Combined Synopsis_Solicitation Vitrectomy System.pdf

COMBINED SYNOPSIS/SOLICITATION INSTRUCTIONS

1. Issue Date: 15 April 2020

2. Close Date: 14 May 2020

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: Anterior Vitrectomy System

6. Solicitation Number: W81XWH-20-Q-0070

7. Description of Requirement: The USAMMDA WDMSP has a requirement to modernize the Anterior

Vitrectomy System equipment used in field environments in far forward locations around the world. The end item must be small, lightweight, portable, durable, reliable, easily maintainable, and capable of transport and operation in forward areas / field hospital settings.

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 be not be issued.

7.2 The solicitation document and incorporated provisions and clauses are those in effect through Federal

Acquisition Circular (FAC) FAC 2020-05; effective 30 March 2020

7.3 This acquisition is being competed using full and open competition. The North American Industry

Classification System (NAICS) code is 339115 – Ophthalmic Goods Manufacturing.

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

7.5 The Contract Line Item Number (CLIN) numbers and items, quantities, units of measure and description are identified under the Supplies/Services Section of the RFQ.

7.6 The anticipated date of delivery are as follows:

Equipment Set Test Articles – 15 June 2020

Training In Support of Operational Test – 11 August 2020

The Optional Delivery Dates are as follows:

Anterior Vitrectomy System and Spare Parts Option #1 – 29 January 2021

Annual Training Option #1 – 26 February 2021 – 25 February 2022

Anterior Vitrectomy System and Spare Parts Option #2 – 29 January 2022

Annual Training Option #2 – 26 February 2022 – 25 February 2023

Annual Training Option #3 – 26 February 2023 – 25 February 2024

Annual Training Option #4 – 26 February 2024 – 25 February 2025

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 quote.

8. Point-of-Contact: The point-of-contact for this acquisition is Mr. Brandon Roebuck, Contract Specialist, brandon.m.roebuck.civ@mail.mil. No telephone calls will be accepted.

mailto:brandon.m.roebuck.civ@mail.mil

9. Instructions for the Preparation and Submission of Quotes

9.1 Quotes shall be prepared in accordance with this solicitation and FAR provision 52.212-1, Instructions to

Offerors – Commercial Items including the Addendum M, which is included with the attached RFQ.

9.2 All quotes shall be evaluated in accordance with the evaluation criteria identified in FAR 52.212-2

Evaluation – Commercial Items included with the attached RFQ.

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, apples 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 quotes, and to award no contract at all, depending on the quality of the quote(s) submitted and the availability.

9.6 Questions: Questions shall be submitted via e-mail to Mr. Brandon Roebuck, brandon.m.roebuck.civ@mail.mil, no later than 10:00 AM Eastern Time on 29 April 2020. Questions received after this date will not be accepted. An Amendment to this RFQ will be posted to https://beta.sam.gov/ with responses to the questions received. Only one set of questions per Contractor will be accepted. No telephone calls will be accepted.

9.7 Quotes: Quotes in response to this RFQ are due via e-mail no later than 10:00 AM Eastern Time on 14

May 2020 to Mr. Brandon Roebuck, Contract Specialist, brandon.m.roebuck.civ@mail.mil.

9.8 The Offeror shall agree to honor proposed prices for 90 days from the due date for receipt of quotes.

https://beta.sam.gov/

STATEMENT OF NEED

STATEMENT OF NEED

ANTERIOR VICTROMETY SYSTEM

1. Introduction

The U.S. Army Medical Materiel Development Activity (USAMMDA), Warfighter Deployed Medical Systems

PMO (WDMSP). The Medical Modernization (MOD) program office is lead for this effort. The USAMMDA is the

Department of Defense's (DOD) medical 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 enhance readiness, ensures the provision of the highest quality medical care to the DOD, and maximizes survival of medical casualties on the battlefield.

1.1 Mission

The USAMMDA WDMSP has a requirement to modernize the Anterior Vitrectomy System equipment used in field environments in far forward locations around the world. The end item must be small, lightweight, portable, durable, reliable, easily maintainable, and capable of transport and operation in forward areas / field hospital settings. Field conditions for transport include temperature extremes which are higher and lower than typical room temperature conditions in laboratories or other fixed facilities. Transport case and equipment lock-down capabilities should ensure the equipment can survive shock, introduced in drops or other jarring, during shipping. Power usage should be minimized.

2. SCOPE

2.1 USAMMDA WDMSP requires a modernized Anterior Vitrectomy System to be used in field hospital settings around the world. FDA Clearance is mandatory. The end item shall be small, lightweight, portable, durable, reliable, easily maintainable, and capable of transport and operation in field conditions.

2.2. Anterior Vitrectomy System Performance Requirements

Technical performance attributes of the vitrectomy system are articulated in the MINIMUM ESSENTIAL

CHARACTERISTICS (MECs) section of this solicitation. The Contractor shall meet, at a minimum, the Threshold level Essential Characteristics (ECs) and Additional Performance Parameters (APPs). Objective level ECs and

APPs identify desired technical performance attributes.

2.3 Capability shall include attributes as defined below with “minimum required” as mandatory, and “additional desired” as objective level, but not mandatory.

2.3.1 Minimum Required Attributes

a) FDA 510k approval for use in ophthalmic surgery

b) Capability for anterior (not posterior) vitrectomy procedures

c) Vitrector which utilizes speeds of at least 2000 cuts per minute (cpm)

d) Minimum trocar/surgical diameter shall be at least 23 gauge

e) Shall include a console for powering and controlling the device functions

f) Shall have a multifunction foot switch to operate the functions of the system

g) Ruggedized case(s) for transport and storage

h) The total system in its cases should not exceed approximately 1.0 cu m (35.3 cubic ft.).

i) The total system in its cases should not exceed 70 lbs. If more than one case is needed, no one case may exceed 70 lbs.

j) System should be able to operate on standard 110/220V, 50/60 Hz power supplies.

2.3.2 Additional Desired Attributes

k) Shall include vitrector which utilizes speeds up to 2500 cuts per minute.

l) The minimum trocar/surgical diameter shall be 27 gauge.

m) The aspiration vacuum should have a minimum range encompassing 30 mmHg to 600 mmHg

n) The unit should have phacoemulsification capability.

o) The total system in its cases should not exceed approximately 0.3 cu m (10.6 cubic ft.).

p) The total system in its cases should not exceed 50 lbs.

q) Unit should include an embedded diathermy unit.

r) Ability to store items (non-operating) in their ruggedized cases up to 140oF

s) Ability to store items (non-operating) in their ruggedized cases up to 90% Rh

t) Packaged in ruggedized cases to survive shock and/or jarring that would be typical of transport conditions

2.4 Surgeries using the vitrectomy system will be performed in semi-permanent structures, at Field Hospitals.

Operational conditions for the vitrectomy systems will be climate controlled, though temperatures will vary considerably, as compared to fixed facility conditions. However, field conditions for transport are significantly higher and lower than typical room temperature conditions in laboratories or other fixed facilities, and equipment must be able to withstand temperature extremes in transportation and storage conditions. Transport case and equipment lock-down capabilities shall ensure the equipment can survive shock, introduced in drops or other jarring during shipping. Power usage should be minimized.

2.5 Initially the Government intends to procure two equipment sets and one training event, to be used in support of formal test and evaluation (T&E). Following successful completion of the T&E phase, the Government intends to execute an option to begin procurement of production quantities for fielding.

2.6 If the Government exercises the option to award production quantities, the contractor shall consent to allow

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. Additionally, the contractor shall notify DLA no less than twelve (12) months prior to any part becoming obsolete or otherwise unavailable.

2.7. Equipment Sets

The Contractor shall provide equipment sets, to include:

vitrectomy system consumables, such as needles, aspirator tubes, and the like; all should be in sufficient quantity to perform one surgery ancillary items, as needed, such as power cords, connection cables, etc.

tools required for on-going repairs, calibration or other routine maintenance equipment set-up and re-packing instructions user/operator manual and maintainer manual (two each per set) (reference section 2.9 below for further details regarding manuals) reusable ruggedized case(s) to provide consolidation of items as well as protection during storage and transport

2.8. Consumables

The Contractor shall provide a listing denoting the configuration of items required for each surgery. 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-proprietary items

Quantities of each of the above

Ordering information for replacement of consumables

2.9. Manuals (Data Requirement #1)

Maintainer and user/operator manuals to be included in equipment sets shall include the following information, as a minimum:

Environmental or other constraints for operating equipment

Environmental or other constraints for storage and transportation

Instructions for set-up as well as for re-packing for transport

Drawings showing parts or exploded view of parts, including part numbers of field-replaceable components

Photos and/or drawings, as needed, to depict proper set-up, operation, storage, parts isolation, trouble-shooting, etc.

Details regarding any regular/routine/scheduled inspections

Details regarding any regular/routine/scheduled calibrations or maintenance

Cleaning procedures, and acceptable cleaning solutions

List of required tools including special, proprietary tools

Special calibration tools or equipment, as well as procedures

Maintenance accessories and consumables

Software/firmware updates, interval/procedures, as needed

List of recommended repair parts

Troubleshooting procedures in step-by-step format

Website and/or customer service phone contact information for technical support, warranty, etc.

Information in manuals shall be presented in a logical format to facilitate understanding by trained users/operators and maintainers.

Additionally, manuals shall be provided in searchable electronic format. The Government shall have data rights allowing for distribution/accessibility of electronic manuals to Government users/operators and maintainers, uploaded to a DoD secured network.

2.10 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.

Examples of “routine maintenance” are actions such as changing cutters, lubrication, replacement of aspirator tubing or other consumables used during surgeries, 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.

2.11 Customer Service

Customer Service is required as reach-back for technical support and potentially to order parts for replacement of consumables and/or for repairs. The Contractor shall provide contact information for customer service, as well as hours of availability.

2.12 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. Anterior Vitrectomy System User/Operator (technician or physician); and 2. DoD

Maintainer (BMET). Trainings shall be conducted at a single CONUS location, 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.

2.13 Warranty

The Contractor shall provide a manufacturer warranty for at least one (1) year for the vitrectomy system. 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 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.

2.14 System Data (Data Requirement #2)

The Government is required to conduct a Risk Management Framework (RMF) analysis on all equipment intended for deployment. The RMF process supports cybersecurity risk analysis, and generally applies to any equipment that includes electronics, particularly if there exists a possibility for wireless communication, 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. Following contract award, the

Government will submit questions, as needed, to the Contractor. The Contractor shall designate a point of contact for questions and 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; the Contractor is not required to perform the RMF analysis. (Reference Appendix A – Cyber Security Evaluation Example Questions for an example of the types of cybersecurity-related questions the Government may ask, following contract award.

(NOTE: The Appendix A that is included in the solicitation is not required to be completed at the time of proposal.)

2.15 Additional Logistics Requirements

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 surgeries performed, or other cause. The contractor shall recommend a list of replacement parts to be procured with each equipment set.

Upon contract award Contractor shall provide part numbers as well as dimensions and weights for the system level as well as any additional major components.

-System level is defined as inclusive of:

Vitrectomy system

Any ancillary system or subsystem required to remove waste material

Ancillary items, as needed, such as power cords, connection cables, tubing for removal of waste, etc.

Replacement consumables required for operation over a 72-hour period

Tools required for on-going repairs, calibration or other maintenance

Set-up and re-packing instructions

Maintainer manual and user/operator manual (two each)

Reusable ruggedized case(s) to provide consolidation of items as well as protection during storage and transport

-Major components are defined as any items that may require replacement due to wear-out or loss, such as:

Ancillary items, including any ancillary system or subsystem required to remove waste material, if needed

Replaceable consumables

Ruggedized case(s)

The ruggedized case(s) shall have approved marked data plates with the following information:

i) National Stock Number(s) – Actual NSN(s) to be provided by Government technical point of contact within 60 days following receipt of part numbers, dimensions and weights as defined above.

ii) Serial number of unit

iii) Item Unique Identification (IUID) on each system/unit in accordance with clause Department of

Defense (DoD) Federal Acquisition Regulation Supplement (DFARS) 252.211-7003, Item Unique

Identification and Valuation (DEC 2013).

3. Quantities, Delivery Instructions

3.1 The Government intends to initially procure two test articles for test and evaluation, during its Research, Development, Test and Evaluation (RDT&E) phase, aka Test and Evaluation (T&E). These will be used to assess the functionality of equipment, as well as its suitability for the intended purpose. Additionally, the Government intends to procure a training event, in support of test and evaluation. Optional contract line items (CLINs), if exercised, will require deliveries of production equipment items, as well as annual training.

3.2. Equipment deliveries for test articles shall be FOB Destination, to:

US Army Medical Materiel Development Activity

Attn: K Grochowski, Rm. 213

1430 Veterans Drive

Fort Detrick, MD 21702-5009

3.3 Equipment deliveries for production equipment shall be FOB Destination, to:

Tobyhanna Army Depot

Tobyhanna Army Medical Depot

Warehouse 4 Bay 1

Tobyhanna, PA 18466-5063

3.4 Training shall be conducted at a to-be-determined CONUS location. However, for planning purposes, assume the following location:

Walter Reed National Military Medical Center

4494 North Palmer Road

Bethesda, MD 20889

MECS

MINIMUM ESSENTIAL CHARACTERISTICS (MECs)

Title: ANTERIOR VITRECTOMY SYSTEM REQUEST FOR PROPOSAL MECS

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

Deployed Medical Systems PMO (WDMSP). The USAMMDA is the Department of Defense's (DOD) medical 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 enhance readiness, ensures the provision of the highest quality medical care to the DOD, and maximizes survival of medical casualties on the battlefield.

Program Name: ANTERIOR VITRECTOMY SYSTEM

1. PURPOSE: USAMMDA WDMSP has a requirement to modernize the Anterior Vitrectomy System equipment used in field environments in far forward locations around the world. The end item must be small, lightweight, portable, durable, reliable, easily maintainable, and capable of transport and operation in forward areas / field hospital settings.

A vitrectomy is a surgery where some or all of the vitreous humor is removed from the eye, generally completed by a vitreoretinal surgeon through the back structures of the eye. However, anterior vitrectomy entails removing small portions of vitreous humor from the front structures of the eye by any ophthalmologist, particularly after a traumatic eye injury. An anterior vitrectomy system typically includes a vitrector drive, an aspirator, and may have phacoemulsification capability. The Army has a requirement to perform anterior vitrectomy to treat injuries in deployed settings. The Anterior Vitrectomy System should include capability to perform the following procedures:

repairs to the eye structure; removal of scar tissue; removal of cataract.

Field conditions for transport include temperature extremes which are higher and lower than typical room temperature conditions in laboratories or other fixed facilities. Transport case and equipment lock-down capabilities should ensure the equipment can survive shock, introduced in drops, or other jarring during shipping. Power usage should be minimized.

2. ESSENTIAL CHARACTERISTICS

The essential characteristics must be met in order for the device to be considered acceptable. Additional parameters are identified, with minimum acceptable criteria. Each parameter is subdivided into a threshold (T) and an objective

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

Essential Characteristic (EC) Threshold [T] (Minimum) Objective [O]

FDA Clearance

Shall have FDA 510k approval for use in for use in ophthalmic surgery T=O

Vitrector Cutting Speed

Shall include vitrector which utilizes speeds of at least 2000 cuts per minute (cpm) Vitrector speeds up to 2500 cuts per minute (cpm)

Trocar/Surgical Wound Diameter

The minimum trocar/surgical diameter shall be at least 23 gauge Trocar/surgical diameter 27 gauge

Console

Shall have a console for powering and controlling the device functions T=O

Foot Switch

Shall have a multifunction foot switch to operate the functions of the system T=O

Additional Performance

Parameter (APP)

Threshold [T] (Minimum) Objective [O]

Aspiration Vacuum Range

The aspiration vacuum should have a minimum range encompassing 30 mmHg to 600 mmHg

Additional Performance

Parameter (APP)

Threshold [T] (Minimum) Objective [O]

Phacoemulsification capability

The unit should have phacoemulsification capability T=O

Shipping Cube

The total system in its cases should not exceed approximately 1.0 cu m

(35.3 cubic ft.)

Not exceed approximately 0.3 cu m (10.6 cubic ft.).

System Weight

The total system in its cases should not exceed 70 lbs. Not exceed 50 lbs.

Ophthalmic Diathermy

Unit should include an embedded diathermy unit T=O

Power Requirements

System should be able to operate on standard 110/220V, 50/60 Hz power supplies

3. INTEGRATED PRODUCT SUPPORT (IPS)

This list of parameters details the logistical characteristics and practices with which the system and offeror should comply.

ILS Parameter Threshold [T] (Minimum) Objective [O]

Transportation and Storage

Ruggedized case(s)

System shall be packed in ruggedized case(s) for transport and storage

Ability to store items (non-operating) in their ruggedized cases up to 140oF, up to 90% Rh, and able to survive shock and/or jarring that would be typical of transport

Cybersecurity

Cybersecurity information

Provide system-specific information regarding data processed, stored or transmitted by the equipment

T=O

Maintenance/Supply Support

Parts list Provide listing of replaceable parts, including part numbers

T=O

Manuals

Provide user and maintainer manuals, in hard copy with each equipment item shipped, as well as electronically

T=O

Training and Training Support

User and maintainer training Provide user and maintainer training

T=O

Support Equipment

Tools and accessories

Provide any specialized tools and/or accessories required for maintenance and repairs with each equipment item shipped

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0001 2 Each Anterior Vitrectomy System Test Articles

FFP

The Contractor shall provide two (2) Anterior Vitrectomy System Test Articles in accordance with (IAW) the Statement of Need and the Minimum Essential

Characteristics. NOTE: The requirements in DFARS 252.211-7003, Item

Identification and Valuation, are applicable for this line item. The contractor shall provide DoD unique identification or a DoD recognized unique identification equivalent.

FOB: Destination

PSC CD: 6540

NET AMT

0002 1 Each Training

FFP

The Contractor shall provide Training in support of the Operational Test in accordance with (IAW) the Statement of Need and the Minimum Essential

Characteristics. NOTE: The requirements in DFARS 252.211-7003, Item

Identification and Valuation, are applicable for this line item. The contractor shall provide DoD unique identification or a DoD recognized unique identification equivalent.

1001 8 Each OPTION Anterior Vitrectomy System

FFP

The Contractor shall provide four (4) Anterior Vitrectomy Systems and four (4)

Sets of Spare Parts in accordance with (IAW) the Statement of Need and the

Minimum Essential Characteristics. NOTE: The requirements in DFARS 252.211-

7003, Item Identification and Valuation, are applicable for this line item. The contractor shall provide DoD unique identification or a DoD recognized unique identification equivalent.

1002 1 Each OPTION Training

FFP

The Contractor shall provide Training in support of the Anterior Vitrectomy

Systems in accordance with (IAW) the Statement of Need and the Minimum

Essential Characteristics. NOTE: The requirements in DFARS 252.211-7003, Item

Identification and Valuation, are applicable for this line item. The contractor shall provide DoD unique identification or a DoD recognized unique identification equivalent.

1003 4 Each OPTION Extended Warranty

FFP

The Contractor shall provide extended warranties for the four (4) Anterior

Vitrectomy Systems in accordance with (IAW) the Statement of Need and the

Minimum Essential Characteristics. NOTE: The requirements in DFARS 252.211-

7003, Item Identification and Valuation, are applicable for this line item. The contractor shall provide DoD unique identification or a DoD recognized unique identification equivalent.

2001 10 Each OPTION Anterior Vitrectomy System

FFP

The Contractor shall provide five (5) Anterior Vitrectomy Systems and five (5)

Sets of Spare Parts in accordance with (IAW) the Statement of Need and the

Minimum Essential Characteristics. NOTE: The requirements in DFARS 252.211-

7003, Item Identification and Valuation, are applicable for this line item. The contractor shall provide DoD unique identification or a DoD recognized unique identification equivalent.

2002 1 Each OPTION Training

FFP

The Contractor shall provide Training in support of the Anterior Vitrectomy

Systems in accordance with (IAW) the Statement of Need and the Minimum

Essential Characteristics. NOTE: The requirements in DFARS 252.211-7003, Item

Identification and Valuation, are applicable for this line item. The contractor shall provide DoD unique identification or a DoD recognized unique identification equivalent.

2003 5 Each OPTION Extended Warranty

FFP

The Contractor shall provide extended warranties for the five (5) Anterior

Vitrectomy Systems in accordance with (IAW) the Statement of Need and the

Minimum Essential Characteristics. NOTE: The requirements in DFARS 252.211-

7003, Item Identification and Valuation, are applicable for this line item. The contractor shall provide DoD unique identification or a DoD recognized unique identification equivalent.

3001 1 Each OPTION Training

FFP

The Contractor shall provide Training in support of the Anterior Vitrectomy

Systems in accordance with (IAW) the Statement of Need and the Minimum

Essential Characteristics. NOTE: The requirements in DFARS 252.211-7003, Item

Identification and Valuation, are applicable for this line item. The contractor shall provide DoD unique identification or a DoD recognized unique identification equivalent.

4001 1 Each OPTION Training

FFP

The Contractor shall provide Training in support of the Anterior Vitrectomy

Systems in accordance with (IAW) the Statement of Need and the Minimum

Essential Characteristics. NOTE: The requirements in DFARS 252.211-7003, Item

Identification and Valuation, are applicable for this line item. The contractor shall provide DoD unique identification or a DoD recognized unique identification equivalent.

INSPECTION AND ACCEPTANCE TERMS

Supplies/services will be inspected/accepted at:

CLIN INSPECT AT INSPECT BY ACCEPT AT ACCEPT BY

0001 Destination Government Destination Government

0002 Destination Government Destination Government

1001 Destination Government Destination Government

1002 Destination Government Destination Government

1003 Destination Government Destination Government

2001 Destination Government Destination Government

2002 Destination Government Destination Government

2003 Destination Government Destination Government

3001 Destination Government Destination Government

4001 Destination Government Destination Government

DELIVERY INFORMATION

CLIN DELIVERY DATE QUANTITY SHIP TO ADDRESS DODAAC /

CAGE

0001 15-JUN-2020 2 USA MED MATERIEL DEV ACTIVITY

KATHY A. GROCHOWSKI

1504 PATCHEL STREET

FORT DETRICK MD 21702-9232

301-619-7862

W806YH

0002 11-AUG-2020 1 (SAME AS PREVIOUS LOCATION)

1001 29-JAN-2021 8 (SAME AS PREVIOUS LOCATION)

1002 POP 26-FEB-2021 TO

25-FEB-2022

N/A (SAME AS PREVIOUS LOCATION)

1003 POP 29-JAN-2021 TO

28-JAN-2026

N/A (SAME AS PREVIOUS LOCATION)

2001 29-JAN-2022 10 (SAME AS PREVIOUS LOCATION)

2002 POP 26-FEB-2022 TO

25-FEB-2023

N/A (SAME AS PREVIOUS LOCATION)

2003 POP 29-JAN-2022 TO

28-JAN-2027

N/A (SAME AS PREVIOUS LOCATION)

3001 POP 26-FEB-2023 TO

25-FEB-2024

N/A (SAME AS PREVIOUS LOCATION)

4001 POP 26-FEB-2024 TO

25-FEB-2025

N/A (SAME AS PREVIOUS LOCATION)

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

52.204-24 Representation Regarding Certain Telecommunications and

Video Surveillance Services or Equipment.

DEC 2019

52.209-7 Information Regarding Responsibility Matters OCT 2018

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

52.217-5 Evaluation Of Options JUL 1990

52.232-39 Unenforceability of Unauthorized Obligations JUN 2013

52.232-40 Providing Accelerated Payments to Small Business

Subcontractors

DEC 2013

252.201-7000 Contracting Officer's Representative DEC 1991

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

252.211-7008 Use of Government-Assigned Serial Numbers SEP 2010

252.223-7008 Prohibition of Hexavalent Chromium JUN 2013

252.225-7001 Buy American And Balance Of Payments Program-- Basic DEC 2017

252.225-7021 Trade Agreements--Basic SEP 2019

252.225-7036 Buy American--Free Trade Agreements--Balance of

Payments Program--Basic

DEC 2017

252.225-7052 Restriction on the Acquisition of Certain Magnets and

Tungsten.

DEC 2019

252.226-7001 Utilization of Indian Organizations and Indian-Owned

Economic Enterprises, and Native Hawaiian Small Business

Concerns

APR 2019

252.227-7015 Technical Data--Commercial Items FEB 2014

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

252.246-7008 Sources of Electronic Parts MAY 2018

252.247-7023 Transportation of Supplies by Sea FEB 2019

CLAUSES INCORPORATED BY FULL TEXT

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).

(End of provision)

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 (OCT 2018)

(a) North American Industry Classification System (NAICS) code and small business size standard. The NAICS code and small business size standard for this acquisition appear in Block 10 of the solicitation cover sheet (SF

1449). 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

(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 exceeding $3,500, and offers of $3,500 or less 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 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.

https://assist.dla.mil/online/start/ http://quicksearch.dla.mil/ http://assistdocs.com/ https://assist.dla.mil/wizard/index.cfm http://www.sam.gov/

(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 CONTRACTS

The Government reserves the right to award multiple Purchase Orders (PO) resulting from this solicitation. These

PO’s will utilize Firm-Fixed Price (FFP) Contract Line Item Numbers (CLINs).

M.2. TECHNICAL QUESTIONS

Questions are due no later than 10:00 AM Eastern Time on 29 April 2020. Questions shall be submitted to Mr.

Brandon Roebuck at brandon.m.roebuck.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. Any additional questions submitted will be accepted at the

Government’s discretion.

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

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

“Unacceptable.” The Government will not consider pages submitted in excess of the stated page limitations.

Proposals should provide a minimum offer acceptance period of 90 days from the end of the solicitation closing date

(including an agreement to hold the prices in offer firm).

The proposal shall be submitted electronically via e-mail to brandon.m.roebuck.civ@mail.mil no later than 10:00

AM Eastern Time on 14 May 2020. The Offeror is responsible for ensuring receipt by the POC.

M.4. PROPOSAL EVALUATION

To aid in evaluation, proposals shall be practical, specific complete, and logically assembled. The proposal 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 PROPOSAL

The overall proposal shall consist of three (3) separate volumes, individually titled. Each copy of each volume should be appropriately titled as follows:

https://beta.sam.gov/

Proposal

Volumes Volume Title Page Limitation

Volume I Executed Solicitation Documents N/A

Volume II Executive Summary, Technical Compliance, and

Maintenance

60 pages

Volume III Executive Summary and Price Proposal N/A

Volume IV Users/Operators and Maintainers Manuals N/A

M.6. ADDITIONAL PROPOSAL SUBMITTAL INFORMATION

M.6.1. All commitments made by the Offeror in the proposal will become a part of the resultant contract.