36C10G18R0003-00003001.pdf

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TABLE OF CONTENTS

SECTION A

A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 SUBCONTRACTING-- MONITORING AND COMPLIANCE

B.3 PRODUCT DESCRIPTION

B.4 PRICE/COST SCHEDULE

B.5 IDIQ TERMS AND CONDITIONS

SECTION C - CONTRACT CLAUSES

C.1 ADDENDUM TO FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—

COMMERCIAL ITEMS (JAN 2017)

C.2 52.216-18 ORDERING (OCT 1995)

C.3 52.216-19 ORDER LIMITATIONS (OCT 1995)

C.4 52.216-22 INDEFINITE QUANTITY (OCT 1995)

C.5 RESERVED……………………………………………………………………………..25

C.6 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.7 VAAR 852.203-70 COMMERCIAL ADVERTISING (JAN 2008)

C.8 VAAR 852.203-71 DISPLAY OF DEPARTMENT OF VETERAN AFFAIRS

HOTLINE POSTER (DEC 1992)

C.9 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV

2012)

C.10 VAAR 852.246-70 GUARANTEE (JAN 2008)

C.11 VAAR 852.246-71 INSPECTION (JAN 2008)

C.12 SAC 16-01 – SAC SERVICE LEVEL AGREEMENT FEE AND SUBMISSION OF

QUARTERLY SALES REPORTS; OPEN MARKET (JANUARY 2016)

C.13 MANDATORY WRITTEN DISCLOSURES

C.14 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (JAN 2018)

C.15 52.216-2 ECONOMIC PRICE ADJUSTMENT -- STANDARD SUPPLIES

(JAN 1997)……………………………………………………………………………………...39

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

D.1 ATTACHMENT 1 – INVOICE INQUIRY FORMAT

D.2 ATTACHMENT 2 – CONTRACTOR DISCREPANCY REPORT

D.3 ATTACHMENT 3 AMENDMENT 00002– EXCEL PRICE/COST SCHEDULE

D.4 ATTACHMENT 4 – PAY.GOV VENDOR SUBMITTAL INSTRUCTIONS

D.5 ATTACHMENT 5 – QUESTION SUBMISSION FORMAT

D.6 ATTACHMENT 6 AMENDMENT 00002 – TECHNICAL ACCEPTABILITY

WORKSHEET

D.7 ATTACHMENT 7 –LETTER OF COMMITMENT

SECTION E - SOLICITATION PROVISIONS

E.1 52.204-5 WOMEN-OWNED BUSINESS (OTHER THAN SMALL BUSINESS) (OCT

2014)

E.2 52.209-2 PROHIBITION ON CONTRACTING WITH INVERTED DOMESTIC

CORPORATIONS, REPRESENTATION (NOV 2015)

E.3 52.209-5 CERTIFICATION REGARDING RESPONSIBILITY MATTERS (OCT

2015)

E.4 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (JUL 2013)44

E.5 52.209-11 REPRESENTATION BY CORPORATIONS REGARDING DELINQUENT

TAX LIABILITY OR A FELONY CONVICTION UNDER ANY FEDERAL LAW (FEB 2016)

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E.6 52.216-1 TYPE OF CONTRACT (APR 1984)

E.7 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL ITEMS (NOV 2017)

E.8 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.9 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.10 VAAR 852.211-72 TECHNICAL INDUSTRY STANDARDS (JAN 2008)

E.11 VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE

RESOLUTION (JAN 2008)

E.12 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (JAN 1998)

E.14 BASIS OF AWARD

E.15 QUESTIONS

E.16 PROPOSAL SUBMISSION INSTRUCTIONS

E.17 ADDENDUM TO FAR 52.212-2 EVALUATION –COMMERCIAL ITEMS (OCT

2014)

E.18 ORAL PRESENTATIONS……………………………………………………………….77

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SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1.1 CONTRACT ADMINISTRATION

1.1.1 The Strategic Acquisition Center (SAC) Contracting Officer (CO) is 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 SAC 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 Indefinite Delivery Indefinite Quantity (IDIQ) contract level. The CO shall issue a designation letter to the COR and the contractor to ensure that all parties understand the limited authority of the COR.

1.1.2 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.

1.1.3 All contract administration matters shall be handled by the following individuals:

a. CONTRACTOR: TBD

b. GOVERNMENT: Contracting Officer 36C10G

U.S. Department of Veterans Affairs Strategic Acquisition Center 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 Federal Acquisition Regulation (FAR):

[X] 52.232-34, Payment by Electronic Funds Transfer—Other than System For Award Management, or

[X] 52.232-36, Payment by Third Party

1.3 INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [x] (As specified per order)

1.4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with Veterans Affairs Acquisition Regulation (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:

• Name and address of the contractor

• Invoice date and number

• VA Facility Name & Address

• Purchase Order No.

• Contract No.

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

• Date of Surgery

• Implant Device Serial/Lot Number

• Patient Unique Identifier

• Cumulative billing (per line item and total)

• Proof of supplies delivered or services performed MUST also be provided

• 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 and approved by the VA Information Security Officer and Privacy Officer.

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

AMENDMENT NO DATE

0001 May 3, 2018 0002 May 15, 2018

1.6 CONTRACT MINIMUM AND MAXIMUM DOLLAR VALUES

The minimum guaranteed amount for contracts awarded under this solicitation is $10,000 per awardee which shall be obligated at the time of IDIQ award. Orders beyond the minimum shall be determined by department needs. The Government has no obligation to award orders beyond the minimum guaranteed amount. In accordance with FAR 16.504(a)(4)(ii), the maximum aggregate value for all orders awarded under the contracts award under this solicitation shall not exceed $2,103,393,326.64. The Government’s obligation for the minimum guarantee amount applies only to the base period of the contract

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.

1.7.4 The Performance Metrics, Section B.5.11 (Performance Metrics), is a listing of the metrics that will be monitored during the contract term. The Performance Metrics provides the minimum standard of acceptable performance as well as the minimum acceptable quality level of the standard.

B.2 SUBCONTRACTING-- MONITORING AND COMPLIANCE

2.1 This solicitation includes Small Business Subcontracting Plan, VAAR 852.219-9.

Accordingly, any 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 Department of Veterans Affairs (VA) Prosthetics Sensory Aid Service (PSAS) requires the acquisition biologics and biological Implants. VHA manages the United States’ largest integrated healthcare system. Veterans’ healthcare is separated geographically into 21 Veterans Integrated Services Networks (VISNs) with approximately 168 VA Medical Centers (VAMCs), 1,053 outpatient sites , and various other Federal facilities to include Community Living Centers (CLCs), Vet Centers and Domiciliary. Together these health care facilities, and the more than 53,000 independent licensed health care practitioners who work within them, provide comprehensive care to about 9.3 million enrolled Veterans.

3.1.2 VHA PSAS have a need for biologics and biological implants. The objective of this procurement 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.

The goal is for the implant to restore or replace a body function, or restore appearance.

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.

This requirement does NOT include organs for transplant, virus, therapeutic serums, toxins, antitoxins, or vaccines.

3.1.5 All allograft 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 human allograft medical products. Xenograft products may use any of the standards (GS1 and HIBCC) currently FDA approved Unique Device Identifiers (UDI). Biological implants must be tracked from human donor or animal source at each step of distribution to implantation so that all patients who receive biological implants 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 shall provide an uninterrupted supply of products and delivery of biologics and biological Implants as specified in the contract. The contractor shall delivery products in accordance with Normal”, Expedited, “Just-In-Time (JIT)” and Consignment delivery methods as outlined in section B.5.6 (delivery requirements).

The contractor shall conduct 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 IDIQs shall be decentralized. The orders shall indicate the specific items ordered, item quantities, and all necessary delivery and payment procedures.

3.2.3 The contractor shall responsible for providing a VA specific product catalog that will allow streamlined ordering for the PSAS, local VA Contracting Officers and/or appointed Ordering Officers (when authorized by VA policy for Prosthetic purchases).

3.2.4 All VA issued orders shall comply with FAR 52.225-5 Trade Agreements.

3.2.5 The allograft products shall be FDA and labeled in accordance with ISBT for human allograft medical products. The contractor shall be in compliance for allograft ISBT standard by the first anniversary date of the effective award date of the IDIQ contract award. The xenograft products shall be FDA and labeled using any of the standards (GS1 and HIBCC) currently FDA approved UDI. Failure to meet labeling requirement by first anniversary date of effective award date of IDIQ contract award shall be removed from the Attachment 3 Amendment 000002 – Excel Price/Cost Schedule in the resulting award or terminated.

3.3 GENERAL INFORMATION

3.3.1 Orders issued under this contract shall be firm fixed price.

3.3.2 The ordering period is performance is 60 months.

3.4 DESCRIPTION OF SUPPLIES

PRODUCT LINE PRODUCT DESCRIPTION

Biologics and Biological Implants Allografts and Xenografts

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.

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.

3.5.6 If invoice follow up is required with ordering activity. Then transmission will be done by fax or encrypted mail. Contractor shall encrypt mail by purchasing licenses of Virtru Pro to initiate encrypted emails to VA. Government will not reimburse contractor for purchases of Virtru Pro licenses.

3.5.7 Reserved

3.5.7.1 Reserved

B.4 PRICE/COST SCHEDULE

The negotiated pricing will apply through the life of the contract unless modify by the

SAC CO.

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES

QUANTITY UNIT UNIT

PRICE

AMOUNT

0000 See Attachment 3 Amendment 00002 – Excel Price/Cost Schedule for details

GRAND TOTAL __________

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 or distributor shall to take following steps immediately:

5.1.2 Notify the CO at the SAC 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 TECHNOLOGY REFRESH, ITEM ADDITION, PRICE ADJUSTMENTS AND

DELETION

5.2.1 The contractor shall provide improved items within the awarded product line as appropriate new industry technologies emerge and/or products become obsolete during the term of the contract. A revised product listing and documentation identified below shall be submitted in writing to the CO, CS and COR.

5.2.2 Further, the contractor shall ensure that all biological products offered are state-of-the-art. "State-of-the-art" is defined as the most recently designed components approved by the FDA and are announced for marketing purposes. All improved, enhanced, or replacement products shall contain the manufacturer’s commercial warranty.

5.2.3 The contractor shall ensure that all upgraded improved/replaced products meet American with Disabilities Act (ADA) and Health Information Portability and Accountability Act (HIPAA) Federal requirements. 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, if applicable, and labeled appropriately for biologic Implants. Any Medical Products of Human Origin (e.g.

allografts) shall be labeled in accordance with ISBT 128. Xenograft products may use any of the two (GS1 and HIBCC) currently FDA approved Unique Device Identifiers

(UDI).

5.2.4 The contractor shall provide the following information to the CO, CS and COR for review and approval:

(1) A complete modification request form that includes a list of specific awarded item(s) to be updated or/and added in the Attachment 3 Amendment 00002 - Excel Price/Cost Schedule;

(2) Product literature for the item(s);

(3) A detailed description of the differences or benefits of products 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;

(5) FDA approval (if applicable);

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

7) Copy of commercial warranty.

5.2.5 If approved, FDA new items may be added to the contract via bilateral modification to contract and negotiation of pricing so long as items are within scope and pricing is determined fair and reasonable.

5.2.5.1 Item Additions: In addition to the items that are included in the initial award, the Government may add items to the contract that meet the scope outlined in the Product Description and which are determined to have a fair and reasonable price. New additions will not be accepted during the 1st twelve months after contract award. The Contractor may request addition of new items as outlined by the Contracting Officer.

5.2.5.2 Administration of Additions: Any requested additions must be approved by the Contracting Officer and PSAS before they may be offered under the contract. In order to be considered, any addition request must include a completed spreadsheet using Attachment 3 Amendment 00002 - Excel/Price Cost Schedule with all required information completed. Additionally, other than cost or pricing data must be provided that supports the offered pricing. The items requested will go through the same evaluation procedures as items under the initial proposal evaluation. Approval of addition requests shall be implemented by issuance of a contract modification along with the updated Attachment 3 Amendment 00002 - Excel/Price Cost Schedule incorporating all additions. The Government reserves the right to not accept new additions.

5.2.5.3 Item Price Adjustments: At any time during the performance of this contract, the Contractor may request changes to the price of an item already on the contract. In order to be considered, any change request must include a completed spreadsheet using the Attachment 3 with all required information completed. An acceptable explanation of why the change is required shall be submitted to support the request.

Upward price adjustments will on be considered in accordance with FAR 52.216-2. No price increase will be considered in year one of the contract. Contractors will be notified of approval of any change requests through issuance of a contract modification and an updated contract price book.

5.2.5.4 Item Deletions: At any time during the performance of this contract, the Government may elect to delete any item or items at no cost to the Government. Also, at any point during contract performance the Contractor may submit a request to delete items from the contract based on the items being obsolete, unavailable, out of production or superseded. All deletions from the contract shall be at no cost to the Government. Vendors will be notified of approval of any deletion requests through issuance of a contract modification and an updated Attachment 3.

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 micro-purchase threshold shall be placed by warranted CO. 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 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.

5.4.4 Orders shall be made via one of the following methods:

To be identified by the contractor in response to the solicitation (i.e. fax, email etc.) The contractor shall acknowledge receipt of a government purchase order and make every effort to confirm receipt back to the VA ordering official within the same business day of receipt but no later than the following business day.

5.4.5 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

5.4.6 Authorized to Purchase - Any individual at VHA who has ordering/contracting authority, on behalf of VHA, to place orders, may use the IDIQ. Other Governmental Agencies will require an interagency agreement with the Department of Veterans Affairs to place orders against this IDIQ.

5.4.7 One or more delivery orders will be issued during the performance period of the contract. It is the expectation that the field will comply with regulatory guidance provided in FAR when executing orders. The Government does not guarantee any equality of orders placed. Orders are placed based upon a physician’s determination of medical necessity for use during medical or surgical services and/or procedures. As a result of the consultation between the physician and patient, a determination is made as to the implant required for favorable medical outcome of the patient.

5.5 REPORTS

5.5.1 In order to track compliance, VA requires the contractor to submit the quarterly sale report (QSR). The QSR shall include part number, quantity sold, unit cost, and station location. Format to be developed by the contractor and submitted to Government for review upon award. The QSR shall be submitted on Government fiscal calendar year. See below:

QUARTER PERIOD OF SALES SUBMISSION DUE DATE

1st October – December Due last day in February

2nd January – March May 31st

3rd April – June August 31st

4th July – September November 30th

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 and Contracting Officer identified in B.1, and VA Program Advisory Services (PAS) at VA003B1DEmp@va.gov; until the contractor is notified, in writing, of different point of contact. The contractor shall identify the remittance amount and submit the QSR to CO and CS for review prior to remitting SLA fee in pay.gov. The SLA fee remitted in pay.gov shall match the SLA reported on the QSR.

5.5.3 A closeout report shall cover all sales not shown in the QSR and reconcile all errors and credits. If the contractor reported all contract sales and reconciled all errors and credits on the QSR, then a closeout report is not required. All closeout reports shall be submitted by December 31st (if required).

5.5.4 The Government reserves the right to inspect without further notice such records of the Contractor as they pertain to sales under this contract. Willful failure or refusal to furnish the required reports, or falsification thereof, may be cause for Government contractual remedies under FAR 52.212-4 Contract Terms and Conditions – Commercial Items.

5.6 DELIVERY REQUIREMENTS

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

mailto:VA003B1DEmp@va.gov

5.6.2 Delivery shall be made Free On Board (FOB) destination in accordance with FAR 52.247-34 to any VAMC (which may include outpatient facilities) within the Continental United States (CONUS) and U.S. Territories 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 and storage requirement, if necessary.

5.6.4 Expedited - This delivery method allows biologics and biological implant products to be delivered to facilities the same day of the surgery that when contractor is notified no later than 2:00 PM local time the day before the surgery. Implants shall arrive pre-packaged, pre-sterilized (ready to be implanted). The Government will pay the difference between normal delivery (five days) and expedited freight charges. The charge will be identified in the order and pre-approved. 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 VAMC will call the sales representative when surgery is scheduled to discuss the case, make a product selection from contractor’s VA specific product catalog (outlined in the Attachment 3 - excel Price/Cost Schedule) 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 VAMCs shall pay only for the "biologics and biologic implants" that are used. Consignment agreements shall only be established if proper storage is available.

at the VAMCs as specified in VA Acquisition Manual 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. Contractor can invoice for materials used in a surgery after receipt of a purchase (delivery) order. If a Consignment Agreement is identified as the most appropriate method of delivery to meet clinical demands the items to be consigned and par levels will be established at the order level by a warranted CO. The terms and conditions in the awarded contract are applicable to all consignment agreements established.

5.6.6.1 Title for the consigned items shall remain with the contractor until such items are used. The contractor agrees to furnish and maintain an inventory per facility directions of implants, FDA regulations and related supplies at the VAMC on consignment basis in accordance with the terms and conditions of the contract. Items will be placed in the VAMC at no additional expense to the Government upon request by each VAMC. The contractor agrees to provide biologics and biological implants at each facility receiving the consignment. The designated vendor representative assigned to the facility to initiate and oversee the consignment will update the consignment inventory based on volume/utilization/delivery times determined by the facility. A complete listing of part numbers will be provided to the field level COR upon delivery of the initial inventory.

5.6.6.2 Actual initial inventory will be determined by each individual VAMC. Initial consignment inventory shall be placed in the VAMC within ten calendar days after notification that a VAMC will be using the consignment option of the contract.

Consignment inventory will be placed in a location designated by the VAMC staff. The VAMC will provide adequate space/shelving and storage for biologics and biological implants.

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

5.6.6.4 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. The contractor will ship products directly to VAMC at no additional charge. The contractor shall re-sterilize and/or replace, at no additional charge, any item(s) that are handled but not implanted. The contractor shall pick-up or have handled items shipped back to the sterilization facility at no additional expense to the Government.

5.6.6.5 All consignment inventories shall be coordinated with COR. The contractor shall remove or replace inventory as necessary. Inventory having less than 90 days storage/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 devices that are allowed to expire.

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

5.6.6.7 Contractor’s personnel will periodically (no less than once per quarter) conduct a physical inventory of the consignment inventory, with copy of inventory furnished to the order level CO and COR. Unused items will be returned to the vendor at the end of the term of this contract without reimbursement or other expense to the Government.

5.6.7 Schedule for Deliverables - The following provisions apply to all shipments:

Inspection: Destination Acceptance: Destination

5.6.8 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(a) 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 FOOD AND DRUG ADMINISTRATION (FDA)

5.9.1 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 contractors that the FDA issues have been resolved. A letter to the contractor 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. A distributor shall obtain FDA warning and resolution letters from manufacture, as applicable.

5.10 CUSTOMER SERVICE AND TRAINING

5.10.1 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.

5.10.2 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.

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

5.10.4 Contractor shall provide on-site, in-service demonstration to Prosthetic personnel, the same as what is provided to commercial customers. Distributor shall have manufacture authorized representative provide demonstration as necessary.

5.11 PERFORMANCE METRICS

5.11.1 The performance requirement summary below defines the performance standards and acceptable performance levels associated with this IDIQ contract and resulting orders. The contractor’s performance shall be evaluated based on standards in table below.

5.11.2 The contractor shall monitor performance against the terms and conditions outlined in the contract. Contractor performance will be monitored and measured using a Quality Assurance Surveillance Plan (QASP).

PERFORMANCE

OBJECTIVE

PERFORMANCE

STANDARDS

PWS

REFERENCE

ASSESSMENT REMEDIES

Product Modification, Removal or Recall

Provide notification of as outlined in B.5.1 immediately.

No more than 2 occurrences of unreported known product modification, removal recall

Section B.5.1 Random Inspection and Customer Feedback

Document performance in CPARS

Submission of Quarterly Sales Report.

Submission no later than 60 days after end of each calendar quarter ending March, June, September, December. All Quarterly Sales Reports are submitted within 60 days.

Section B.5.5 100% Inspection

Document performance

Delivery

5.6.3 Normal

delivery shall be delivered in manner to comply with the 72 hour sterilization requirement (if applicable)

5.6.4 Expedited -

These prosthetics shall be delivered after receiving notification no later than 2:00 PM local time the day before surgery and the contractor shall supply the items prior to the surgery.

5.6.5 JIT - The

VAMC will call the sales representative when surgery is

Section B.5.6 Random Inspection and Customer Feedback

Document scheduled to discuss the case, make a product selection from Contractor's product line and inform the sales representative of the surgery date and time.

No more than 5 missed deliveries within a quarter

Replacement with Alternate Supplies

Maintain continuous source of supply. No more than 3 occurrences of supply unavailability per option year

Section B.5.8 Random Inspection and Customer Feedback

Document

SECTION C - CONTRACT CLAUSES

C.1 ADDENDUM TO FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—

COMMERCIAL ITEMS (JAN 2017)

Clauses that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

The following clauses are incorporated into 52.212-4 as an addendum to this contract:

C.2 52.216-18 ORDERING (OCT 1995)

(a) Any supplies and services to be furnished under this contract shall be ordered by issuance of delivery orders or task orders by the individuals or activities designated in the Schedule. Such orders may be issued from TBD through TBD (date to be inserted at award)..

(b) All delivery orders or task orders are subject to the terms and conditions of this contract. In the event of conflict between a delivery order or task order and this contract, the contract shall control.

(c) If mailed, a delivery order or task order is considered "issued" when the Government deposits the order in the mail. Orders may be issued orally, by facsimile, or by electronic commerce methods only if authorized in the Schedule.

(End of Clause)

C.3 52.216-19 ORDER LIMITATIONS (OCT 1995)

(a) Minimum order. When the Government requires supplies or services covered by this contract in an amount of less than $100. the Government is not obligated to purchase, nor is the Contractor obligated to furnish, those supplies or services under the contract.

(b) Maximum order. The Contractor is not obligated to honor—

(1) Any order for a single item in excess of $150,000.00;

(2) Any order for a combination of items in excess of $500,000; or

(3) A series of orders from the same ordering office within days that together call for quantities exceeding the limitation in paragraph (b)(1) or (2) of this section.

(c) If this is a requirements contract (i.e., includes the Requirements clause at subsection 52.216-21 of the Federal Acquisition Regulation (FAR)), the Government is not required to order a part of any one requirement from the Contractor if that requirement exceeds the maximum-order limitations in paragraph (b) of this section.

(d) Notwithstanding paragraphs (b) and (c) of this section, the Contractor shall honor any order exceeding the maximum order limitations in paragraph (b), unless that order (or orders) is returned to the ordering office within days after issuance, with written notice stating the Contractor's intent not to ship the item (or items) called for and the reasons. Upon receiving this notice, the Government may acquire the supplies or services from another source.

(End of Clause)

C.4 52.216-22 INDEFINITE QUANTITY (OCT 1995)

(a) This is an indefinite-quantity contract for the supplies or services specified, and effective for the period stated, in the Schedule. The quantities of supplies and services specified in the Schedule are estimates only and are not purchased by this contract.

(b) Delivery or performance shall be made only as authorized by orders issued in accordance with the Ordering clause. The Contractor shall furnish to the Government, when and if ordered, the supplies or services specified in the Schedule up to and including the quantity designated in the Schedule as the "maximum." The Government shall order at least the quantity of supplies or services designated in the Schedule as the "minimum."

(c) Except for any limitations on quantities in the Order Limitations clause or in the Schedule, there is no limit on the number of orders that may be issued. The Government may issue orders requiring delivery to multiple destinations or performance at multiple locations.

(d) Any order issued during the effective period of this contract and not completed within that period shall be completed by the Contractor within the time specified in the order. The contract shall govern the Contractor's and Government's rights and obligations with respect to that order to the same extent as if the order were completed during the contract's effective period; provided, that the Contractor shall not be required to make any deliveries under this contract after TBD .

(End of Clause)

C.5 RESERVED

C.6 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es): http://www.acquisition.gov/far/index.html (FAR) and http://www.va.gov/oal/library/vaar/index.asp (VAAR).

(End of Clause) http://www.acquisition.gov/far/index.html http://www.va.gov/oal/library/vaar/index.asp

FAR NUMBER TITLE DATE

52.202-1 DEFINITIONS NOV 2013

52.203-16 PREVENTING PERSONAL CONFLICTS OF

INTEREST CONTRACTOR EMPLOYEE

WHISTLEBLOWER RIGHTS AND REQUIREMENTS

TO INFORM EMPLOYEES OF WHISTLEBLOWER

RIGHTS

DEC 2011

52.203-17 CONTRACTOR EMPLOYEE WHISTLEBLOWER

RIGHTS AND REQUIREMENT TO INFORM

EMPLOYEES OF WHISTLEBLOWER RIGHTS

APR 2014

52.203-19 PROHIBITION ON REQUIRING CERTAIN INTERNAL

CONFIDENTIALITY AGREEMENTS OR

STATEMENTS

JAN 2017

52.204-4 PRINTED ON COPIED DOUBLE SIDED ON POST

CONSUMER FIBER CONTENT PAPER

MAY 2011

52.209-10 PROHIBITION ON CONTRACTING WITH INVERTED

DOMESTIC CORPORATIONS

NOV 2015

52.212-4 CONTRACT TERMS AND CONDITIONS—

COMMERCIAL ITEMS

JAN 2017

52.232-35 DESIGNATION OF OFFICE FOR GOVERNMENT

RECEIPT OF ELECTRONIC FUNDS TRANSFEREE

INFORMATION

JUL 2013

52.232-37 MULTIPLE PAYMENT ARRANGEMENTS MAY 1999

52.232-39 UNENFORCEABILITY OF UNAUTHORIZED

OBLIGATIONS

JUN 2013

52.232-40 PROVIDING ACCELERATED PAYMENTS TO

SMALL BUSINESS SUBCONTRACTORS

DEC 2013

52.242-13 BANKRUPTCY JUL 1995

52.247-32 F.o.b. DESTINATION NOV 1991

C.7 VAAR 852.203-70 COMMERCIAL ADVERTISING (JAN 2008)

The bidder or offeror agrees that if a contract is awarded to him/her, as a result of this solicitation, he/she will not advertise the award of the contract in his/her commercial advertising in such a manner as to state or imply that the Department of Veterans Affairs endorses a product, project or commercial line of endeavor.

(End of Clause)

C.8 VAAR 852.203-71 DISPLAY OF DEPARTMENT OF VETERAN AFFAIRS

HOTLINE POSTER (DEC 1992)

(a) Except as provided in paragraph (c) below, the Contractor shall display prominently, in common work areas within business segments performing work under VA contracts, Department of Veterans Affairs Hotline posters prepared by the VA Office of Inspector General.

(b) Department of Veterans Affairs Hotline posters may be obtained from the VA Office of Inspector General (53E), P.O. Box 34647, Washington, DC 20043-4647.

(c) The Contractor need not comply with paragraph (a) above if the Contractor has established a mechanism, such as a hotline, by which employees may report suspected instances of improper conduct, and instructions that encourage employees to make such reports.

C.9 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS

(NOV 2012)

(a) Definitions. As used in this clause—

(1) Contract financing payment has the meaning given in FAR 32.001.

(2) Designated agency office has the meaning given in 5 CFR 1315.2(m).

(3) Electronic form means an automated system transmitting information electronically according to the

Accepted electronic data transmission methods and formats identified in paragraph (c) of this clause. Facsimile, email, and scanned documents are not acceptable electronic forms for submission of payment requests.

(4) Invoice payment has the meaning given in FAR 32.001.

(5) Payment request means any request for contract financing payment or invoice payment submitted by the contractor under this contract.

(b) Electronic payment requests. Except as provided in paragraph (e) of this clause, the contractor shall submit payment requests in electronic form.