36S79723R0001_2.docx

36S79723R0001

GENERAL INFORMATION

SET-ASIDE

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

Hines IL 60141

POINT OF CONTACT*

Contract Specialist Michelle B Williams Michelle.Williams4@va.gov 708-786-4927

PLACE OF PERFORMANCE

ADDRESS

POSTAL CODE

COUNTRY

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

DESCRIPTION

Amendment to a Previous Combined Solicitation

Amendment to a Previous Combined Solicitation The Department of Veterans Affairs (VA) has identified Prosthetic Feet (PF), Prosthetic Knee Units (PKU), Prosthetic Modular Adapters (PMA), and Prosthetic Suspension Systems (PSS),and Prosthetic Liners (PL) for use with prosthetic (artificial) limbs, as preferred products for consolidated contracting. The consolidated contracting is to obtain quality products at lower than current contract and open-market prices. 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 Feet (PF), Prosthetic Knee Units (PKU), Prosthetic Liners (PL), Prosthetic Modular Adapters (PMA), and Prosthetic Suspension Systems (PSS). The objective is to award multiple Firm Fixed Price (FFP) Indefinite-Delivery Indefinite -Quantity (IDIQ) contracts to cover the various needs of the Government. Another objective is to ensure availability and consistency of products for national usage and to obtain volume-based pricing.

Page 1 of

Amendment to a Previous Combined Solicitation

The Department of Veterans Affairs (VA), Commodities & Services Acquisition Service (CSAS), 555 Corporate Circle, Golden, CO 80401, has a requirement to provide prosthetic limb includes various types of Prosthetic Feet (PF), Prosthetic Knee Units (PKU), Prosthetic Liners (PL), Prosthetic Modular Adapters (PMA), and Prosthetic Suspension Systems (PSS).

The applicable North American Industry Classification System (NAICS) is 339113– Surgical and Medical Instrument Manufacturing.

The VA intends to award Multiple Firm Fixed-Price, Indefinite-Delivery, Indefinite-Quantity (IDIQ) contract. The resulting awards will consist of a one-year (1) base with four (4) option years. Any awards will be based on the lowest price technical acceptable to the Government. This requirement will be solicited as a Full and Open procurement.

Questions concerning this announcement should be directed to the Contracting Officer (CO) Michelle Williams michelle.williams4@va.gov.

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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

36S79723R0001 12-05-2023 Michelle Williams 01-26-2024 16:00

CST

VA NAC / 003B6A

PO Box 76 1st Ave., One Block N of 22nd Hines IL 60141 X 339113 800 Employees N/A X

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

See CONTINUATION Page Solicitation for Artificial Limbs- Lower See CONTINUATION Page X Page 1 of Page 1 of 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 36S797

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:

36S79723R0001

SECTION B - CONTINUATION OF SF 1449 BLOCKS

ABBREVIATIONS AND DEFINITIONS

Throughout 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

CD-ROM Compact Disc, Read-Only Memory

CEU Continuing Education Unit

CFR Code of Federal Regulations

CLIN Contract Line Item Number cm Centimeter

CO Contracting Officer

CPARS Contractor Performance Assessment Reporting System

CSAS Commodities and Services Acquisition Service

DLC Denver Logistics Center

DER Dynamic Energy Response

DoD U.S. Department of Defense

DUNS Data Universal Numbering System

EA Each

EFT Electronic Funds Transfer

FAR Federal Acquisition Regulation

FDA U.S. Food and Drug Administration

FOB Free on Board

FFP Firm Fixed Price

FSC Federal Supply Classification

FSC Financial Services Center

FSG Federal Supply Group

GAO U.S. Government Accountability Office

GSA U.S. General Services Administration

IDIQ Indefinite Delivery Indefinite Quantity

ISSO Information System Security Officer

ISO International Organization for Standardization mm Millimeter

PD Prosthetic Device

PF Prosthetic Foot

PKU Prosthetic Knee Unit

PPIRS Past Performance Information Retrieval System

PQDR Product Quality Deficiency Report

PL Prosthetic Liner

PO Purchase Order

Pub. L. Public Law

ROES Remote Order Entry System

SAM System for Award Management

SF Standard Form

TIN Taxpayer Identification Number

U.S. United States

USB Universal Serial Bus

U.S.C. United States Code

VA U.S. Department of Veterans Affairs

VAAR Veterans Affairs Acquisition Regulation

VAMC Veterans Affairs Medical Center

VSD Veteran Services Division (see DLC)

VIP Vendor Information Pages

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

WTO GP World Trade Organization’s Agreement on Government Procurement

DEFINITIONS

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 made in order to improve the quality of function to the end user (e.g., knee stiffness, knee stability).

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

Adjustment - Component changes within the same option package.

Channel - Definable frequency region with independently controlled properties such as gain. Properties of channels are usually under the control of the prosthetist by use of programming software. For the this solicitation/contract, the term “band” is synonymous with the term “channel.”

Circuit - Combination of electronic components carrying an electric current.

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 prosthetic foot, prosthetic knee unit, and prosthetic liner.

Dorsiflexion - Movement at the ankle joint that points the foot up towards the leg or movement of the toes that lifts them away from the sole of the foot.

Dynamic Response Foot- Prosthetic feet designed to store and return energy during the gait cycle to assist the amputee with limb advancement. The material components of DER feet have properties and geometry specifically intended to dissipate, absorb, or return energy.

Energy Storing Foot - A prosthetic foot in the class of the so-called energy storing prosthetic feet, called the Lambda “f.” It is designed to store energy at heel strike. The foot behaves like a spring where the potential energy is stored when it is loaded.

Endoskeletal - For this solicitation/contract, endoskeletal refers to modular prosthetic components that are interchangeable (i.e., pylon, connector, etc.).

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.

External Keel - A Exoskeletal Prosthetic foot having the front (anterior) skeletal rocker exposed.

Flexible Keel Foot - A prosthetic foot having a compliant anterior rocker.

Flex Foot System - An integrated prosthetic foot/shank system comprised of carbon fiber reinforced polymer material and soft foot shell cover.

Flex Walk System - A low profile prosthetic foot comprised of carbon fiber reinforced polymer material and soft foot shell cover.

Group - A group is a categorization of prosthetic foot, knee unit, or prosthetic liner 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. For this solicitation/contract, groups are defined as follows: Group 1 (Prosthetic Feet PF), Group 2 (Prosthetic Knee Units PKU), and Group 3 (Prosthetic Liners PL), Group 4 (Modular Components, e.g. Pylons, Adapters, Ankles); Group 5 (Prosthetic Suspension Systems).

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.

Interface - Device or circuit that links dissimilar technologies (e.g., t-coil, direct audio input boot, Bluetooth™ mediated devices, near field magnetic induction, RF).

ISO-9001 and ISO-13485 – Quality Management System, International Organization for Standardization. ISO-13485 is the standard for a medical device quality management system based on the requirements of ISO-9001.

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 knee with a built-in central processing unit (CPU) controlling aspects of stance and/or swing phase motion.

Model - A manufacturer’s commercial designation of a prosthetic foot, prosthetic knee unit, or prosthetic liner device.

Model Change - A model package change, when indicated in the 30-day trial period, when the originally ordered model is identified as not suitable for the selected fitting (with the exception of Group 3 Prosthetic Liners) .

Modular Components - A system of elemental parts which can be combined in a variety of ways to arrive at the functional entity desired from among a variety of functional options which the prosthetic system allow. An accessible number of interchangeable components which can be assembled easily and quickly into a prosthesis.

Multi-Axial Ankle/Foot - For this solicitation/contract, multi-axial refers to a prosthetic ankle/foot design with articulation in multiple planes of motion.

Non-VA Care - Health care services purchased from non-VA providers.

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

Plantarflexion - Movement at the ankle joint that points the foot downwards away from the leg, or movement of the toes that curls them down towards the sole.

Primary Features - Features that primarily define the prosthetic device: circuit, components (switches, buttons), foot shell, sock, battery, pylon, charger.

Programmable - Programmable prosthetic devices are devices whose characteristics are determined by modification of the settings of the unit using a computer system, cables and a software program. The programmable function allows adjustment of the frequency response, gain, output, and other characteristics (e.g., flexion, extension). Some user functions may be controlled manually with buttons, switches and/or remote controls.

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

Prosthetic Foot - An artificial foot designed for use with external prosthetic limb, to include foot shell protective sock (e.g., spectra sock) and connection cap or faring.

Prosthetic Knee Unit - An artificial knee designed for use with external prosthetic limb, to include when specified specialized pylons and/or connectors for microprocessor systems and software.

Prosthetic Liner - A device designed for use with external prosthetic limb that provides suspension of prosthetic device to the body.

Prosthetic Suspension System - A device or system that secures the residual limb inside the prosthetic socket and enables easy donning and doffing; provides a secure connection between the socket and limb.

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

S.A.C.H. - Refers to a prosthetic foot design also known as Solid Ankle Cushion Heel. Usually a foam/rubber prosthetic foot with an internal wood or plastic material keel with a soft compressible external material.

Secondary Features - Features to customize the prosthetic device: foot shell color, size, width, length, weight limit, activity level, etc.

Shank foot System - A prosthetic foot and pylon system that is joined together (integrated) and purchased as a single unit.

Single Axis Ankle Foot - For this solicitation/contract, single axis refers to a prosthetic foot/ankle design with articulation in a single plane of motion.

Swing Phase Active Dorsiflexion Feature - A prosthetic foot/ankle design characteristic lifting the front to the foot (anterior) during swing phase.

Vertical Load Pylon - A prosthetic pylon design characteristic allowing compressibility or dampening of vertical load during prosthetic stance.

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 and prosthetic foot and/or knee unit device which allows wireless communication between PC and the programming unit and is wireless connection between the programming interface and the prosthetic foot and/or knee unit device.

Wireless Receiver - A wireless receiver is a device that receives signals (e.g., DM/FM) from a wireless transmitter.

Wireless Transmitter - Device that converts a sound signal, either acoustic or electric representation, to a wireless signal and transmits it to a prosthetic foot and/or prosthetic knee unit device, either directly or through a wireless adaptor.

Year - For this solicitation/contract, a full calendar year includes leap years during the period of performance.

B.1 BACKGROUND

The Department of Veterans Affairs (VA) has identified Prosthetic Feet (PF), Prosthetic Knee Units (PKU), and Prosthetic Liners (PL) for use with prosthetic (artificial) limbs, as preferred products for consolidated contracting. The consolidated contracting is to obtain quality products at lower than current contract and open-market prices.

B.2 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 Feet (PF), Prosthetic Knee Units (PKU), Prosthetic Liners (PL), Prosthetic Modular Adapters (PMA), and Prosthetic Suspension Systems (PSS).

(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.3. SCOPE

(a) This schedule covers the following types of prosthetic items: Prosthetic Feet (PF), Prosthetic Knee Units (PKU), Prosthetic Liners (PL), Prosthetic Modular Adapters (PMA), and Prosthetic Suspension Systems (PSS). It also includes wireless adaptors/receivers and transmitters required for certain prosthetic limb components to function; primary and secondary features, extra components, programming software and training related to the devices are covered within the schedule.

(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.

(c) Prosthetic Feet, Prosthetic Knee Units, Prosthetic Liners, Prosthetic Modular Components, and Prosthetic Suspension Systems will be ordered on an “as needed” basis for 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.4 SCHEDULE OF ITEMS

See attachment D. 1 Price Schedule in support of the schedule of items details.

Prosthetic Foot (PF) - Solid Ankle Cushion Heal (SACH), Flexible Keel (FK), Single Axis (SA), Multi-Axis (MA), Vertical Loading (VL), Stored Energy (SE), Microprocessor Controlled (MC), Ankle, and Power Assist (PA) or combinations thereof.

Prosthetic Knee Units (PKU) - Manual Lock (ML), Single Axis (SA), Polycentric (PC), Frictions (FRC), Hydraulic (HY), Pneumatic (PN), Fluid, Microprocessor Controlled (MC), Power Assist (PA), High Activity Knee Frames (HA), and/or combinations thereof.

Prosthetic Liners (PL) - For use with lock mechanism, for use without lock mechanism, Silicone, Gel, Elastomeric or Equal or combinations thereof: (Not separately priced if included within a package for a PF or PKU.)

Prosthetic Covers (PC) – Protective cover, shield, guard that can be easily fitted to suit the particular needs of the patient. Cover, shield, or guard that safeguards the prosthetic system against jolts, the environment, and normal wear and tear.

Prosthetic Modular Components (PMC) - Interchangeable components/adapters connect and align the prosthetic components (knees, feet, sockets, or Osseointegrated implants) to make a prosthesis; effective length of the limb adjustable to suit the particular needs of the patient.

Prosthetic Suspension Systems (PSS) – Suspension systems shall include but not limited to any element of the prosthesis that suspends the socket to the patient’s residual limb when in a non-weight bearing “open chain” state (e.g. when the foot is off the floor) to include drop in locking laminated and thermo-formed mechanism, elevated vacuum system, cuff suspension, suspension sleeves, valves, push-button locking, pull-button locking, clutch locking, suspension straps, sleeves, belts, lanyard, magnetic or any other type that serve to suspend the prosthetic system.

Wireless Systems - Wireless systems include transmitters, receivers, adaptors, and interfaces designed to function with contracted microprocessor controlled prosthetic limb devices as an integrated system to optimize functionality in various environments. Wireless systems shall be compatible with all devices in Group 1-5, if offered.

B.5 GUARANTEED MINIMUM

(a) The minimum amount of supplies that the Government agrees to order per contract is $20,000.00. 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 $20,000.00. 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 $20,000.00 as stated herein.

B. 6 CONTRACT CEILING AMOUNT

The maximum value of supplies that the Government may order per contract during the contract period, including all options if exercised, will be $265,399,000.00.

B. 7 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.8 PRODUCT TECHNICAL REQUIREMENTS

I. GENERAL

(a) All prosthetic feet and prosthetic knee units, prosthetic liners, prosthetic modular components, prosthetic suspension systems, wireless transmitters, receivers and remote controls shall be serialized if that is your commercial practice.

(b) Specific group requirements are listed below. Any exceptions will be noted under the group requirements.

(c) All products must meet or exceed ISO standards identified.

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

II. DESCRIPTION of Prosthetic Foot, Prosthetic Knee Unit, Prosthetic Liner, Modular Adapters, Prosthetic Suspension Systems.

Group 1 (Prosthetic Foot), Group 2 (Prosthetic Knee Unit), Group 3 (Prosthetic Liners), Group 4 (Prosthetic Modular Components (e.g., Pylons, Adapters, Ankles), Group 5 (Prosthetic Suspension Systems)

(a) Prosthetic Foot, Prosthetic Knee Unit, Prosthetic Liners, Prosthetic Modular Adapters, and Prosthetic Suspension Systems shall be fully functional and operational.

(b) Minimum shade/color availability of any product (e.g., foot shells, knee covers) shall match commercial product availability. Multiple shades may be available.

(c) At a minimum the following items shall be included in packaging:

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

(2) Packaging list/invoice

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

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

(d) The following shall be included if that is standard commercial practice:

(1) Small tote bags, when applicable, shall be included with the device for the patient’s use to carry the device(s), and supplies, and literature if standard commercial practice.

(2) 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 standard commercial practice.

(3) Shipping containers shall not include advertising, surveys or questionnaires, cross-selling literature, or insurance offers.

(e) If applicable, packaging should include everything needed for the device to be operational (e.g., batteries and charger) if standard commercial practice.

(d) These instructions, when applicable for the categories, apply to all prosthetic limb feet, prosthetic knee units, prosthetic liners, prosthetic modular components, and prosthetic suspension systems.

(e) Products shall have serial number (if applicable/standard commercial practice).

III. GROUP 1 – PROSTHETIC LIMB FOOT (PF)

(a) Physical Characteristics: For the purpose of this solicitation/contract, the term PF shall include prosthetic foot for use with endoskeletal prosthetic limb devices; and shall include foot shell, faring cover connector, protective sock, microprocessor(s), motor(s), power source (battery)(s) and control device (e.g., electronic tools/devices that assist in programming an alignment, and control software) as applicable. Group 1 PF foot shell shall be available in all commercially available colors. PF shall be fully functional and operational.

(b) Product Line: At minimum, the contractor shall offer all adult commercially available options (length, width, heel heights, weight limits), and wireless connectivity when applicable. Shall be fully functional and operational. ISO certified if applicable.

(c) Minimum Technical Requirements for Group 1 PF Products:

(1) Foot size must be at least 24-30 cm for male feet and at least 22-28 cm for female feet (may also offer larger and smaller sizes).

(2) Must be both right and left sides.

(3) Must be for weight ranges from 100-220 lbs. at a minimum and when applicable 220-350 lbs.

(4) Must be endoskeletal design.

(5) Wireless programmability (as applicable).

(6) Must have power source (as applicable).

(7) Must have charger (as applicable).

(8) The contractor shall have models (as applicable) appropriate for a variety of activity levels and weight ranges, and sizes.

(9) Minimum shade/color availability of any product (e.g., foot shells, knee covers) shall match commercial product availability. Multiple shades and covers may be available.

(10) Shall be fully functional and operational.

(11) Written documentation or tracking method/process of a standardized protocol for recall notices.

(12) FDA approval/exemption: Classification must be identified (Class 1, 2, 3)

(13) The product shall meet all applicable ISO standards/testing and include certification documentation.

(14) The contractor warrants that the product 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.

III. GROUP 2 – PROSTHETIC LIMB KNEE UNIT (PKU)

(a) Physical Characteristics: For the purpose of this solicitation/contract, the term PKU shall include prosthetic knee unit for use with endoskeletal prosthetic limb devices. The device shall include any and all associated PKU knee components. In addition devices shall include any and all associated microprocessor(s), motor(s), power source (battery)(s) and control device (e.g., electronic tools/devices that assist in programming an alignment), and control software as applicable.

(b) Product Line: At minimum, the contractor shall offer the following: activity specificity, weight specificity (100-220 lbs and when applicable 220-350 lbs) and wireless connectivity when applicable. Shall be fully functional and operational. ISO certified.

(c) Minimum Technical Requirements for Group 2 PKU Products:

(1) Must include weight ranges 100-220lbs at a minimum and when applicable 220-350lbs.

(2) Must be endoskeletal design.

(3) Wireless programmability (as applicable).

(4) Must have power source (as applicable).

(5) Must have charger (as applicable).

(6) The contractor shall have a range of models (as applicable) appropriate for a variety of activity levels and weight ranges.

(7) Shall be fully functionable and operational.

(8) The product shall meet all applicable ISO standards/testing and include appropriate certificate of compliance.

(9) FDA approval/exemption: Classification must be identified (Class 1, 2 3).

(10) Must include any specialized tool and all bits to secure/adjust/align the product.

(11) Written documentation or tracking method/process of a standardized protocol for recall notices.

(12) FDA approval/exemption: Classification must be identified (Class 1, 2, 3)

(13) The product shall meet all applicable ISO standards/testing and provide certification documentation.

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

III. GROUP 3 – PROSTHETIC LINERS (PL)

(a) Physical Characteristics: For this solicitation/contract, the term PL shall include prefabricated prosthetic liners for use with prosthetic limb devices.

(b) Product Line: At minimum, the contractor shall offer the following but not limited to: activity specificity, resistance to elongation, dermatological compliance, thermo-formability, durometer, and clear explanation of dimensional profile.

(c) Minimum Technical Requirements for Group 3 PL Products:

(1) Standard pin receptor sizing without adapter.

(2) Sold per single unit.

(3) Include clear care/use instructions.

(4) Shipped sealed in protective, packaging.

(5) Clearly indicate sizing, profile, locking/non-locking.

(6) Clearly indicate the material used in contact with skin.

(7) Written documentation or tracking method/process of a standardized protocol for recall notices.

(8) FDA approval/exemption: Classification must be identified (Class 1, 2, 3).

(9) The product shall meet all applicable ISO standards/testing and provide certification documentation.

(10) The contractor warrants that for three years the product furnished under this contract will be free from defects in material and workmanship and will conform to all requirements of this contract. Warranty covers all aspects of the product supplied. Normal “wear and tear” is excluded.

III. GROUP 4- PROSTHETIC MODULAR COMPONENTS (MC) (e.g., Pylons, Adapters, Ankles)

(a) Physical Characteristics: For this solicitation/contract the MC shall include any number of interchangeable components to connect the prosthetic foot to the socket or the prosthetic knee to the socket, which can be assembled into a prosthesis. Material shall be tested and relevant for prosthetic usage.

(b) Product Line: At minimum, the contractor shall offer the following but not limited to: adjustable, non-adjustable, off-set slide and rotation. Dynamic capability (e.g. torsion, shock) if applicable.

(c) Minimum Technical Requirements for Group 4 MC Products:

(1) Industry Standard Sizing.

(2) Sold per single unit.

(3) Include clear technical instructions.

(4) Shipped sealed in protective, packaging.

(5) Clearly indicate sizing, material, component adjustability.

(6) 100-220lbs minimum and when applicable 220-350lbs.

(7) Documented weight limitations and activity level specificity.

(8) Written documentation or tracking method/process of a standardized protocol for recall notices.

(9) FDA approval/exemption: Classification must be identified (Class 1, 2, 3)

(10) The product shall meet all applicable ISO standards/testing and provide certification documentation.

(11) The contractor warrants that for three years the product furnished under this contract will be free from defects in material and workmanship and will conform to all requirements of this contract. Warranty covers all aspects of the product supplied. Normal “wear and tear” is excluded.

III. GROUP 5 – PROSTHETIC SUSPENSION SYSTEMS (PSS)

(a) Physical Characteristics: For this solicitation/contract, the term PSS shall include any element of the prosthesis that suspends the socket to the patient’s residual limb when in a non-weight bearing “open chain” state (e.g. when the foot is off the floor).

(b) Product Line: Suspension systems, shall include but not limited to any element of the prosthesis that suspends the socket to the patient’s residual limb (e.g. pin, sleeve, locking and non-locking systems, vacuum, or any other type that falls within the physical characteristics).

(c) Minimum Technical Requirements for Group 5 (PSS) Products:

(1) Contractor shall provide all dimensions of suspension componentry.

(2) Industry Standard Sizing.

(3) Sold per single unit.

(4) Include clear technical instructions.

(5) Shipped sealed in protective packaging.

(6) Clearly indicate sizing, material of component.

(7) 100-220lb minimum.

(8) Written documentation or tracking method/process of a standardized protocol for recall notices.

(9) FDA approval/exemption: Classification must be identified (Class 1, 2, 3)

(10) The product shall meet all applicable ISO standards/testing and provide certification documentation.

(11) The contractor warrants that for three years the product furnished under this contract will be free from defects in material and workmanship and will conform to all requirements of this contract. Warranty covers all aspects of the product supplied. Normal “wear and tear” is excluded.

B. 9 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.10 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.11 PROGRAMMING SOFTWARE

(a) 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).

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

B.12 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.13 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. TRAINING IS CONSIDERED TO BE PART OF THIS CONTRACT AND IS NOT CONSIDERED TO BE A GIFT, subject to the approval of attendees’ facility director or designee. Government personnel may monitor training sessions.

(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 o 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 contractor sponsors the program. Contractor hosts the training at its own facility or an authorized hotel and pays for the cost of the hotel space.

(2) Combined Training:

(i) Combined training means a training program authorized under the contract in which two or more contract contractors agree to offer training on each companies’ contracted products, programming software, and customer support features during a single training program.

(ii) Such combined training is authorized only for on-site (e.g. at Government facility or sponsored by the Government), and only when requested or approved by the Government facility. Combined training at in in-house (contractor-sponsored) event will be considered under the contracting training requirement.

(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. Training may be held at the contractor’s facility, business office, or hotel. Facility means the contractor’s home office, manufacturing plant, or a wholly owned subsidiary facility where customer service personnel are located. Contractors shall provide at least one training session per contract year at the DLC for DLC personnel at no expense to the Government.

(f) Authorized Expenses for In-house Training:

(1) The contractor is authorized to cover only travel mode (airfare, bus or train), transportation to and from airport/hotel and hotel/restaurant (where meals provided by the contractor will be served), accommodations, and meals, plus applicable hotel tax. Excluded expenses or extras include hotel incidentals, transportation to and from home/airport, car rental, mileage (gas), baggage fees, entertainment of any kind, cruises, tours, or tickets to any form of entertainment (5 CFR §2635.202 and §26356.203; 41 CFR, Part 304-1). In-house training is limited to the contiguous 48 states unless regional training is conducted for Government facilities located outside the continental United States. Regional training outside of the contiguous 48 states requires approval by the Contracting Officer.

(2) Contractors shall not pay expenses for spouses or partners of Government employees.

(3) Beverages and snacks may be provided during training breaks as long as the total expenses do not exceed the total per diem expenses as specified in (g) (6) below. Welcome receptions are allowed.