36C26123Q0592.pdf

PAGE 1 OF 1. REQUISITION NO.

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NO. 5. SOLICITATION NUMBER 6. SOLICITATION ISSUE DATE

a. NAME b. TELEPHONE NO. (No Collect Calls) 8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY CODE 10. THIS ACQUISITION IS UNRESTRICTED OR SET ASIDE: % FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ IFB RFP

15. DELIVER TO CODE 16. ADMINISTERED BY CODE

17a. CONTRACTOR/OFFEROR CODE FACILITY CODE 18a. PAYMENT WILL BE MADE BY CODE

TELEPHONE NO. UEI: EFT:

PHONE: FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19. 20. 21. 22. 23. 24.

ITEM NO. SCHEDULE OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

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

25. ACCOUNTING AND APPROPRIATION DATA 26. TOTAL AWARD AMOUNT (For Govt. Use Only)

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA ARE ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA ARE ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________ 29. AWARD OF CONTRACT: REF. ___________________________________ OFFER COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DATED ________________________________. YOUR OFFER ON SOLICITATION DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY (BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION (REV. NOV 2021)

PREVIOUS EDITION IS NOT USABLE Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

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

36C26123Q0592 05-26-2023

Cynthia Diezel 916-923-4567 06-10-2023

10:00 PDT

612MCP

Department of Veterans Affairs VA Sierra Pacific Network (VISN 21) Network Contracting Office (NCO) 21 5342 Dudley Blvd, Bldg 209 McClellan CA 95652-2609

X

621991

$40 Million

N/A

X

Reference the Performance Work Statement

612MCP

Department of Veterans Affairs Department of Veterans Affairs Network Contracting Office (NCO) 21 3230 Peacekeeper Way, Bldg. 209 McClellan CA 95652-1012

FMS VA-9(101) Financial Services Center

PO Box 149971 Austin TX 78714-9971

See CONTINUATION Page

Contractor shall provide packaging, storage and transportation of autologous bone tissue services for the VA Palo Alto Health Care System in accordance with the Performance Work Statement.

Services to be completed at Palo Alto VA Health Care Center at 3801 Miranda Ave, Palo Alto, CA 94304.

See schedule at pages 5-12

See PWS at pages 13-23

Questions regarding this RFQ are due by 6/2/2023 by 10:00AM PST by email to cynthia.diezel@va.gov

See CONTINUATION Page

X X

Cynthia Diezel Contracting Officer

36C26123Q0592

Table of Contents

SECTION A

A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

B.3 PERFORMANCE WORK STATEMENT

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES (DEC 2022)

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

C.3 52.204-14 SERVICE CONTRACT REPORTING REQUIREMENTS (OCT 2016)

C.4 52.204-21 BASIC SAFEGUARDING OF COVERED CONTRACTOR INFORMATION

SYSTEMS (NOV 2021)

C.5 52.209-9 UPDATES OF PUBLICLY AVAILABLE INFORMATION REGARDING

RESPONSIBILITY MATTERS (OCT 2018)

C.6 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.7 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

C.8 VAAR 852.201-70 CONTRACTING OFFICER'S REPRESENTATIVE (DEC 2022)

C.9 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

C.10 VAAR 852.215-70 SERVICE-DISABLED VETERAN-OWNED AND

VETERANOWNED SMALL BUSINESS EVALUATION FACTORS (JAN 2023)

(DEVIATION)……………………………………………………………………………………41

C.11 VAAR 852.215-71 EVALUATION FACTOR COMMITMENTS (OCT 2019)

C.12 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV

2018)

C.13 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020)

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

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (MAR 2023)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (MAR 2023)

E.2 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.3 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.4 VAAR 852.273-70 LATE OFFERS (NOV 2021)

E.5 VAAR 852.273-73 EVALUATION - HEALTH-CARE RESOURCES (JAN 2003)

E.6 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES (DEC 2022)

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

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

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C261 Cynthia Diezel

Network Contracting Office (NCO) 21 5342 Dudley Blvd., Bldg. 209 McClellan CA 95652

c. ADMINISTRATION: Contract Specialist 36C261 Cynthia Diezel

Network Contracting Office (NCO) 21 5342 Dudley Blvd., Bldg. 209 McClellan CA 95652

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

[X] 52.232-33, Payment by Electronic Funds Transfer—System For Award Management, or

[ ] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly [ ]

b. Semi-Annually [ ]

c. Other [X] Monthly in arrears

4. GOVERNMENT INVOICE ADDRESS: Invoices will be electronically submitted to the Tungsten website at http://www.tungstennetwork.com/uk/en/ Tungsten direct vendor support number is 877- 489-6135 for VA contracts. The VA-FSC pays all associated transaction fees for VA orders. During Implementation (technical set-up) Tungsten will confirm your Tax Payer ID Number with the VA- FSC. This process can take up to 5 business days to complete to ensure your invoice is automatically routed to your Certifying Official for approval and payment. In order to successfully submit an invoice to VA-FSC please review “How to Create an Invoice” within the how to guides. All invoices submitted through Tungsten to the VA-FSC should mirror your current submission of Invoice, with the following items required. Clarification of additional requirements should be confirmed with your Certifying Official (your CO or buyer). The VA-FSC requires specific information in compliance with the Prompt Pay Act and Business Requirements. For additional information, please contact:

Tungsten Support

Phone: 1-877-489-6135 Website: http://www.tungsten-network.com/uk/en/

Department of Veterans Affairs Financial Service Center Phone: 1-877-353-9791 Email: vafscched@va.gov

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

AMENDMENT NO DATE

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

5.00 EA __________________ __________________

Autologous Storage Kit and Service for 2 years at Contractor's facility

Contract Period: Base POP Begin: 07-01-2023 POP End: 06-30-2024 PRINCIPAL NAICS CODE: 621991 - Blood and Organ Banks PRODUCT/SERVICE CODE: Q999 - Medical - Other

MANUFACTURER PART NUMBER (MPN): N/A

4.00 EA __________________ __________________

In-State Inter-facility transfer to or from another hospital’s inventory.

Contract Period: Base POP Begin: 07-01-2023 POP End: 06-30-2024 PRINCIPAL NAICS CODE: 621991 - Blood and Organ Banks

Out-of-State Inter-facility transfer to or from another hospital’s inventory.

Contract Period: Base POP Begin: 07-01-2023 POP End: 06-30-2024 PRINCIPAL NAICS CODE: 621991 - Blood and Organ Banks

Standard return shipping to Hospital.

Contract Period: Base POP Begin: 07-01-2023 POP End: 06-30-2024 PRINCIPAL NAICS CODE: 621991 - Blood and Organ Banks

STAT Shipping Fee for same day return to hospital, or requiring air freight, courier, or Fed/Ex First Overnight service.

Contract Period: Base POP Begin: 07-01-2023 POP End: 06-30-2024 PRINCIPAL NAICS CODE: 621991 - Blood and Organ Banks

Improperly packaged tissue

Contract Period: Base POP Begin: 07-01-2023 POP End: 06-30-2024 PRINCIPAL NAICS CODE: 621991 - Blood and Organ Banks

Replacement of lost or damaged autologous storage kits.

Contract Period: Base POP Begin: 07-01-2023 POP End: 06-30-2024 PRINCIPAL NAICS CODE: 621991 - Blood and Organ Banks

Disposal of autologous tissue.

Contract Period: Base POP Begin: 07-01-2023 POP End: 06-30-2024 PRINCIPAL NAICS CODE: 621991 - Blood and Organ Banks

2.00 EA __________________ __________________

Tissue recovered prior to start of contract to be stored at contractor facility Contract Period: Base POP Begin: 07-01-2023 POP End: 06-30-2024 PRINCIPAL NAICS CODE: 621991 - Blood and Organ Banks

Contract Period: Option 1 POP Begin: 07-01-2024 POP End: 06-30-2025 PRINCIPAL NAICS CODE: 621991 - Blood and Organ Banks

Contract Period: Option 1 POP Begin: 07-01-2024 POP End: 06-30-2025 PRINCIPAL NAICS CODE: 621991 - Blood and Organ Banks inventory.

Contract Period: Option 1 POP Begin: 07-01-2024 POP End: 06-30-2025 PRINCIPAL NAICS CODE: 621991 - Blood and Organ Banks

Contract Period: Option 1 POP Begin: 07-01-2024 POP End: 06-30-2025 PRINCIPAL NAICS CODE: 621991 - Blood and Organ Banks freight, courier, or Fed/Ex First Overnight service.

Contract Period: Option 1 POP Begin: 07-01-2024 POP End: 06-30-2025 PRINCIPAL NAICS CODE: 621991 - Blood and Organ Banks

Contract Period: Option 1 POP Begin: 07-01-2024 POP End: 06-30-2025 PRINCIPAL NAICS CODE: 621991 - Blood and Organ Banks

Contract Period: Option 1 POP Begin: 07-01-2024 POP End: 06-30-2025 PRINCIPAL NAICS CODE: 621991 - Blood and Organ Banks

Contract Period: Option 1 POP Begin: 07-01-2024

POP End: 06-30-2025 PRINCIPAL NAICS CODE: 621991 - Blood and Organ Banks

Contract Period: Option 2 POP Begin: 07-01-2025 POP End: 06-30-2026 PRINCIPAL NAICS CODE: 621991 - Blood and Organ Banks

Contract Period: Option 2 POP Begin: 07-01-2025 POP End: 06-30-2026 PRINCIPAL NAICS CODE: 621991 - Blood and Organ Banks inventory.

Contract Period: Option 2 POP Begin: 07-01-2025 POP End: 06-30-2026 PRINCIPAL NAICS CODE: 621991 - Blood and Organ Banks

Contract Period: Option 2 POP Begin: 07-01-2025 POP End: 06-30-2026 PRINCIPAL NAICS CODE: 621991 - Blood and Organ Banks freight, courier, or Fed/Ex First Overnight service.

Contract Period: Option 2 POP Begin: 07-01-2025 POP End: 06-30-2026 PRINCIPAL NAICS CODE: 621991 - Blood and Organ Banks

Improperly packaged tissue Contract Period: Option 2 POP Begin: 07-01-2025 POP End: 06-30-2026 PRINCIPAL NAICS CODE: 621991 - Blood and Organ Banks

Contract Period: Option 2 POP Begin: 07-01-2025 POP End: 06-30-2026 PRINCIPAL NAICS CODE: 621991 - Blood and Organ Banks

Contract Period: Option 2 POP Begin: 07-01-2025 POP End: 06-30-2026 PRINCIPAL NAICS CODE: 621991 - Blood and Organ Banks

Contract Period: Option 3 POP Begin: 07-01-2026 POP End: 06-30-2027 PRINCIPAL NAICS CODE: 621991 - Blood and Organ Banks

Each additional year of storage upto 5 years maximum from recovery or until use/disposal at Contractor's facility Contract Period: Option 3 POP Begin: 07-01-2026 POP End: 06-30-2027 PRINCIPAL NAICS CODE: 621991 - Blood and Organ Banks

Contract Period: Option 3 POP Begin: 07-01-2026 POP End: 06-30-2027 PRINCIPAL NAICS CODE: 621991 - Blood and Organ Banks inventory.

Contract Period: Option 3 POP Begin: 07-01-2026 POP End: 06-30-2027 PRINCIPAL NAICS CODE: 621991 - Blood and Organ Banks

Contract Period: Option 3 POP Begin: 07-01-2026 POP End: 06-30-2027 PRINCIPAL NAICS CODE: 621991 - Blood and Organ Banks freight, courier, or Fed/Ex First Overnight service.

Contract Period: Option 3 POP Begin: 07-01-2026 POP End: 06-30-2027 PRINCIPAL NAICS CODE: 621991 - Blood and Organ Banks

Contract Period: Option 3 POP Begin: 07-01-2026 POP End: 06-30-2027 PRINCIPAL NAICS CODE: 621991 - Blood and Organ Banks

Contract Period: Option 3 POP Begin: 07-01-2026 POP End: 06-30-2027 PRINCIPAL NAICS CODE: 621991 - Blood and Organ Banks

Contract Period: Option 3 POP Begin: 07-01-2026

POP End: 06-30-2027 PRINCIPAL NAICS CODE: 621991 - Blood and Organ Banks

Contract Period: Option 4 POP Begin: 07-01-2027 POP End: 06-30-2028 PRINCIPAL NAICS CODE: 621991 - Blood and Organ Banks

Each additional year of storage upto 5 years maximum from recovery or until use/disposal at Contractor's facility Contract Period: Option 4 POP Begin: 07-01-2027 POP End: 06-30-2028 PRINCIPAL NAICS CODE: 621991 - Blood and Organ Banks

Contract Period: Option 4 POP Begin: 07-01-2027 POP End: 06-30-2028 PRINCIPAL NAICS CODE: 621991 - Blood and Organ Banks inventory.

Contract Period: Option 4 POP Begin: 07-01-2027 POP End: 06-30-2028 PRINCIPAL NAICS CODE: 621991 - Blood and Organ Banks

Contract Period: Option 4 POP Begin: 07-01-2027 POP End: 06-30-2028 PRINCIPAL NAICS CODE: 621991 - Blood and Organ Banks freight, courier, or Fed/Ex First Overnight service.

Contract Period: Option 4 POP Begin: 07-01-2027 POP End: 06-30-2028 PRINCIPAL NAICS CODE: 621991 - Blood and Organ Banks

Contract Period: Option 4 POP Begin: 07-01-2027 POP End: 06-30-2028 PRINCIPAL NAICS CODE: 621991 - Blood and Organ Banks

Contract Period: Option 4 POP Begin: 07-01-2027 POP End: 06-30-2028 PRINCIPAL NAICS CODE: 621991 - Blood and Organ Banks

Contract Period: Option 4 POP Begin: 07-01-2027 POP End: 06-30-2028 PRINCIPAL NAICS CODE: 621991 - Blood and Organ Banks

GRAND TOTAL __________________

B.3 PERFORMANCE WORK STATEMENT

1. Contracting Officer’s Representative (COR).

Name: Carole Amos

Section: SIPS/NURSING SERVICES (118)

Address: 3801 Miranda Ave., Palo Alto, CA 94304-1290

Phone Number: (650)493-5000 x 69924

Fax Number: (650) 858-3988

E-Mail Address: Carole.amos@va.gov

2. Contract Title.

Autologous Bone Tissue Storage and Interfacility Transfer Contract

3. Background.

The VA Palo Alto Health Care System (VAPAHCS) requires a safe and efficient process for the storing and transferring of autologous bone tissue. The contractor, an American Association of Tissue Banks (AATB) accredited tissue bank, will assist the facility in meeting The Joint Commission, FDA, and VHA requirements related to autologous tissue management.

Duties include, but are not limited to, the packaging, transport, and storage of autologous bone tissue. The contractor will provide interfacility bone flap transfers, autologous tissue storage, and will deliver the tissue back to the facility upon request.

The contractor maintains annual AATB certification and keeps current with all regulatory compliance requirements related to autologous tissue.

Objectives

Maintain safe and compliant storage and transfer of autologous tissue The packaging, transport, and storage of autologous bone tissue.

Provide interfacility bone flap transfers, autologous tissue storage, and will deliver the tissue back to the facility upon request.

The contractor maintains annual AATB certification and keeps current with all regulatory compliance requirements related to autologous tissue.

4. Specific Tasks.

Contractor’s Terms and Scope of Services

4.1. TISSUE RECOVERY PROCEDURE

The contractor shall provide VAPAHCS with packaging and storage” materials to use in the surgical recovery of autologous tissue by VAPAHCS. VAPAHCS shall be responsible for any contactor provided packaging and storage material and shall maintain the safe and adequate storage of packaging and storage materials provided by the contractor and liable for the adequacy of all other supplies and instruments used in its tissue recovery process.

Any contractor provided packing and storage materials that are lost, damaged, misused, or that are unable to be located by VAPAHCS will be replaced by the contractor as necessary, and the contractor shall be entitled to charge VAPAHCS for such replacement in accordance with the fee schedule.

VAPAHCS shall immediately notify the contractor by telephone of the readiness and availability of human autologous bone or skull flaps for shipment to the contractor. VAPAHCS shall provide to the contractor all aseptically procured autologous tissue, bone or skull flaps in packaging and storage materials provided by the contractor to VAPAHCS, or other suitable packaging which complies with applicable federal, state and local requirements for transportation of human autologous bone or skull flaps and/or blood specimens. Any packaging other than that supplied by the contractor must be approved by the contractor prior to its use by VAPAHCS.

VAPAHCS shall assure that its surgical staff reads, becomes familiar with, and will follow the instructions provided by the contractor.. The instructions may be modified from time to time to comply with American Association of Tissue Banks standards, regulatory requirements, or to improve clarity of the instructions and the process of tissue recovery and packaging.

VAPAHCS shall include with each shipment of autologous bone or skull flap to the contractor, all requested documents, fully completed and signed. If only trauma names (aliases) are available at the time of recovery and packaging of the autograft, patient identification such as the true name and medical record number shall be provided to the contractor when the true identity of the patient becomes known by VAPAHCS.

Upon request by the contractor, VAPAHCS shall provide to the contractor complete copies of the results of bacteriological cultures and/or serological testing results performed by VAPAHCS on the autologous bone or skull flaps corresponding to each shipment of autologous bone or skull flap to the contractor. Such requests shall be limited to purposes of audit, quality assurance, or regulatory requirement.

VAPAHCS shall be solely responsible for obtaining an informed consent from the patient prior to the recovery of autologous tissue, or skull flap bone that is shipped to the contractor. It is agreed between City and Contractor that the recovery of tissue from the patient by VAPAHCS shall be covered by VAPAHCS’s informed consent it obtains and that is applicable to the surgical procedure confirming that there is no warranty as to the viability, suitability, or any other aspect of the patient’s tissue or skull flap bone if, and when re-implanted back in the patient. The tissue recovered by VAPAHCS shall be subject to the cautions and provisions included in, implied, and contemplated by VAPAHCS’s informed consent that is obtained and applicable to the surgical procedure.

4.2. SHIPPING

The contractor shall arrange for and pay for the cost of couriers, shipment, and carriage for donor autologous bone and skull flaps picked up by courier or otherwise shipped from VAPAHCS to the contractor’s facility. The contractor shall facilitate for the return processing, shipping, and handling on all shipments which the contractor returns to VAPAHCS and charge VAPAHCS for said processing, shipping, and handling of the autologous bone and skull flaps in accordance with the fees set forth in the fee schedule.

The contractor shall inspect the outer packaging that autologous bone or skull flaps are received in from VAPAHCS and shall promptly notify VAPAHCS if it determines the outer packaging of any autologous bone or skull flap, or other tissue it receives from VAPAHCS has been breached or is in a condition that renders the autologous bone or skull flap or other tissue compromised or not suitable for re-implantation. Any inspection of autologous bone or skull flaps or other tissue by the contractor shall be of the outer visible packaging only, and not of the bone or other tissue contained within. Therefore, nothing in the contractor’ inspection of the outer packaging that autologous bone or skull flaps and other tissue is received in from VAPAHCS shall be construed in any way to be a determination by the contractor of the usability, safety, suitability, determination of the presence or absence of any communicable disease, or a determination of the presence or absence of any serological or bacteriological testing of the tissue received.

4.3. RIGHT TO REFUSE

The contractor reserves the exclusive right to refuse acceptance of autologous bone, skull flaps, or other tissue it is sent by VAPAHCS, its physicians or staff without obligation or liability. The contractor may exercise this right to refuse acceptance for several reasons, including but not limited to:

a. Failure by VAPAHCS, its physicians and staff to timely and adequately notify The contractor that an autologous bone or skull flap or other autograft tissue has been recovered and is ready for pick-up by The contractor.

b. Failure by VAPAHCS, its physicians and staff to timely make the autograft tissue accessible and available to The contractor’ staff or authorized representatives at the VAPAHCS for pick-up and retrieval for shipment to The contractor.

c. Failure by VAPAHCS, its physicians and staff to utilize contractor provided packaging and storage materials. Deviation from using these materials must be done in a manner that is safe and suitable and will not cause the possibility of personnel exposure to any communicable disease. Deviations from normal packaging materials and/or procedures must be done in conjunction with timely notice to the contractor of a deviation and the nature of the deviation.

d. Failure by VAPAHCS to fully complete the contactor requested preservation forms or to obtain the surgeon’s or other authorized signature at the bottom of the form.

e. Failure by VAPAHCS, its physicians and staff to follow the contractor’s instructions as provided and/or updated as to the correct packaging and shipment of autologous bone or skull flaps or other autograft tissue.

f. Improper and/or unsafe packaging of autologous bone or skull flaps or other autograft tissue by VAPAHCS, its physicians and staff. Improper or unauthorized use of solutions, media, or other materials in the preparation or packaging of the autograft tissue. Infection of the tissue with a biological agent that would render it unsafe or dangerous despite using normally accepted procedures for handling donor tissue and Universal Precautions as published by the CDC.

g. Failure by VAPAHCS to include the prescribed quantity of solidly frozen ice, or other suitable cold packs to the box containing the tissue for shipment to the contractor, or in an adequate quantity, prior to making packaging or storage materials available for pick-up by the contractor or its authorized representative.

4.4. LICENSURE/FEDERAL REGISTRATION

The contractor hereby represents and warrants that it will comply with all standards of procedure and operation required by the American Association of Tissue Banks and all applicable Federal (21 CFR 1271) and State of California laws and regulations throughout the term of this Agreement. These warranties are the contractor' only warranties and they are exclusive an in lieu of all other warranties whether oral or written. The contractor will maintain licensure by the California Department of Public Health Laboratory Field Services as a Tissue Bank and registered with the United States Food and Drug Administration (FDA) for the storage and distribution of human tissue.

4.5. COMPLIANCE WITH STANDARDS

VAPAHCS hereby represents and warrants to the contractor that VAPAHCS will comply with all standards for procedure and operation required of it by The Joint Commission, whether or not VAPAHCS is accredited by The Joint Commission. VAPAHCS will also comply will all applicable Federal (21 CFR 1271), State, and local laws and regulations throughout the term of this Agreement.

4.6. INSTRUCTION MODIFICATION

If VAPAHCS modifies any documents that the contractor has previously approved for VAPAHCS's use in the autologous bone or skull flap recovery process, VAPAHCS shall provide copies of such documents to the contractor for review, and the contractor must first approve all such modifications prior to their use by VAPAHCS. The contractor shall also have the right to require VAPAHCS to use updated the contractor forms and placards whenever they are provided to VAPAHCS or otherwise made available by the contractor.

4.7. STATUS OF PATIENT

VAPAHCS, its physicians, and agents shall timely notify the contractor of the death of patients VAPAHCS is aware of that have provided autologous bone or skull flap to the contractor, and that still have autologous bone or skull flaps banked with the contractor’s autograft storage program. VAPAHCS shall notify the contractor of any change of contact information it knows of for the treating physician for patients that have autologous bone or skull flap on deposit with the contractor.

The contractor shall periodically send a form to VAPAHCS regarding the disposal or continued storage of autologous bone or skull flap. VAPAHCS shall complete the form and return them to the contractor thereby instructing the contractor on the continued storage or destruction of the autologous bone or skull flap stored. Failure to return these patient status forms with best known information within sixty (60) days of receipt of the forms may result in charges for continued storage.

4.8. DESTRUCTION

If, after two (2) years from the date of autologous bone or skull flap recovery and shipment of the autologous bone or skull flap to the contractor for storage, the contractor can no longer contact the patient, identify the patient’s legal guardian, and cannot reasonably ascertain the patient’s treating physician or a medical professional legally authorized to advocate on behalf of the patient, the contractor shall send a certified letter with return receipt to the address where the patient was last known to reside stating this fact and the intention of the contractor to dispose of the autologous bone or skull flap being stored. The contractor shall dispose of the autologous bone or skull flap as biomedical waste under the following conditions:

1) In the event the patient is deceased and/or the contractor has reliably confirmed from public records, or from VAPAHCS, the death of a patient for whom skull flap(s) or autologous tissue has been stored at the contractor’s facility; or

2) Thirty (30) days has passed after the receipt of the notice to the patient/the patient’s legal guardian to contact the contractor regarding continuing autologous bone or skull flap storage arrangements; or

3) Thirty (30) days has passed after return of the letter as undeliverable by the US Postal Service and the contractor has made reasonable attempts to locate the patient; or

4) Passage of time beyond the five (5) year expiration date assigned to the autograft tissue by the contractor, in the absence of written overriding instruction from VAPAHCS or patient’s treating physician; or

5) Nonpayment to the contractor after invoicing for additional storage periods after the initial two-year period for storage of autologous tissue or bone has elapsed by VAPAHCS or Patient, the patient’s legal guardian, or patient’s current healthcare provider to, or in the alternative the absence of instruction to the contractor to arrange to forward the tissue or bone onward to another suitable licensed tissue bank for continued storage; or

6) The contractor has first obtained from VAPAHCS or the patient’s treating physician, the patient, or the patient’s legally authorized representative a signed request for destruction and disposal, a signed authorization for the destruction and disposal of the tissue, or in the event the contractor obtains verifiable proof of the death of the patient or upon expiration of the tissue.

The contractor shall only destroy or dispose of any tissue sent to it by VAPAHCS and that has been accepted by the contractor for storage, by safe and legal means, and such destruction and disposal shall be performed in compliance with all applicable regulatory requirements.

VAPAHCS, its physicians and agents shall not unreasonably withhold authorization for the destruction and disposal of any autologous bone or skull flap or autograft tissue stored by the contractor.

If the contractor is unable to obtain a signed authorization for the destruction and disposal of any tissue sent to it by VAPAHCS, its physicians or staff, and the contractor is unable to independently and reliably ascertain the death of the patient it belongs to, the contractor shall have the right to charge and invoice VAPAHCS for the continued storage of such tissue on an annual basis prepaid until such time that the contractor has reasonably determined that it can legally destroy and dispose of the tissue.

4.9. SERVICES PROVIDED BY contractor

It is agreed by and between the parties that the contractor is providing autograft storage services to VAPAHCS as outlined in this Agreement. The services under this agreement are being rendered by the contractor as an IRS qualified 501(c)3 public charity. It is agreed between the parties that the contractor is not, and it shall not be construed in any way that the contractor is in control, supervision, or direction of patient care. The decision to recover any autograft tissue, or to re-implant it in a patient rests with VAPAHCS and the surgical surroundings, surgical procedures, general medical arts and care provided by VAPAHCS to its patients is outside the services provided by THE contractor. The contractor is not in control of or responsible for the outcome of any surgical procedure performed by VAPAHCS related to this Agreement. The VAPAHCS understands and agrees that the VAPAHCS controls, and is solely responsible for, the autograft tissue while in the VAPAHCS’s possession. VAPAHCS is responsible for the tissue recovery from the patient, processing, storage, labeling, packaging for shipment, and distribution of the tissue to the contractor, as well as after receipt of the tissue that is returned to it from the contractor’ facility including pre-implant storage, processing, and the implant of the tissue into the patient. The contractor does not warrant the success or failure of any medical procedure.

The VAPAHCS and the contractor agree that the contractor controls and is responsible for the handling of the autograft tissue as provided by the VAPAHCS once received and accepted by the contractor at the the contractor facility. The contractor shall only be in control of labeling and processing, if any, that is performed by it, and for storage of the autograft tissue only while the tissue is in the contractor’ custody at its facility.

Furthermore, it is agreed by VAPAHCS and the contractor that at no time shall it be construed by and between the parties that the contractor is providing anything but a service, and that nothing under this Agreement shall be deemed the sale or dispensing of a product, or any act or activity that is subject to the Uniform Commercial Code.

4.10. TRANSPORTATION DELAY AND LOSS OF TISSUE DURING TRANSPORT

The VAPAHCS and the contractor agree that the contractor is responsible for paying for and arranging transportation and shipping of the autograft tissue between VAPAHCS and the contractor’ facility. Because the contractor makes use of couriers, common carrier airlines, and possibly other types of transportation that the contractor is not in direct control of, it is agreed between the parties that the contractor is not responsible for delays, rerouting, or any potential damage to or loss of tissue during transportation between VAPAHCS and the contractor’ facility that is caused by couriers or common carriers. For clarity, the contractor is not responsible for damages, economic loss, bodily harm, or even loss of life that is the result of damage caused to the tissue during transport, or for its loss caused by circumstance or event that may render the tissue unusable or unsuitable for acceptance by the contractor when received at its facility, or after return shipment to VAPAHCS for surgical re-implantation caused during transportation.

The contractor shall use its commercially reasonable efforts to track and mitigate any delay to help ensure the safe and timely shipment of tissue between VAPAHCS and the contractor’ facility.

4.11. FORCE MAJEURE

Performance under this Agreement, or any part thereof, may be excused or delayed, and neither party shall be held in breach of any of its obligations under this Agreement or be liable for damages or offset resulting from such delay if such delay is due to causes beyond the reasonable control of either party such as, but not limited to, acts of God, acts of civil or military authority, terrorism, fires, floods, failure of electrical services or other public utilities, labor troubles, cancellation, delay, or unavailability of essential components, dry ice, equipment, materials, transportation, epidemics, war, or riot.

4.12. COMMENT OR COMPLAINT NOTIFICATION

The contractor and VAPAHCS shall immediately notify the other party upon receipt of any adverse serological or bacteriological test results and/or any adverse reactions, or deviations from procedure either during the autograft tissue recovery or resulting from any use of human autologous bone or skull flap under this Agreement that becomes known to either party. In the event of an adverse reaction, VAPAHCS will immediately notify the contractor for determination of suitability of FDA adverse reaction notification that may be required by 21 CFR 1271.

4.13. RETURN OF TISSUE

The contractor shall promptly return autologous bone and skull flaps, or other autograft tissue after it has received verbal telephonic instructions from an authorized representative of VAPAHCS and is in receipt of a valid purchase order number issued by VAPAHCS for the return handling and shipping fees relating to the tissue stored. The contractor shall have the right to have any order for the return of autograft tissue to VAPAHCS concurrently followed-up with the order in writing via mail or fax to the contractor’ offices. All orders for return of autograft tissue shall be made with reasonable advance notice sufficient to allow the contractor to safely transport the tissue to VAPAHCS, or other designated location without extraordinary means or jeopardizing the safety of personnel or the autograft. Notice for the return of tissue shall be given to the contractor by VAPAHCS as soon as possible, but not later than 24 hours in advance prior to the time the tissue must arrive at the receiving location prior to the scheduled surgery. It is agreed by VAPAHCS that tissue requested for return shall be sent for specific scheduled surgery dates and shall not be ordered for continued day to day storage at VAPAHCS or returned for arrival at VAPAHCS greater than 24 hours prior to the scheduled dates of re-implant of the tissue.

If return of an autograft tissue cannot be accomplished by the contractor to meet a day and time as specified by VAPAHCS because of the unavailability of flights or couriers, the contractor shall have the right to notify VAPAHCS of the situation, and VAPAHCS shall schedule or reschedule surgery times according to its requirements and available transportation schedules. However, the contractor shall use its commercially reasonable efforts to meet the scheduling requirements of the VAPAHCS.

The contractor shall return autograft tissue pursuant to receiving proper legal demand from authorized parties (legal next of kin), government agencies (Office of the Chief Medical Examiner), or funeral director to appropriate and suitable locations. The VAPAHCS agrees to reimburse the contractor in accordance with the fee schedule.

4.14. TRAINING

It is the objective of the contractor for the autologous tissue storage service to run smoothly, without incident or error, and for the benefit of VAPAHCS and the patient. Toward achieving this goal, the contractor makes available periodic in-service training for VAPAHCS’s surgical staff.

VAPAHCS shall make available appropriate operating room staff for reasonable periodic in-service training at times convenient to both VAPAHCS and the contractor. There shall be no additional charge to VAPAHCS or staff for this in-service training.

4.15. OWNERSHIP OF SUPPLIES

Any packaging, storage or written materials provided to VAPAHCS by the contractor are and remain the property of The contractor, Inc. at all times and if lost VAPAHCS shall be charged for replacement cost.

4.16. TERMINATION OF AGREEMENT BY VAPAHCS OR contractor

In the event this agreement is cancelled or terminated by VAPAHCS for any reason, services shall no longer remain in effect after the cancellation or termination.

4.17. MISCELLANEOUS

a. The services provided herein are exempt from HIPPA authorization requirements under HHS Regulations: Uses and Disclosures for Organ, Eye or Tissue Donation Purposes - § 164.512(h).

b. In the event this agreement expires and VAPAHCS continues to send or receive new autologous tissue for storage to the contractor that storage falls under the same terms of the most recent agreement in that was force.

5.1 Task 1 - Enterprise Management Controls.

Deliverables or Deliver Schedule:

The vendor must provide for training to include the process users and end users.

Continue offering a comprehensive, on-site consulting that will assure our process will conform to the Joint Commission Standards and relevant FDA CFR 271 standards.

Provide expertise and assistance for scheduled upgrades to the packaging and services at minimum once every 12 months

6. Performance Monitoring

If there are performance problems with the service, it will be reported to Facility Tissue Management Coordinator and the Contracting Officer’s Representative (COR) to assist. The COR will monitor the execution and contract performance to meet contractual agreement and approve invoices for payment of this contract.

7. Security Requirements

The product will be located in assigned units/wards and will be included in the packaging supplies EIL reviews as assigned by Logistics.

VA Management Official will be appointed by the certification program office to formally authorize operation of the system in accordance with VA Handbook 6500 and 6500.3.

The contractor performance (timely submission of deliverables, compliance with personnel screening requirements, maintenance of security system configurations and participation in annual IT Federal Information Security Management Act (FISMA) assessments ensuring compliance with FISMA.

Ensure yearly FISMA assessments are completed and uploaded in SMART.

7.1 Security Considerations

Vendor contractors requiring access to VA systems will continue to maintain active VA credentials and complete mandatory training as needed.

8. Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI).

N/A

9. Other Pertinent Information or Special Considerations.

The contractor, will enter a contract with VAPAHCS and is the storer of the Autologous tissue. I believe this is the best price for the service and they are equipped to honor the warranty to the satisfaction of the government needs.

a. Identification of Possible Follow-on Work.

Warranty. NOT WITHSTANDING ANY PROVISION IN THIS AGREEMENT, contractor

MAKES NO WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR USE

OF ANY PRODUCT OR SERVICE IT PROVIDES, EXPRESSED OR IMPLIED, IN THIS

DOCUMENT. THERE ARE NO WARRANTIES PROVIDED.

b. Identification of Potential Conflicts of Interest (COI).

There are no anticipated conflicts of interest.

c. Identification of Non-Disclosure Requirements.

N/A

d. Packaging, Packing and Shipping Instructions.

Packaging and shipping will be done by contractor. Goods will be shipped to: VA Palo Alto Health Care Systems (VAPAHCS); 3801 Miranda Avenue, Palo Alto, CA 94304.

e. Inspection and Acceptance Criteria.

The COR will provide inspection to product to issue to units. She will make certain that shipping did not damage the products. .

10. Risk Control.

N/A

11. Place of Performance. VA Palo Alto Health Care Systems (VAPAHCS)

12. Period of Performance.

Performance period is one year from the day of award. The contractor shall provide deliveries and maintenance under this contract during normal VA working hours (8:00 a.m. – 4:30 p.m.), Monday through Friday unless otherwise approved by the Contracting Officer.

Base Year (The contractor, Inc. first Year) – One year from Award date Option Year 1 (2nd year fees) – (2nd year fees) – One year from award date Option Year 2 (3rd year fees) - One year from award date Option Year 3 (4th year fees) - One year from award date Option Year 4 (5th year fees) - One year from award date

.13. Delivery Schedule.

SOW

Task# Deliverable Title Format Number

Calendar Days After CO Start

Standard

Distribution*

Draft - 15

Final - 30

2 Monthly Status Report Contractor-Determined

Format email to COR; Letter

Only to CO Monthly, on 5th Workday

14. Invoice / Payment: The contractor shall submit the invoice at the completion of services to the POC/COR prior to submitting it to OB10 for verification. OB10 shall forward The contractor’s invoice directly to DFAS Austin (also known as the Finance Service Center) for payment. All invoices shall include the Contract number, Purchase Order number, Order Date, Period of Performance, and Description of Services. The invoices shall provide significant detail to enable reconciliation.

15. OB10 electronic registration. VA entered into a relationship with OB10, a global provider of electronic invoicing. With OB10, all Contractors will be able to securely submit invoices directly from their existing billing systems. Contractors can easily submit invoices electronically through OB10.

By submitting invoices electronically through OB10, The contractor will experience prompt payment with reduced exceptions. Your participation is required in order to continue providing product or services to the VA in compliance with the Improper Payments Elimination and Recovery Act of 2010 (IPERA) and Mandate AN97. The rule mandating electronic invoice submission was published on Nov 27, 2012, and has an effective date of Dec 27, 2012.

Mandata AN97 can be located on the Federal Registry at the link provided:

https://federalregister.gov/a/2012-28612 .

16.1 “How-to register with OB10” instructions will be provided to the vendor if needed.

16.2 Vendor e-Invoice Set-Up Information: Contact OB10 at the phone number or email address listed below to begin submitting your electronic invoices to the VA Financial Services Center for payment processing, free of charge. If you have question about the e-invoicing program or OB10, contact the FSC at the phone number or email address listed below:

OB10 e-Invoice Setup Information: 1-877-489-6135

OB10 e-Invoice email: VA.Registration@ob10.com

FSC e-Invoice Contact Information: 1-877-353-9791

FSC e-invoice email: vafsccshd@va.gov

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES (DEC 2022)

(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 Federal Acquisition Regulation (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)…