36C79121R0006.docx

36C79121R0006

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.

DUNS:

DUNS+4:

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 ATTA

CHED

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. SIGNAT

URE 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. 2/2012)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

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

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

36C79121R0006 02-01-2021 Joanna Hudson-Lundquist 303-273-6225 03-01-2021

12:00PM

MST

Department of Veterans Affairs Commodities & Services Acquisition Svc (003B6E) 555 Corporate Circle Golden CO 80401-5621 X 339113 750 Employees N/A X Department of Veterans Affairs Commodities & Services Acquisition Svc 555 Corporate Circle Golden CO 80401-5621 Department of Veterans Affairs Commodities & Services Acquisition Svc (003B6E) 555 Corporate Circle Golden CO 80401-5621

VA Denver Logistics Center Finance Division (001AL-M1C), P.O. Box 25166 Denver CO 80225 See CONTINUATION Page This solicitation is for auditory osseointegrated implants, abutments,magnetic plates, sound processors, compatible accessories, and replacement parts for the Veterans Health Administration (VHA). CSAS anticpates to award Indefinite Quantity Indefinite Delivery contract(s) for base year and four (4) Opt ion Years as a result of this Solicitation.

SEE SCHEDULE

$0.00 X X

THOMAS BRICK

CONTRAVTING OFFICER

Table of Contents

A.2 CONTRACT ADMINISTRATION DATA

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

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C791 Department of Veterans Affairs Commodities & Services Acquisition Svc (003B6E) 555 Corporate Circle Golden CO 80401-5621

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:

VA Denver Logistics Center Finance Division (001AL-M1C) P.O. Box 25166, Denver, CO 80225-0166 ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

Page 1 of Page 1 of Page 1 of Page 1 of

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 BACKGROUND

Commodities and Services Acquisition Service (CSAS) and the Denver Logistics Center (DLC) has been tasked with the procurement of Auditory Osseointegrated Implants abutments, magnetic plates, sound processors, compatible accessories, and replacement parts (AOI), including training, associated software/hardware, and services as a uniform preferred product aligning with the VA Mission Act to meet the needs of the Veterans. CSAS/DLC strategy is to obtain committed pricing and implement streamlined ordering processes through innovative integration using a combination of CSAS Remote Order Entry System (ROES) and contractors’ commercial system by other Government agencies, as authorized.

B.2 PURPOSE AND OBJECTIVE

The purpose of this Solicitation is to obtain newest AOI technologies including training, associated software/hardware, and services to secure a continuous supply of products to the Department of Veterans Affairs (VA) and potentially other Government agencies’ clinical programs. These items will be purchased and distributed to patients to meet their medical needs.

The objective of the program is to: a) establish a multiple award national contract(s) that will standardize the ordering processes for the entire United States, its territories, and overseas locations for medically prescribed AOI to eligible Veterans and potentially other patients and b) establish favorable pricing by streamlining internal processes and billing practices.

Established Indefinite Delivery Indefinite Quantity (IDIQ) contract(s) will be for twelve-month base period with four-twelve-month option periods and will be used as a primary source by the VA. Other Government agencies may be authorized and able to procure contract line items by placing orders directly utilizing contractors’ commercial system. Option periods will or will not be exercised at the sole discretion of the Government.

B.3 SCOPE

The Solicitation is issued to request proposals for AOI, including training, associated software/hardware, and services. The products purchased under the respective contracts will be used to improve service delivery outcomes for Veterans/patients and reduce waiting times.

The North American Industrial Classification System (NAICS) code for this procurement is 339113 Surgical Appliance and Supplies Manufacturing with a small business size standard of 750 employees. The requirement is being competed on an unrestricted open market basis.

This Solicitation may result in one or more firm-fixed-price (FFP), IDIQ contracts, which will be used as a primary source of supply by the VA and other authorized Government agencies. Contracted items will be ordered from time to time and in such quantities as needed to fulfill agencies’ requirements in accordance with applicable supply procedures.

Offerors may propose on one or more CLIN and sub-CLIN items listed in B.5. below. The Government reserves the right not to make an award on all CLINs and/or sub-CLINs and to determine how many awards be made. More than one award may be made for each CLIN to the offeror(s) whose proposal conforms to this Solicitation and is most advantageous to the Government, price and other factors considered.

For evaluation purposes, the total price offered for each CLINs listed in B.5 (a) will be used to determine the lowest price. The Total Price is the price offered for the base year and all option years combined, as more particularly identified in Section E, below.

Sub-CLINs will be evaluated for price reasonableness and will only be awarded if a corresponding CLIN is awarded.

B.4 CONTRACT USERS

(a) Veterans Health Administration. The contractor shall provide the products listed in B.5, herein, at the prices awarded and under the terms and conditions set forth in the IDIQ contract(s) upon the receipt of a delivery order signed by the Ordering Officer (OO).

DLC is the only entity with authorization to place orders against the contract(s) for the VA. DLC delivery orders (DO) will be sent using the method agreed upon with contractors after the award. Upon the receipt of DO the contractor shall fulfill the order and ship the items to the DLC address listed in B.6 (e) below. Delivery is freight on board (f.o.b.) destination.

(b) Other Government agencies. Department of Defense (DOD) and Indian Health Services (IHS) may be authorized and able to procure contract line items by placing delivery orders directly with the contractor(s).

B.5 SCHEDULE OF ITEMS AND CONTRACT PERIOD OF PERFORMANCE

(a) The following CLINs identify the products required by this solicitation:

(b) The following sub-CLINS identify the accessories and replacement parts. Sub-CLINs can only be offered if the corresponding CLIN is also offered.

ACCESSORIES

OPTIONAL

sub-CLIN 05.02

ACCESSORIESAND FOR SOUND PROCESSOR – OTHER THAN HEADBAND

REPLACEMENT PARTS

OPTIONAL sub-CLIN. 04.02

REPLACEMENT PARTS FOR ABUTMENT (ALIT I) AND/OR MAGNETIC PLATE

(ALT II)

All offerors are required to propose on SUB-CLIN 05.01 ACCESSORIES FOR SOUND PROCESSOR - HEADBAND, if they propose on CLIN 5. (This is NOT an optional SUB-CLIN.)

(c) Estimated contract period of performance:

CONTRACT PERIOD OF PERFORMANCE

The products, accessories, and replacement parts must meet or exceed each of the minimum technical requirement (salient characteristics), descriptions, and perform the functions listed in Attachment B, Minimum Technical Requirements (Salient Characteristics); be FDA Device Registered (FDA 21 CFR 874.3300) and software properly certified/compatible, and be in accordance with the Scope of Contract (SOC).

Offeror must provide the Required FDA documentation, including company registration, device listing, and 510(k) letter confirming substantial equivalency and clearance for marketing. Failure to the above FDA registration will result in offeror being rejected and withdrawn from further consideration.

The Software offered must be: a) Hearing Instrument Manufacturers Software Association (HIMSA) certified, b) compliant with Federal Information Processing Standards (FIPS) Publication 140-2 to allow for installation on any VA IT systems and inclusion on the VA Audiology Workstation baseline, and c) compatible with the Microsoft Windows 10 operating system(s) as more particularly described in PWS. Failure to demonstrate certification/compliance with HIMSA and FIPS will result in offeror being rejected and withdrawn from further consideration.

All products offered shall be state-of-the-art technology. Products and components with a contractor’s planned obsolescence are not acceptable.

Completing the Schedule and Associated Attachments: The offeror shall provide prices for a base and four option periods for the items offered in conformance with this Solicitation by completing ATTACHMENT D, PRICE SCHEDULE (AOI). Prices awarded for the base and option periods will remain in effect during the entire term of the respective contract(s), without an increase, including exercised options. Evaluation of options pricing and award of option periods shall not obligate the Government to exercise any options.

Note: The Government will reject proposals that are priced for base years and not priced on all option periods.

Compliance with HIPPA regulations: The contractor(s) own the Veteran/patient treatment information and are Health Insurance Portability and Accountability Act of 1996 (HIPPA) (45 C.F.R. § 1601.103) covered entities subject to HIPPA regulations (45 C.F.R. Part 160 and Part 164, Subparts A and E). The contractor(s) must comply with the provisions of HIPAA.

The contractor(s) will adopt measures to ensure that all personally identifiable information (PII) and personal health information (PHI) associated with individual patients is adequately protected from loss, misuse, or unauthorized disclosure. This applies to any PII and PHI provided by VA, DoD, or IHS as necessary for the performance of the contract(s). The contractor will ensure that the transmission of all protected electronic data is secured and confidential. The contractor agrees to protect any and all PII and PHI and transmission, thereof, in accordance with the contractor established HIPPA measures to be submitted with the proposal.

Estimated Quantities: The estimated quantities listed in Attachment D Price Schedule are estimates only, are NOT committed quantities or in any way binding. They represent the Government’s best estimate of the total annual quantities for each item. The Government may place orders at quantities greater than the estimated total quantity. There is no express or implied guarantee that the estimated quantities will be ordered on a regular basis.

Sub-CLINs and OPTIONAL sub-CLINs: Sub-CLINs listed in B.5 (b) herein are reserved for the accessories and replacement parts offered for the corresponding contract CLINs in B.5 (a). The offeror must submit a proposal for the base and all option years for each accessory and replacement part. After an award determination has been made for a specific CLIN, the corresponding sub-CLIN will be evaluated for price reasonableness. If pricing is determined to be unreasonable for accessories and/or parts no award will be made for these items.

Commercial Packaging: Items supplied under the contract shall be individually commercially packaged in a manner which ensures arrival at destination in a satisfactory condition (not damaged due to packaging failures during normal handling) for further redistribution to individual users, unless otherwise agreed. Packaging should not include cross-selling literature for other products, which have not been specifically awarded.

B.6 CONTRACT ADMINISTRATION DATA

(a) The Contracting Officer (CO) is the only Government point of contact authorized to make commitments or issue changes that will affect the price, quantity, delivery or terms of the contract.

Primary POC: Thomas J. Brick, Senior Contracting Officer (36C791), Division Chief, Commodities and Services Acquisition Service, Phone No: 303-273-6217 E-mail Address: thomas.brick@va.gov

Secondary POC: Joanna Hudson-Lundquist, Contract Specialist, Phone No: (303) 273-6225, E-mail Address: joanna.hudson-lundquist@va.gov.

(b) The contractor shall designate a primary and alternate contract administrator for the contract within two (2) business days after contract award and maintain a current letter of designation throughout (D001). Designation should be on company letterhead with the following information:

Name of contractual authority ______ Address Phone Number E-Mail

The contract administrator will have contractual authority and be responsible for overall compliance with contract terms and conditions and will be contacted for daily administration and invoicing.

Any changes to the designated individual(s) must be provided to the CO in writing within 24 hours of the proposed change (D002).

The Contractor’s designation of representatives to handle certain functions under this contract does not relieve the contract administrator of responsibility for contract compliance.

(c) The contractor shall designate a person to serve as the Customer Service/Product Support point of contact and provide the following information therefor:

Name of CS/PS POC: _______________________ Address Phone Number E-Mail

(d) The contractor shall designate a person to serve as the Software Support (SS) point of contact and provide the following information therefor:

Name of SS POC: _______________________ Address Phone Number E-Mail

The information in (c)-(d) above shall be provided in writing to the CO within two (2) business days after contract award and thereafter within 24 hours after the change of contractor personnel.

(e) Government Agency:

(VAAR 852.247-71 DELIVERY LOCATION (OCT 2018))

Mail and Parcel Address: Department of Veterans Affairs, National Acquisition Center, Commodities and Services Acquisition Service, PO Box 25166, Denver, Colorado 80225-0166

Overnight and Common Carrier: Department of Veterans Affairs, National Acquisition Center, Commodities and Services Acquisition Service, 555 Corporate Circle, Golden, CO 80401

Invoicing and Payment Administration:

Regular Mail/Fax: Finance Division (001AL-M1C), VA Denver Logistics Center, P.O. Box 25166, Denver, CO 80225-0166; Fax: 303-215-9140 Federal Express: Finance Division (001AL-M1C), VA Denver Logistics Center, 555 Corporate Circle, Golden, CO 80401

B.7 SHIPPING REQUIREMENTS

(a) The shipping container (box/package) shall be clearly marked to indicate the following:

(b) A packing list must be included and contain the description of material shipped, including name of items, items number, quantity, number of containers, and package number (if any).

(c) If more than one order is shipped per container, each order shall be packaged in a separate internal container or package and must contain an individual packing list, as specified above, for that order.

(d) Items supplied under the contract shall be individually commercially packaged in a manner which insures arrival at destination in a satisfactory condition (not damaged due to packaging failures during normal handling) for further redistribution to individual users. Packaging shall not include cross-selling literature for other products, which have not been specifically awarded.

B.8 DELIVERY INFORMATION

Items ordered shall be delivered in accordance with Part 3.3. Delivery Information, SOC. Delivery schedule specified on delivery orders issued against resultant contract is the due delivery date and NOT the shipping date. Orders may be shipped early in order to ensure delivery prior to the due delivery date. Delivery shall be f.o.b. destination.

Partial deliveries are authorized, however, the complete order is due within the agreed contract delivery period. Any items not received within the agreed period will be considered delinquent. Urgent delivery may be required.

B.9 INVOICING PROCEDURES

DESIGNATION. The Government has designated DLC as the office to receive the Contractors’ electronic funds transfer (EFT) information.

The contractor shall send all EFT information, and any changes to EFT information to the DLC office designated below. The contractor shall not send EFT information to the payment office, or any other office not designated in Section B.6. The Government need not use any EFT information sent to any office other than the office designated herein.

PROPER INVOICE DOCUMENT. Proper Invoice Document, as defined in Part 3.4.2 of the SOC shall be delivered within twenty (20) days after the receipt of order (FAR 52.212-4(i)) certified per Part 3.4.2 (p) of the SOC utilizing the approved transmission method selected by the contractor after award.

Invoices will be processed in accordance with the Prompt Payment Act (31 U.S.C. 3903) and Office of Management and Budget (OMB) Circular a-125, Prompt Payment.

B.10 ORDERING PROCEDURES

CO and/or OO are the only individuals authorized to place orders under the contract(s). Orders placed are the result of clinical assessments concerning the patients’ needs and the needs of the medical staff.

Any supplies and services to be furnished under the contract(s) shall be ordered by issuing separate DOs. DLC DOs and completed product order forms will be sent electronically or faxed to the contractor. The product order form will be patient specific- contain the DO number authorizing the transaction and patient serial number.

Contractors must acknowledge the receipt for all DOs referencing the item name and DO number. Such acknowledgement will serve as a confirmation that the order was received and entered the vendor’s order fulfillment cycle. Acknowledgements will be returned on a corresponding real-time basis, or as agreed upon by the parties.

Orders will be sent to the address listed on the DO. In case of shipping address discrepancies between the product order form and DO, the address listed on the DO shall prevail.

Shipments shall include a copy of the packing slip or invoice. The packing slips/invoices must contain the patient’s last name and last four of his/her social security number. All invoices must be Proper Invoice documents.

Ref.: 6.4 ATTACHMENT 4 – AOI PURCHASE ORDER AND INVOICE of the SOC for detailed electronic ordering and invoicing procedures.

B.11 GUARANTEED MINIMUM

The minimum amount of supplies that the Government agrees to order per contract is $5,000.00, inclusive of all option periods, if exercised.

B.12 CONTRACT CEILING AMOUNT

The maximum value of supplies that the Government may order during the contract performance period is $9,269,089.00. This amount shall be a shared ceiling among all awarded contracts, including the base year and all option years, if exercised.

B.13 GRAY MARKET PREVENTION

(a) Gray market items are Original Equipment Manufacturers (OEM) goods sold through unauthorized channels in direct competition with authorized distributors. This procurement is for new OEM medical supplies, medical equipment and/or services contracts for maintenance of medical equipment (i.e. replacement parts) for VA Medical Centers. No remanufactures or gray market items will be acceptable.

(b) The delivery of gray market items to the VA in the fulfillment of an order/award constitutes a breach of contract. Accordingly, the VA reserves the right enforce any of its contractual remedies. This includes termination of the contract or, solely at the VA’s election, allowing the Vendor to replace, at no cost to the Government, any remanufactured or gray market item(s) delivered to a VA medical facility upon discovery of such items.

(c) Vendor shall be an OEM, authorized dealer, authorized distributor or authorized reseller for the proposed medical supplies, medical equipment and/or services contracts for maintenance of medical equipment (i.e. replacement parts), verified by an authorization letter or other documents from the OEM, such that the OEM’s warranty and service are provided and maintained by the OEM. All software licensing, warranty and service associated with the medical supplies, medical equipment and/or services contracts for maintenance of medical equipment shall be in accordance with the OEM terms and conditions.

B.14 STATEMENT OF CONTRACT (SOC)

PART 1 – DEFINITIONS & ACRONYMS

1.1. DEFINITIONS:

1.1.1 ABUTMENT. A support or anchor used to affix a prosthetic device. A titanium post that transmits vibrations to the osseointegrated implant.

1.1.2 AUDITORY OSSEOINTEGRATED IMPLANT SYSTEM. A system designed to transfer sounds through the bones in the skull to the inner ear. The AOI system can be attached to the head using a magnetic connection or an abutment. The auditory osseointegrated implant system has both implanted and external components (Ref: 5.2.1. below).

1.1.3 CONTRACTED MEDICAL PERSONNEL. Any individual or legal entity that has NOT directly or indirectly submitted an offer(s) in response to the AOI Solicitation. Contracted medical personnel, contractor personnel, and contractor employees are not government employees.

1.1.4 CONTRACTOR. A supplier or vendor awarded a contract to provide specific supplies or service to the government. The term used in this contract refers to the prime contractor.

1.1.5 CONTRACTING OFFICER (CO). A person with authority to enter into, administer, and terminate contracts, and make related determinations and findings on behalf of the Government. Note: CO is the only individual who can legally bind the government.

1.1.6 CONTRACTING OFFICER'S REPRESENTATIVE (COR). An employee of the U.S. Government appointed by the CO to administer the contract. Such appointment shall be in writing and shall state the scope of authority and limitations. This individual has authority to provide technical direction to the contractor provided that direction is within the scope of the contract, does not constitute a change, and has no funding implications. This individual does NOT have authority to change the terms and conditions of the contract.

1.1.7 DEFECTIVE SERVICE. A service output that does not meet the standard of performance defined in the awarded contract.

1.1.8 DELIVERABLE. Anything that can be physically delivered but may include non-manufactured things such as meeting minutes, or reports.

1.1.9 DELIVERY ORDER. An order for supplies placed against an established contract or under this contract (as defined in FAR Part 2). May be used interchangeably with Purchase order. (Delivery Order and Purchase Order are used interchangeably throughout this document).

1.1.10 E-LEARNING. learning conducted via electronic media, typically on the Internet. Also referred to as, distance learning, computer-based learning or online learning.

1.1.11 EMPLOYEE/GOVERNMENT EMPLOYEE. As defined IAW 5 CFR § 550.202, “Employee means an individual employed in or under an agency who is appointed to a position with a scheduled tour of duty.” Only Government employees or its approved exceptions would be authorized to receive training under the terms of the contract.

1.1.12 HEADBAND. An adjustable and removable band that houses a receptacle for the sound processor, with an opposing flat surface that sits against the skin/skull to transmit sound through the skin to the underlying bone (Ref.: 5.2.6 above).

1.1.13 IMPLANT. Osseointegrated device that is permanently affixed to the skull (Ref: 5.2.2. below)

1.1.14 INVOICE. IAW FAR 2.101 “Invoice” means a contractor’s bill or written request for payment under the contract for supplies delivered or services performed.

1.1.15 KEY PERSONNEL. Contractor personnel that are evaluated in a source selection process and that may be required to be used in the performance of a contract by the key personnel list provided by the contractor as required in this SOC. When key personnel are used as an evaluation factor in best value procurement, an offer can be rejected if it does not have a firm commitment from the persons that are listed in the proposal.

1.1.16 MAGNETIC PLATE. Titanium plate and magnet that transmit vibrations to the osseointegrated implant

1.1.17 MEETING. Multi-Function Team Meetings (MFT). Members include the contractor’s contract manager, contract administrator, and Government personnel as deemed necessary including Contracting Officer Representative (COR).

1.1.18 OFFICIAL STATION. An area defined by the agency that includes the location where the employee regularly performs his or her duties or an invitational traveler’s home or regular place of business (see §301-1.2). The area may be a mileage radius around a particular point, a geographic boundary, or any other definite domain, provided no part of the area is more than 50 miles from where the employee regularly performs his or her duties or from an invitational traveler’s home or regular place of business. If the employee’s work involves recurring travel or varies on a recurring basis, the location where the work activities of the employee’s position of record are based is considered the regular place of work IAW Part 300-3 Part 300-1 - The Federal Travel Regulation.

1.1.19 OFFICIAL TRAVEL. Travel under an official travel authorization from an employee’s official station or other authorized point of departure to a temporary duty location and return from a temporary duty location, between two temporary duty locations, or relocation at the direction of a Federal agency IAW Part 300-3 Part 300-1 - The Federal Travel Regulation.

1.1.20 SOUND PROCESSOR. Component that converts sound to vibration for transmission to the implant via the abutment or magnetic connection (Ref.: 5.2.5. below).

1.1.21 SUBCONTRACTOR. One that enters into a contract with a prime contractor. The Government does not have privity of contract with the subcontractor.

1.1.22 STATE-OF-THE-ART. Defined as the most recently designed components and products incorporating the newest ideas and the most up-to-date features that are announced and promoted as available in the market and available, maintained, and supported in accordance with the software requirements in this Solicitation. Components and products with a contractor’s planned obsolescence are not acceptable.

1.1.23 WORK WEEK. Monday through Friday, unless specified otherwise.

1.2. ACRONYMS:

PART 2 - GENERAL INFORMATION

2.1 SCOPE. The Government intends to purchase and distribute Auditory Osseointegrated Implants abutments, magnetic plates, sound processors, compatible accessories, and replacement parts (AOI), including training, associated software/hardware, and services.

The contractor is required to comply with all applicable United States Government laws, regulations, policies, procedures, and guidelines in the performance of this SOC, unless otherwise stated.

2.2 INHERENTLY GOVERNMENTAL FUNCTIONS. IAW FAR 7.5 Contracts shall not be used for the performance of inherently governmental functions. An “inherently governmental function” is one that has been determined to be—through statute or otherwise—a function that must be performed by Government personnel, either civilian or military, and that may not be performed by a contractor. The contractor (nor their employees) shall not make inherently governmental decisions. The contractor (nor their employees) shall not supervise Government employees.

2.3 MEETINGS. Multi-Function Team Meetings (MFT). MFT will consist of the contractor’s contract administrator and Government personnel, as agreed after the award, including Contracting Officer Representative (COR) and will meet on a quarterly basis. The contractor may request a meeting with the Contracting Officer (CO) when the contractor believes such a meeting is necessary. The CO will keep and publish minutes of such meetings and provide a copy to the contractor.

PART 3 – ORDERING, DELIVERY & INVOICING

3.1 ORDERING PROCEDURES.

3.1.1 DELIVERY ORDERS. Any supplies and services to be furnished under the contract shall be ordered by issuance of a delivery order (DO). CO and Ordering Officers (OO) are the only ordering officials authorized to order products as specified in this SOC.

3.1.1.1 The contractor shall provide DLC with and maintain the most current product order form in a fillable PDF format for the purpose of uploading into the Remote Order Entry System (ROES).

DOs and completed product order forms will be sent to the contractor utilizing the approved transmission method selected by the contractor after award. The product order form will indicate optional components, features, customizations, etc. that do not affect the product price. The product order form will include the DO number authorizing the procurement. Any discrepancies between the DO and product order form shall be resolved in favor of DO.

3.1.1.2 The contractor shall ship the items to the facility addressed on DO. One copy of either a packing slip or invoice which provides the patient’s last name and last four of the social security number shall be enclosed with the shipment. Ordering official may direct other deliverythe contractor to ship the auditory osseointegrated implant (internal) directly to the medical/surgical center and the rest of the auditory osseointegrated system (external) to the audiology clinic.

3.2 ORDER REPORTING. The contractor shall provide a report of all orders fulfilled each month to the CO and COR by the 5th day of the following month. This report shall detail orders received and filled and shall include a) order received date, b) order acknowledged date, c) shipped date, d) shipped to location, e) invoice date, and f) invoice paid date.

3.3 OTHER DELIVERY INFORMATION.

1. Delivery is f.o.b. destination, worldwide.

2. Normal delivery is required within five (5) business days after receipt of order (ARO), or as otherwise indicated on DO. Any device not received within the required time will be considered delinquent. Urgent delivery will be required and shall be at no additional cost.

3. No device that is ordered under this contract will be sent directly to a patient, unless it replaces a defective external part under warranty, or as directed by the DLC ordering official.

4. Delivery may be to single or multiple destinations.

a. DLC ordering official may specify alternative delivery options. It may direct the contractor to ship the AOI (internal) directly to the medical/surgical center and the rest of the auditory osseointegrated system (external) to the audiology clinic.

b. Expedited delivery:

i. When the delivery schedule does not justify an urgent need, the Government reserves the right to request expedited deliveries.

ii. If expedited delivery is requested, the ordering official will telephonically contact the contractor and inquire into the feasibility thereof.

iii. The contractor shall communicate its acceptance of the request within 1 business day.

iv. If the contractor accepts an expedited delivery request, it will ship the product within the agreed schedule at no additional shipping cost to the Government.

v. Requests for expedited delivery are not intended to be used as a substitute for placing timely orders by the Government.

6. Shipments should be marked with purchase order number and contact information of the requesting person. Shipping requirements include:

a. The shipping container (box/package) shall be clearly marked to indicate the following:

i. Name and complete return address of the contractor;

ii. Government DO number(s).

b. A packing list, including the description of material shipped with the name of item, item number, quantity, number of containers, and package number (if any).

c. If more than one order is shipped per container, each order shall be packaged in a separate internal container or package and must contain an individual packing list, as specified above, for that order.

d. Items supplied under the contract shall be individually commercially packaged in a manner which insures arrival at destination in a satisfactory condition (not damaged due to packaging failures during normal handling) for further redistribution to individual users. Packaging shall not include cross-selling literature for other products, which have not been specifically awarded.

3.4 INVOICING PROCEDURES.

DLC is designated as the billing office for purposes of determining the date of receipt of items delivered under the contract to the designated delivery destinations. DLC will be responsible for processing requests, creating purchase/delivery orders for each order/request, conveying to each vendor their respective purchase/delivery orders on a daily basis, maintaining a database of products and paying vendors in a timely manner upon the receipt of Proper Invoices.

The provisions of FAR 52.212-4(g) do not apply to DLC orders.

Available Invoicing methods:

VA Denver Logistics Center, PO BOX 25166, Denver, CO 80225-0166

c) delivered to DLC by Federal Express: Finance Division (001AL-M1C), VA Denver Logistics Center, 555 Corporate Circle, Golden, CO 80401

d) secure electronic file transfer Ref.: 8.4. Attachment 4 of the SOC.

Upon award, DLC and each contractor will jointly determine the preferred invoice submission method. Inquiries regarding payment administration and invoicing shall be submitted to DLC using the selected transmission method.

All invoices for products supplied to other Government agencies shall be mailed to the billing address noted on individual delivery order(s). Invoices submission shall be in accordance with FAR 52.212-4(g).

3.4.2 INVOICE DOCUMENT. The contractor shall submit a proper invoice document. Proper Invoice is an invoice containing at a minimum the following information:

a. Contractor name

b. Contractor invoice number

c. Invoice date

d. Date of order

e. Date of contractor shipped item(s)

f. Contract Number

g. Delivery Order Number

h. Purchase Order number (13 digits)

i. Ordering clinic (Station number for electronic invoices).

j. Date of order

k. Name of Individual who requested the order

l. Itemized list of item(s) and/or product(s) delivered

m. Device model name, quantity, unit price, total price of each item

n. Serial number of implants, processor, and abutments

o. Patient’s last name and last four of the social security number.

p. Certification statement: This certifies that the foregoing Device was shipped on date noted above and receipted by “insert mail carrier” (i.e., Airborne, FedEx), “Signature of company officer, title.”, as well as the shipment tracking number (“IVS” record in the Invoice Record Layout). The date of shipment shall coincide with the Invoice Date, i.e., date invoice file is generated.

Warranty terms must not be included. Invoices must match any partial orders shipped.

Proper Invoice shall be submitted to DLC on the day of shipment, however, invoices submitted within 20 days after receipt of the order will be considered timely submitted. (FAR 52.212-4(i)).

3.4.3 DELINQUENT INVOICES. Invoices not submitted within the required 20 days after receipt of the order will be considered delinquent. DLC will track orders for invoice delinquencies, notify contractors via email of any due bur not received invoices, and request submission thereof. Invoices sent in response to the delinquent invoice notification will be attached to the delinquent invoice report, stamped "Delinquent”, and processed.

3.4.4 CANCELATIONS. If an invoice is not received within 120 calendar days from the date of the order, DLC will cancel the order for payment purposes and return the product. Invoices for cancelled orders will not be processed by DLC. Should the contractor not receive the returned product, it must notify the DLC expeditiously.

3.4.5 SUBSEQUENT INVOICES. Invoices that do not meet the Proper Invoice definition will be returned by the designated billing office to the contractor for re-submission with the reason why it is not a Proper Invoice. The corrected invoice must be stamped “2nd REQUEST” and re-submitted to DLC using the selected transmission method. Invoices re-submitted to the billing office for any other reasons must be likewise stamped.

3.4.6 PROMPT PAYMENT REQUIREMENT. Invoices will be processed in accordance with the Prompt Payment Act (31 U.S.C. 3903) and Office of Management and Budget (OMB) Circular a-125, Prompt Payment.

The time frames for any discount terms and other prompt payment act provisions will begin with the later of:

3.5 CREDITS.

Unopened products and/or unusable products that have not been opened, implanted, or issued to the patient may be returned to the contractor for credit within 30 calendar days after product receipt without a restocking fee. The reason for the return will be indicted in the FTP server when the transaction is flagged for return.

DO or an individual item on a DO may be cancelled by DLC if the order cannot be fulfilled in a timely manner because the item(s) are backordered. The contractor shall issue a credit memo not later than 10 business days after receipt of DLC cancellation notice. Credit memos must: a) meet the definition of a Proper Invoice, b) be issued within 10 business days after the receipt of DLC cancellation notice (D003) and be transmitted to DLC using the selected transmission method.

If the contractor receives a cancellation notice (for a product requested in ROES by the ordering clinician) but does not receive the returned product, the contractor must immediately notify the DLC. This will allow DLC to take an appropriate action to prevent unsupported credits.

DLC may be contacted on the phone by calling 303-273-6230 or by other means listed in 3.4. Invoice Procedures a)-d) above. In addition, the contractor must provide DLC with a monthly report in an excel format listing all outstanding returns (D004).

If the contractor receives a returned product but does not receive a cancellation notice for such product, the contractor must immediately notify the DLC Veterans Service Division, Customer Service Section, DLC.CSS@VA.GOV

The said notifications/reports must be in the following format and submitted on the 1st business day of each month. Copy thereof must be emailed to COR at the same time. COR name and email address will be confirmed upon the award.

Monthly notifications are required even if there are no actions to report.

DLC Veterans Services Division, Customer Service Section, DLC.CSS@VA.GOV must also be notified of any Serial Number Changes. The serial number change notification must include a) old and new serial number, and b) reason for the change (loss and damage, repair, or serial number correction) and be given within 48 hours of the change.

Electronic transmissions must be in accordance with the instructions in 8.4 ATTACHMENT 4 – AOI ELECTRONIC PURCHASE/DELIVERY ORDER AND INVOICE.

3.6 FAIR OPPORTUNITY. The Department of Veterans Affairs has made the determination to exercise its authority under 38 USC § 8123 to procure these prosthetic devices. 38 U.S.C. § 8123 states, ‘The Secretary may procure prosthetic appliances and necessary services required in the fitting, supplying, and training and use of prosthetic appliances by purchase, manufacture, contract, or in such other manner as the Secretary may determine to be proper, without regard to any other provision of law.’ AOI have been determined to be prosthetic appliances. As such, VA has exempted the requirement of fair opportunity for orders under these multiple award contracts.

Due to the highly specialized nature of these items, critical timeframes, audiology clinicians must determine which medical device is best suited for each patient based on an assessment that takes into consideration the specific features of AOI and clinical needs of patients as assessed by medical professionals.

PART 4 –SAMPLES AND DEMO KITS

Except as provided in paragraph (d) below, within (10) business days from the contract award date, the contractor shall forward items identified in (a)-(f) below, not separately priced and at no additional cost to the Government, to Audiology Clinics identified by the CO.

(a) Technical specifications for hardware and software.

(b) Demonstration auditory osseointegrated system for counseling and assessment purposes. The demonstration models shall be marked with “DEMO NOT FOR ISSUE” OR “DEMO”.

(c) Clinical kit including, but not limited to functioning sound processor, cable(s), rechargeable batteries, or (as applicable), disposable batteries, magnet kit, remote control, wireless accessories, headband and all necessary adaptors.

(d) To the extent an Audiology Clinic already has the required hardware and software from the contractor, this section does not require the replacement of said items. However, any new hardware or software that may become available to the contractor’s commercial customers shall be furnished to the Government.

(e) Damaged items or nonfunctional units are to be replaced.

(f) Contractors must submit technical specifications on battery types, and estimated battery drain in mAh for each Sound Processor model or any other item that is offered that requires batteries. (Ref: 8.2 ATTACHMENT 2 – BATTERY INFORMATION).

PART 5 – MINIMUM TECHNICAL REQUIREMENTS, TRINING, WARRANTY, RECALL AND TRIAL PERIOD

5.1. CERTIFICATIONS AND REGISTRATIONS

5.1.1 U.S. FOOD AND DRUG ADMINISTRATION (FDA) REGISTRATION. The product proposed must be FDA Device Registered (FDA 21 CFR 874.3300) auditory osseointegrated implant system and applicable components that meets the technical specifications described below in this section.

Required FDA documentation includes company registration, device listing, and 510(k) letter confirming substantial equivalency and clearance for marketing. Failure to provide evidence of FDA approval will result in offeror being rejected and withdrawn from further consideration.

5.1.2 SOFTWARE CRETIFICATION AND COMPLIANCE. The software proposed must be a) Hearing Instrument Manufacturers Software Association (HIMSA) certified, b) compliant with Federal Information Processing Standards (FIPS) Publication 140-2 to allow for installation on any VA IT systems and inclusion on the VA Audiology Workstation baseline, and c) compatible with the Microsoft Windows 10 operating system(s).

5.2 CLINS AND DEVICE TECHNICAL REQUIREMENTS. All devices offered shall state-of-the art technology. Components and products with a contractor’s planned obsolescence are not acceptable. Products supplied under this contract must meet the following:

5.2.1 CLIN 1: AUDITORY OSSEOINTEGRATED IMPLANT SYSTEM. *

a. A hearing device that provides an auditory signal through bone conduction. It consists of three components (minimum requirements listed below for implant; abutment/magnetics plate and sound processor):

1. an osseointegrated implant that is…