36S79725R0001.docx

36S79725R0001

PAGE 1 OF

1. REQUISITION NO.

2. CONTRACT NO.

3. AWARD/EFFECTIVE DATE

4. ORDER NO.

5. SOLICITATION NUMBER

6. SOLICITATION ISSUE DATE

a. NAME

b. TELEPHONE NO. (No Collect Calls)

8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY

CODE

10. THIS ACQUISITION IS

UNRESTRICTED OR

SET ASIDE:

% FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ

IFB

RFP

15. DELIVER TO

CODE

16. ADMINISTERED BY

CODE

17a. CONTRACTOR/OFFEROR

CODE

FACILITY CODE

18a. PAYMENT WILL BE MADE BY

CODE

TELEPHONE NO.

UEI:

EFT:

PHONE:

FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER 18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19.

20.

21.

22.

23.

24.

ITEM NO.

SCHEDULE OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA

26. TOTAL AWARD AMOUNT (For Govt. Use Only) 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________

29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

DATED ________________________________. YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER) 30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION

(REV. NOV 2021)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

01-12-2026 DLC IRM Limbs

03-27-2026

CST

VA NAC / 003B6A

PO Box 76 1st Ave., One Block N of 22nd

Hines IL 60141

X

339113 800 Employees

N/A

Department of Veterans Affairs OPAL / National Acquisition Center Building 37 1st Avenue, One Block North of Cermak Hines IL 60141

Department of Veterans Affairs

CHIEF, FISCAL DIVISION (901A)

HINES SERVICE AND DISTRIBUTION CENTER

PO BOX 7005

HINES IL 60141-7005

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C791

VA NAC / 003B6A

PO Box 76 1st Ave., One Block N of 22nd Hines IL 60141

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

3. INVOICES: Invoices shall be submitted in arrears:

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

B.2 ABBREVIATIONS & DEFINITIONS

As used through this solicitation/contract the following abbreviations, words or terms are used as defined.

ABBREVIATIONS

AAOP American Academy of Orthotists and Prosthetists

AOPA American Orthotic and Prosthetic Association

ARO After Receipt of Order

CCN Community Care Network

CD-ROM Compact Disc, Read Only Memory

CEP Customer Engagement Portal

CEU Continuing Education Unit

CFR Code of Federal Regulations

CLIN Contract Line-Item Number

Cm Centimeter

CO Contracting Officer

CONUS Continental United States

CPARS Contractor Performance Assessment Reporting System

CS Control System(s)

CSAS Commodities & Services Acquisition Service

DLC Denver Logistics Center

DLS Denver Logistics Service

DoD U.S. Department of Defense

DOJ U.S. Department of Justice

DUNS Data Universal Numbering System

EA Each

EFT Electronic Funds Transfer

EMG Electromyography

FAR Federal Acquisition Regulation

FDA U.S. Food and Drug Administration

FISMA Federal Information Security Management Act

FOB Free on Board

FFP Firm Fixed Price

FSC Financial Services Center

FSRs Force Sensing Resistors

GAO U.S. Government Accountability Office

GSA U.S. General Services Administration

IAW In Accordance With

IDIQ Indefinite Delivery Indefinite Quantity

ISO International Organization for Standardization

ISSO Information System Security Officer

Lbs abbreviation for pounds (unit of weight/mass) Li-ion Lithium-ion mAh milliampere-hour mm Millimeter

N Newton

OCONUS Outside Continental United States

PCA Prosthetic Components and Accessories

PEU Prosthetic Elbow Unit

PHCA Prosthetic Hand Components and Accessories

PL Prosthetic Liner

PLS Prosthetic Limb Suspension

PO Purchase Order

Polypro Polypropylene

PPIRS Past Performance Information Retrieval System

PTD Prosthetic Terminal Device

Pub. L. Public Law

PWU Prosthetic Wrist Unit

ROES Remote Order Entry System

ROM Range of Motion

SAM System for Award Management

SF Standard Form

SS Suspension System

TD Terminal Device

TIN Taxpayer Identification Number

U.S. United States

USC United States Code

VA U.S. Department of Veterans Affairs

VAAR Veterans Affairs Acquisition Regulation

VAMC Veterans Affairs Medical Center

VHA Veterans Health Administration

VIP Vendor Information Pages

VSD Veteran Service Division

Wi-Fi Wireless computer network protocols based on IEEE 802.11 family of standards

WTO GP World Trade Organization Agreement on Government Procurement

DEFINITIONS

Automatic - any engagement or disengagement of a feature in a prosthetic device based on preset criteria for specific environmental factors.

Adaptive – Any variable change in a prosthetic device setting, settings, frequency response or directional characteristics that results from programmable input to the instrument’s environment that are mad in order to improve the quality of function to the end user (e.g. stiffness, stability) Adjustment - Component changes within the same option package.

Automatic – Any engagement or disengagement of a feature in a prosthetic device based on preset criteria for specific environmental factors.

Circuit - Combination of electronic components carrying an electric current.

Dacron Webbing – A brand of polyester textile fiber that is wrinkle-resistant and strong woven fabric Data logging - Internal tracking and storage of data on such things as total daily use, average daily use, use of different programs or features, and/or changes in gain or programs.

Device - Unless otherwise noted, device means Upper Extremity Component or related part.

Endoskeletal - for purpose of this contract endoskeletal refers to modular prosthetic components that are interchangeable (i.e. pylon, connector, etc.)

Exoskeletal – for the purpose of this contract exoskeletal design refers to a type of construction with a rigid external plastic structure in the shape of a limb.

Extra Component - Interfaces and components that are offered in the packages and for which the Government may place individual open market orders following the expiration of the 30-day trial period, during the new device warranty.

Force Sensing Resistors (FSRs) – A Force Sensing Resistor is a material or thin-film polymer sensor whose electrical resistance changes predictably when a force, pressure, or mechanical stress is applied to its surface; commonly placed within the prosthetic socket, between the skin/liner and the socket wall, to monitor pressure distribution during activities. Data from FSRs can be used to provide real-time haptic or electrotactile feedback to the user, simulating a sense of touch or pressure (e.g. grip force in a prosthetic hand); FSR signals act as inputs for the prosthesis’s control system.

Group - A group is a categorization of prosthetic device characteristics defined by the physical aspects and HCPCS classifications of the device such as size, casing, configuration, technology, body part, function, or therapeutic benefit.

HCPCS - The Healthcare Common Procedure Coding System (HCPCS) is a standardized coding system for describing specific items and services necessary for medical providers in the delivery of health care and submit healthcare claims in a consistent and orderly manner. (also see L Code) HCPCS Classification – A uniform method of describing and classifying prosthetic devices by design, function, programmable functions, and other features.

Integrated Wireless Connectivity - Technology that connects a prosthetic device through wireless (e.g. Bluetooth, magnetic induction, or proprietary RF) interfaces to other devices.

Lbs – lbs is the abbreviation for pounds, a unit of weight or mass, unit primarily used for measuring the mass or weight of an object.

L Code - A particular series of HCPCS codes particular to prosthetics. It is used interchangeably with HCPCS throughout the document and holds the same general meaning of those codes or series of codes.

Microprocessor Controlled Feature - A prosthetic elbow, terminal devices, joint with a built in CPU controlling aspects of motion.

Milliampere-hour – A unit measuring battery capacity, indicating how much charge a batter holds Model – A: manufacturer’s commercial designation (e.g. model name or model number) of an upper extremity product or feature.

B: Three-dimensional representation of an anatomical part or structure.

Modular Components - New: Modular components are prosthetic items that work together to form a single functioning prosthetic item.

Myoelectric Prosthesis – An externally powered prosthesis that is electrically controlled; electrical impulses, generated by muscles of the body which may be amplified and used to control prosthetic limbs Newton International system of units for force Non-VA Care - Health care services purchased from non-VA providers. Non-VA Medical Care was called “fee care,” “fee basis care,” or “Community Care Network (CCN) in the past.

Package - The combination of compatible and/or supporting components or parts that may be contained within a single device order.

Passive – For the purpose of this contract, a passive prosthesis is a cosmetic or supportive device that does not move on its own, resembling a natural limb for appearance, balance or protection.

Primary Features – Features that are critical for the function of the device. The prosthesis (terminal device, wrist, elbow, arm, shoulder) interposing joints, components, sockets, suspension system(s) (e.g.: harness, cables), and control system (body-powered, externally powered, or hybrid control system).

Secondary Features - Options to customize the prosthetic device: shell color, size, width, activity specific, weight and length.

Activity Specific Component – A prosthetic component optimally designed for a specific activity.

Body-Powered Prosthetic Component – operation of the prosthetic component by user anatomical motion.

Externally Powered Prosthetic Component – Battery-powered systems, electric switches or myoelectric signals used for control of the prosthesis.

Hybrid Prosthetic Component – A combination of body-powered and electrically powered components in one prosthesis.

Myoelectric Prosthetic Component – An externally powered prosthetic component that is electromyographic (EMG) signals generated during muscle contractions providing digital or proportional control for functional use.

Passive Prosthetic Component – an upper extremity prosthetic component designed to resemble an arm, hand, or fingers; a lightweight prosthesis that may be combined with multi-positional joints to give the user the ability to position the finger joints, wrist, elbow, or shoulder for improved function.

Prosthetic Socket Component – The framework that holds the device onto the remaining limb, must optimize stability while controlling for movement. (Pre-made) Prosthetic Terminal Device – The component of a prosthesis that substitutes for the functions of the hand that include passive, body-powered, and externally powered devices.

Prosthetic Wrist – A connector unit from the terminal device to the forearm of the prosthesis.

Transhumeral Prosthesis - An artificial arm that attaches/connects to the body above the elbow but below the shoulder.

Transradial Prosthesis – An artificial arm that attaches/connects to the body below the elbow.

Product Device Change - A product device package change, when indicated in the 30-day trial period, and the originally ordered product is identified as not suitable for the selected fitting. (With the exception of Group 3 Prosthetic Liners.) VA791-17-D-0025.

Programmable - Programmable prosthetic devices are devices whose characteristics are determined by modification of the settings of the unit using a computer system, cables and/or a software program. The programmable function allows adjustment of features such as grasp position(s), electrode threshold sensitivity, and other characteristics (e.g., flexion, extension, wrist and elbow control). Some user functions may be controlled manually with buttons, switches, and/or Bluetooth device applications.

Prosthetic Control Systems - Wireless systems consist of a full suite of transmitters, receivers adaptors, and interfaces designed to function with microprocessor controlled prosthetic limb devices as an integrated system to optimize functionality in various environments.

Programming Device – Any external and/or independent device that links to the prosthetic device for programming functional control, meeting all applicable ISO standards.

Programming Parameters - Mechanical properties or user functions of the prosthetic device controlled by programming software.

Prosthetic Liner - A device designed for use with external prosthetic limb that provides suspension of the prosthesis and/or provides protection of the skin.

Prosthetic Limb Suspension System - A device or system that secures the residual limb inside the prosthetic socket and enables donning and doffing; provides a secure connection between the socket and limb. (e.g. harness, vacuum, passive suction, interface with a locking pin).

ROES - Remote Order Entry System is the prosthetic device ordering and decision support system used by VA prosthetists ordering through the Denver Logistics Center.

Wireless Adaptor - A wireless adaptor is a device that serves as an interface between a wireless receiver or transmitter and a prosthetic device.

Wireless Programmability - Wireless communication between the programming interface device, prosthesis, and related components.

Wireless Receiver - Wireless technology that uses a radio frequency to share data over a short distance, eliminating the need for wires.

Wireless Transmitter - Device that transmits a signal to a wireless receiver.

Year - For this contract, a full calendar year, 365 days (366 days for Leap year) during performance from the time of award.

B. 3 BACKGROUND

The Department of Veterans Affairs (VA) has identified Prosthetic Terminal Device (PTD): Prosthetic Wrist Unit (PWU), Prosthetic Elbow Unit (PEU), Prosthetic Limb Suspension (PLS), Prosthetic Components & Accessories (PCA) and Partial Hand Components and Accessories (PHCA) for use with prosthetic (artificial) limbs, as preferred products for consolidated contracting. The consolidated contracting is to establish enterprise scale and consistency in fabrication using these customized products and to obtain quality products at lower than current contract and open-market prices.

B.4 PURPOSE AND OBJECTIVE

(a) The purpose of this program is to consolidate and streamline the process of acquiring and tracking prosthetic limb components for VA prosthetic clinics in the United States and its territories. Products will be ordered electronically using the DLC’s Remote Order Entry System (ROES) and will be shipped from the contractor directly to the ordering clinic. This mechanism will be the primary source for contracted products for the VA and will be an optional source for authorized Department of Defense agencies. The prosthetic limb includes various types of Prosthetic Terminal Device (PTD): Prosthetic Wrist Unit (PWU), Prosthetic Elbow Unit (PEU), Prosthetic Limb Suspension (PLS), Prosthetic Components & Accessories (PCA), and Partial Hand Components and Accessories (PHCA).

(b) The objective is to award multiple Firm Fixed Price (FFP) Indefinite-Delivery Indefinite -Quantity (IDIQ) contracts to cover the various needs of the Government.

(c) Another objective is to ensure availability and consistency of products for national usage and to obtain volume-based pricing.

B.5 SCOPE

a) This schedule covers the following types of prosthetic items: Prosthetic Terminal Device (PTD): Prosthetic Wrist Unit (PWU), Prosthetic Elbow Unit (PEU), Prosthetic Limb Suspension (PLS), Prosthetic Components & Accessories (PCA), and Partial Hand Components and Accessories (PHCA).

b) This solicitation will result in multiple fixed-priced single award IDIQ contracts for a base year, with four (4) one-year options to be exercised at DLC’s discretion IAW FAR Part 17.

Prosthetic Terminal Device, Prosthetic Wrist Unit, Prosthetic Elbow Unit , Prosthetic Limb Suspension, and Prosthetic Components & Accessories and Partial Hand Components and Accessories will be ordered on an “as needed” basis for individual patients as needs arise. Quantities will be ordered as needed to fill agency requirements in accordance with current applicable supply procedures. Orders will be in accordance with Federal Acquisition Regulations, agency procurement policy and requirements specified within the resulting contract(s). Items will be for delivery within the U.S.A. and its territories, f.o.b. destination. The Contractor will be obligated to deliver all items that may be ordered during the term of the contract. There is no expressed or implied guarantee that the estimated quantities stated within the contracts will be ordered as these items are ordered specifically for each order.

B.6 GUARANTEED MINIMUM

a) The minimum amount of supplies that the Government agrees to order per contract is $1,000.00. If option periods are exercised, the contract will be deemed to be extended by the terms of the option and there will be no change to the stated guaranteed minimum. In the event that the minimum is not ordered, by the expiration date of the contract, the Government will pay (upon request) the difference between the amount ordered and $1,000.00. Request for payment of any amount due shall be submitted in writing to the Contracting Officer within 30 calendar days after the end of the contract period.

b) The guaranteed minimum does not apply if the contract is terminated for cause.

c) The sole purpose of the funds obligated in the initial order is to fund the guaranteed minimum of $1,000.00 as stated herein.

B.7 CONTRACT CEILING AMOUNT

The maximum value of supplies that the Government may order during the contract period, including all options if exercised, will be $37,000,000.00. This ceiling is neither divided nor multiplied by the number of awardees.

B.8 DELIVERY INFORMATION

a) Delivery is f.o.b. destination, USA and its territories.

b) Delivery time frame after receipt of order (ARO) is five (5) calendar days for CONUS (Continental United States) deliveries, and seven (7) calendar days for OCONUS (Outside Continental United States) deliveries. Any items not received within the agreed period will be considered delinquent and subject to corrective action to include but not limited to Quality Inspection Reports (QIR) and contractual actions for correction.

c) Delivery schedule specified on delivery orders issued against the resulting contract(s) are the dates materials are due in, not the shipping date.

d) Delivery shall be made to government locations (VA or DoD facilities only) identified within each order. No orders placed under this contract shall require items to be sent directly to a patient.

e) Expedited Delivery. When the contract delivery schedule does not meet an urgent need of the ordering activity, the Government reserves the right to request accelerated deliveries under this contract. If the contractor agrees to this expedited delivery, then the order shall arrive on or before the agreed delivery date, which will be identified in the order. The ordering facility shall pay for any and all expedited orders placed.

B.9 SCHEDULE OF ITEMS

See in support of the awarded pricing schedule of items for details. All groups listed below include Passive, Body Powered, Activity Specific and Powered Myo Devices.

Prosthetic Terminal Device (PTD): Active (open and close); passive (assist in holding items). Form of a hook or a hand with or without glove covering, activity specific (e.g., cooking, sporting, mechanics). Can be body powered, external (electric, myoelectric) powered, or hybrid powered. Device may include digit options.

Prosthetic Wrist Unit (PWU): Mechanical (e.g., Quick disconnect, flexion), External powered (e.g., electric wrist rotator), Passive.

Prosthetic Elbow Unit (PEU): Passive Function; Body Powered; External Powered (electrical or external powered); and/or Hybrid designed.

Prosthetic Limb Suspension (PLS): Prosthetic Limb Suspension shall include but not limited to any element of the prosthesis that suspends the socket to the patient’s residual limb to include harness systems and cables, chest straps, close fit, suction, locking and non-locking, vacuum system, cuff suspension, suspension sleeves, valves, and adjustable system(s).

Prosthetic Components & Accessories (PCA): Prosthetic components shall include but not limited to primary parts of the prosthetic device that are necessary for full functionality (e.g., battery packs, myo control elements, hinges, locking, non-locking, friction units). Prosthetic Accessories shall include but not limited to items that enhance or support the functionality, fit and cosmesis of the prosthesis. (e.g., battery chargers, cosmetic gloves, electrode cables, adapters).

Partial Hand Components and Accessories (PHCA): Passive Function; Body Powered; and/or External Powered (electrical or external powered) designed prosthetic components shall include but not limited to primary parts and assembly of the partial hand prosthetic device that are necessary for full functionality (e.g. passive positioning ratcheting digits, body driven digits, externally powered motorized digits, mounting brackets, vendor assembly). Comment by Mello, Lisa: @Quinn, Ryan D. (STL) Chris added some language for PHCA, you agree? Comment by Quinn, Ryan D. (STL): Looks good

B.10 GENERAL INFORMATION AND REQUIREMENTS FOR ALL GROUPS

The following information is applicable to all product groups (Terminal Devices, Wrist Units, Elbow Units, Prosthetic Limb Suspensions, Prosthetic Components and Accessories, and Partial Hand Components and Accessories): Products shall be serialized if that is your commercial practice.

All products must be commercial products as defined in FAR 2.101 in order to be considered for award.

The contractor shall list all necessary parts and/or components to ensure optimum function and operation of the device The contractor warrants that the product(s) furnished under the resulting contract will be free from defects in material and workmanship and will conform to all requirements of this solicitation and resulting contract. The Contractor warrants and implies that the items delivered hereunder are merchantable and fit for use for the particular purpose described in this contract. Adequate warranty and post-sales support must be provided as part of the product/service offering. Warranty covers all aspects of the product(s) supplied for a time period consistent with commercial practice. Normal “wear and tear” is excluded.

MINIMUM TECHNICAL REQUIREMENTS (ARTIFICIAL LIMBS – UPPER EXTREMITY PRODUCT(S)

The following requirements as listed below are applicable to all product groups. Additional specific minimum technical requirements for the individual groups are listed under that Group heading:

Group 1 (Prosthetic Terminal Device) Group 2 (Prosthetic Wrist Unit) Group 3 (Prosthetic Elbow Unit) Group 4 (Prosthetic Limb Suspension) Group 5 (Prosthetic Components and Accessories).

Group 6 (Partial Hand Components and Accessories)

1. Terminal Devices, Wrist Units, Elbow Units, Prosthetic Limb Suspensions, Prosthetic Components and Accessories, and Partial Hand Components and Accessories shall be ready to perform its operational function(s) as intended upon receipt.

2. Terminal Devices, Wrist Units, Elbow Units, Prosthetic Limb Suspensions, and Prosthetic Components and Accessories shall be ready to perform its operational function(s) as intended upon receipt.

3. Minimum shade/color availability of any product shall match commercial product availability as applicable to the product. Multiple shades may be available.

4. All materials in contact with the skin must be hypoallergenic to prevent skin irritation.

5. At a minimum the following items shall be included with every product:

a) Product literature must be specific to the enclosed item(s) and its features.

b) Packaging list/invoice.

c) Patient education materials that allow the patient to maintain or use the device(s) effectively (e.g., instructions on cleaning and maintenance).

d) Items that allow the patient to maintain or use the devices effectively e.g., cleaning solutions, tools, control devices.

e) Small tote bags or carry cases, when applicable, shall be included with the device for the patient’s use to carry the device(s), supplies, and literature.

f) Clinician instructions that will assist the clinician in fitting or instructing the patient in the use of the instrument, small hand tools, electronic tools/devices that assist in programming and alignment, software instructions, fitting instructions, shall be included with the device(s) if that is standard commercial practice.

6. Shipping containers shall not include advertising, surveys or questionnaires, cross-selling literature, or insurance offers of any kind.

7. Products shall have part number and serial number when applicable to the product.

8. All products shall be shipped in sealed, protective packaging

9. All products shall be sold per single unit or/as per commercially available packaging.

10. Serial and/or Product number shall be identified on the outside of packaging.

11. All products must meet ISO identified standards 13405.

12. The contractor shall warrant that the product(s) furnished under the resulting contract will be free from defects in material and workmanship and will conform to all requirements of this solicitation and resulting contract. Warranty covers all aspects of the product supplied for a time consistent with commercial standards. Normal “wear and tear” is excluded.

GROUP 1 – PROSTHETIC TERMINAL DEVICE (PTD)

1. Physical Characteristics: For the purpose of this solicitation/contract, the term PTD shall include prosthetic terminal device for use with endoskeletal and/or exoskeleton prosthetic limb devices. The device is the component of the prosthesis to replace a person’s hand and about restoring function and quality of life. The PTD shall include a complete hand, or other terminal device and protective cover for all, as applicable products.

2. Product Line: The Prosthetic Terminal Device shall include a complete hand in the form of active (open and close); and/or passive. Products may be in a form of a hook, claw, or device that more closely resembles the form of a hand, or in form of recreational activity specific and may, when applicable, include a glove covering. Products may include conventional (body powered) and/or externally powered systems.

3. Minimum Technical Requirements for Group 1 PTD Products:

a) Availability:

Shall be available in left and right configurations or be of ambidextrous design.

Commercial size availability must be offered.

b) Functional requirements: Programmable (as applicable to the product).

c) External powered systems: Shall include battery and battery charger or be compatible with those commonly used in prosthetics industry

Technical Specifications for powered items:

a) Grip Strength: Powered terminal devices shall be able to achieve a gripping force of 8N

b) Precision: Must include fine motor control for delicate tasks, ensuring precision grip capabilities for handling small objects.

c) Socket Compatibility: Must be compatible with standardized prosthetic componentry required to control the device. (i.e. electromyography, , prosthetic battery systems).

d) Accessory Integration/Compatibility: Must allow for integration/compatibility with a wide range of industry-standard accessories, including sensors, universal prosthetic accessories and components such as common wrists, rotators and coaxial plugs.

e) Battery Type and safety: Lithium-ion (Li-ion) batteries. All batteries used in prosthetic devices will comply with travel regulations, ensuring safety and performance during transportation.

f) Battery Capacity: No less than 300 mAh.

Performance Requirements:

a) Runtime: Minimum operational runtime on a full charge - 4 hours for internal batteries, 3 hours for external replaceable or minimum of 400 opening and closing cycles per run time.

b) Charge Time: Maximum allowable time to reach full charge in 5 hours.

Safety and Compliance:

Environmental Conditions: Must list safe operating temperature ranges.

GROUP 2 – PROSTHETIC WRIST UNIT (PWU)

1. Physical Characteristics: For the purpose of this solicitation/contract, the term PWU shall include prosthetic wrist unit for use with endoskeletal and/or exoskeletal design upper extremity prosthetic limb devices.

2. Product Line: Must include one or more of the following conventional (body powered) (e.g., Quick disconnect, flexion/ extension), externally powered (e.g., electric wrist rotator), and passive attaching the forearm to a terminal device.

3. Minimum Technical Requirements for Group 2 PWU Products:

Requirements for Passive and Manual Wrist Units:

a) Compatibility: Wrist components must use standardized/universal connection mechanisms that allow them to be easily attached and integrated with existing industry-standard options.

b) Weight: no heavier than .5lb.

c) Spare parts: Spare parts must be readily available and easily replaceable, if applicable.

Requirements for Powered Wrist Units:

a) Functional Abilities: Must at the minimum provide pronation/ supination.

b) Control Compatibility: Must be compatible with EMG, switch, or similar controls.

c) Software: Powered Wrists must come with programming software.

d) Hand Compatibility: The powered wrist must be compatible with one or more powered prosthetic hand units that allow the unit to be easily attached and integrated with existing industry-standard option that used widely in the prosthetics industry.

Safety and Compliance:

Environmental Conditions: Must list safe operating temperature ranges.

GROUP 3 – PROSTHETIC ELBOW UNIT (PEU)

1. Physical Characteristics: Prosthetic Elbow Unit replaces a missing elbow joint, allowing for movement and function in the arm.

2. Product Line: PEU shall include elbow unit for use with endoskeletal and/or exoskeletal upper extremity prosthetic limb devices. At minimum, the contractor shall offer the following: Passive function; conventional (body powered), externally powered and/or may include hybrid designed PEUs.

3. Minimum Technical Requirements for Group 3 PEU Products:

a) Availability:

(i) Shall be available in left and right configurations or be ambidextrous in design.

(ii) If the forearm section (passive or body- powered) is included, it must be available in a minimum of two (2) colors.

b) Functional Requirements: If forearm counterbalance or lift assist is available, it must be adjustable.

c) Battery Type and safety: Lithium-ion (Li-ion) batteries. All batteries used in prosthetic devices will comply with travel regulations, ensuring safety and performance during transportation.

d) Battery Capacity: No less than 300 mAh.

e) Safety and Compliance:

Environmental Conditions: Must list safe operating temperature ranges.

f) Control System and Power Source:

(i) Shall include control system or power source (on/off switch).

(ii) Shall include battery and battery charger as applicable to the product if externally powered.

g) Powered Locks: Must be able to bear a static load of 15 ft-lbs force.

GROUP 4 – PROSTHETIC LIMB SUSPENSION (PLS)

1. Physical Characteristics: For this solicitation/contract, the term PLS shall include any product that suspends the prosthesis to the patient’s residual limb.

2. Product Line: Prosthetic Limb Suspension shall include at the minimum suspension systems (e.g., suction, harness suspensions, and/or a combination of these), and sleeves (e.g., boa type closure system(s), pin, sleeve(s), valves, locking and non-locking systems, vacuum, or any other type that fall within the physical characteristics) to the prosthesis.

3. Minimum Technical Requirements for Group 4 PLS Products:

a. Availability: Shall be available for Transhumeral and/or Transradial

b. Features: Shall have one (1) or more of the following features:

(i) Suction (one-way valve to create a vacuum seal, holding the prosthesis in place).

(ii) Pin-Lock (uses a silicone liner with a pin that locks the socket and reliable attachment).

(iii) Elevated Vacuum (system using a pump to actively maintain a vacuum between the liner and the socket).

(iv) Sealing Liner (liner that has a sealing-ring for a secure fit)

(v) Harness/Straps to include Lanyards.

(vi) Hybrid Systems (combination of mechanical and electrical components).

h) Compatibility: Suspensions must be designed to be compatible with at least one of the prosthetic socket systems that are widely recognized and utilized within the industry.

i) Ease of Use: Clear instructions shall be provided for proper setup and making adjustments.

GROUP 5– PROSTHETIC COMPONENTS AND ACCESSORIES (PCA)

1. Physical Characteristics: For this solicitation/contract the term Prosthetic Components and Accessories (PCA) shall include any number of interchangeable components that assists with the assembly/construction and function of the prosthesis.

2. Product Line: At minimum, the contractor shall offer one or more of the following componentry cabling, modular components, control mechanisms, wire harness, battery, battery charger, electric switches (myoelectric, FSRs, EMG), and pattern recognition. Other categories include pre-made cosmetic glove and may include kits with all parts required for repair and replacement of the device.

3. Minimum Technical Requirements for Group 5 PCA Products:

a. Externally Powered Control Devices:

(i) Myoelectric and FSR components (including pattern recognition systems):

1. Myoelectric components must be compatible and able to function correctly and seamlessly integrate with systems (e.g. control unites, hands, wrists, software) with one or more prosthetic manufacturers.

2. Suppliers must offer all necessary components for a fully functional prosthesis in the form of a kit or individually (i.e. emgs, electrodes, electrode cables, emg plugs, switches).

3. Switch controlled components: shall be compatible with external powered configurations( e.g., pressure switch, rocker switch, linear transducer/potentiometer), as applicable.

(ii) Replacement Batteries and Battery Chargers:

1. Lithium-ion (Li-ion) batteries. All batteries used in prosthetic devices will comply with travel regulations, ensuring safety and performance during transportation.

2. Both batteries and their respective charger must be offered.

b. Body Powered System Componentry: Shall support all componentry required for body powered systems.

(i) Body Powered Terminal Devices:

1. Hooks and Prehensors.

a. Shall be available in various functional designs (e.g., voluntary opening/closing).

b. Shall have a minimum grip strength of 40 N capable of completing Activities of Daily Living (ADLs), must be adjustable.

2. Activity Specific Terminal Devices.

a. Device must allow patient to perform a specific task; this may be body powered or be static in nature. (I.e. fishing, cooking, ADLs).

(ii) Body Powered Harnessing and Cabling:

1. Must be made of a strong lightweight durable material such as steel, braided Polypropylene (Polypro) and nylons or similar to dacron webbing that help in prevention of stretching, shrinking and provides for a secure fit

2. Supplier must offer all components for full assembly of the harnessing and functionality of the hand.

3. Harnessing and cabling Kits shall be provided as commercially available, containing all parts for the full assembly of the harness system.

(iii) Prosthetic Gloves:

1. Gloves shall be available in a minimum of 2 colors

2. Gloves shall be available in a minimum of 2 adult sizes to fit appropriate shells. If the glove fits onto a shell, the shell must be offered as well.

GROUP 6– PARTIAL HAND COMPONENTS AND ACCESSORIES (PHCA)

1. Physical Characteristics: For this solicitation/contract the term Partial Hand Components and Accessories (PHCA) shall include any number of interchangeable components and related assembly that assists with the construction and function of the partial hand prosthesis.

2. Product Line: At minimum, the contractor shall offer one or more of the following partial hand digits (mechanical and myoelectric), mounting brackets, partial hand related accessories, and related assembly components.

3. Minimum Technical Requirements for Group 6 PHCA Products:

a. Availability: Shall be available for Partial hand.

b. Features: Shall have one (1) or more of the following features:

(i) Heavy-duty ratcheting mechanism for component range of motion (ROM).

(ii) Passive, positional digits through various ROM

(iii) Body-driven ability to achieve digit ROM

(iv) Myoelectric controlled motorized digits

(v) Mounting brackets for proper digit alignment

(vi) Suppliers must offer all necessary components for a fully functional partial hand prosthesis in the form of a kit or individually

d. Ease of Use: Clear instructions shall be provided for proper setup and making adjustments.

B.11 SATISFACTION PERIOD

The contractor agrees to a minimum 60-calendar day satisfaction period based on the shipped date which a determination will be made whether the device received provides the patient with the desired prosthetic need. If within the 60-calendar day period, the prosthetists/clinic determines that the device is inadequate, the device will be returned to the contractor for credit.

B.12 BACK ORDERS

(a) The VA’s ability to provide quality healthcare to its patient population is severely impaired when a contract item is not available due to backorders. The purpose of this clause is to provide guidance to the awarded contractor regarding a temporary solution to contract item backorders that may be implemented in lieu of the Government terminating the contract for cause. However, consideration of this clause shall not waive any of the Government’s rights to terminate the contract for cause in accordance with FAR 52.212-4.

(b) For purposes of this contract, a backorder occurs when the Government issues an order for a contract item, and the complete order quantity is not delivered to the Government within the required delivery time. The contractor shall send the order acknowledgement indicating a backorder status within 24 hours of receiving the ROES purchase order. The contractor shall provide an estimated date when the backorder will be shipped and may propose a temporary solution to satisfy the Government’s needs for the contract items until the backorder is resolved. The Government reserves the right to accept or reject any possible solutions that the contractor may propose to alleviate the backorder situation. In the event of multiple backorder instances, the Government reserves its right under Clause 52.212-4 to terminate the contract for a breach.

B.13 PROGRAMMING SOFTWARE

Any software, software module or contractor’s proprietary interface provided by the contractor to the Government shall conform to the following requirements for software and software support; FDA or other regulatory agencies that apply to each device. This includes, but is not limited to, software provided to aid clinicians or other staff in fitting of devices, management of prosthetic measurements, patient education, or other functions:

(1) One or more point(s) of contact for Prosthetics staff to ask questions, obtain information, or report problems related to the software.

(2) Preliminary response to questions and problem notification within 1 business day.

(3) Problem resolution within (5) business days or explanation as to why resolution cannot be accomplished within that time frame and what action is being taken (explanation to be provided to the government office who reported the problem).

(a) Upgrades to software shall be available to the government as soon as the upgrades are offered and at the commercial price.

B.14 ISO 9001 and/or 13485 REQUIRED

(a) The contractor’s facility and manufacturing facility(s) shall be ISO 9001 and/or ISO 13485 certified. For the purpose of this solicitation/contract, ISO-9001 and/or 13485 means all relevant ISO standards.

(b) If the manufacturing facility is not ISO-9001 and/or 13485 certified at the time of proposal submission, the contractor shall provide evidence that the facility has obtained certification for ISO 9001 and/or 13485 certification(s) within 30 days of contract award or the contract will be terminated for cause.

(c) After award, it is the Contractor’s responsibility to provide the Contracting Officer with updated valid copies of facility(s) certification, prior to certification expiration date.

B.15 CONTRACT PRODUCT TRAINING

a) Purpose: The purpose of product training is for the Government to receive training on products or services available under this contract or to present or exchange substantive information concerning a subject of mutual interest to a number of parties and is specifically allowed in accordance with 41 CFR, Parts 304-1 through 304-9 Government personnel may monitor training sessions. TRAINING IS CONSIDERED TO BE PART OF THIS CONTRACT AND IS NOT CONSIDERED TO BE A GIFT. Attendance and/or travel is subject to the approval of the attendee’s facility director or designee. Government personnel may monitor training sessions. The Office of the Inspector General may audit the contractor regarding any training provided

b) Content: Promotional activity, such as upcoming products, of any kind is strictly prohibited under this contract.

(1) Training shall be focused only on contract items.

(2) The training shall be within the context of professional education designed to enhance the effective utilization of technology or technology that the Government has purchased not for the purposes of sales promotion.

(3) Contractors may provide updates on emerging technology that is currently under research or has been submitted for contract updates. These updates shall not exceed 20% of the training time frame and shall adhere to the context of professional education and are not promotional in nature.

(4) Topics unrelated to prosthetic technology such as professional practice or issues shall not be included in training agenda(s).

(5) Topics related to prosthetic management of clinical conditions may be included. The contractor may provide a limited amount of introductory material on prosthetic management such as epidemiology of amputation and amputation treatment, but the content shall not be exclusively devoted to professional education or amputation.

c) Training Program: The Contractor must offer a minimum of one in-house, vendor sponsored, training program per year. Contractors may offer a maximum of two (2) in-house programs with multiple sessions of the program to allow for increased capacity. All sessions of a given program must be completed within the contract year. This training shall be in addition to all programs provided by Government or other professional meetings including but not limited to the Federal Amputation System of Care, The VA American Academy of Orthotists and Prosthetists Breakout Session, and the Extremity Trauma and Amputation Center of Excellence Conference (EACE). There is no specified maximum number of on-site or e-learning training opportunities a contractor may offer. Contractors shall create training plans consistent with their stated educational philosophy that meet the training needs of Government prosthetists and health technicians. Contractors shall make maximum use of e-learning techniques including, but not limited to, recorded or interactive web-seminars, commercial internet such as AOPA or AAOP e-learning, training sessions downloaded from the contractor’s website, or DVD training sessions received in the mail.

(1) Definitions of On-site Training and In-house Training:

(i) On-site training means a Government facility sponsors the training program. Government facility, regional group of Government facilities, or a network of Government facilities hosts the training at a Government facility or pays for the cost of the hotel space.

(ii) In-house training means the vendor sponsors the program and follows the authorized expense guidelines as describe in section (g) Authorized Expenses, subsection (2) In-house training below. The vendor hosts the training at its own facility or an authorized hotel and pays for the cost of the hotel space. In-house trainings are limited to the contiguous 48 states.

d) Restrictions:

(1) The contractor shall not attempt to unduly or inappropriately influence Government prosthetists or healthcare technicians or suggest, implicitly or explicitly, that the Government should purchase such products and services. Training shall not seek to influence Government prosthetists on what they should buy, but rather to educate prosthetists on technical issues.

(2) Promotional activities of any kind are specifically prohibited. Promotional activity includes any activity where a non-Federal source introduces, presents, represents, compares, discusses, demonstrates, or otherwise markets products or services not on contract unless otherwise specified in this contract.

e) Location(s):

(1) Contractors are encouraged to provide training at Government medical centers or by electronic means including recorded material (e.g., CD-ROM) or telecommunication media (videoconference), or Internet-based distance learning.