B08-W81XWH20Q0188-Dental-Field-Operating-System.pdf

W81XWH20Q0188

Dental Field Operating System (DOS)

COMBINED SYNOPSIS/SOLICITATION INSTRUCTIONS

1. Original Issue Date: 3 August 2020

2. Close Date: 24 August 2020 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: Dental Field Operating System DOS

6. Solicitation Number: W81XWH20Q188

7. Description of Requirement: The USAMMDA, Medical Modernization, Deployed Medical Systems

PMO requires Dental Field Operating Systems (DOS) to upgrade its existing units in deployed military settings, primarily to treat service members injured in combat or non-combat accidents. The current system is large which requires a shipping case to be moved by 6-8 soldiers. Therefore a more portable unit is required.

The stakeholders requested a dental operative unit with a smaller footprint that could be easily transportable in the Roll of Care 3 (ROC3) environment. . This requirement is for the establishment of one Blanket

Purchase Agreement for Dental Field Operating Systems.

7.1. This is a combined synopsis/solicitation issued as a Request for Quote (RFQ) 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; quotes 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 as a 100% Small Business Set-Aside. The North American

Industry Classification System (NAICS) code is: 339114 Dental Equipment and Supplies Manufacturing with a Size Standard of 750 employees.

7.4. Contract award shall be made on a competitive best-value basis using the “Lowest Price, Technically Acceptable (LPTA)” approach.

7.5. 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.

7.6 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 quote.

7.7 To be eligible for award, Offeror’s must have a valid registration in the Government’s System for Award

Management (SAM) at https://www.sam.gov. Offerors will not be considered for award if registration has not been completed prior to the close of this solicitation.

8. Point of Contact: The Point of Contact (POC) for this acquisition is Mr. Rudolph J Spencer, Contract Specialist, rudolph.j.spencer.civ@mail.mil; No telephone calls will be accepted.

https://www.sam.gov/

9. Instructions for the Preparation and Submission of Quotes

9.1 Quotes shall be prepared in accordance with (IAW) this solicitation and FAR provision 52.212-1, Instructions to Offerors – Commercial Items including the (m) Addendum.

9.2. All quotes 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. 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 this RFQ.

9.3. 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.

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

9.5. Questions: Questions shall be submitted via e-mail to Mr. Rudolph J. Spencer, Contract Specialist, rudolph.j.spencer.civ@mail.mil no later than 14 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 BetaSam, https://beta.sam.gov/ to address the questions received. Only one (1) set of questions per Contractor will be accepted by the Government. No telephone calls will be accepted.

9.7 Quotes: Quotes in response to this solicitation are due via e-mail no later than 24 August 2020 at

10:00 AM Eastern Time to Mr. Rudolph J Spencer, Contract Specialist, rudolph.j.spencer.civ@mail.mil; late quotes will not be accepted.

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

https://beta.sam.gov/ mailto:rudolph.j.spencer.civ@mail.mil

DESCRIPTION OF REQUIREMENT

DESCRIPTION OF REQUIREMENT

1. BLANKET PURCHASE AGREEMENT

1.1. The Government intends to award one (1) Blanket Purchase Agreement (BPA) IAW FAR 13.303 on a competitive basis, using the best-value Lowest Price Technically Acceptable (LPTA) source selection procedures among price and non-price factors IAW FAR 15.101-2. The Government intends to evaluate and award without discussions; however, the Government reserves the right to conduct discussions. If discussions are required, they will be conducted with Offerors IAW FAR 15.306.

1.2. The resultant BPAs will be issued on a DD 1155 and will not include Contract Line Items Numbers

(CLINs). As a result, no CLINs are included in the solicitation. The Federal Supply Code (FSC) for this

BPA is 6520: Dental Instruments.

1.3. The resultant Call Orders off the BPA will be Firm Fixed Price (FFP).

1.4. The ordering period for the BPA awarded as a result of this solicitation is for five (5) years. IAW FAR

13.303- 6(b) The Contracting Officer shall review at least annually the resultant BPA and, if necessary, update at that time to maintain awareness of changes in market conditions, sources of supply, and other pertinent factors that may warrant making new arrangements with different suppliers or modifying existing arrangements.

2. EXTENT OF OBLIGATIONS

2.1. The Government is obligated only to the extent of authorized purchases/Call Orders ordered and received under the resultant BPA.

2.2. The maximum amounts identified in the Statement of Need (SON) Section 3.1.1. below shall not be construed as a commitment on the part of the Government for guaranteed Call Order Value.

2.3. The cumulative ceiling amount of all Call orders issued against the resultant BPAs for the five (5) year ordering shall not exceed $1,000,000.00.

3. ISSUANCE OF CALL ORDERS

3.1. All required supplies provided under the BPA shall be set forth in individual Call Orders. A Call Order

Request for Quote (CO-RFQ) shall be issued to the BPA Holder for quantities, description pricing and estimated delivery. All Call Orders will be awarded LPTA and IAW the Statement of Need (SON) and the terms and conditions of the resultant BPA.

3.2 IAW Army Federal Acquisition Regulation Supplement (AFARS) 5113.303-5(b)(2), individual Call

Orders shall not exceed $1,000,000.00.

4.0 INVOICING:

To be determined at the BPA Call order Level.

STATEMENT OF NEED

STATEMENT OF NEED

Title: DENTAL FIELD OPERATING SYSTEM (LIN: D44052)

Requiring Activity/Agency Name: U.S. Army Medical Material Development Activity (USAMMDA)/Medical

Modernization, Warfighter Deployed Medical Systems PMO

Program Name: Medical Modernization, Warfighter Deployed Medical Systems PMO

1. PURPOSE

The USAMMDA, Medical Modernization, Deployed Medical Systems PMO requires Dental Field Operating

System (DOS) to upgrade its existing units in deployed military settings, primarily to treat service members injured in combat or non-combat accidents. The current system is large which requires a shipping case to be moved by 6-8 soldiers. Therefore a more portable unit is required. The stakeholders requested for a dental operative unit with a smaller footprint that could be easily transportable in the Roll of Care 3 (ROC3) environment. The Army currently has 523 of the 579 devices called for in the Army Acquisition Objective, The Program Objective Memorandum

(POM) has 47 devices planned for procurement in the current POM cycle.

2. HISTORY

A replacement product for the currently fielded DOS is required. The current device has been discontinued by the manufacturer and is no longer procurable.

3. SCOPE OF WORK

3.1 Task 1 – Supply Support

3.1 The Contractor shall provide approximately 47 DOS during the ordering period of the resultant BPA.

3.1.2 The Contractor shall ensure that each system includes all accessories and consumables necessary for the function, service and maintenance of the DOS.

3.1.3 The Contractor shall provide a full listing of repair parts, accessories, optional items, and consumables. Any proprietary, or required special tools shall be included. Requirements for these items would be solicited under separate Task Orders issued in accordance with Federal Acquisition Regulation (FAR) Part 13.

3.1.4 The following additional information shall be furnished for the system and for all proposed parts:

a) Name / Description

b) Part Number

c) Weight

d) Dimensions

e) Price

f) ECRI Device Code

g) Shelf Life

h) Picture

i) Country of origin

j) MTBF, if available

k) MTTR, if available

3.1.5 The contractor shall agree to support all repair parts, accessories, consumables, and optional items under this contract; the contractor must provide an acceptable contract addition request along with their quote. Any such items that cannot be added to the contract (i.e. pricing cannot be determined as fair and reasonable, etc.) may result in rejection of the quote.

3.1.6 The Contractor shall identify all items considered to be high-failure repair parts. Contractor shall include high-failure repair parts as separate items to be purchased from ECAT. The government may request additional repair parts are added to ECAT.

3.1.7. The Contractor shall notify the USAMMDA, Technical Point of Contact (TPOC) and the Contracting Officer when the system and parts are coming to the end useful life, or that it is no longer available for procurement within

12 months of such date.

Task 2 – Packaging, Storage, and Transportation

3.2.1. The Contractor shall provide the DOS, with all its components and accessories, packaged and packed safely and securely in one self-contained hardened case (e.g., Hardigg, Pelican, ECS Case, or equivalent) with closed-cell foam. The case shall have the approved marked data plates with the following information:

a) Nomenclature – Nomenclature to be provided at time of award

b) National Stock Number (NSN) – Actual NSN(s) to be provided at time of award Manufacturer Model

c) Item Unique Identification (IUID) on each system/unit in accordance with clause DFARS 252.211-7003, Item Unique Identification and Valuation (DEC 2013).

3.2.2 The transport case for the system shall provide protection to the system from harsh environments. Transport case shall be validated with MIL-STD-810G up to vibration, temperature, and humidity specifications.

3.2.3 Dental Field Operating System (DOS) devices and accessories shall be able to function with no degradation of performance up to original manufacturer specifications in regards to:

i) Storage Temperature

ii) Operating Temperature

iii) Storage Humidity

3.2.4 System shall be ready for operation when removed from out of the transport case (plug and play).

3.2.5 Contractor shall provide storage instructions for both short-term (less than 6 months) and long-term (greater than 6 months) storage to include required maintenance before returning to service.

Task 3 – Warranty and Maintenance

3.3.1 Contractor shall provide a manufacturer warranty for at least one (1) year. This warranty shall include all Parts and In-House Labor and Technical Support during the warranty period. Contractor shall provide extended warranty contractual options in accordance with the FAR.

3.3.2 The contractor shall detail the warranty and maintenance support they will provide that meets and/or exceeds minimum requirements of the contract. The preference is for maintenance support that minimizes disruption to patient care while reducing workload. Maintenance support will be evaluated to determine if the contractor will reduce down-time during the warranty and post-warranty period. Contractors should provide information related to how the installed system will be supported; this includes any spares, repair parts and technical support that is included in the warranty, at or above contract requirements. The contractor shall provide the location(s) of all maintenance facilities capable of providing any needed support. The contractor should describe repair and preventative strategies they would offer for their system. If it is supported by technician(s) going to the Government location, then response times should be provided along with location of Service Office(s).

3.3.3 The contractor shall provide a two-level maintenance plan for both field (what maintenance can be performed by the Operator and equipment specialists in remote locations) and sustainment (what maintenance can be performed by the equipment maintainers in CONUS locations [e.g., depots]). The contractor shall clearly outline what tasks can be performed by the Dental Field Operating System (DOS) Operator and Dental Field Operating

System (DOS) Biomedical Equipment Specialist (BES) without voiding the warranty. The contractor shall clearly describe preventative maintenance tasks, expected time requirements to complete, and recommended intervals in the maintenance plan.

3.3.4 The Contractor shall allow Army Depot personnel to contact manufacturer and/or contractor to request information, verify, and order supplies as required (i.e. Fed-ex, or DHL, or UPS tracking Number).

3.3.5 The Contractor shall provide contractual options for one (1) year maintenance agreements to include software/hardware upgrades (software updates and security patches). Contractor shall provide all relevant information and supplies that allow government BMET personnel to conduct maintenance to the device.

3.3.6 The Contractor shall notify the Army depot and Technical Points of Contact (TPOC) of all field change orders, alerts, recalls and equipment notices affecting the system for the life cycle of the system.

3.3.7 The DOS shall be serviced and repaired using the minimum amount of specialized test, measurement, and diagnostic equipment (TMDE) and tools available at unit and support maintenance levels.

3.3.8 The Contractor shall provide Operator/Maintainer telephone support during the hours of 8:00 AM to 5:00 PM for the entire life of the system.

Task 4 - Software

3.4.1 The Contractor shall provide software updates for the life of the system.

3.4.2 The Contractor shall provide a software obsolescence plan for addressing the maintenance of any third-party software that is no longer supported from the third-party vendor.

Task 5 - Training

3.5.1 The contractor shall provide a training plan that shall include but is not limited to, the following:

1. Two types of training shall be offered;

a. Dental Field Operating System (DOS) Operator (technician or physician); and

b. DoD Maintainer (BES) at the contractor’s location, CONUS locations, and OCONUS (e.g., Germany).

2. 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.

3. Operator and Maintainer training at CONUS and OCONUS (e.g., Germany) locations. Group Trainings will support a minimum of three (3) trainees and a maximum of six (6) trainees. No more than 6 trainees per group training. The efficacy of the training should not be compromised by group size or location.

4. An outline of the respective training plan that includes training details, locations, costs, materials, dates, curriculum, responsibilities and documentation.

5. The contractor shall provide training materials for each trainee covering topics listed in Section ii) as part of their training cost.

6. How the contractor will evaluate trainees based on the training provided (i.e. written test).

7. The contractor shall be able to accommodate annual CONUS training classes at the Joint Base, San Antonio, TX and Tracy Defense Distribution Depot, Tracy, CA if requested by the Government.

8. The contractor shall be able to accommodate OCONUS (e.g., Germany) training classes as requested.

Contractor shall include operator and maintenance Applications training with teaching modules on CD-ROM or

DVD and printed material. This training material must be added as a deliverable for the Army to use (upload) to

DoD secured network.

3.6 TECHNICAL DATA ACCESSIBILITY

3.6.1 The contractor shall include operator and manufacturer service manuals, in both electronic and hard copy with each DOS, which includes:

i) Theory of Operation

ii) Troubleshooting instructions and videos

iii) All Maintenance and Calibration Requirements

iv) Illustrated Parts Breakdown with part numbers for each replaceable component

v) Applicable schematics [electronic, pneumatic, hydraulic, etc.] for the device.

3.6.2 The contractor shall create, or provide access to existing on-line media (web-based) to all Army biomedical equipment repairers and operators. Online training (or on DVD) should include all the recommended preventive maintenance services and troubleshooting procedures necessary to operate and maintain the system. This training material must be added as a deliverable for the Army to use (upload) to DoD secured network.

3.7 CYBERSECURITY ASSESSMENT

3.7.1 If applicable, the selected device shall undergo Cybersecurity Testing prior to starting any performance and delivering any items to the Government. Testing will be based on DoD Instruction 8500.01, “Risk Management

Framework (RMF)”. Government points of contact will provide all pertinent Cybersecurity requirements.

4. CONTRACT ADMINISTRATION

4.1 The Contract Administration Team will consist of the following members:

4.1.1 The Contracting Officer will have overall responsibility for administering the Contract. The Contracting

Officer is the only person authorized to obligate the Government and make changes to the Contract. The Contracting

Officer will manage Contract administration and performance delivery surveillance supported by Contract administrators and the Technical Point of Contact (TPOC).

4.1.2 The TPOC will be appointed in writing and will be directly responsible to the Contracting Officer. The TPOC serves as the Government’s point-of-contact for Contract-level coordination and administration. The TPOC will assist the Contracting Officer in overseeing the administration of the Contract as appropriate; assist in resolving issues; initiate changes; notify the Contracting Officer of any disputes or contractual issues that cannot be resolved;

and conduct other activities as specified by appointment.

5. PERIOD OF PERFORMANCE/DELIVERY DATE:

The anticipated ordering period of this BPA is five years. This will include the purchase of the COTS products. In addition, it will include supply support, technical data accessibility, training & training support, and maintenance planning and management, as stated above.

FY20 FY21 FY22 FY23 FY24

Projected

Number of

Systems

8 18 1 3 17

Shipping: Delivery location will be to a CONUS Government site. The specific address will be provided at the

Task-Order level.

6. DIRECTIVES

The procurement of the Dental Field Operating System (DOS) will support FDA requirements, MEDCOM Reg 40-

35, and AR 40-050 Management of Regulated Medical Waste.

7. FEDERAL HOLIDAYS

The following Federal holidays are observed and no work or deliveries shall occur on the dates specified. Any of the below holidays falling on a Saturday will be observed on the preceding Friday;

holidays falling on a Sunday will be observed on the following Monday.

1. New Year’s Day, 1 January

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

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

4. Memorial Day, last Monday in May

5. Independence Day, 4 July

6. Labor Day, 1st Monday in September

7. Columbus Day, 2nd Monday in October

8. Veteran’s Day, 11 November

9. Thanksgiving Day, 4th Thursday in November

10. Christmas Day, 25 December

8. DELIVERABLES

SON Reference Title/Description Due

3.1.3 Supply Support

The Contractor shall provide a full listing of repair parts, accessories and consumables. Any proprietary tools shall be included.

RFQ

3.1.4 Supply Support

The following additional information shall be furnished for the system and for all proposed parts:

• Name / Description

• Part Number

• Weight

• Dimensions

• Price

• ECRI Device Code

• Shelf Life

• Picture

• Country of origin

• MTBF, if available

• MTTR, if available

RFQ

3.1.6 Supply Support

The Contractor shall identify all items considered to be high-failure repair parts. Mean time between failure (MTBF) and mean time to repair (MTTR) shall be provided for these parts.

RFQ

SON Reference Title/Description Due

3.3.3 Warranty

and Maintenance

The Contractor shall provide a two- level maintenance concept plan

RFQ

3.5.1 Training

The Contractor shall provide a Training Plan and Program for

Department of Defense (DoD) Clinical Staff operator, and maintainer for the proposed system RFQ

3.5.2 Training

The Contractor shall provide all available user and maintainer manuals, training videos, and documentation. RFQ

3.6.2 Technical Data

Accessibility

Media Availability (Access): Vendor shall provide access to all technical data. Award

MINIMUM ESSENTIAL CHARACTERISTICS

MINIMUM ESSENTIAL CHARACTERISTICS (MECs)

Title: DENTAL FIELD OPERATING SYSTEM (LIN: D44052)

Requiring Activity/Agency Name: U.S. Army Medical Material Development Activity (USAMMDA)/Medical

Modernization, Warfighter Deployed Medical Systems PMO

Program Name: Medical Modernization, Warfighter Deployed Medical Systems PMO

1. MINIMUM ESSENTIAL CHARACTERISTICS

These characteristics are essential and must be met in order for the device to be considered acceptable. The threshold

(T) is the minimum acceptable essential characteristic value while the objective is a desired level of performance above the threshold.

Number Essential Characteristics (EC) Threshold [T] (Minimum)

1. Regulatory Approvals Shall have FDA 510(k) Clearance as Class II Medical

Device prior to issuance of the first Delivery Order

2. Electrical Safety & EMC Vendor shall adhere to IEC 60601-1 and IEC 60601-1-2

3. Operating System

Shall have an electrically operated dental operating unit that includes any air compressor required for full operation.

4. Operational Availability Shall have at least .95 when operated for a 30 day period.

5. Oral Evacuation System

Shall have a suction flow of no less than 3.5 standard cubic feet per minute (SCFM), at a negative pressure of 4 inches of mercury.

6.

Saliva Ejector (Aspiration

System)

Shall be capable of flow of no less than 1.2 standard cubic feet per minute (SCFM) at 1.5 inches of mercury.

7. Water System Shall be self-contained and have a volume capacity of no less than 500 milliliters.

8. Water System Check Valves Shall have check valves to prevent water from flowing back into air and water systems.

9. Internal Air System Shall provide air to the air/water

Syringe, and air for cooling the hand piece head.

10. Power Source Shall operate from 110/220 voltage, alternating current+/-

10%, 50/60 hertz.

11. Pedal Shall be able to control the water group and also the functions of the hand pieces.

12. Drainage System Shall allow a means for fluid drainage prior to storage.

13. Operational Noise Level The system shall not exceed noise level of 75 decibels

(dB).

14. Waste Storage Shall provide a 1 liter or larger waste container with auto-overflow cut-off.

15. Operational Environment

The system shall operate after being stored in temperatures ranging from 0 to 120 degrees F, from 20 to 95% humidity, non-condensing, once brought up to operating temperature.

16. Hand Pieces

a. Shall have a fiber optic lighting system that provides a minimum of 40,000 lux with the light beam existing at the dental burr. The light system shall also serve as an intraoral exam light with the capability of illumination on demand, or remain illuminated for a period of 10 to 20 seconds after the burr is no longer rotating.

Number Essential Characteristics (EC) Threshold [T] (Minimum)

b. The air and water cooling spray that exits at the burr shall be located within the body of the hand piece motor and attachment.

c. The speed of the motor shall be 0- 40,000 revolutions per minute. The burr speed shall be adjustable via either the foot switch or the instrument panel.

d. The unit shall include an ultrasonic scaler capability.

e. The motor shall be compatible with hand pieces that have the capability to perform:

(1) Surgery Straight Nosecone - 1:1.

(2) High Speed General Dentistry Hand Piece - 1:5.

(3) Endodontic Hand Piece 8:1.

f. Shall operate the high-speed hand piece/s simultaneously with the oral evacuation and saliva ejector systems.

17. Packaging

a. The container(s) for the system shall permit transportation by normal modes to include land, sea, and air without damage to the equipment.

b. The systems shall be packaged in two containers, with a weight no greater than 70 pounds (lbs.), without shipping case, and 120 lbs. with shipping case.

c. In the appropriate container(s), the system shall be capable of being carried by no more than three soldiers.

18. Logistics

a. The system shall be repairable with standard tools at organization and support level maintenance tiers.

b. The mean time between operational mission failure shall be at least 360 hours.

c. The mean time to repair shall be less than three hours.

d. The complete system shall fit into a High Mobility

Multipurpose Wheeled Vehicle for transportation (Space

Dimensions: 84.3" x 52" x 35").

19.

Environmental, Safety and

Occupational Health

a. The system shall present no uncontrolled safety hazards to personnel throughout its lifecycle.

b. The system shall be mutually compatible with other equipment in the operational electromagnetic environment.

2. INTEGRATED PRODUCT SUPPORT (IPS)

This list of parameters details the logistical characteristics and practices the system and vendor should be complicit with.

Number ILS Parameter Threshold [T] (Minimum)

1. Packaging Case

The complete Dental Operating system with all parts and accessories shall be packaged in a single hardened transport case.

2. Repair Tools

The system shall be able to be maintained with the tools found in the existing Biomedical Equipment specialist toolkit (Government to supply the current list) and not require any proprietary tools for maintenance.

Number ILS Parameter Threshold [T] (Minimum)

3. Operating Temperature

Shall withstand low and high operating temperatures mentioned in the OEM technical literature without degradation of performance.

4. Humidity Shall be capable of being stored in locations where humidity would be up to 90%.

5. Low Temperature Storage The system shall be capable of low temperatures storage to

-33°C IAW MIL-STD-810G-502.5: Basic Cold (C1).

6. High Temperature Storage The system shall be capable of high temperatures storage to +71°C IAW MIL-STD-810G-501.5: Hot Dry (A1).

7. Loose Cargo Transport

The system shall be fully operational after military transport as loose cargo IAW MIL-STD-810G method

514.6.

8. Drop Test

The system shall function after being dropped from heights of 4 feet in the transit case IAW MIL-STD-810G method

516.6, procedure IV.

CLAUSES INCORPORATED BY REFERENCE

52.202-1 Definitions NOV 2013

52.203-3 Gratuities APR 1984

52.203-12 Limitation On Payments To Influence Certain Federal Transactions

JUN 2020

52.204-7 System for Award Management OCT 2018

52.204-13 System for Award Management Maintenance OCT 2018

52.204-16 Commercial and Government Entity Code Reporting JUL 2016

52.204-18 Commercial and Government Entity Code Maintenance JUL 2016

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

DEC 2019

52.204-25 Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

AUG 2019

52.204-26 Covered Telecommunications Equipment or Services-- Representation.

DEC 2019

52.212-4 Contract Terms and Conditions--Commercial Items OCT 2018

52.232-39 Unenforceability of Unauthorized Obligations JUN 2013

52.246-16 Responsibility For Supplies APR 1984

252.203-7000 Requirements Relating to Compensation of Former DoD Officials

SEP 2011

252.203-7003 Agency Office of the Inspector General AUG 2019

252.203-7005 Representation Relating to Compensation of Former DoD

Officials

NOV 2011

252.204-7012 Safeguarding Covered Defense Information and Cyber Incident Reporting

DEC 2019

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

252.225-7012 Preference For Certain Domestic Commodities DEC 2017

252.225-7021 Trade Agreements--Basic SEP 2019

252.225-7052 Restriction on the Acquisition of Certain Magnets and Tungsten.

DEC 2019

252.227-7015 Technical Data--Commercial Items FEB 2014

252.227-7037 Validation of Restrictive Markings on Technical Data SEP 2016

252.232-7003 Electronic Submission of Payment Requests and Receiving Reports

DEC 2018

252.232-7010 Levies on Contract Payments DEC 2006

252.243-7002 Requests for Equitable Adjustment DEC 2012

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)

52.204-20 Predecessor 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.

Predecessor means an entity that is replaced by a successor and includes any predecessors of the predecessor.

Successor means an entity that has replaced a predecessor by acquiring the assets and carrying out the affairs of the predecessor under a new name (often through acquisition or merger). The term “successor” does not include new offices/divisions of the same company or a company that only changes its name. The extent of the responsibility of the successor for the liabilities of the predecessor may vary, depending on State law and specific circumstances.

(b) The Offeror represents that it [____] is or [____] is not a successor to a predecessor that held a Federal contract or grant within the last three years.

(c) If the Offeror has indicated “is” in paragraph (b) of this provision, enter the following information for all predecessors that held a Federal contract or grant within the last three years (if more than one predecessor, list in reverse chronological order):

Predecessor CAGE code: ____ (or mark “Unknown”).

Predecessor legal name: ____.

(Do not use a “doing business as” name).

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

(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 ASSIST may be ordered from the Department of Defense Single Stock Point

(DoDSSP) by--

(i) Using the ASSIST Shopping Wizard (https://assist.dla.mil/wizard/index.cfm);

(ii) Phoning the DoDSSP Customer Service Desk (215) 697-2179, Mon-Fri, 0730 to 1600 EST; or https://assist.dla.mil/online/start/ http://quicksearch.dla.mil/ http://assistdocs.com/ https://assist.dla.mil/wizard/index.cfm

(iii) Ordering from DoDSSP, Building 4, Section D, 700 Robbins Avenue, Philadelphia, PA 19111-5094, Telephone

(215) 697-2667/2179, Facsimile (215) 697-1462.

(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 items, the make and model of the item 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.

(m) ADDENDUM

M.1 CONTRACT

The Government intends to award one (1) Blanket Purchase Agreement (BPA) for a five (5) year ordering period for an estimated quantity of 47 Dental Field Operating Systems (DOS).

M.2. TECHNICAL QUESTIONS

Questions are due no later than 10:00 AM Eastern Time on 14 August 2020. Questions shall be submitted to

Rudolph Spencer at rudolph.j.spencer.civ@mail.mil. An amendment to the solicitation will be posted to https://beta.sam.gov/ in order to address the questions received. Please note that only one (1) set of questions per

Offeror will be accepted by the Government.

M.3. INSTRUCTIONS FOR THE PREPARATION AND SUBMISSION OF QUOTES

http://www.sam.gov/

Failure to submit all documents concurrently and in accordance with these instructions may render a quote

“Unacceptable.” Quotes should provide a minimum offer acceptance period of 60 days from the end of the solicitation closing date (including an agreement to hold the prices in offer firm).

The quote shall be submitted electronically via e-mail to rudolph.j.spencer.civ@mail.mil no later than 10:00 AM

Eastern Time on 24 August 2020. The Offeror is responsible for ensuring receipt by the POC. Late quotes will not be accepted.

M.4. QUOTE EVALUATION

To aid in evaluation, quotes shall be practical, specific, complete, and logically assembled. The quotes shall be in a clear, concise format satisfying all requirements of this solicitation. It shall be in sufficient detail to demonstrate a clear understanding of the solicitation requirements.

M.5. THE QUOTE

The overall quote shall consist of three (3) separate Volumes, individually titled. Each copy of each Volume should be appropriately titled as follows:

Quote

Volumes Volumes Titles Page Limitation

Volume I Executive Summary, Executed Solicitation Documents and Pricing

N/A

Volume II Technical Capability and Deliverables N/A

Volume III Past Performance 15

M.6. ADDITIONAL QUOTE SUBMITTAL INFORMATION

All commitments made by the Offeror in the quote will become a part of the resultant contract. Data submitted with each quote should be complete and concise. Any reliance on promotional brochures is unacceptable.

M.7. CONTENT OF QUOTE VOLUMES

The Offeror shall submit the content of quote sections for the evaluation of the Offeror’s non-price evaluation factors and price evaluation factors IAW (m) ADDENDUM of this Solicitation.

The Government will evaluate only one quote from each prime Offeror; therefore, the Government will not accept alternate quotes.

The Offeror’s quote is presumed to represent the Offeror’s best effort in response to the Solicitation, as an…