36C10G18R0003-002.docx

36C10G18R0003

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 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. 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

Lawrence B Toperoff 202-632-9024 See Sec E.10

3:00 PM

36C10G U.S. Department of Veterans Affairs Office of Acquisition Operations Strategic Acquisition Center 10300 Spotsylvania Ave | STE 400 Fredericksburg VA 22408-2697

X

Y 339113 750 Employees

N/A

See individual order for details.

36C10G U.S. Department of Veterans Affairs Office of Acquisition Operations Strategic Acquisition Center 10300 Spotsylvania Ave | STE 400 Fredericksburg VA 22408-2697

See individual orders for details.

See CONTINUATION Page

Title: Biologics and Biological Implants.

See B.4 Price/Cost schedule for details.

This is a Request for Proposal (RFP) for multiple

Firm Fixed Price (FFP) Indefinite Delivery Indefinite Quantity (IDIQ) contracts for the acquisition of Biologics and

Biological Implants. The period of performance is a base period (12 months) and four option (12 month) period to be exercised at th

Exercised at the convenience of the Government.

$0.00

See CONTINUATION Page

LeShanna Calahan Contracting Officer

Table of Contents

B.3.2 SCOPE OF WORK……………………………………………………………………….9

B.3.3 GENERAL INFORMATION………………………………………………………………9

B.3.4 DESCRIPTION OF SUPPLIES………………………………………………………….9

B.3.5 INFORMATION SECURITY CONSIDERATIONS…………………………………….9

B.4 PRICE/COST SCHEDULE………………………………………………………………10

B.5 IDIQ TERMS AND CONDITIONS 10

B.5.1 PRODUCT REMOVAL OR RECALL…………………………………………………10

B.5.2 PRODUCT REFRESH…………………………………………………………………11

B.5.3 NOTIFICATION OF SUBSTITUTED AND BACK-ORDERED ITEMS…………….12

B.5.4 ORDERING………………………………………………………………………………12

B.5.5 REPORTS………………………………………………………………………………..13

B.5.6 DELIVERY REQUIREMENTS…………………………………………………………13

B.5.7 INSPECTION AND ACCEPTANCE…………………………………………………15

B.5.8 REPLACEMENT WITH ALTERNATE SUPPLIES…………………………………15

B.5.9 EXPIRING INVENTORY………………………………………………………………15

B.5.10 DEFECTIVE ITEMS……………………………………………………………………15

B.5.11 TECHNOLOGY REFRESH 16

B.5.12 NEW ADDITIONS……………………………………………………………………16

B.5.13 FOOD AND DRUG ADMINISTRATION (FDA)……………………………………17

B.5.14 CUSTOMER SERVICE AND TRAINING……………………………………………17

SECTION C - CONTRACT CLAUSES 18

C.1 52.203-99 PROHIBITION ON CONTRACTING WITH ENTITIES THAT REQUIRE CERTAIN INTERNAL CONFIDENTIALITY AGREEMENTS (DEVIATION) (FEB 2015)…………………………………………………………………………….………………18

C.5 52.216-18 ORDERING (OCT 1995)……………………………………………………30

C.13 VAAR 852.237-70 CONTRACTOR RESPONSIBILITIES (APR 1984)…………….33

C.14 SLA 16-01 - SAC SERVICE LEVEL AGREEMENT FEE AND SUBMISSION OF QUARTERLY SALES REPORTS; OPEN MARKET (JAN 2016)……………………….34

E.3 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (JUL 2013)42

E.4 52.216-1 TYPE OF CONTRACT (APR 1984)…………………………………………43

E.5 52.233-3 SERVICE OF PROTEST (SEP 2006)………………………………………..43

E.6 VAAR 852.211-72 TECHNICAL INDUSTRY STANDARDS (JAN 2008)……………43

E.7 VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE RESOLUTION (JAN 2008)………………………………………………………………………………………44

E.8 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (JAN 1998)……………44

E.9 VAAR 852.252-70 SOLICITATION PROVISIONS OR CLAUSES INCORPORATED BY REFERENCE (JAN 2008)………………………………………………………………..45 E.10 VAAR 852.270-1 REPRESENTATIVES OF CONTRACTING OFFICERS (JAN 2008)…………………………………………………………………………………………….45

E.11 BASIS OF AWARD………………………………………………………………………45

E.14 PROPOSAL SUBMISSION INSTRUCTIONS………………………………………45

E.15 EVALUATION PROCEDURES AND APPROACH………………………………….56

E.16 EVALUATION……………………………………………………………………………56

E.17 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL ITEMS (JAN 2017) 57

E.18 52.233-2 SERVICE OF PROTEST (SEP 2006)………………………………………74

E.19 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (JAN 1998)…………..74

E.20 VAAR 852.219-71 VA MENTOR-PROTÉGÉ PROGRAM (DEC 2009)…………….74

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1.1 Contract Administration: The Strategic Acquisition Center (SAC) Contracting Officer (CO) who signed the contract is the primary CO responsible for providing overall scope oversight, maintaining communication between contractors and the United States Department of Veterans Affairs (VA), ensuring contract compliance, administering base contract and modifications, and ensuring that annual performance evaluations are completed at the base contract level. Nevertheless, any CO assigned to the Strategic Acquisition Center and acting within his/her warrant authority may take formal action on this contract when a contract action needs to be taken and the primary CO is unavailable. The CO reserves the right to designate a Contracting Officer’s Representative (COR) at the IDIQ contract. The CO will issue a designation letter to the COR and the contractor to ensure that all parties understand the limited authority of the COR.

The IDIQ contract may only be modified by written modification, executed by a SAC warranted CO. The contractor shall not provide products that are not expressly stated in the contract or order. A COR does not have the authority or means to obligate the Government or change the terms and conditions of the IDIQ contract.

All contract administration matters will be handled by the following individuals:

a. CONTRACTOR: (To be inserted at time of award)

Contract Specialist Prosthetic Team Strategic Acquisition Center 10300 Spotsylvania Ave., STE 400 Fredericksburg VA 22408 Telephone No: (540) 479-8450

U.S. Department of Veterans Affairs Strategic Acquisition Center Prosthetic Team A4 10300 Spotsylvania Ave., STE 400 Fredericksburg VA 22408

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

1.3 INVOICES: Invoices shall be submitted in arrears:

1.4. 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.

1.4.1 Submission of a proper invoice – The following data must be included in invoice for it to constitute a proper invoice:

a. Name and address of the contractor

b. Invoice date and number

c. VA Facility Name & Address

d. Purchase Order No.

e. Contract No.

f. Item number, description, quantity, unit of measure, price, extended price and a total of supplies delivered or services performed.

g. Date of Surgery

h. Implant Device Serial/Lot Number

i. Patient Unique Identifier

j. Cumulative billing (per line item and total)

k. Proof of supplies delivered or services performed MUST also be provided

l. Signature, printed name and title of Government receiving official and date of delivery or performance period must be included or accompany with invoice.

1.4.2 Invoice inquires - If you have questions about the payment status of submitted invoice. Complete the Attachment 1 – Invoice Inquiry Format and submit to order Point of Contact (POC). All inquiries containing patient information (PII, PHI) must be transmitted via facsimile or encrypted email by using “Virtru Pro”. Contractor would need to purchase “Virtru Pro” licenses, at contractor expense without reimbursement by the Government, in order to initiate encrypted emails to the VA. Transmission by any other method is unacceptable, unless authorized in writing by the SAC CO.

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

1.6 CONTRACT MINIMUM AND MAXIMUM DOLLAR VALUES

The minimum guaranteed amount for the base year of each awarded contract is $10,000.00 which will be obligated at the time of award In accordance with FAR 16.504(a)(4)(ii). The Government has no obligation to award orders beyond the base year minimum guaranteed amount. The maximum aggregate value for all orders awarded under the contract, inclusive of option years exercised, shall not exceed $TBD (Ceiling amount per individual contractor).

1.7 CONTRACTOR PERFORMANCE

1.7.1 Attachment 2 - Contractor Discrepancy Report (CDR), may be issued by a CO or COR to document less than acceptable performance by the contractor at any point during the period of performance. It should be noted that issuance of a CDR should not be the first form of communication or plan of resolution unless the seriousness of the situation warrants such formal documentation from onset. The CO, COR and contractor shall maintain open and effective communications to avoid the issuance of CDRs to the maximum extent practicable. All parties acknowledge that a finalized CDR will become part of the official file and will be used to report on annual performance under the IDIQ.

1.7.2 If use of a CDR is warranted, the CO/COR shall complete the CDR, citing the IDIQ and/or Delivery Order (DO) number and the specific IDIQ and/or DO section or clause related to the performance issue. The CO/COR shall provide a detailed and descriptive narrative of the background and issue. Upon receipt of the CDR, the contractor shall provide a timely and detailed response by the contractor. The contractor’s response shall include any important or relevant information or justification for the performance issue and a proposed resolution. The CO/COR will review the response from the contractor and the CO will issue a final recommendation or plan of action. The CO, COR, and contractor will maintain communication to ensure that the recommendation or plan of action is carried out.

1.7.3 The contractor’s performance on the IDIQ will be reported to the Contractor Performance Assessment Reporting System (CPARS) on an annual basis. The CO and COR will make use of information from CDRs, as well as any additional knowledge and information available to them with respect to the contractor’s performance, to complete the CPARS. Contractors shall familiarize themselves with the CPARS process and be prepared to respond to reports entered by the CO and COR.

B.2 LIMITATIONS ON SUBCONTRACTING-- MONITORING AND COMPLIANCE (JUN 2011)

2.1 This contract includes Federal Acquisition Regulation (FAR) clause 52.219-14. Accordingly, any Indefinite Delivery Indefinite Quantity (IDIQ) contract resulting from this solicitation will include this clause. The contractor is advised in performing IDIQ contract administration functions, the CO may use the services of a support contractor(s) retained by VA to assist in assessing the contractor's compliance with the limitations on subcontracting or percentage of work performance requirements specified in the clause. To that end, the support contractor(s) may require access to contractor's offices where the contractor's business records or other proprietary data are retained and to review such business records regarding the contractor's compliance with this requirement.

2.2 All support contractors conducting this review on behalf of VA will be required to sign an “Information Protection and Non-Disclosure and Disclosure of Conflicts of Interest Agreement” to ensure the contractor's business records or other proprietary data reviewed or obtained in the course of assisting the CO in assessing the contractor for compliance are protected to ensure information or data is not improperly disclosed or other impropriety occurs. Furthermore, if VA determines any services the support contractor(s) will perform in assessing compliance are advisory and assistance services as defined in FAR 2.101, Definitions, the support contractor(s) must also enter into an agreement with the contractor to protect proprietary information as required by FAR 9.505-4, obtaining access to proprietary information, paragraph (b). The contractor is required to cooperate fully and make available any records as may be required to enable the CO to assess the contractor's compliance with the limitations on subcontracting or percentage of work performance requirement.

B.3 PRODUCT DESCRIPTION

3.1 INTRODUCTION

3.1.1 The fundamental mission of the Department of Veterans Affairs, Veterans Health Administration (VHA) is to provide Veterans, service members, and their families the benefits they have earned through their military service to the United States. VHA accomplishes its mission by delivering patient-centered, personalized services that help Veterans readjust to civilian life and enhance their well-being.

3.1.2 VHA Prosthetic & Sensory Aids Service (PSAS) have a need for biologics and biological implants. The objective of this contract is to ensure availability and consistency of products for nationwide usage and to obtain volume-based, standardized pricing by establishing enterprise-wide IDIQ contracts. The Government desires to continue the practice of reducing costs by standardizing the ordering of products and sources of supply while, simultaneously, balancing clinician considerations for obtaining quality products.

3.1.3 The commodities to be acquired are various types of biologics and biological implants, which include any human cell, tissue, or cellular or tissue-based product or animal product inserted or grafted into the body for prosthetic, therapeutic purposes.

3.1.4 These biologics and biological implants are to be used in various surgeries, treatments, and medical procedures to treat, prevent, or diagnose diseases. Biologics and Biologic implants will consist of Allograft and Xenograft tissue. Allografts are bone and soft tissue grafts taken from human cadavers of genetically non-identical member of the same species. Most human tissue and organ transplants are Allografts. Xenografts are bone and soft-tissue grafts taken from animals, typically pigs and cows.

3.1.4 All products shall be Food and Drug Administration (FDA) approved and labeled in accordance with the International Standard for Blood and Transplant (ISBT) 128, which is the global standard for the identification, labeling, and information transfer of medical products. Biological implants must be tracked from human donor or animal source at each step of distribution to implantation so that all patients who receive a biological implant by the VA can be notified of a recall subject to the evaluation by appropriate medical personnel.

3.2 SCOPE OF WORK

3.2.1 The contractor agrees to provide a supply of products and delivery of Biologics and Biological Implants, and accessories as specified in the contract. The contractor shall conduct biologic and biological business operations that adhere to all applicable Federal, State, local laws and regulations.

3.2.2 Purchases by the Government of products established under the resulting IDIQ will be ordered by VA field offices. The orders will indicate the specific items ordered, item quantities, and all necessary delivery and payment procedures.

3.2.3 The contractor will be responsible for providing a VA specific catalog system that will allow streamlined ordering for the Prosthetics & Sensory Aids Services (PSAS), Contracting Officers and/or appointed Ordering Officers(when authorized).

3.3 GENERAL INFORMATION

3.3.1 Type of Contract: The contract shall be an Indefinite Delivery/Indefinite Quantity (IDIQ) contact Firm Fixed Price (FFP) for individual Contract Line Item Numbers (CLINs). Orders shall be issued on a firm-fixed price basis. VA organizations will issue orders against the IDIQ contract.

3.3.2 Contract Period of Performance: The IDIQ contract period of performance is 1-year base and four 1-year options.

3.4 DESCRIPTION OF SUPPLIES

Biologics and Biological Implants

Allografts and Xenografts Tissue

3.5 INFORMATION SECURITY CONSIDERATIONS

3.5.1 The Certification and Accreditation (C&A) requirements do not apply and a Security Accreditation Package is not required (See VA 6500).

3.5.2 The contractor shall safeguard Protected Health Information (PHI) and Personally Identifiable Information (PII). The Department of Veteran defines personally identifiable information as: “information which can be used to distinguish or trace an individual's identity, such as their name, social security number, biometric records, etc. alone, or when combined with other personal or identifying information which is linked or linkable to a specific individual, such as date and place of birth, mother’s maiden name, etc."

3.5.3 Protected Health Information - Protected Health Information (PHI) is a subset of Health Information, including demographic information collected from an individual, that: (1) is created or received by a health care provider, health plan, or health care clearinghouse (e.g., a HIPAA-covered entity, such as VHA); (2) relates to the past, present, or future physical or mental condition of an individual, or provision of or payment for health care to an individual; and, (3) identifies the individual or where a reasonable basis exists to believe the information can be used to identify the individual. NOTE: VHA uses the term PHI to define information covered by the Privacy Act and the Title 38 confidentiality statutes in addition to HIPAA.

3.5.4 Personally Identifiable Information - Personally Identifiable Information (PII) is any information pertaining to an individual that is retrieved by the individual’s name or other unique identifier, as well as PHI regardless of how it is retrieved. PII is a subset of personally identifiable information and is protected by the Privacy Act.

3.5.5 The HIPAA Privacy Rule defines Protected Health Information as PII transmitted or maintained in any form or medium by a covered entity, such as VHA. NOTE: VHA uses the term protected health information to define information that is covered by HIPAA but, unlike PII, may or may not be covered by the Privacy Act or Title 38 confidentiality statutes. In addition, PHI excludes employment records held by VHA in its role as an employer.

B.4 PRICE/COST SCHEDULE

B.5 IDIQ TERMS AND CONDITIONS

5.1 PRODUCT REMOVAL OR RECALL

5.1.1 For any product awarded under this contract removed or recalled by the manufacturer due to defects in the product or potential dangers to patients, or if any required removal or recall is suggested or mandated by a regulatory or official agency, the manufacturer agrees to take following steps immediately:

5.1.2 Notify the Contracting Officer (CO) at the Strategic Acquisition Center in writing, by the most expeditious manner possible.

5.1.3 Provide copies of the notification to CO, Contracting Specialist, Contracting Officer Representative, and Manager at Product Recall Office, all Agencies and VA Facilities who purchased the product, which include, but not be limited to the following:

(1) Complete item description and/or identification, order numbers from customers and the contract number assigned as a result of an issuance on the solicitation;

(2) Reasons for modifications, removal or recall; and

(3) Necessary instructions for return for credit, replacement or corrective action.

5.1.4 A copy of the notification will be provided to:

Manager, Product Recall Office National Center for Patient Safety Veterans Health Administration 24 Frank Lloyd Wright Drive, Lobby M Ann Arbor, MI 48106

5.2 PRODUCT REFRESH

5.2.1 Product refresh is when a current CLIN is no longer being manufactured due to obsolescence and the product item is being replaced with a newer, and more often, a superior version of the same item. The current CLIN product will be revised to reflect the refreshed product information, manufacturer’s part number, IDIQ price (inclusive of SLA fee), etc.

5.2.2 The Government reserves the right to not accept the products offered under product refresh. All products offered shall be provided with the contractor’s commercial warranty.

5.2.3 The contractor agrees to ensure that all upgraded improved/replaced products meet American with Disabilities Act (ADA) and Health Information Portability and Accountability Act (HIPAA) Federal requirements. Further, the contractor shall ensure that all biologics and biological implants offered are state-of-the-art. "State-of-the-art" is defined as the most recent designed components approved by the FDA and are announced for marketing purposes. The contractor shall ensure that all new products are approved in accordance with the pre-market notification under the Food and Drug Administration (FDA) 510K process and labeled appropriately for biologic Implants.

5.2.4 The contractor shall provide the COR and CO the following information for product refresh:

(1) A list of specific awarded item(s) being refreshed in the Price/Cost Schedule (to include commercial pricing, discount offered, and IDIQ price (inclusive of SLA fee));

(2) Product literature for the item(s) refreshed.

(3) A detailed description of the differences or benefits of refreshed as compared to the item(s) being discontinued or added.

(4) Proper identification of any product requirements and/or procedures related to those product(s) proposed to be refreshed or upgraded.

(5) FDA approval. If applicable

(6) Provide historical sales to VA by item(s), if applicable

(7) Copy of Commercial Warranty.

The request shall be submitted to the COR, copy to the Contract Specialist and Contract Officer, for review and recommendation of approval to be submitted to the CO. The CO shall prepare a bilateral modification for execution.

5.3 NOTIFICATION OF SUBSTITUTED AND BACK-ORDERED ITEMS

5.3.1 The contractor shall notify the authorized purchaser point of contact within one (1) business day for non-emergency orders and within four (4) hours of an emergency order if any parts/materials cannot be delivered in accordance with the individual delivery order requirements. To ensure that the correct items are shipped, the contractor shall not substitute items without prior approval by order point of contact. Instances where the contractor cannot meet the Government’s requirement(s), the contractor shall notify the order point of contact of the shortest delivery period available. If the contractor’s shortest delivery period is not acceptable to the Government, the Government reserves the right to procure the item(s) from other sources.

5.4 ORDERING

5.4.1 The resultant IDIQ will be decentralized. Orders below $3,500.00 will be placed by Prosthetics. Orders over $3,500.00 shall be placed by warranted CO or until such time as Ordering Officers are authorized. Orders exceeding the micro-purchase threshold may be placed against this IDIQ via Electronic Data Interchange (EDI), via facsimile or in writing. No verbal/oral orders can be placed or accepted on this IDIQ.

5.4.2 “Government wide commercial purchase card” means a uniquely numbered credit card issued by a contractor under GSA’s Government wide Contract for Fleet, Travel, and Purchase Card Services to named individual Government employees or entities to pay for official Government purchases.

5.4.3 The contractor may accept payments for written orders made using the Government wide commercial purchase card. Invoicing instructions will be identified in orders.

5.4.4 The contractor shall not process a transaction for payment through the purchase card clearinghouse until the purchased supplies have been accepted. Purchase card transactions shall be included in the quarterly sales reporting.

5.4.5 Orders shall be made via one of the following methods: by fax at insert method to receive orders.

5.4.6 At a minimum order shall contain the following information

· Date of order.

· Contract number and order number.

· For supplies and services, line item number, subline item number (if applicable), description, quantity, and unit price or estimated cost inclusive of Service Level Agreement fee (as applicable). The corresponding line item number and subline item number from the base contract shall also be included.

· Delivery or performance schedule.

· Place of delivery or performance (including consignee).

· Any packaging, packing, and shipping instructions.

· Accounting and appropriation data.

· Method of payment and payment office, if not specified in the contract

5.4.7 Authorized to Purchase - Any individual at VHA who has ordering/contracting authority, on behalf of VHA, to place orders, may use the IDIQ. Governmental agencies will require an interagency agreement with the Department of Veterans Affairs to place orders against this IDIQ. Ordering Officers may be appointed and delegated the responsibility to place orders against this contract, if authorized. All ordering officers will be appointed and delegated by a warranted Contracting Officer in accordance with VA Procurement Policy.

5.5 REPORTS

5.5.1 In order to track compliance, VA requires the contractor to submit a Quarterly Sales Report (QSR) based on Government fiscal calendar year. See below:

5.5.2 The contractor agrees that they shall adhere to this requirement. The contractor shall provide a QSR, after the end of each fiscal quarter ending December, March, June, and September and no later than the submission due date. Reports shall be sent electronically to the SAC IDIQ Government points of contact, Contract Specialist at (TBD MAILBOX), Financial Management Analyst at SACPAY@va.gov, and VA PAS at VA003B1DEmp@va.gov; until the contractor is notified, in writing, of different point of contact.

5.6 DELIVERY REQUIREMENTS

5.6.1 Delivery shall be in accordance with “Just-In-Time (JIT)”, Normal”, Expedited, and Consignment delivery methods.

5.6.2 Delivery shall be made Free On Board (FOB) destination to any Veterans Affairs Medical Centers (VAMC) facility (which may include outpatient facilities) within the Continental United States (CONUS) and Outside the Continental United States (OCONUS) to include delivery to Philippines and Puerto Rico. All orders to Philippines will contain an identified transshipment point location at the time of order by the ordering activity. Delivery is defined by each order placed against the contract during the specific period of performance. Each order will contain the chosen delivery method.

5.6.3 Normal - Facilities shall contact contractors at a minimum five (5) days prior to the anticipated date of surgery. The required biologics and biological implants shall be delivered in the manner to comply with any sterilization requirement, if necessary.

5.6.4 Expedited - This delivery method allows biologics and biological implant products to be delivered to facilities the same day it is to be implanted. Implants shall arrive pre-packaged, pre-sterilized (ready to be implanted). These biologics and biological implants shall be delivered after receiving notification no later than 2:00 PM local time the day before surgery. The Government will pay the difference between normal delivery (5 days) and urgent freight charges. The charge will be identified in the order. In emergency situations, the contractor must be capable of delivering within a few hours on the same day. The contractor must have the ability to receive and deliver the required products seven days per week.

5.6.5 Just–In-Time - The Medical Treatment Facility (MTF) will call the sales representative when surgery is scheduled to discuss the case, make a product selection from contractor’s product line schedule of supplies and inform the sales representative of the surgery date and time. The sales representative will transport the biologics and biological implants necessary for surgery to the designated site at the scheduled time upon receipt of order.

5.6.6 Consignment Agreement –

Under this contract Consignment Agreements will be used as an ordering method only. Incorporated in each consignment shall be a statement that MCs shall pay only for the "procedural packages" that are used. As specified in VHA PM Part 801.102 paragraph 3 definitions, a Consignment Agreement is an agreement for a specified period of time under which a vendor provides an item to the Department of Veterans Affairs, reimbursement for which is made only if and when use of the item is made by the Department of Veteran Affairs. Unused items are returned to the vendor at the end of the effective period of the agreement without reimbursement or other expense to the Government.

5.6.6.1 The Government assumes no liability for any items assigned to the MTF on a consignment basis until such time as a requirement for the item exists and a purchase (delivery) order is placed against this contract/consignment agreement. An exception to contractor liability is loss or damage of any consignment item by VA.

5.6.6.2 All consignment inventories shall be coordinated with COR. The contractor shall remove or replace inventory as necessary. Consignment agreements shall only be established if proper storage is available at the MTF.

5.6.6.3 After each procedure, the VAMC will provide a list of items used and the contractor will provide replacements within 48 hours. Replacements will be shipped/delivered FOB Destination. Contractor will ship products directly to VAMC at no additional charge.

5.6.9 Schedule for Deliverables: The following provisions apply to all shipments:

Inspection: Destination Acceptance: Destination

5.6.10 Ship To and Mark For: - Deliveries shall be marked and shipped to various VHA locations nationwide which will be identified under each order placed against the IDIQ

5.7. INSPECTION AND ACCEPTANCE

5.7.1 The acceptance paragraph in FAR 52.212-4 is based upon the assumption that the Government will rely on the contractor’s assurances that the commercial item tendered for acceptance conforms to the IDIQ requirements. The Government’s inspection of commercial items will not prejudice its other rights under the acceptance paragraph.

5.8 REPLACEMENT WITH ALTERNATE SUPPLIES

5.8.1 The contractor agrees to supply established item(s) to satisfy the Government’s requirement when an order is placed under the contract during the duration of the effective period of the contract. If, however, contractor determines to terminate production or supply of the selected item and contemplates replacement with alternative item, the Government reserves the right to evaluate the potential replacement item(s). There is no guarantee that the Government will evaluate any replacement item(s) favorably. If the Government determines the replacement item(s) as unacceptable, the individual item(s) may be cancelled.

5.9 EXPIRING INVENTORY

5.9.1 Inventory having less than 90 days sterility/expiration date must be removed and replaced. A list of all products having an expiration date of less than 90 days will be provided to the COR at the individual VAMC. These services will be completed at no additional cost to the Government. The VA is not liable for inventory that is allowed to expire.

5.10 DEFECTIVE ITEMS

Defective biologics and biological implants will be replaced by Contractor at no charge to the Government, unless the Government has misused or lost the biologics and biological implant.

5.11 TECHNOLOGY REFRESH

a. All implants, instruments, and accessories offered shall be state-of-the-art technology. "State-of-the-art" is defined as the most recently designed components which are announced for marketing purposes, available, maintained and supported in accordance with requirements specified in the solicitation.

Components and products with a manufacturer's planned obsolescence within the first year of contract award is not acceptable.

b. If upgrades of instruments, implants, or supplies become available after award of this contract, the contractor, at the earliest opportunity alert the COR/CO of the necessity for a modification.

c. The contractor will provide to the contracting officer the following information:

(1) A list of awarded items which shall be updated.

(2) Suggested new Item pricing

(3) Product literature for the new items and a detailed description of the differences between the awarded items and the new items, and a specific analysis of the comparative advantages/ disadvantages of the items involved.

d. The Contracting Officer will provide the information to the Program Office for approval. Upon approval, the contract will be modified to acknowledge the updated items.

e. All new products that replace awarded items and released to the market during the term of the contract will be made available to the government at a negotiated discount price.

f. All other new products that are added to a vendor's catalog and released to the market during the term of the contract will be made available to the government at a negotiated discount price Pricing on new technologies will be negotiated separately.

5.12 NEW ADDITIONS

When preparing submission for new additions please keep the following in mind:

a. Modification request for new adds have to be within scope of the product line/description identified in original awarded contract

b. Submitted with complete modification request form (Attachment 7), product literature, FDA approval documentation etc.

c. Request will be rejected if incomplete package is submitted

d. Recommendations for new additions will only be accepted on a semi-annual basis.

(1). First submission due January 1, by Close of Business.

(2). Second submission due July 1, by Close of Business.

e. New addition submissions will not be routed on rolling basis. All submissions will be routed and subject to review by Program Executive Office/Prosthetic & Sensory Aids Services/Clinicians after the due date.

f. If approved, pricing will be negotiated with contractor and modification will be executed

CO has to be able to determine that the pricing is fair and reasonable in order to execute a modification. Otherwise the modification will be rejected.

5.13 FOOD AND DRUG ADMINISTRATION (FDA)

The contractor shall not have any outstanding actions from the FDA or other regulatory agencies or unresolved FDA warning letters on the manufacturing processes or quality control issues involving the products covered by this contract within the last three years. VA will require proof from the vendors that the FDA issues have been resolved. A letter to the vendor from the regulatory agency will meet this requirement. Items involved in a recall cannot be added into this contract via modification until the recall is resolved.

5.14 CUSTOMER SERVICE AND TRAINING

5.14.1 Access to contractor support within one hour via telephone/fax/e-mail during ordinary business hours in event of an emergency. Access to vendor support consultant within three working days for non-emergent needs.

5.14.2 A designated contractor representatives shall be assigned to each facility to oversee the consignment process. This contractor representative shall work directly with the assigned VA COR. Upon award, contractor shall inform CORs of appropriate contacts and provide phone numbers.

5.14.3 Designated contractor representatives shall make periodic site visits for in-service presentations on new techniques, instrumentation, and parameters.

5.14.4 Contractor shall provide on-site, in-service training to Prosthetic personnel, the same as what is provided to commercial customers.

SECTION C - CONTRACT CLAUSES

C.1 52.203-99 PROHIBITION ON CONTRACTING WITH ENTITIES THAT REQUIRE CERTAIN INTERNAL CONFIDENTIALITY AGREEMENTS (DEVIATION) (FEB 2015)

(a) The Contractor shall not require employees or contractors seeking to report fraud, waste, or abuse to sign or comply with internal confidentiality agreements or statements prohibiting or otherwise restricting such employees or subcontractors from lawfully reporting such waste, fraud, or abuse to a designated investigative or law enforcement representative of a Federal department or agency authorized to receive such information.

(b) The contractor shall notify employees that the prohibitions and restrictions of any internal confidentiality agreements covered by this clause are no longer in effect.

(c) The prohibition in paragraph (a) of this clause does not contravene requirements applicable to Standard Form 312, Form 4414, or any other form issued by a Federal department or agency governing the nondisclosure of classified information.

(d)(1) In accordance with section 743 of Division E, Title VII, of the Consolidated and Further Continuing Resolution Appropriations Act, 2015 (Pub. L. 113-235), use of funds appropriated (or otherwise made available) under that or any other Act may be prohibited, if the Government determines that the Contractor is not in compliance with the provisions of this clause.

(2) The Government may seek any available remedies in the event the contractor fails to comply with the provisions of this clause.

(End of Clause)

C.2 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (JAN 2017)

(a) Inspection/Acceptance. The Contractor shall only tender for acceptance those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. If repair/replacement or reperformance will not correct the defects or is not possible, the Government may seek an equitable price reduction or adequate consideration for acceptance of nonconforming supplies or services. The Government must exercise its post-acceptance rights—

(1) Within a reasonable time after the defect was discovered or should have been discovered; and

(2) Before any substantial change occurs in the condition of the item, unless the change is due to the defect in the item.

(b) Assignment. The Contractor or its assignee may assign its rights to receive payment due as a result of performance of this contract to a bank, trust company, or other financing institution, including any Federal lending agency in accordance with the Assignment of Claims Act (31 U.S.C. 3727). However, when a third party makes payment (e.g., use of the Governmentwide commercial purchase card), the Contractor may not assign its rights to receive payment under this contract.

(c) Changes. Changes in the terms and conditions of this contract may be made only by written agreement of the parties.

(d) Disputes. This contract is subject to 41 U.S.C. chapter 71, Contract Disputes. Failure of the parties to this contract to reach agreement on any request for equitable adjustment, claim, appeal or action arising under or relating to this contract shall be a dispute to be resolved in accordance with the clause at FAR 52.233-1, Disputes, which is incorporated herein by reference. The Contractor shall proceed diligently with performance of this contract, pending final resolution of any dispute arising under the contract.

(e) Definitions. The clause at FAR 52.202-1, Definitions, is incorporated herein by reference.

(f) Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without its fault or negligence such as, acts of God or the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, unusually severe weather, and delays of common carriers. The Contractor shall notify the Contracting Officer in writing as soon as it is reasonably possible after the commencement of any excusable delay, setting forth the full particulars in connection therewith, shall remedy such occurrence with all reasonable dispatch, and shall promptly give written notice to the Contracting Officer of the cessation of such occurrence.

(g) Invoice.

(1) The Contractor shall submit an original invoice and three copies (or electronic invoice, if authorized) to the address designated in the contract to receive invoices. An invoice must include—

(i) Name and address of the Contractor;

(ii) Invoice date and number;

(iii) Contract number, line item number and, if applicable, the order number;

(iv) Description, quantity, unit of measure, unit price and extended price of the items delivered;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading;

(vi) Terms of any discount for prompt payment offered;

(vii) Name and address of official to whom payment is to be sent;

(viii) Name, title, and phone number of person to notify in event of defective invoice; and

(ix) Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the invoice only if required elsewhere in this contract.

(x) Electronic funds transfer (EFT) banking information.

(A) The Contractor shall include EFT banking information on the invoice only if required elsewhere in this contract.

(B) If EFT banking information is not required to be on the invoice, in order for the invoice to be a proper invoice, the Contractor shall have submitted correct EFT banking information in accordance with the applicable solicitation provision, contract clause (e.g., 52.232-33, Payment by Electronic Funds Transfer—System for Award Management, or 52.232-34, Payment by Electronic Funds Transfer—Other Than System for Award Management), or applicable agency procedures.

(C) EFT banking information is not required if the Government waived the requirement to pay by EFT.

(2) Invoices will be handled in accordance with the Prompt Payment Act (31 U.S.C. 3903) and Office of Management and Budget (OMB) prompt payment regulations at 5 CFR part 1315.

(h) Patent indemnity. The Contractor shall indemnify the Government and its officers, employees and agents against liability, including costs, for actual or alleged direct or contributory infringement of, or inducement to infringe, any United States or foreign patent, trademark or copyright, arising out of the performance of this contract, provided the Contractor is reasonably notified of such claims and proceedings.

(i) Payment.—

(1) Items accepted. Payment shall be made for items accepted by the Government that have been delivered to the delivery destinations set forth in this contract.

(2) Prompt payment. The Government will make payment in accordance with the Prompt Payment Act (31 U.S.C. 3903) and prompt payment regulations at 5 CFR part 1315.

(3) Electronic Funds Transfer (EFT). If the Government makes payment by EFT, see 52.212-5(b) for the appropriate EFT clause.

(4) Discount. In connection with any discount offered for early payment, time shall be computed from the date of the invoice. For the purpose of computing the discount earned, payment shall be considered to have been made on the date which appears on the payment check or the specified payment date if an electronic funds transfer payment is made.

(5) Overpayments. If the Contractor becomes aware of a duplicate contract financing or invoice payment or that the Government has otherwise overpaid on a contract financing or invoice payment, the Contractor shall—

(i) Remit the overpayment amount to the payment office cited in the contract along with a description of the overpayment including the—

(A) Circumstances of the overpayment (e.g., duplicate payment, erroneous payment, liquidation errors, date(s) of overpayment);

(B) Affected contract number and delivery order number, if applicable;

(C) Affected line item or subline item, if applicable; and

(D) Contractor point of contact.

(ii) Provide a copy of the remittance and supporting documentation to the Contracting Officer.

(6) Interest.

(i) All amounts that become payable by the Contractor to the Government under this contract shall bear simple interest from the date due until paid unless paid within 30 days of becoming due. The interest rate shall be the interest rate established by the Secretary of the Treasury as provided in 41 U.S.C. 7109, which is applicable to the period in which the amount becomes due, as provided in (i)(6)(v) of this clause, and then at the rate applicable for each six-month period as fixed by the Secretary until the amount is paid.

(ii) The Government may issue a demand for payment to the Contractor upon finding a debt is due under the contract.

(iii) Final decisions. The Contracting Officer will issue a final decision as required by 33.211 if—

(A) The Contracting Officer and the Contractor are unable to reach agreement on the existence or amount of a debt within 30 days;

(B) The Contractor fails to liquidate a debt previously demanded by the Contracting Officer within the timeline specified in the demand for payment unless the amounts were not repaid because the Contractor has requested an installment payment agreement; or

(C) The Contractor requests a deferment of collection on a debt previously demanded by the Contracting Officer (see 32.607-2).

(iv) If a demand for payment was previously issued for the debt, the demand for payment included in the final decision shall identify the same due date as the original demand for payment.

(v) Amounts shall be due at the earliest of the following dates:

(A) The date fixed under this contract.

(B) The date of the first written demand for payment, including any demand for payment resulting from a default termination.

(vi) The interest charge shall be computed for the actual number of calendar days involved beginning on the due date and ending on—

(A) The date on which the designated office receives payment from the Contractor;

(B) The date of issuance of a Government check to the Contractor from which an amount otherwise payable has been withheld as a credit against the contract debt; or

(C) The date on which an amount withheld and applied to the contract debt would otherwise have become payable to the Contractor.

(vii) The interest charge made under this clause may be reduced under the procedures prescribed in 32.608-2 of the Federal Acquisition Regulation in effect on the date of this contract.

(j) Risk of loss. Unless the contract specifically provides otherwise, risk of loss or…