W81XWH20Q0131.pdf

COMBINED SYNOPSIS/SOLICITATION INSTRUCTIONS

1. Original Issue Date: 28 July 2020

2. Close Date: 12 August 10:00 AM Eastern Time

3. Contracting Activity: U.S. Army Medical Research Acquisition Activity (USAMRAA) located at 820 Chandler Street, Fort Detrick, MD 21702.

4. Requiring Activity: U.S. Army Medical Materiel Development Activity (USAMMDA)

5. Subject: Test, Measurement, and Diagnostic (TMDE) Calibrator Set, X-Ray

6. Solicitation Number: W81XWH20Q0131

7. Description of Requirement: USAMMDA has a requirement to field Test, Measurement, and Diagnostic Equipment (TMDE) for the calibration and safety measure analysis of its deployed radiologic imaging systems. This requirement is for first article testing of X-Ray Calibration Sets.

7.1. This is a combined synopsis/solicitation issued as a Request for Proposal (RFP) for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued.

7.2. This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2020-07; effective 02 July 2020.

7.3. This acquisition is being competed using full and open competition. The North American Industry Classification System (NAICS) code is 334515 Instrument Manufacturing for Measuring and Testing Electricity and Electrical Signals–with a Size Standard of 750 employees.

7.4. Contract award shall be made on a competitive best value basis using Tradeoff procedures.

7.5. The Contract Line Item Numbers (CLINs) and items, quantities, units of measure and descriptions are identified under the Supplies/Services Section of the RFP.

7.6. The anticipated required delivery date is 30 days ADC with shipping Free On Board (FOB) Destination to: The US Army Medical Materiel Development Agency, Veterans Dive, Fort Detrick, MD 21702.

7.7. Offerors responding to this combined synopsis/solicitation shall include a completed copy of the provision at 52.212-3 Offeror Representations and Certifications – Commercial Items with its proposal.

8. Point of Contact: The Point of Contact (POC) for this acquisition is Ms. Rebecca Wisner Contract Specialist, rebecca.c.wisner.civ@mail.mil; No telephone calls will be accepted.

9. Instructions for the Preparation and Submission of Proposals

9.1 Proposals shall be prepared in accordance with (IAW) this solicitation and FAR provision 52.212-1, Instructions to Offerors – Commercial Items including the Addendum M, which is included in the attached RFQ.

9.2. All proposals shall be evaluated in accordance with the Evaluation Criteria identified in the Addendum to FAR 52.212-2 Evaluation – Commercial Items within the Contract Clauses Section.

9.3. The FAR clause 52.212-4 Contract Terms and Conditions – Commercial Items applies to this acquisition. Additional contract requirements and terms and conditions are identified in the attached RFQ.

9.4. The FAR clause 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders – Commercial Items, applies to this acquisition. See the clause for additional FAR clauses cited and marked which are applicable to this acquisition.

9.5. The Government reserves the right to reject any or all proposals, and to award no contract at all, depending on the quality of the proposals(s) submitted and the availability of funds.

9.6. Questions: Questions shall be submitted via e-mail to Ms. Rebecca Wisner, Contract Specialist, rebecca.c.wisner.civ@mail.mil no later than 05 August 2020 at 10:00 AM Eastern Time. Questions received after this date will not be accepted. An Amendment to the solicitation will be posted to beta.SAM.gov with responses to the questions received.

Only one (1) set of questions per Contractor will be accepted. No telephone calls will be accepted.

9.7 Proposals: Proposals in response to this solicitation are due via e-mail no later than 12 August 2020 at 10:00 AM Eastern Time to Ms. Rebecca Wisner, Contract Specialist, rebecca.c.wisner.civ@mail.mil

9.8. The Offeror shall agree to honor proposed prices for 60 calendar days from the due date for receipt of proposals.

W81XWH20Q0131

STATEMENT OF NEED

STATEMENT OF NEED

X-RAY CALIBRAITON SET

1.0 Introduction

The U.S. Army Medical Materiel Development Activity (USAMMDA), Warfighter Deployed Medical Systems Product Management Office (WDMS); for which the Medical Modernization Product Management Office is the program office lead for this effort. USAMMDA is the Department of Defense’s (DOD) medial product development activity for products designed to protect and preserve the lives of Warfighters. The USAMMDA develops new drugs, vaccines, devices, and medical support equipment that enhances readiness, ensures the provision of the highest quality medical care to the DOD, and maximizers survival of medical casualties on the battlefield.

2.0 Mission

USAMMDA, Medical Modernization PMO has requirements to field Test, Measurement, and Diagnostic Equipment (TMDE) for the calibration and safety measure analysis of its deployed radiologic imaging systems. USAMMDA requires the next generation X-Ray Calibrator system for use within a wide variety of clinical and environmental conditions, including deployment in austere environments throughout the word and contingency operations. Then end item must be FDA approved.

2.1 Background

The X-ray calibrator is a piece of TMDE used to evaluate the capabilities of diagnostic radiologic imaging equipment’s ability to safely deliver accurate and precise results across a spectrum of different imaging modalities.

This system verifies the performance of equipment used in radiographic diagnostic rooms. Without this calibration system, proper functioning of critically important medical equipment cannot be verified in medical treatment facilities which can compromise the accuracy of the images obtained resulting in incorrect or reduced ability to both diagnose and treat patients. Critically, lack of this device could result in patients and providers being exposed to dangerous levels of radiation during use.

A replacement product for the currently fielded X-Ray Calibrator set is required to maintain Army readiness and the ability of medical treatment facilities in the field to treat patients with internal injuries and broken bones to reduce mortality and morbidity. Biomedical Equipment Specialists (BMETs) are the operators for this system. The X-Ray Calibrator Set is considered TMDE that requires regular calibration in accordance with National Institute of Standards and Technology (NIST) standards. These calibration intervals are set forth by the Original Equipment Manufacturer (OEM); normally on at a minimum of annual or biannually. Once the TMDE is calibrated, the radiation devices in the field are calibrated and safety validated with the TMDE prior to use in the field. If the TMDE is not present, the radiation equipment in the field is not considered mission capable.

After approximately ten (10) years, the current device was discontinued by the manufacturer and is no longer procurable. The current system used by the Army is the Raysafe Unfors Xi, and its end of life was December 2018.

The goal is to procure a device that meets user requirements and the Army’s needs to replace failing devices in the field and fill shortages as needed.

3. Scope

USAMMDA requires the next generation X-Ray Calibrator system for use within a wide variety of clinical and environmental conditions, including deployment in austere environments throughout the word and contingency operations. The equipment and part numbers that are FDA approved, TAA compliant, and commercially available at the time of proposal submission, may be offered under this requirement. Promises to upgrade the system in the future to meet Government requirements such as proving a supported operating system or IA requirements is prohibited.

Initial calibration and certification of imaging systems shall be conducted by U.S. Army personnel at the depots prior to fielding after completion of Original Equipment Manufacturer (OEM) training for technicians prior to fielding. Regular calibration of these devices by U.S. Army personnel is required in order to maintain image quality and ensure safety requirements are met in the field throughout the globe.

Selection of a single vendor shall be on an all or none basis where vendors must quote on all requirements contained in the Request for Proposal (RFP).

3.1 TMDE Fielding Overview

USAMMDA intends to procure test articles for testing and evaluation from up to three (3) Offerors who meet the Army’s requirements. The first test articles will be tested to ensure the selected system meets the minimum requirements listed in this RFP, requirements in the RFP attachments, and the vendor’s own commercial specifications. Additional Testing and Evaluation will include operational testing, environmental testing, and Cybersecurity/RMF testing/review to obtain Authority to Operate (ATO) if applicable. Testing and evaluation will be used to determine the next generation device via a down-selection for this need.

USAMMDA intends to purchase the X-Ray calibration equipment from the Offeror selected under the RFP to replace the current generation of fielded equipment.

The intended delivery offer for production equipment is for an Indefinite Quantity Indefinite Delivery (IDIQ) contact is estimated to last five (5) years or as long as the selected system is available commercially and meets the Army’s requirements, for a minimum of two (2) and a maximum of up to three hundred (300) units.

Selection of a single vendor to provide next generation X-Ray Calibration equipment shall be on an all or none basis. Offerors vendors must quote on all requirements contained in the Request for Proposal (RFP).

3.1.1. Standard Configuration

The Contractor shall offer a standard configuration as a single part number (assembly) for the proposed TMDE System that shall include, but is not limited to the following:

TMDE Requirement Overview - Standard Configuration X-Ray Calibrator Power Cord Operator Manual (paper copy) Maintenance Manual (paper copy) Warranty (minimum 1 year parts and labor) Hard Transport Case

3.1.2. X-Ray Calibration Performance Requirements

The Technical performance attributes of the TDME X-Ray Calibration Set are articulated in the MINIMUMAL ESSTENTIAL CHARACTERSISITCS (MECs) Section of this solicitation. The Contractor shall meet, at minimum the Threshold Minimum Requirement level of Essential Characteristics.

3.1.3. Government Testing and Evaluation

Up to three (3) Offerors best meeting the requirements outlined in this RFP will be selected to participate for First Article Testing (FAT) prior to the down-selection. Testing will be performed to evaluate the device’s performance against the minimum essential characteristics and maintenance and sustainment for use in an austere environment including evaluation of training and ability for Army personnel to calibrate and repair the device in the field. The

Government reserves the right to waive any part of FAT including the requirement of an ATO. The selected vendor shall have to pass all FAT prior to being allowed to provide production quantities. Failure to pass FAT may form a basis for a termination for cause of all orders and result in selection of a different vendor.

(1.) The vendor shall deliver two (2) test articles within 30 calendar days from the date of the selection delivery order to the Government provided location. The unit shall consist of the fully configured system that meets all minimum requirements, vendor specifications, and other feature/items that were part of the vendor’s evaluated offer.

(2.) The Government may be required to conduct a Risk Management Framework (RMF) analysis on all equipment intended for deployment as part of the FAT. The RMF process supports cybersecurity risk analysis of device software, and generally applies to any equipment that includes electronics, particularly if there exists a possibility for wireless communications, and/or electronic upload/download of software or information. During the course of the RMF process, the Government will require system-specific information about the functionality of data transfer capabilities. The Government will submit questions, as needed, to the Contractor. The Contractor shall provide system specific-information regarding data processed, stored or transmitted by the equipment, as responses to Government queries, in support of the Government’s analysis within five (5) business days of each inquiry; the Contractor is not required to perform the RMF analysis.

(3.) Vendor shall provide Biomedical Equipment Specialist (BES) training to personnel prior to the start of the operational test event of FAT if applicable at either the vendor location or at the testing location if available.

(4.) The shipping documentation shall contain the contract and delivery order number and Item identification.

(a.) The first test articles will be tested to ensure the selected system meets the minimum requirements listed in this RFP requirements in the RFP Attachments, and the vendor’s own commercial specifications. There are three testing events planned: operational testing, environmental testing, and Cybersecurity/RMF testing/review to obtain Authority to Operate (ATO) if applicable.

(b.) The vendor will be required to be available, with a response time within 24 hours, during the testing in order to answer operational questions or conduct repairs, if needed. Within fifteen (15) calendar days after the Government receives the first test articles, the Contracting Officer will notify the Contractor, in writing, the time and location of the testing. The vendor must inform the Government within seven (7) calendar days whether the date is acceptable.

It is the vendor’s responsibility to make all arrangements, including any base access, and cover all associated costs including travel, lodging, etc.

(c.) Within thirty (30) calendar days after the Government concludes testing, the Contracting Officer shall notify the Contractor, in writing, of the down-selection results.

(d.) The notice of conditional approval or approval shall not relieve the Contractor from complying with all requirements of the specifications and all other terms and conditions of this contract. A notice of conditional approval shall state any further action required of the Contractor. A notice of disapproval shall cite reasons for the disapproval.

(e.) If the first article is disapproved, the Contractor, upon Government request, shall make corrections to the first article unit or submit an additional first article for testing within fifteen (15) calendar days. After each request, the Contractor shall make any necessary changes, modifications, or repairs to the first article or select another first article for testing. All costs related to these tests are to be borne by the Contractor, including any and all costs for additional tests following a disapproval. This includes providing an additional first article to the Government which shall be at no cost the Government. The Government shall act on this first article within the time limit specified in paragraphs (c.) and (d.) of this section. The Vendor will be given at least one opportunity to resubmit an acceptable FAT within five (5) days prior to testing and evaluation event before the Government may terminate the order. In the event that the Government entertains any extension or allows additional FAT resubmissions, the Government reserves the right to require an equitable adjustment of the contract price for any extension of the delivery schedule or for any additional costs to the Government related to these tests.

(f.) If the Contractor fails to deliver any first article on time, or the Contracting Officer disapproves any first article, the Contractor shall be deemed to have failed to make delivery within the meaning of FAR 52.212-4(m), Termination for cause.

(g) The Contractor shall remove and dispose of any first article from the Government test facility at the Contractor’s expense if the first test article is consumed or destroyed in testing at no additional cost to the Government.

(h.) The Contractor is responsible for providing operating and maintenance instructions, spare parts support, training, and repair of the first article during any first article test at no additional cost to the Government.

(i.) Before first article approval, the acquisition of materials or components for, or the commencement of production of, the balance of the contract quantity is at the sole risk of the Contractor. Before first article approval, the costs thereof shall not be allocable to this contract for (1) progress payments, or (2) termination settlements if the contract is terminated for the convenience of the Government.

3.1.4. System Sustainment

If the Government exercises the option to award production quantities, the contractor shall consent and work with the Defense Logistics Agency (DLA) to place all repair parts and consumable list items on the DLA Electronic Catalog (ECAT) for direct online ordering by DoD customers. The Government shall be included on correspondence and information provided including the DLA contract officer name, phone number, and email during this process. Additionally, the contractor shall notify DLA and USAMMDA no less than twelve (12) months prior to any part becoming obsolete or otherwise unavailable.

3.1.5. Maintainability

The item shall be field-maintainable by trained technicians, including the ability to replace system components to sustain item in working condition. This indicates that for routine maintenance, the items must be maintainable on-site at deployed locations and not require return to the OEM nor to a Depot within the continental United States.

Examples of “routine maintenance” are actions such as changing batteries, lubrication, replacement of fuses or other consumables used during use, powering down/locking down at end of use and for storage, and similar types of actions that sustain the equipment in good working condition. “Routine maintenance” does not refer to major repair actions nor to warranty repairs.

The vendor shall provide the organizational points of contact for maintenance and technical support including hours of operation, phone numbers, emails, and mailing address. Customer service is required as reach-back for technical support and potentially to order parts for replacement of consumables and/or repairs. The Contractor shall provide customer service and technical support, at minimum, during business hours at no additional cost to the Government.

3.1.6. Warranty

The Contractor shall provide a manufacturer warranty for at least one (1) year for the X-Ray Calibration Set. This warranty shall include all parts and on-site labor and technical support during the warranty period. The Contractor shall offer an extended warranty for minimum additional one (1) year period; i.e. Contractor must offer optional warranty for at least one year, but may offer optional warranty for longer periods, up to the duration of the resultant contract (to the end of the period of performance). Warranty shall be included for a minimum of one year.

Additionally, extended warranty shall be offered for up to a minimum of five (5) years. The Contractor shall support the system for a minimum of seven (7) years following delivery. This support shall include: technical support for U.S. Army technicians, software updates if applicable, and availability of consumable and repair parts for purchase, as needed.

3.1.7. Repair Parts and High Failure Rate Accessories

High Failure Parts

The Contractor shall identify the most frequently replaced parts, due to wear-out or failure, and shall recommend an estimated frequency of replacements required, based on time, number of uses, or other cause. The contractor shall recommend a list of replacement parts to be procured with each equipment set. This list will be provided at initial contract award for test articles.

Repair Parts (consumables)

The Contractor shall provide a listing denoting the configuration of items required for each unit. The configuration information shall include:

• A list of required items, including part numbers, which are proprietary to the system.

• A list of any required non-propriety items including part numbers

• Quantities of each of the above

• Ordering information for replacement of consumables

• Cost for each part number and country of origin

• The weight and size of each item outside of the packaging with a picture

• The weight and size of the configuration outside the packaging with a picture

• The weight and size of the configuration in OEM packaging

• The weight and size of each item in OEM packaging (replacements)

3.1.8. Training

In addition to equipment items, the Government requires training, warranty, and data in support of its testing and maintenance obligations.

Training for use/operation and maintenance of the equipment shall be provided by the Contractor. Two types of training shall be offered; 1. X-Ray Calibration Set User/Operator and 2. DoD Maintainer (BMET). The Training location may be either at the OEMs location or the Governments location. Training for first article testing shall be at a single CONUS location and shall accommodate up to ten (10) personnel. Trainings for production equipment shall be conducted at a multiple CONUS/OCONUS locations, and shall accommodate up to ten (10) personnel at each training event.

Trainings shall include: principles of operation, preparation for use and installation, software applications training, startup/shutdown, operating instructions (control settings, start-up, normal operation, shutdown, and emergency shutdown), maintenance and servicing instructions (preventive and corrective), cleaning and lubrication, performance verification, inspection, troubleshooting, software updates and security patch instructions (if applicable), preparation for shipment and long term storage, safety hazard identification and mitigation, and required tools, test equipment, and consumables, as applicable.

4. Quantities and Delivery Instructions:

4.1. The Government initially intends to procure a total of six (6) test articles, two (2) each from up to three (3) vendors for test and evaluation. Testing and evaluation will be used to determine the next generation device via a down-selection for this need.

4.1.1. Equipment deliveries for First Article Testing Units shall be FOB Destination to:

US Army Medical Materiel Development Activity Attn: Wendy Hagan 1430 Veterans Drive Fort Detrick, MD 21702-5009

4.1.2. The Training location for First Article Testing unit may be either at the OEMs location or the Governments location identified below:

PD TMDE Test Equipment Modernization (TEMOD)/ General Purpose Electronics Test Equipment (GPETE) TS-4549T Radio Test Set Project Lead Redstone Arsenal, AL 35898-5000

4.1.3. Period of Performance is thirty (30) days after dated contract.

4.2. Next Generation Equipment

4.2. If the Government exercises the option to award production quantities; Optional CLINS will include technical data accessibility, package, handling, storage and transportation, support equipment, training and support, and maintenance planning and management as well as product support and maintenance.

4.2.1. Equipment delivery for Next Generation equipment procurement shall be FOB Destination to either of the following FOB Destinations to:

US Army Medical Materiel Agency Medical Maintenance Operations Division California 25600 S. Chrisman Road Building T-255 Tracy, CA 95304 USA

4.2.2. Equipment Training for Next Generation equipment procurement shall be either of the following FOB Destinations to:

US Army Medical Materiel Agency Medical Maintenance Operations Division California 25600 S. Chrisman Road Building T-255 Tracy, CA 95304 USA

PD TMDE Test Equipment Modernization (TEMOD)/ General Purpose Electronics Test Equipment (GPETE) TS-4549T Radio Test Set Project Lead Redstone Arsenal, AL 35898-5000

US Army Medical Materiel Center, Europe (USAMMCE) Husterhoeh Daseme Massachusetts Avenue 66953 Pirmasens Germany

4.2.3. Period of performance for the production equipment will be upon purchase of the COTS product.

MINIMUM ESSENTIAL CHARACTERIST

TEST, MEASUREMENT, AND DIAGNOSTIC EQUIPMENT (TMDE) CALIBRATOR SET, X-RAY (LIN:

C05856)

Program Name: C05856 – Medical Modernization of the Test, Measurement, and Diagnostic (TMDE) Calibrator Set, X-Ray

MECS are reflected as the Threshold, with additional desired Characteristics being reflected as Objectives. The Contractor shall meet all Threshold requirements in the Table Below.

X-Ray Calibration Minimum Essential Characteristics (MEC’s) Essential Characteristic Threshold (T) Minimum Requirement Objective

1. Regulatory Approvals

Shall meet IEC standards: 61010-1 (1:2010) Testing and Measuring Equipment 61674 (2:2012): Dosimeters with ionization chambers and/or semiconductor detectors as used in X-Ray diagnostic imaging

T=O

2. Current Measurement

The system shall be able to measure current in radiographic systems in the following parameters:

- mA (milliAmpere-second)

- Pulse

- Pulse Rate

In addition to the threshold; the system will be able to measure (mA) using a non-invasive method.

3.

Radiography/Fluoroscopy (R/F) Measurement

The system shall be able to measure the performance of X-Ray and Fluoroscopic devices by the following parameters:

- kVp (kiloVolt potential)

- HVL (Half-Value Layer)

- Dose

- Dose Rate

- Pulse Rate

T=O

4. Mammography Measurement

The system shall be able to measure the performance of Mammographic devices by the following parameters:

- kVp

- HVL

- Dose

- Dose Rate

- Pulse Rate

T=O

5. Computed Tomography (CT) Measurement

The system shall be able to measure the performance of Computed Tomography (CT) devices by the following parameter:

computed tomography dose index (CTDI) using a 100-mm pencil ionization chamber that fits commonly available acrylic CTDI phantoms.

T=O

6. Survey Measurement

The system shall be able to measure leakage and scatter resulting from diagnostic X-Ray devices in the following parameters or equivalent:

- H*(10) (Ambient Dose Equivalent)

- H*(10) Rate

- Air Kerma

- Air Kerma Rate

- Mean Energy

T=O

7. Light Measurement

The system shall be able to perform luminance and illuminance measurements

T=O

8. Display The system shall be able to display key measurements and waveforms in real time

9. Rechargeable Battery

The system shall be able to perform all expected calibration functions per device for 8 hours of continuous use on a single charge

Greater than 8 hours and the battery is hot swappable.

10. Operational Power

The system shall be able to operate on A/C power when not charged

The system will be able to charge the battery at the same time the system is in use under A/C power.

11. Data Generation

The system shall be able to export measurement data

T=O

12. System Sustainment

Vendor shall provide access to all resources necessary to allow the Army to sustain the system at the Tracy and United States Army Medical Materiel Center, Europe (USAMMCE) depots. Sustainment shall be IAW the vendor's calibration, services, and repair procedures. Such program shall be validated and approved by the vendor. The vendor shall provide the Original Equipment Manufacturers (OEM) calibration procedures, Standard Operating Procedures (SOPs), and copy of the NIST standards used.

Device is capable of being calibrated to the NIST standard by Army personnel without being sent to the OEM for annual or bi-annual calibration.

13. Field Maintainability T=O

Unit will be equipped with tools, supplies, and accessories required for immediate setup and day-to-day operations, to be included in ruggedized case. Vendor shall provide a maintenance plan.

14. Weight

The system inclusive of all accessories and ruggedized cases for transport shall be no more than 15 pounds

15. Cube

The system in its active use configuration shall be no larger than 50 cubic inches

T=O

16. Accuracy

The system shall be able to measure all data with no greater than a 5% error margin

T=O

17. Precision

The system shall be able to demonstrate repeatability of measurements with no greater than a 2% error margin

T=O

18. Display Quality

The system shall be equipped with a legible display that can show the full array of real-time data

The system will be able to display key measurements and waveforms in real time without the requirement for an additional display.

19. Internal Memory Shall display, print, store or export the readings from the current test being conducted

20. Stand-By Charge

The system shall have 48 hours of stand-by power on a single charge

T=O

21. Calibration Frequency

The system shall demonstrate a calibration requirement of no more than once in 12 months

T=O

22. Calibration Certification

The system shall come packaged with a NIST traceable certificate of calibration

T=O

23. Documentation

The system shall come packaged with a hard copy of the operator manual and maintenance manual.

T=O

24. Ruggedized case(s)

Ruggedized, reusable transportation and carrying case configured to include device and accessories needed. Additional case for ancillary equipment, if needed for protection during transport

25. Warranty

Contractor will provide a minimum 12 month warranty that includes all parts, software updates, labor, and technical support during the warranty period

Contractor will provide a greater than 12 month warranty that includes all parts, software updates, labor, and technical support during the warranty period

26. Repair Parts and High Failure Rate Accessories

Vendor will provide a list of all repair parts including National Stock Number (if applicable), part number, size, weight, picture, country of origin, and cost for all repair parts and consumable required for the configuration. High Failure Rate Accessories will be identified.

T=O

27. Training Plan Vendor will provide training plan, SOP’s for first article and next generation equipment

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0001 2 Each X-Ray CALIBRATION SET

FFP

The Contractor shall provide First Article Testing Units in accordance with (IAW) the Statement of Need and the Minimum Essential Characteristics.

FOB: Destination

NET AMT

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0002 1 Each Training

FFP

Systems in accordance with (IAW) the Statement of Need and the Minimum Essential Characteristics. The Contractor shall provide Training in support of the X-Ray Calibrator TMDE Systems in accordance with (IAW) the Statement of Need and the Minimum Essential Characteristics.

NET AMT

INSPECTION AND ACCEPTANCE TERMS

Supplies/services will be inspected/accepted at:

CLIN INSPECT AT INSPECT BY ACCEPT AT ACCEPT BY

0001 N/A N/A N/A Government 0002 N/A N/A N/A Government

DELIVERY INFORMATION

CLIN DELIVERY DATE QUANTITY SHIP TO ADDRESS DODAAC /

CAGE

0001 30 dys. ADC 2 FORT DETRICK

USAMMDA

1430 VETERANS DR.

FREDERICK MD 21702

W806YH

0002 30 dys. ADC 1 (SAME AS PREVIOUS LOCATION)

W806YH

CLAUSES INCORPORATED BY REFERENCE

52.204-7 System for Award Management OCT 2018 52.204-13 System for Award Management Maintenance OCT 2018 52.204-16 Commercial and Government Entity Code Reporting JUL 2016 52.204-18 Commercial and Government Entity Code Maintenance JUL 2016 52.204-19 Incorporation by Reference of Representations and

Certifications.

DEC 2014

52.204-21 Basic Safeguarding of Covered Contractor Information Systems

JUN 2016

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

DEC 2019

52.209-6 Protecting the Government's Interest When Subcontracting With Contractors Debarred, Suspended, or Proposed for Debarment

OCT 2015

52.225-25 Prohibition on Contracting with Entities Engaging in Certain Activities or Transactions Relating to Iran-- Representation and Certifications.

JUN 2020

52.232-39 Unenforceability of Unauthorized Obligations JUN 2013 52.232-40 Providing Accelerated Payments to Small Business

Subcontractors

DEC 2013

52.233-4 Applicable Law for Breach of Contract Claim OCT 2004 52.242-15 Stop-Work Order AUG 1989 52.243-1 Changes--Fixed Price AUG 1987 252.203-7000 Requirements Relating to Compensation of Former DoD

Officials

SEP 2011

252.203-7002 Requirement to Inform Employees of Whistleblower Rights SEP 2013 252.203-7005 Representation Relating to Compensation of Former DoD

Officials

NOV 2011

252.204-7003 Control Of Government Personnel Work Product APR 1992 252.204-7006 Billing Instructions OCT 2005 252.204-7008 Compliance With Safeguarding Covered Defense Information

Controls

OCT 2016

252.204-7015 Notice of Authorized Disclosure of Information for Litigation Support

MAY 2016

252.204-7016 Covered Defense Telecommunications Equipment or Services -- Representation

DEC 2019

252.204-7017 Prohibition on the Acquisition of Covered Defense Telecommunications Equipment or Services -- Representation

DEC 2019

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

DEC 2019

252.223-7008 Prohibition of Hexavalent Chromium JUN 2013 252.225-7001 Buy American And Balance Of Payments Program-- Basic DEC 2017 252.225-7048 Export-Controlled Items JUN 2013 252.227-7015 Technical Data--Commercial Items FEB 2014 252.227-7037 Validation of Restrictive Markings on Technical Data SEP 2016 252.232-7010 Levies on Contract Payments DEC 2006 252.243-7001 Pricing Of Contract Modifications DEC 1991 252.244-7000 Subcontracts for Commercial Items JUN 2013 252.247-7023 Transportation of Supplies by Sea FEB 2019

CLAUSES INCORPORATED BY FULL TEXT

52.204-17 OWNERSHIP OR CONTROL OF OFFEROR (JUL 2016)

(a) Definitions. As used in this provision--

Commercial and Government Entity (CAGE) code means—

(1) An identifier assigned to entities located in the United States or its outlying areas by the Defense Logistics Agency (DLA) Commercial and Government Entity (CAGE) Branch to identify a commercial or government entity;

or

(2) An identifier assigned by a member of the North Atlantic Treaty Organization (NATO) or by the NATO Support and Procurement Agency (NSPA) to entities located outside the United States and its outlying areas that the DLA Commercial and Government Entity (CAGE) Branch records and maintains in the CAGE master file. This type of code is known as a NATO CAGE (NCAGE) code.

Highest-level owner means the entity that owns or controls an immediate owner of the offeror, or that owns or controls one or more entities that control an immediate owner of the offeror. No entity owns or exercises control of the highest level owner.

Immediate owner means an entity, other than the offeror, that has direct control of the offeror. Indicators of control include, but are not limited to, one or more of the following: Ownership or interlocking management, identity of interests among family members, shared facilities and equipment, and the common use of employees.

(b) The Offeror represents that it [ ___ ] has or [ ___ ] does not have an immediate owner. If the Offeror has more than one immediate owner (such as a joint venture), then the Offeror shall respond to paragraph (c) and if applicable, paragraph (d) of this provision for each participant in the joint venture.

(c) If the Offeror indicates ``has'' in paragraph (b) of this provision, enter the following information:

Immediate owner CAGE code:

Immediate owner legal name: ___

(Do not use a ``doing business as'' name)

Is the immediate owner owned or controlled by another entity?:

[ ___ ] Yes or [ ___ ] No.

(d) If the Offeror indicates ``yes'' in paragraph (c) of this provision, indicating that the immediate owner is owned or controlled by another entity, then enter the following information:

Highest-level owner CAGE code:

Highest-level owner legal name:

(Do not use a ``doing business as'' name)

(End of provision)

52.209-4 FIRST ARTICLE APPROVAL--GOVERNMENT TESTING (SEP 1989)

(Contracting Officer shall insert details)

(a) The Contractor shall deliver 2 unit(s) of Lot/Item X-Ray Calibration Set within 30 calendar days from the date of this contract to the Government at location identified in the Statement of Need for first article tests. The shipping documentation shall contain this contract number and the Lot/Item identification. The characteristics that the first article must meet and the testing requirements are specified elsewhere in this contract.

(b) Within 30 calendar days after the Government receives the first article, the Contracting Officer shall notify the Contractor, in writing, of the conditional approval, approval, or disapproval of the first article. The notice of conditional approval or approval shall not relieve the Contractor from complying with all requirements of the specifications and all other terms and conditions of this contract. A notice of conditional approval shall state any further action required of the Contractor. A notice of disapproval shall cite reasons for the disapproval.

(c) If the first article is disapproved, the Contractor, upon Government request, shall submit an additional first article for testing. After each request, the Contractor shall make any necessary changes, modifications, or repairs to the first article or select another first article for testing. All costs related to these tests are to be borne by the Contractor, including any and all costs for additional tests following a disapproval. The Contractor shall furnish any additional first article to the Government under the terms and conditions and within the time specified by the Government. The Government shall act on this first article within the time limit specified in paragraph (b) of this clause. The Government reserves the right to require an equitable adjustment of the contract price for any extension of the delivery schedule or for any additional costs to the Government related to these tests.

(d) If the Contractor fails to deliver any first article on time, or the Contracting Officer disapproves any first article, the Contractor shall be deemed to have failed to make delivery within the meaning of the Default clause of this contract.

(e) Unless otherwise provided in the contract, the Contractor--

(1) May deliver the approved first article as a part of the contract quantity, provided it meets all contract requirements for acceptance and was not consumed or destroyed in testing; and

(2) Shall remove and dispose of any first article from the Government test facility at the Contractor's expense.

(f) If the Government does not act within the time specified in paragraphs (b) or (c) of this clause, the Contracting Officer shall, upon timely written request from the Contractor, equitably adjust under the Changes clause of this contract the delivery or performance dates and/or the contract price, and any other contractual term affected by the delay.

(g) The Contractor is responsible for providing operating and maintenance instructions, spare parts support, and repair of the first article during any first article test.

(h) Before first article approval, the acquisition of materials or components for, or the commencement of production of, the balance of the contract quantity is at the sole risk of the Contractor. Before first article approval, the costs thereof shall not be allocable to this contract for (1) progress payments, or (2) termination settlements if the contract is terminated for the convenience of the Government.

(i) The Government may waive the requirement for first article approval test where supplies identical or similar to those called for in the schedule have been previously furnished by the Offeror/Contractor and have been accepted by the Government. The Offeror/Contractor may request a waiver.

(End of clause)

52.209-11 REPRESENTATION BY CORPORATIONS REGARDING DELINQUENT TAX LIABILITY OR A

FELONY CONVICTION UNDER ANY FEDERAL LAW (FEB 2016)

(a) As required by sections 744 and 745 of Division E of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235), and similar provisions, if contained in subsequent appropriations acts, the Government will not enter into a contract with any corporation that--

(1) Has any unpaid Federal tax liability that has been assessed, for which all judicial and administrative remedies have been exhausted or have lapsed, and that is not being paid in a timely manner pursuant to an agreement with the authority responsible for collecting the tax liability, where the awarding agency is aware of the unpaid tax liability, unless an agency has considered suspension or debarment of the corporation and made a determination that suspension or debarment is not necessary to protect the interests of the Government; or

(2) Was convicted of a felony criminal violation under any Federal law within the preceding 24 months, where the awarding agency is aware of the conviction, unless an agency has considered suspension or debarment of the corporation and made a determination that this action is not necessary to protect the interests of the Government.

(b) The Offeror represents that--

(1) It is [ ] is not [ ] a corporation that has any unpaid Federal tax liability that has been assessed, for which all judicial and administrative remedies have been exhausted or have lapsed, and that is not being paid in a timely manner pursuant to an agreement with the authority responsible for collecting the tax liability; and

(2) It is [ ] is not [ ] a corporation that was convicted of a felony criminal violation under a Federal law within the preceding 24 months.

52.212-1 INSTRUCTIONS TO OFFERORS--COMMERCIAL ITEMS (JUN 2020)

*** Includes (m) ADDENDUM below***

(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 which submits an offer in its own name, but which proposes to furnish an item which it did not itself manufacture, is 500 employees.

(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 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 subpart 4.10 of the Federal Acquisition Regulation), or alternative commercial items 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 specifications, standards, and commercial item descriptions cited in this solicitation may be obtained for a fee by submitting a request to--GSA Federal Supply Service Specifications Section, Suite 8100, 470 East L'Enfant Plaza, SW, Washington, DC 20407, Telephone (202) 619-8925, Facsimile (202) 619-8978.

(ii) If the General Services Administration, Department of Agriculture, or Department of Veterans Affairs issued this solicitation, a single copy of specifications, standards, and commercial item descriptions cited in this solicitation may be obtained free of charge by submitting a request to the addressee in paragraph (i)(1)(i) of this provision.

Additional copies will be issued for a fee.

(2) Most unclassified Defense specifications and standards may be downloaded from the following ASSIST websites:

(i) ASSIST (https://assist.dla.mil/online/start/).

(ii) Quick Search (http://quicksearch.dla.mil/).

(iii) ASSISTdocs.com (http://assistdocs.com).

(3) Documents not available from…