guidance from the COR to proceed with analysis to meet holding times. The contractor shall immediately report all samples lost or broken in shipment, with as much detail as possible, to the COR. In addition, the sample receipt temperature must be reported to the COR if applicable within 24 hours of sample receipt (Deliverable 2).

6.2.1.2 Key Task 2 – Perform Sample Analysis within the stated Turnaround Time

(TAT). The Government will designate samples as either “STANDARD”, “HIGH PRIORITY”, “TOP PRIORITY”, or “URGENT”. Turnaround times are calculated from the date of contractor receipt of samples to the date of receipt of technically acceptable analysis results acceptance by the Government.

For each sample designation, the contractor shall complete the sample analysis, final reporting and Electronic Data Deliverable transmission within the following TAT timeframes:

STANDARD: Maximum 8 calendar days from date of sample receipt.

HIGH PRIORITY: Maximum 5 calendar days from the date of sample receipt.

TOP PRIORITY: Maximum 3 calendar days from the date of sample receipt.

URGENT: Maximum 1 calendar day from date of sample receipt.

Turnaround time is defined as the intervening time period between the date of sample receipt in the contractor’s laboratory (or Outsource Document for Direct Shipped Samples) to the date of receipt of a complete and technically acceptable data package (Final PDF copy + Electronic Data Deliverable (EDD)), (Attachment 4), by the DCPH-A laboratory. Technical acceptability will be determined by a thorough review by qualified DCPH-A technical Subject Matter

Experts and communicated to the COR for any required actions with the Contractor. Holidays and weekends are considered ‘calendar’ days.

If a report is identified as not technically acceptable, the COR will notify the Contractor to obtain a revision or clarity. In cases where the revision is due to a problem caused by the Contractor, the TAT will continue from the date the Contractor is notified of the revision request. If the revision is due to a government change (such as a change in the sample ID requiring a revised report), the Contractor TAT clock will not continue.

Approximately 15% of the total samples forwarded to the contractor per year shall be designated high priority and 5% of the total samples sent to the contractor shall be designated top priority. Urgent shall be defined as samples involved in a catastrophic national emergency situation; less than 0.5% of samples, if any, could be classified as urgent.

Provide final analytical results to the COR. The contractor shall submit the results of all analyses within the TAT timelines as defined on the Outsource Document for each set of samples (Deliverable 3). The results shall be submitted electronically to the COR and include the information requested in the format outlined in the Final Reporting Requirements (Attachment 4).

Extensions for matrix issues and sample analysis anomalies may be negotiated with the COR on a case by case basis. However, these issues must be communicated to the COR when they occur, prior to the due date and when the lab believes a delay is possible, not after the data package is overdue.

6.2.1.3 Key Task 3 – Provide Quality sample Analysis on Industrial Hygiene Samples for various parameters as identified in this PWS in accordance with the documented methodology.

6.2.1.3.1 Use industry standard state-of-the-art instrumentation, technologies and methodologies to analyze samples for any of the parameters listed in Attachment 3 – Limits of Quantitation. Any special analyses or additional testing requirements will be stated on the sample. It is anticipated that the contractor will perform between 500 and 2,500 analyses per year. Natural disasters or military mobilization may alter these estimates to an increased amount at or above 5,000 analyses per year.

When the contract laboratory is performing sample analyses using the methodologies specified in Attachment 3 – Limits of Quantitation, the contract laboratory shall follow quality control guidelines specified in that particular method and American Industrial Hygiene Association (AIHA) accreditation requirements.

6.2.1.3.2 Quality control data shall be analyzed and, where they are found to be outside pre-defined criteria, planned actions shall be taken to correct the problem and to prevent incorrect results from being reported. If additional quality assurance/quality control protocol is designated in the methodologies, these guidelines shall also be strictly followed.

6.2.1.3.3 Analyze samples within the maximum holding times specified in the method, even if these times are less than the 8 calendar day, 5 calendar day or 3 calendar day completion times allowed in this contract.

If a sample is not processed within the specified holding time per method, the sample will be considered “lost”, unable to analyze and require recollection by the DCPH-A project officer. When this occurs, the contractor shall not bill the government for tests performed on samples beyond their holding times Extenuating circumstances can be negotiated on a case by case basis with the COR. (Examples – Weekends/Holidays, late arrivals, unannounced arrivals.)

The Contractor shall at least report at or below the limits identified in Attachment 3 - Limits of Quantitation.

6.2.1.4 Key Task 4—Disposal of unused sample volumes and return of

Government shipping containers.

Unless otherwise instructed by the COR, the Contractor shall be required to dispose of unused sample volume and used industrial hygiene sampling media (excluding carbon disulfide which shall be disposed immediately) no earlier than 60 days following submission of analytical data. Sample disposal and disposal of unused sample bottles/containers is the responsibility of the contractor and should be done in accordance with all applicable laws and regulations governing disposal of such materials.

All Government shipping containers, unless otherwise specified, shall be returned to the COR within three business days of receipt. The Government will provide return shipping labels to the Contractor for the shipping containers to be returned back to the Government.

6.2.1.5 Key Task 5 – Sampling Media Request for Support

The DCPH-A COR may request the Contractor to supply media only (no subsequent analysis will be ordered). The Contractor shall invoice the Government for the price of the media, and the DCPH-A will provide the shipping account to ship the media if requested.

For Sample analysis being requested by DCPH-A and performed at the Contractor, the Contractor price of the test should include the media required for analysis listed in Attachment 3 – Limits of Quantitation. The Government will request this media on an as needed basis (not for every set of samples).

6.2.1.6 Key Task 6 – Liquidated Damages assessment for late or deficient reporting.

The Contractor shall submit Final and Preliminary reports as well as electronic.

If the contractor does not submit data packages on time and/or submits incomplete/technically deficient data packages, the contractor may be required to pay liquidated damages to the Government as follows:

- 5% per day late to a maximum of 100%

If a preliminary report ( Level-2 data package) is delivered within the initial 8-day Standard Priority TAT, then a grace period will be granted, up to 7 calendar days, before the final delivery of the Level-4 data package.

Extensions for matrix issues and sample analysis anomalies may be negotiated with the COR on a case by case basis. However, these issues must be made known to the COR when they occur and when the lab believes a delay is possible, not after the data package is overdue.

6.3 Laboratory Qualifications and Capabilities

Laboratory Instrumentation/Technology Requirements. The contractor must have the following instrumentation/technologies to ensure the contractor’s ability to process sample analyses within a timely manner based on the anticipated volume:

6.3.1 Instrumentation/Technology (minimum requirements to perform the required testing methods)

a) Gas Chromatographs (GC) with various detectors as required for each method

b) High Pressure Liquid Chromatographs (HPLC)

c) Ion Chromatographs (IC)

d) Inductively Coupled Plasma (ICP)

e) Atomic Emission Spectrometers (AES)

f) Mass Spectrometers (MS)

g) Transmission Electron Microscope (TEM)

h) Microscopes

i) X-Ray Fluorescence (XRF)

6.3.2 Laboratory Facilities (minimum requirements):

a) Adequate electrical service.

b) Reagent water to meet American Society for Testing and Materials (ASTM) Type II classification.

c) Class A volumetric glassware for all analyses.

d) Adequate fume hood system to provide safe storage of hazardous materials.

6.3.3 Laboratory Certifications and Qualifications for Industrial Hygiene Sample Analyses

The contract laboratory shall be accredited by the American Industrial Hygiene Association Laboratory Accreditation Program (AIHA LAP) for analyzing industrial hygiene samples for all analysis required in this contract Schedule of Services. Also, the contract laboratory shall have and provide demonstrated proficiency in the appropriate fields of testing for two consecutive Proficiency Testing (PT) rounds from an AIHA- LAP approved PT Program in accordance with AIHA LAP requirements defined in the AIHA LAP, LLC Policy Module 6 The accreditation certifications and qualification of the contract laboratory will be reviewed to determine acceptance prior to contract award. If accreditation certification and/or qualification are changed due after an offer is placed and prior to contract award, the Contracting Officer (KO) must be notified within 48 hours. Loss and/or changes in the laboratory’s accreditation(s) may result in a technically unacceptable evaluation of a potential contract laboratory.

6.3.4 The contractor is required to notify the COR, in writing, within 48 hours of changes that a result in the loss of any of the required laboratory certifications (to include loss of accreditation in individual methods or analytes). The contractor shall cease performance of any sample analysis impacted until accreditation is restored and evidence of such is provided to the COR. If accreditation is not restored within 30 calendar days from notification, the contract may be terminated for default. The contractor shall provide the COR with the most current accreditation certificates that relate to this contract within five (5) business days of receipt of the updates accreditation certificates.

6.3.5 Quality Documentation: At a minimum, the contract laboratory shall have, in writing, documented procedures (e.g. Standing Operating Procedures) for the following:

6.3.5.1 Sample receipt, handling, storage and control.

6.3.5.2 Security, chain of custody and document control.

6.3.5.3 Hazardous waste/sample disposal.

6.3.5.4 Sample analysis (to include types of analyses required, sample preparation, modifications to established methods, peculiarities of instrumentation, etc.)

6.3.5.5 Calibration of standards, traceability (show traceability of standards to National Measurement Systems (e.g. National Institute of Standards and Technology)

6.3.5.6 Ongoing or routine laboratory operations (including maintenance of instrumentation, procurement of supplies, scheduling of calibration for balances, thermometers, etc.)

6.3.5.7 Laboratory Safety and Chemical Hygiene (should address wearing of coats, gloves, goggles, handling of hazardous materials, eye washing, storage of hazardous materials, safety showers, fire safety, etc.).

6.3.5.8 Lab Quality Assurance (QA)/Quality Control (QC) (to include procedures for conducting in house audits; procedures for allowing technicians and chemists to have an independent means of checking the quality of their results; procedures for the development and implementation of contingency plans; and procedures for the initiation of corrective action.

6.3.5.9 Data production, reduction, transcription, verification, review, distribution and in house storage

6.3.5.10 Determination of Reporting Limits. (Contractor must document the criteria under which the reporting limits are established/re-established for each analytical process. Must also include acceptance criteria for such reporting limit evaluation)

6.3.6 Analytical Training Records

All Contractor personnel performing sample handling/processing/analysis in support of this Government contract shall have records demonstrating proficiency in performing methodologies detailed in Attachment 3 – Limits of Quantitation.

6.4 On-Site Laboratory Inspections. The Government reserves the right to conduct on-site inspections of the contractor’s and subcontractor’s laboratories to ensure that appropriate processes and quality assurance procedures are being followed in order to ensure that samples are being analyzed in accordance with the appropriate standards, the requirements found in the published method, as well as the requirements in the applicable The NELAC Institute (TNI) Modules and corresponding checklist(s).

6.5 Subcontracting.

The Contractor shall be responsible for any subcontract management necessary to integrate work performed on this contract and shall be responsible and accountable for subcontractor performance. The prime Contractor will manage work distribution to ensure there are no Organizational Conflict of Interest (OCI) considerations. A notification must be sent to the KO and COR within 30 days of the agreement between the prime and the subcontractor.

Due to the need to maintain the integrity of the sampling and the laboratory certifications, the contractor may subcontract with no more than three other laboratories. The subcontractor laboratories and personnel shall hold the same qualifications and certifications as required by the prime. The prime contractor shall not subcontract more than half of the methods listed in Attachment 3 – Limits of Quantitation.

The Government reserves the right to conduct on-site inspections of the contractor’s and subcontractor’s laboratories to ensure that appropriate processes and quality assurance procedures are being followed in order to ensure that samples are being analyzed in accordance with the appropriate standards, the requirements found in the published method, as well as the requirements in the AIHA Accreditation and corresponding checklist(s). The lab(s) used for subcontracting must first be audited to the same standards as the prime and approved by DCPH- A prior to submitting samples. No exceptions to this requirement will be accepted.

Sending samples to any location for analysis other than the physical location that is placing the bid is considered sub-contracting even if it is within the same corporation.

Subcontractor(s) shall adhere to the same quality requirements as the oversight contractor, to include all applicable sections of the PWS. It should be noted that every time the term “contractor” is used throughout this performance work statement, the term “sub-contractor” is also applicable.

6.6 Management Reports and Plans

6.7.1 Monthly Financial Tracking Report (Deliverable 5). The contractor shall provide a spreadsheet with expenditure levels of every contract line item number (CLIN). The initial report is due 30 days after contract award and by the first of each month thereafter.

6.7.2 Results Status Report (Deliverable 6). The contractor shall provide a weekly summary of all DCPH-A analysis currently being analyzed by the Contractor. A weekly summary is still to be provided to the Government if analyses are not being completed due to samples not arriving in that given week.

The summary shall be provided to the DCPH-A COR on the first business day each week and contain the following information at a minimum:

6.7.2.1 Outsource Report Number

6.7.2.2 Pick Up Order Number

6.7.2.3 DCPH-A assigned Due date

6.7.2.4 Status of the Report – i.e. on-time, delayed, etc.

6.7.2.5 If the report will be provided after the DCPH-A assigned due date, a projected completion date must be provided.

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 shall be made to the COR electronically.

DELIVERABLES TABLE

PWS Ref. Number Title/Description Due

6.2.1.1.3 Deliverable 1 When the contract lab receives the samples and corresponding field COC forms, the Contractor shall sign the COC forms documenting receipt of samples and immediately (within the same business day of receipt) forward the field COC to the COR for review, accountability and LIMS login at the

DCPH-A

Upon receipt of samples

6.2.1.1.3 Deliverable 2 The contractor shall immediately report all samples lost or broken in shipment, with as much detail as possible, to the COR. In addition, the sample receipt temperature must be reported to the COR if applicable within 24 hours of sample receipt

Within 24 hours

6.2.1.2. Deliverable 3 Results of Analyses With each set of samples submitted for analysis

Attachment 4 Deliverable 4 Electronic Data Deliverable With each set of samples submitted for analysis

6.7.1 Deliverable 5 Monthly Financial Tracking Report. The

Contractor shall complete and deliver a monthly Financial Tracking Report.

Monthly (by the first day of each month)

6.7.3 Deliverable 6 Results Status Report First working day of each week

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 ensuring electronically produced documents reflect logical flow of material, for example the 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 responsibilities 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 PWS and all terms and conditions of this contract, including all modifications.

7.3. COR Information

TBD upon contract award

8. GOVERNMENT FURNISHED PROPERTY

Not Applicable

9. Contract Management

9.1. Government Management

The COR for this contract will be appointed by the KO. The COR will serve as the primary Government point of contact (POC) for all activities and issues that occur under this contract. Only the KO has the authority to enact changes to this award.

9.2. Contractor Management

The contractor shall designate a single authorized POC with the COR. The POC will be responsible for coordination with the KO and the COR to resolve any issues that may arise, trends relating to the contract, or proposed changes or modifications to the contract.

9.3. Contractor Organization

The contractor shall establish clear organizational lines of authority and responsibility to ensure effective management of the resources assigned to the requirement. The contractor shall ensure that all contractor personnel are advised of their chain of command and who they should contact if they have questions.

9.4. Subcontract management

9.4.1. The contractor is responsible for any subcontract management necessary to integrate services performed on this contract.

9.4.2. The contractor is responsible and accountable for subcontractor performance on this contract.

9.4.3. The contractor is responsible to manage task distribution to ensure there are no OCI considerations.

9.4.4. Contractor may add subcontractors to their team after notification and written approval from the KO.

9.4.5. Privy of contract is with the contractor and the subcontractor.

10. COMPLIANCE DOCUMENTS

10.1. General Compliance

10.1.1. Federal Law

The services provided under this contract must be conducted in accordance with all Federal law, Department of Defense (DOD), 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.

10.1.2. DoD Compliance Documents

A complete list of Department of Defense compliance documents providing specifications, standards, or guidelines can be found at https://www.esd.whs.mil/dd/

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

11. OTHER TERMS, CONDITIONS, AND PROVISIONS

11.1. 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 KO immediately.

11.2. Severable / Non-Severable Services

This award identifies services that are severable in nature.

11.3. Inherently Governmental Functions

This requirement has been reviewed and contains no services that are inherently governmental functions.

11.4. Invoices

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.

11.5. Dissemination of Information/Publishing

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

11.6. Contractor Identification

The Contractor shall ensure that Contractor personnel identify themselves as Contractors when attending meetings, answering Government telephones, providing any type of written correspondence, or working in situations where their actions could be construed as official Government acts. Contractors may not use or allude to former or current military rank during the performance of this work.

11.7. Attendance at Meetings

Contractor personnel may be required to attend meetings or otherwise communicate with Government and/or other contract or assistance agreement representatives to meet the requirements of this order.

Contractor personnel shall make their contractor status known during introductions.

11.8. 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.

11.9. Compliance with Relevant DoD, Service, and Institutional Policy Regulations.

The Contractor shall comply with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and all relevant DoD/USG regulations for collection, storage, and transfer of sensitive data and PHI. In addition, the Contractor will comply with all requirements for communication of findings and publication in the scientific peer reviewed literature (e.g.

Public Affairs clearance and Operational Security clearance for dissemination).

11.10. Personally Identifiable Information (PII) and Protected Health Information (PHI)

The contractor shall comply with the DHA Procedures, and Information (PGI) 224 – Protection of Privacy and Freedom of Information, revised 17 May 2015. The contractor may access PII in the course of task response to the requirements of this contract, as such the contractor shall comply with the document entitled “Personally Identifiable Information (PII), Protected Health Information (PHI) and Federal Information Requirements”.

The Contractor shall establish appropriate administrative, technical, and physical safeguards to protect any and all Government data. The Contractor shall also ensure the confidentiality, integrity, and availability of Government data in compliance with all applicable laws and regulations, including data breach reporting and response requirements, in accordance with DFARS Subpart 224.1 (Protection of Individual Privacy), which incorporates by reference DoDI 5400.11, “DoD Privacy and Civil Liberties Programs,”, and DoD 5400.11- R, “DoD Privacy Program.” The contractor shall also comply with federal laws relating to freedom of information and records management. The Contractor shall comply with all requirements of HIPAA (Pub. L. 104-191), as implemented by the HIPAA Privacy and Security Rules codified at 45 CFR Parts 160 and 164, and as further implemented within the Military Health System (MHS) by DoD 6025.18-R, "DoD Health Information Privacy Regulation," and DoD 8580.02-R, “DoD Health Information Security Regulation.

Information Technology (IT) services that collect, maintain, use, or disseminate personally identifiable information must be managed in a manner that protects privacy, in accordance with section 552a of Title 5, U.S.C. (Reference (aa)), DoD 5400.11 (Reference (ab)) and DoD 5400.11-R (Reference (ac)). DoDI 5400.16 (Reference (ad)) established the guidance for development, review, and approval of Privacy Impact Assessments, in accordance with chapter 36 of Title 44, U.S.C. (Reference (ae)).

12. ATTACHMENTS

ATTACHMENT 1 – ACRONYMS LIST

Acronym Definition

AKO Army Knowledge Online

APHC Army Public Health Center

AT OPSEC Antiterrorism and Operational Security

CAC Common Access Card

CFR Code of Federal Regulations

CONUS Continental United States

COR Contracting Officer Representative

DCPH-A Defense Centers for Public Health - Aberdeen

DFARS Defense Federal Acquisition Regulation Supplement

DoD Department of Defense

FAR Federal Acquisition Regulation

FPCON Force Protection Condition

GFE Government Furnished Equipment

GFI Government Furnished Information

OCI Organizational Conflict of Interest

OCONUS Outside Continental United States

OPSEC Operational Security PWS Performance Work Statement

QASP Quality Assurance and Surveillance Plan

SHARP Sexual Assault Prevention and Response Program

SOP

TNI

Standing Operating Procedure The NELAC Institute

UIC Unit Identification Code

US United States

WAWF Wide Area Work Flow

52.212-1 INSTRUCTIONS TO OFFERORS--COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

(SEP 2023)

(a) North American Industry Classification System (NAICS) code and small business size standard. The NAICS code(s) and small business size standard(s) for this acquisition appear elsewhere in the solicitation. However, the small business size standard for a concern that submits an offer, other than on a construction or service acquisition, but proposes to furnish an end item that it did not itself manufacture, process, or produce is 500 employees, or 150 employees for information technology value-added resellers under NAICS code 541519, if the acquisition--

(1) Is set aside for small business and has a value above the simplified acquisition threshold;

(2) Uses the HUBZone price evaluation preference regardless of dollar value, unless the offeror waives the price evaluation preference; or

(3) Is an 8(a), HUBZone, service-disabled veteran-owned, economically disadvantaged women-owned, or women-owned small business set-aside or sole-source award regardless of dollar value.

(b) Submission of offers. Submit signed and dated offers to the office specified in this solicitation at or before the exact time specified in this solicitation. Offers may be submitted on the SF 1449, letterhead stationery, or as otherwise specified in the solicitation. As a minimum, offers must show--

(1) The solicitation number;

(2) The time specified in the solicitation for receipt of offers;

(3) The name, address, and telephone number of the offeror;

(4) A technical description of the items being offered in sufficient detail to evaluate compliance with the requirements in the solicitation. This may include product literature, or other documents, if necessary;

(5) Terms of any express warranty;

(6) Price and any discount terms;

(7) "Remit to" address, if different than mailing address;

(8) A completed copy of the representations and certifications at Federal Acquisition Regulation (FAR) 52.212-3 (see FAR 52.212-3(b) for those representations and certifications that the offeror shall complete electronically);

(9) Acknowledgment of Solicitation Amendments;

(10) Past performance information, when included as an evaluation factor, to include recent and relevant contracts for the same or similar items and other references (including contract numbers, points of contact with telephone numbers and other relevant information); and

(11) If the offer is not submitted on the SF 1449, include a statement specifying the extent of agreement with all terms, conditions, and provisions included in the solicitation. Offers that fail to furnish required representations or information, or reject the terms and conditions of the solicitation may be excluded from consideration.

(c) Period for acceptance of offers. The offeror agrees to hold the prices in its offer firm for 30 calendar days from the date specified for receipt of offers, unless another time period is specified in an addendum to the solicitation.

(d) Product samples. When required by the solicitation, product samples shall be submitted at or prior to the time specified for receipt of offers. Unless otherwise specified in this solicitation, these samples shall be submitted at no expense to the Government, and returned at the sender's request and expense, unless they are destroyed during preaward testing.

(e) Multiple offers. Offerors are encouraged to submit multiple offers presenting alternative terms and conditions, including alternative line items (provided that the alternative line items are consistent with FAR subpart 4.10), or alternative commercial products or commercial services for satisfying the requirements of this solicitation. Each offer submitted will be evaluated separately.

(f) Late submissions, modifications, revisions, and withdrawals of offers:

(1) Offerors are responsible for submitting offers, and any modifications, revisions, or withdrawals, so as to reach the Government office designated in the solicitation by the time specified in the solicitation. If no time is specified in the solicitation, the time for receipt is 4:30 p.m., local time, for the designated Government office on the date that offers or revisions are due.

(2)(i) Any offer, modification, revision, or withdrawal of an offer received at the Government office designated in the solicitation after the exact time specified for receipt of offers is “late” and will not be considered unless it is received before award is made, the Contracting Officer determines that accepting the late offer would not unduly delay the acquisition; and--

(A) If it was transmitted through an electronic commerce method authorized by the solicitation, it was received at the initial point of entry to the Government infrastructure not later than 5:00 p.m. one working day prior to the date specified for receipt of offers; or

(B) There is acceptable evidence to establish that it was received at the Government installation designated for receipt of offers and was under the Government's control prior to the time set for receipt of offers; or

(C) If this solicitation is a request for proposals, it was the only proposal received.

(ii) However, a late modification of an otherwise successful offer, that makes its terms more favorable to the Government, will be considered at any time it is received and may be accepted.

(3) Acceptable evidence to establish the time of receipt at the Government installation includes the time/date stamp of that installation on the offer wrapper, other documentary evidence of receipt maintained by the installation, or oral testimony or statements of Government personnel.

(4) If an emergency or unanticipated event interrupts normal Government processes so that offers cannot be received at the Government office designated for receipt of offers by the exact time specified in the solicitation, and urgent Government requirements preclude amendment of the solicitation or other notice of an extension of the closing date, the time specified for receipt of offers will be deemed to be extended to the same time of day specified in the solicitation on the first work day on which normal Government processes resume.

(5) Offers may be withdrawn by written notice received at any time before the exact time set for receipt of offers.

Oral offers in response to oral solicitations may be withdrawn orally. If the solicitation authorizes facsimile offers, offers may be withdrawn via facsimile received at any time before the exact time set for receipt of offers, subject to the conditions specified in the solicitation concerning facsimile offers. An offer may be withdrawn in person by an offeror or its authorized representative if, before the exact time set for receipt of offers, the identity of the person requesting withdrawal is established and the person signs a receipt for the offer.

(g) Contract award (not applicable to Invitation for Bids). The Government intends to evaluate offers and award a contract without discussions with offerors. Therefore, the offeror's initial offer should contain the offeror's best terms from a price and technical standpoint. However, the Government reserves the right to conduct discussions if later determined by the Contracting Officer to be necessary. The Government may reject any or all offers if such action is in the public interest; accept other than the lowest offer; and waive informalities and minor irregularities in offers received.

(h) Multiple awards. The Government may accept any item or group of items of an offer, unless the offeror qualifies the offer by specific limitations. Unless otherwise provided in the Schedule, offers may not be submitted for quantities less than those specified. The Government reserves the right to make an award on any item for a quantity less than the quantity offered, at the unit prices offered, unless the offeror specifies otherwise in the offer.

(i) Availability of requirements documents cited in the solicitation.

(1)(i) The GSA Index of Federal Specifications, Standards and Commercial Item Descriptions, FPMR Part 101-29, and copies of Federal specifications, standards, and product descriptions can be downloaded from the ASSIST website at https://assist.dla.mil.

(ii) If the General Services Administration, Department of Agriculture, or Department of Veterans Affairs issued this solicitation, a copy of specifications, standards, and commercial item descriptions cited in this solicitation may be obtained from the address in paragraph (i)(1)(i) of this provision.

(2) Most unclassified Defense specifications and standards may be downloaded from the ASSIST website at https://assist.dla.mil.

(3) Defense documents not available from the ASSIST website may be requested from the Defense Standardization Program Office by--

(i) Using the ASSIST feedback module (https://assist.dla.mil/feedback); or

(ii) Contacting the Defense Standardization Program Office by telephone at 571-767-6688 or email at assisthelp@dla.mil.

(4) Nongovernment (voluntary) standards must be obtained from the organization responsible for their preparation, publication, or maintenance.

(j) Unique entity identifier. (Applies to all offers that exceed the micro-purchase threshold, and offers at or below the micro-purchase threshold if the solicitation requires the Contractor to be registered in the System for Award Management (SAM).) The Offeror shall enter, in the block with its name and address on the cover page of its offer, the annotation "Unique Entity Identifier" followed by the unique entity identifier that identifies the Offeror's name and address. The Offeror also shall enter its Electronic Funds Transfer (EFT) indicator, if applicable. The EFT indicator is a four-character suffix to the unique entity identifier. The suffix is assigned at the discretion of the Offeror to establish additional SAM records for identifying alternative EFT accounts (see FAR subpart 32.11) for the same entity. If the Offeror does not have a unique entity identifier, it should contact the entity designated at www.sam.gov for unique entity identifier establishment directly to obtain one. The Offeror should indicate that it is an offeror for a Government contract when contacting the entity designated at www.sam.gov for establishing the unique entity identifier.

(k) Reserved.

(l) Debriefing. If a post-award debriefing is given to requesting offerors, the Government shall disclose the following information, if applicable:

(1) The agency's evaluation of the significant weak or deficient factors in the debriefed offeror's offer.

(2) The overall evaluated cost or price and technical rating of the successful and the debriefed offeror and past performance information on the debriefed offeror.

(3) The overall ranking of all offerors, when any ranking was developed by the agency during source selection.

(4) A summary of the rationale for award;

(5) For acquisitions of commercial products, the make and model of the product to be delivered by the successful offeror.

(6) Reasonable responses to relevant questions posed by the debriefed offeror as to whether source-selection procedures set forth in the solicitation, applicable regulations, and other applicable authorities were followed by the agency.

(End of provision)

** 52.212-1 ADDENDUM FOR INSTRUCTIONS TO OFFERORS**

1. TYPE OF CONTRACT

1.1 The Government intends to award a purchase order on a competitive basis using Subjective Tradeoff source selection procedures among price and non-price factors in accordance with FAR 13.106-2. The resultant contract award will utilize Firm-Fixed Price (FFP) Contract Line-Item Numbers (CLINs).

1.2. TECHNICAL QUESTIONS

Questions shall be submitted to the primary point-of-contact, Mr. Daniil Pikus, daniil.y.pikus.civ@health.mil, and Mr. Jesse Nisley, jesse.d.nisley.civ@health.mil, no later than 12 February 2024 at 11:00 AM Eastern Time.

Questions received after this date will not be accepted.

Quotes are due no later than 26 March 2024 at 11:00 AM Eastern Time.

No telephone calls will be accepted. No questions shall be addressed if they were submitted after the due date. If any questions are received, an amendment to this combined synopsis/solicitation will be posted providing the answers to those questions.

2. INSTRUCTIONS FOR THE PREPARATION AND SUBMISSION OF QUOTATIONS

Failure to submit all documents concurrently or in accordance with these instructions may render a quote unacceptable. The Government will not consider pages submitted in excess of the stated page limitations. Quotes should provide a minimum offer acceptance period of 60 days (including an agreement to hold the prices in offer firm) after the required date for receipt of quotes.

2.1…