36C26124R0079.docx

36C26124R0079

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. SIGNAT

URE OF OFFEROR/CONTRACTOR

31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER) 30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION

(REV. 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

36C261-24-AP-2755

36C26124R0079 08-12-2024 Tawnya Krommenhoek tawnya.krommenhoek@va.gov 08-19-2024

12PM

PDT

36C261 Department of Veterans Affairs Network Contracting Office 21 VA Southern Nevada Healthcare System 6900 N. Pecos Road, Building 6 North Las Vegas NV 89086 X 621991 $40 Million N/A X VA Northern California HealthCare System Martinez Outpatient Clinic Transfusion Service 150 Muir Road Martinez CA 94553-4668 36C261 Department of Veterans Affairs Network Contracting Office 21 Southern Nevada Healthcare System 6900 N. Pecos Road, Building 6 North Las Vegas NV 89086

Department of Veterans Affairs Financial Services Center P.O. Box 149971 Austin TX 78714-9971 See CONTINUATION Page This is a Sole Source RFQ to VITALANT (GKT4L2JZJ622) for the purchase of Human Blood and Blood Related Products.

**See Statement of Work and Price List** Period of Performance:

Ordering Period 1: October 1, 2024 – September 30, 2025 Ordering Period 2: October 1, 2025 – September 30, 2026 Ordering Period 3: October 1, 2026 – September 30, 2027 Ordering Period 4: October 1, 2027 – September 30, 2028 Ordering Period 5: October 1, 2028 – September 30, 2029 Quote shall be submitted to David J. Alvarez, Contracting Officer and Tawnya Krommenhoek, Contract Specialist by the date/time listed in box 8.

david.alvarez4@va.gov tawnya.krommenhoek@va.gov See CONTINUATION Page X X David J. Alvarez

VA-VHA-RPOW-2024-0082

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

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

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C261 David J. Alvarez Department of Veterans Affairs Network Contracting Office 21 VA Southern Nevada Healthcare System 6900 N. Pecos Road, Building 6 North Las Vegas NV 89086

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

3. INVOICES: Invoices shall be submitted in arrears:

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

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

All invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests. VA's Electronic Invoice Presentment and Payment System - The FSC uses a third-party contractor, Tungsten, to transition vendors from paper to electronic invoice submission. Please go to this website:

http://www.tungsten-network.com/US/en/veterans-affairs/ to register and begin submitting electronic invoices, free of charge. The Department of Veterans Affairs Tungsten Number is: AAA544240062 (this allows you to file invoices online for free.)

More information on the VA Financial Services Center is available at:

http://www.fsc.va.gov/einvoice.asp.

Vendor e-Invoice Set-Up Information:

If you have questions about the e-invoicing program or Tungsten, please contact the FSC at the phone number or email address listed below:

• Tungsten e-Invoice Setup Information: 1-877-489-6135

• Tungsten e-Invoice email: VA.Registration@Tungsten-Network.com

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

• FSC e-invoice email: vafsccshd@va.gov

B.2 PRICE/COST SCHEDULE

The Contractor shall furnish Human Blood and Blood Related Products for the Department of Veterans Affairs in accordance with the specifications listed herein.

The guaranteed minimum award amount for this contract is $100.00. The maximum aggregate value of orders that can be placed under this contract is $700,000.00. The Government does not guarantee that it will place any orders under this contract in excess of the guaranteed minimum award amount. Quantities provided are estimates only and will be used for price evaluation.

ITEM INFORMATION

Ordering Period ONE (1) - Blood and Blood Byproducts

Please see attached Price List for applicable Ordering Period.

Contract Period: Ordering Period ONE (1) POP Begin: 10-01-2024 POP End: 09-30-2025 PRINCIPAL NAICS CODE: 621991 - Blood and Organ Banks PRODUCT/SERVICE CODE: 6505 - Drugs and Biologicals

MANUFACTURER PART NUMBER (MPN): N/A

LOCAL STOCK NUMBER: N/A

Ordering Period TWO (2) - Blood and Blood Byproducts

Contract Period: Ordering Period TWO (2) POP Begin: 10-01-2025 POP End: 09-30-2026 PRINCIPAL NAICS CODE: 621991 - Blood and Organ Banks PRODUCT/SERVICE CODE: 6505 - Drugs and Biologicals

Ordering Period THREE (3) - Blood and Blood Byproducts

Contract Period: Ordering Period THREE (3) POP Begin: 10-01-2026 POP End: 09-30-2027 PRINCIPAL NAICS CODE: 621991 - Blood and Organ Banks PRODUCT/SERVICE CODE: 6505 - Drugs and Biologicals

Ordering Period FOUR (4) - Blood and Blood Byproducts

Contract Period: Ordering Period FOUR (4) POP Begin: 10-01-2027 POP End: 09-30-2028 PRINCIPAL NAICS CODE: 621991 - Blood and Organ Banks PRODUCT/SERVICE CODE: 6505 - Drugs and Biologicals

Ordering Period FIVE (5) - Blood and Blood Byproducts

Contract Period: Ordering Period FIVE (5) POP Begin: 10-01-2028 POP End: 09-30-2029 PRINCIPAL NAICS CODE: 621991 - Blood and Organ Banks PRODUCT/SERVICE CODE: 6505 - Drugs and Biologicals

B.3 DELIVERY SCHEDULE

VA Martinez Outpatient Clinic Transfusion Service 150 Muir Road Martinez, CA 94553

USA

VA Martinez Outpatient Clinic Transfusion Service 150 Muir Road Martinez, CA 94553

USA

VA Martinez Outpatient Clinic Transfusion Service 150 Muir Road Martinez, CA 94553

USA

VA Martinez Outpatient Clinic Transfusion Service 150 Muir Road Martinez, CA 94553

USA

VA Martinez Outpatient Clinic Transfusion Service 150 Muir Road Martinez, CA 94553

USA

B.4 STATEMENT OF WORK

STATEMENT OF WORK

3.1 BACKGROUND

The Department of Veterans Affairs (VA) Veterans Health Administration (VHA) has a requirement for human blood products and related services. The contractor shall be a blood bank and shall provide supplies and services that conform to the contract.

Period of Performance: 5-year ordering period with five one-year pricing periods.

The proposed period of performance is:

3.2 QUALIFICATIONS

All blood products shall be collected, processed, labeled, tested, packaged, and shipped in accordance with all regulations of the FDA, Center for Biological Evaluation and Review (CBER), as described in the Code of Federal Regulations (CFR) Title 21, Parts 600, 601, 606, 607, 610, 640, and 660, the Clinical Laboratory Improvement Amendments (CLIA), and the California Department of Public Health (CDPH). In addition, the contractor must adhere to 29 CFR Part 1910.1030 Occupational Safety and Health Administration (OSHA) standards for the Occupational Exposure to Blood Borne Pathogens Needlestick and Other Sharps Injuries, and shall be accredited by the Joint Commission (JC) and American Association of Blood Banks (AABB), and licensed with the United States (US) Food and Drug Administration (FDA). The contractor must have a current US registration or license which is issued by the FDA Director of the Bureau of Biologics under Section 351 of the Public Health Service Act as amended, 42 United States Code (USC) Section 262, as a source of supply for leukoreduced red blood cells. Should there be any interstate shipment of blood product(s), then approval must be authorized under Section 251 of the Public Health Service Act, as amended, 42 Section 262. The contractor shall provide current documentation of above qualifications, certifications, registrations, licensure, and accreditations to the CO upon any expiration or organizational change. The contractor shall notify the CO within fifteen (15) minutes of learning about any threatened or actual revocation, suspension, or termination, or material modification of an accreditation, certification, licensure, or permit of the contractor’s blood bank. Donor testing laboratories utilized by the contractor must be registered or licensed with the FDA, be CLIA certified, and shall have a current clinical laboratory license or permit from a state’s department of public health that is applicable to the location of the contractor’s blood bank and VA facility. The contractor shall provide current documentation of above qualifications, certifications, registrations, licensure, and accreditations to the CO upon any expiration or organizational change. The contractor shall include the business name, a POC, the address, and telephone number of donor testing laboratories utilized by the contractor whenever there is a change in a donor testing laboratory utilized.

3.3 SPECIFICATIONS

3.3.1 All cellular blood products (platelets and RBCs) shall be leukoreduced.

3.3.2 Pre-storage leukoreduced RBC units must be provided.

3.3.4 All blood components needed for transfusion(s) must be provided as listed in the price cost schedule of supplies and services.

3.3.5 Allogeneic blood products must be typed for ABO and Rho(D) in accordance with licensedmethodologies and must be tested for all transfusion transmitted disease markers currently required by both the FDA and AABB.

3.3.6 All blood products must be screened and processed utilizing the most current methods and in accordance with all federal, state, and local laws, rules, regulations, and guidelines; including but not limited to, the AABB, FDA, and the US Department of Health and Human Services’ (HHS’) current Good Manufacturing Practices.

3.3.7 All blood shall be collected by closed system under aseptic conditions and shall be stored in currently approved, appropriate solutions and the container shall be correctly labeled. The label shall also bear the expiration date of the contents which shall not exceed forty-two (42) days from date of collection of source blood when collected and stored with anti-coagulant citrate phosphate, dextrose adenine solution (AS) or thirty-five (35) days from the dated of collection of source blood when collected and stored with anticoagulant citrate phosphate dextrose adenine solution.

3.3.8 All blood supplied must be grossly free of visible hemolysis, excessive chyle, and clots.

3.3.9 Autologous blood products must be typed for ABO and Rho(D) in accordance with licensed methodologies and must be tested for all transfusion transmitted disease markers currently required by the FDA.

3.3.10 All blood must be tested as required by the FDA, AABB, HHS CGMP, and State of California’s laws, rules, and regulations.

3.3.11 In the event of a recall, the contractor shall immediately send copies of the recall request to the POC, transfusion service, and transfusion service medical director at the VA.

3.3.12 Unless otherwise specified, all references to “days” are calendar and not business days.

3.3.13 Autologous blood donors that have units drawn at the contractor’s collection site(s) shall not be required to pay any charges. Contractor shall bill the VA facility for the blood and apply a handling fee for an overall charge.

3.3.14 Autologous donors that have units of blood drawn at facilities other than the contractor’s collection site(s) may have their blood delivered to the contractor for shipment to the VA facility.The contractor may charge a processing and handling fee in accordance with the price cost schedule of supplies and services in the contract.

3.3.15 The contractor shall provide blood products and related services as available when ordered.

3.3.16 The contractor shall provide the most current version of the Circular of Information for the Use of Human Blood and Blood Components to the laboratory at the Stockton VA Community Based Outpatient Clinic.

3.3.17 FFP products and/or Cryo products shall be direct sale products.

3.4 DONOR REQUIREMENTS

3.4.1 One hundred (100) percent of blood supplied by the contractor shall be donor blood as defined in CFR Title 21, Chapter I, Subchapter F, Part 606, Subpart G, Section §606.121(c)(8)(v)(B) where a volunteer donor is a person who does not receive monetary payment for blood donation. Benefits, such as time off work, membership in blood assurance programs, and non-replacement fees that are not readily converted to cash, do not constitute any monetary payment.

3.4.2 All blood must be collected from donors in accordance with the requirements of the AABB and FDA.

3.5 DONOR SELECTION CRITERIA

3.5.1 The contractor shall maintain a blood donor list with unique identifier numbers. The list shall indicate the date the blood of a particular donor was furnished to the VA.

3.5.2 All donor selections shall be in accordance with criteria established by the AABB and FDA.

3.5.3 Blood samples that test positive during unit screening shall not be used for transfusion if the results are outside the established limits set by the FDA and AABB. When the FDA or AABB requires a new transfusion transmitted disease marker, it shall be performed by the contractor.

3.6 REFERENCE LAB SERVICES

3.6.1 Reference laboratory services must be available twenty-four (24) hours per day, seven (7) days per week, and three-hundred and sixty-five (365) days per year.

3.6.2 Preliminary results of lab services must be provided within four (4) hours for STAT and as soon as possible (ASAP) orders, and within twenty-four (24) hours for routine orders.

3.6.3 Preliminary results must be provided within four (4) hours for urgent care situations, and within twenty-four (24) hours in non-urgent care situations, when red cell antibody identification reference lab services are ordered.

3.6.4 Screening for negative blood per antigen includes testing donor units for RBC antigens and select units negative for a given antigen.

3.6.5 Crossmatched, or HLA-matched plateletpheresis, shall include a compatibility test between recipient serum and donor platelets. Crossmatched or HLA matched platelet donor recruitment shall include a donor known from previous testing to be compatible with the recipient.

3.6.6 The contractor shall provide educational programs at no charge to the VA that are consistent with the programs offered at no charge to other non-VA contracted customers.

3.7 COLLECTION, PROCESSING, AND TYPING OF BLOOD

3.7.1 Blood shall be typed for ABO and Rh antigens and labeled in accordance with the methods recommended in the current Standard for Blood Banks and Transfusion Services and Technical Methods and Procedures that is published by the AABB.

3.7.2 If there is an error by the contractor in the blood typing, the contractor shall pick up the errant blood immediately and a credit for the errant blood shall be given to the VA.

3.7.3 All blood shall be collected by a closed system under aseptic conditions and shall be processed in appropriate solutions and the container labeled. The label shall bear the expiration date of the contents which shall not exceed the following:

3.7.3.1 Twenty-one (21) days from the date of collection of source blood, or thirty-five (35) days from the date of collection of source blood, if when collected, it is stored with anticoagulant citrate phosphate dextrose adenine solution.

3.7.3.2 Forty-two (42) days from date of collection for blood collected in Adsol.

3.7.4 Irradiated units includes treating units with gamma irradiation to prevent lymphocyte proliferation and transfusion-associated graft vs. host disease.

3.7.5 Pathogen-reduced products that have been approved by the FDA are acceptable in place of irradiated units only when approved by the FDA.

3.7.6 CMV negative blood products shall be screened by the contractor to ensure the absence of antibodies to CMV.

3.8 SHELF LIFE

3.8.1 All blood products must be labeled, stored, and shipped in accordance with the current regulations of both the FDA and the AABB. In the event that these regulations change during the course of the contract, the contractor shall implement the necessary changes as directed/recommended by the regulatory and accrediting agencies.

3.8.2 For routine orders, allogeneic blood products must be supplied with appropriate remaining shelf life, as detailed below.

3.8.3 For STAT orders, the contractor shall provide units with the appropriate remaining shelf life whenever possible, however, the VA understands that the urgency of the situation and the availability of the blood product(s) may preclude this possibility.

3.8.4 The VA has in place the suitable temperature-monitored freezer, refrigerator, and platelet incubator/agitator for appropriate storage of blood products.

3.9 NOTIFICATIONS

3.9.1 With respect to contractor supplied blood, if a blood donor originally tests negative at the time of donation, but then during a later donation, tests repeatedly reactive for the human immunodeficiency virus (HIV) antibody and/or other diseases as required by the FDA and/or AABB, then the contractor shall provide the VA with the results of follow-up testing required or recommended by the FDA. The contractor shall complete the follow-up testing within thirty (30) days after the donor’s repeatedly reactive screening test. Under no circumstances shall the contractor ever reveal the identity of the blood donor.

3.9.2 The contractor shall promptly notify the VA when additional information indicates that blood provided may adversely affect a transfusion recipient, provided that the contractor shall not reveal the identity of the blood donor.

3.9.3 Upon discovery, the VA shall report to the contractor any blood lost or missing due to shipping error, and/or possible infectious disease or other serious complication associated with transfusion which may resulted from the blood, including without limitation, suspected post transfusion hepatitis, transfusion associated HIV or human T-cell lymphotropic virus (HTLV) infection, and/or any other transfusion related infections such as malaria, babesiosis, bacterial contamination or infection, and death due to adverse event (AE). VA shall cooperate with contractor’s investigation of any AE and provide de-identified information regarding the recipient of the blood upon forms provided by the contractor, to the extent permissible under the applicable regulations of patient confidentiality.

3.9.4 VA will make available to the contractor information concerning transfusions to include product names, lot identifications and quantities, any therapeutic AE, complaints, or other pertinent information relating to blood products.

3.9.5 VA shall keep complete and accurate records of patients supplied with blood, including product name, lot identifications and quantities, any therapeutic AEs, complaints, and any pertinent information relating to the blood.

3.9.6 All notices given or required in the contract shall be provided to each of the parties in writing and delivered by certified or registered US first class mail, return receipt requested, or by commercial overnight courier service which provides proof of delivery to the name(s) and address(es) set forth in the signature block.

3.9.7 The VA transfusion service shall report by telephone within twenty-four (24) hours to the contractor any life-threatening AEs, and if appropriate, make arrangements to have a specimen of patient’s blood, and the remaining portion of the blood component in question, sent to the contractor for testing at no additional charge to the Government.

3.10 BUSINESS ASSOCIATE AGREEMENT (BAA) REQUIREMENT

3.10.1 Contractors that are not covered entities under the Health Insurance Portability and Accountability Act (HIPAA) shall be required to sign a BAA before the VA places any orders for apheresis or reference lab services, and before the VA provides any VA patient’s protected health information (PHI) to the contractor in any case where PHI is requested.

3.10.2 “Business Associate” shall have the same meaning as described at 45 C.F.R. § 160.103. “Covered Entity” shall have the same meaning as the term is defined at 45 C.F.R. § 160.103. “Protected Health Information” or “PHI” shall have the same meaning as described at 45 C.F.R. § 160.103.

B.4 PACKAGING AND MARKING

4.1 Each shipment shall be properly packaged, labeled, and accompanied by an itemized shipping list in accordance with the contract. An authorized individual will sign for receipt of blood products.

4.2 Blood products shall be labeled in accordance with all FDA requirements, including kind of component, blood group and type (ABO/Rh), expiration date, unique donor unit identification, and storage and handling.

4.3 All blood products must be labeled according to the most current International Standard for Blood and Transplant (ISBT 128) standard. The ISBT 128 standard shall be used for all deliverables.

4.4 All blood shall be packaged in such a way as to maintain FDA required temperature ranges during shipping. Red cell components shall be maintained at 1° to 10 ° Celsius (° C), frozen plasma components shall be maintained at below – 18 ° C, and platelet components shall be maintained at 20° to 24 ° C.

4.5 Packaging shall be of a protective quality to ensure that the product is undamaged during handling.

B.5 DELIVERIES, RETURNS, AND SPECIMEN PICK-UP

5.1 DELIVERIES

5.1.1 The contractor shall make every effort to deliver routine orders during the time of day suitable to, and as requested by, the VA.

5.1.2 The contractor shall have sole responsibility for the proper care and handling of all blood products until delivery and acceptance has taken place at the designated room at the applicable VA. All deliveries shall be delivered to the VA’s transfusion service(s) at the following address(es):

VA Northern California Health Care System Martinez Outpatient Clinic Transfusion Service 150 Muir Road Martinez, CA 94553-4668

5.1.3 All shipments under the contract shall be accompanied by delivery tickets or sales slips that shall contain the following minimum information: name of supplier/contractor, contract number, date of purchase, purchase order number, itemized list of supplies or services furnished, quantity, unit price, extended price of each item, less applicable discounts, and the date of delivery or shipment.

5.1.4 Orders will be categorized into three (3) types: routine, stock, and STAT orders. These categories are as follows:

5.1.4.1 Routine orders – Shipments of blood products that are ordered on an “as needed” basis. The contractor shall make every effort to make routine deliveries during the time of day suitable to, and as requested by, the VA transfusion service.

5.1.4.2 Stock orders – Shipments of blood products to maintain minimum inventory levels or blood products ordered to fulfill a standing request. One (1) scheduled delivery shall be made on Mondays, Wednesdays, and Fridays. Stock deliveries will not be made on holidays, and alternate delivery days and times will be coordinated between the contractor and VA transfusion service to make up for any missed deliveries due to a holiday. All stock orders shall be delivered before 1 p.m. PST.

5.1.4.3 STAT orders – An emergent, unscheduled need for blood products so acute that a patient’s life could be jeopardized if the request for blood products is unfulfilled. STAT orders must be delivered within one (1) hour. The VA shall make reasonable efforts to minimize the frequency of STAT orders.

5.1.5 The contractor shall make every effort to ensure that delivery of autologous blood components are made prior to the applicable scheduled surgeries.

5.1.6 Deglycerolized cells shall be delivered to the VA within four (4) hours of preparation to assure adequate dating.

5.1.7 The contractor shall provide deliveries of blood products twenty-four (24) hours per day, seven (7) days per week, three-hundred and sixty-five (365) days per year.

5.1.8 Within ten (10) days after any delivery order award, the contractor shall submit a proposal that includes the route (including VA facility room number) and time(s) of delivery it proposes in order to facilitate coordination of deliveries with the VA. Agreed upon schedules may be adjusted periodically.

5.1.9 Once units are accepted by the VA, those units become the property of the VA, and payment will be made appropriately, based on contract terms and proper invoicing. Deliverables are not to be treated as though they are on consignment. However, for inventory control purposes, efforts will be made by the VA transfusion service to assist the contractor and other facilities in meeting patient transfusion needs.

5.1.10 The contractor shall own, control, and solely be responsible for any loss, destruction, or damage to the blood product(s) until delivered or received and accepted. After such delivery or receipt and acceptance, the VA shall own the blood. The VA also agrees and acknowledges that no blood product(s) supplied by the contractor, including part and or derivatives thereof, shall be sold, bartered, traded, or exchanged by the VA without prior authorization from the contractor.

5.1.11 Upon delivery of the blood product(s), the VA transfusion service shall inspect the blood.

5.1.12 Upon acceptance of the blood product(s), the VA shall maintain proper refrigeration or other proper storage facilities for the blood product(s) in compliance with all regulations, as well as the standards of the AABB, as applicable.

5.2 RETURNS

5.2.1 When the VA returns units prior to expiration in accordance with the contractor’s return policy, the contractor shall credit the VA for units which are returned. The contractor shall be responsible for the packaging of blood products for shipment for return(s) or redistribution(s).

5.2.2 The VA will comply with all requirements and regulations associated with the recall and withdrawal of blood products from its inventory.

5.2.3 Credit for returned, unacceptable, transferred, recalled, withdrawn, or rotated blood products shall be included on the billing statements/invoices, along with, the date of return, within thirty (30) days of the return, unaccepted item(s), transfer, recall, withdrawal, or rotation of blood product(s).

5.2.3.1 Full credit shall be given by the contractor, if for a technical reason, the blood component cannot be used, regardless of the expiration date, provided the Government notifies the contractor within twenty-four (24) hours of discovery and the VA transfusion service completes the appropriate documentation.

5.2.3.2 Full credit shall be given by the contractor for any blood product(s) returned or exchanged before the expiration date.

5.2.3.3 The contractor shall assist with, and facilitate the transfer of all blood components, when a transfer is conducted to ensure its use. This includes irradiated and other transferrable blood components.

5.2.4 The contractor shall remove rejected blood products within forty-eight (48) hours of notice of rejection.

5.3 SPECIMEN PICK-UP

5.3.1 The contractor shall pick-up specimens for testing from the VA’s transfusion service at the following address:

VA Northern California Health Care System Martinez Outpatient Clinic Transfusion Service 150 Muir Road Martinez, CA 94553-4668

5.3.2 Specimens for reference lab testing will be picked-up within the time specified as follows:

5.3.2.1 STAT orders: Specimens will be picked-up within one (1) hour of order.

5.3.2.2 ASAP orders: Specimens will be picked-up within two (2) hours of order.

5.3.2.3 Routine orders: Specimens will be picked-up within twenty-four (24) hours of order.

B.6 CONTRACT ADMINISTRATION DATA

6.1 AUTHORIZED REPRESENTATIVES

The primary Contracting Officer (CO) and Contracting Specialist (CS) for this contract are:

David J. Alvarez, CO (David.alvarez4@va.gov) Tawnya Krommenhoek, CS (tawnya.krommenhoek@va.gov)

6.1.2 Each VA facility may have its own POC. The primary POC(s) for projects under this contract is/are:

TBD

6.1.3 Each VA facility may have its own secondary/alternate POC(s) The secondary/alternate POC(s) for projects under this contract is:

TBD

6.1.4 Each of the VA facility’s primary and/or secondary/alternate POC(s) will be responsible for technical monitoring of the contractor's performance and deliveries. The CO and the POC and/or secondary/alternate POC shall work together to ensure that all contractual requirements are being met. The POC(s) will interpret specifications or technical portions of the work. The POC(s) is/are not authorized to perform, formally or informally, any of the following actions:

6.1.4.1 Promise, award, agree to award, or execute any contract, contract modification, or notice of intent that changes or may change the contract.

6.1.4.2 Waive or agree to modification of the schedule.

6.1.4.3 Make any final decision on any contract matter subject to the disputes clause;

6.1.4.4 Terminate, for any reason, the contractor's right to proceed;

6.1.4.5 Obligate in any way, the payment of money by the Government. Only a warranted CO is authorized to obligate funds on this or any other contract action.

6.1.5 The contractor shall immediately notify the CO in writing if the POC(s) or secondary/alternate POC(s) has/have taken an action (or fails to take action) or issues directions (written or oral) that the contractor considers to exceed the above limitations.

6.1.6 The contractor shall provide the CO information copies of all correspondence provided to the POC(s).

6.2 ORDERS

6.2.1 The contractor shall use reasonable efforts to supply the blood product(s) and related service(s) when the blood product(s) and/or related service(s) is/are ordered. In the event that the contractor is unable to fill an order, the contractor shall notify the VA transfusion service immediately upon determination that is not be able to fill an order, in which event, the VA shall complete the order elsewhere. Ordering shall be conducted in accordance with applicable laws and the contract.

6.2.2 Orders may be placed via email, facsimile, electronic data interchange (EDI), telephone, in hard copy format, or in any other manner consistent with accepted commercial business practices.

6.2.3 The CO may designate representatives and alternate representatives to place orders against the contract. Authority limitations for POC(s) and Alternate POC(s) shall be established through individual appointment letters signed by the CO. The CO, POC(s), and Alternate POC(s) are the only individuals authorized to place orders against the contract.

6.2.4 The representative(s) of the VA transfusion service may place orders against a valid contract on an as needed basis within the terms of the contract. Each individual order shall describe the tasks, services, and/or deliverables required.

6.2.5 The contractor shall notify the VA transfusion service if any order(s) are modified. Modified orders for product(s) or service(s) shall be approved by the applicable VA transfusion service either verbally, by email, or by facsimile, prior to the shipment of any such products. The applicable VA transfusion service reserves the right to refuse any modified product(s) offered by the contractor.

6.2.6 The contractor shall have the ability to receive orders via email and fax transmission and shall provide the applicable email address and fax number below. The contractor shall also provide a telephone number, name, and title as a POC for orders.

Hospital Services Department:__________________________ Name/Title:_________________________________________ Email Address_______________________________________ Phone Number_______________________________________ Fax Number_________________________________________

6.3 INDIVIDUALS AUTHORIZED TO PLACE ORDERS

VA authorizes the following entities to place orders:

CO, POC, and Alternate POC

6.4 INVOICES

6.4.1 An itemized invoice shall be submitted monthly or upon expiration of this contract, whichever occurs first, for all deliveries made during a billing period and for which payment has not been received.

6.4.2 Fees that are included on an invoice shall be itemized as processing services or blood services.

6.5 MANAGEMENT CONTROL

The contract holder shall provide to the CO a list of all teaming partners or subcontractors within thirty (30) calendar days after order award. As subcontractors and/or teaming partners are added, and/or deleted, an updated listing shall be provided to the CO within thirty (30) calendar days of such change. All contract holder personnel shall display identification badges at all times while charging hours to an order or while at a Government or Government contractor location. Authorized Government personnel shall accompany all visits to VA program offices, unless other specific arrangements have been made.

6.6 POST AWARD PERFORMANCE CONFERENCE

A post award conference shall be scheduled with the contractor if deemed necessary for contract orientation purposes.

6.7 REPORTS

6.7.1 Reference laboratory reports shall be provided by telephone and facsimile to the VA transfusion service as soon as testing is completed. A written report shall be issued within seven (7) business days following the telephone report.

6.7.2 Complicated reference cases may take longer to report and shall be handled on a case by case basis. Mutually agreeable reporting requirements shall be determined between the VA transfusion service and contractor for more complicated reference cases.

6.8 PRICING DATA

6.8.1 In the event that there is an expansion of blood testing requirements mandated by the FDA during the contract period, specific price adjustments may be requested by the contractor to address the cost of the additional testing. In the event that this should occur, a letter detailing the rationale for the price increase must be submitted to the CO at least thirty (30) days before the intended implementation date. The letter may be mailed or emailed to the CO, and a contract modification may be written. Informal price and cost data shall be included with any request for a price adjustment. The determination as to the sufficiency of the informal price and cost data shall be made by the CO. Cost and price data must be sufficient to be able to determine if a price increase is fair and reasonable.

6.8.2 Any order already placed shall not be affected by any change to contract pricing.

6.9 SMOKING POLICY

Smoking is not permitted within or around VA facility grounds, except in designated areas.

6.10 PARKING

It is the responsibility of the contractor’s personnel or other delivery personnel to park in the appropriate designated parking areas. Parking information is available from the applicable VA police and security service(s). VA facility(ies) will not provide reimbursement for or invalidate parking violations of the contractor’s personnel or any other delivery personnel under any circumstance(s).

6.11 RECORDS MANAGEMENT OBLIGATIONS

A. Applicability This clause applies to all Contractors whose employees create, work with, or otherwise handle Federal records, as defined in Section B, regardless of the medium in which the record exists.

B. Definitions “Federal record” as defined in 44 U.S.C. § 3301, includes all recorded information, regardless of form or characteristics, made or received by a Federal agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them.

The term Federal record:

1. includes VHA records.

2. does not include personal materials.

3. applies to records created, received, or maintained by Contractors pursuant to their VHA contract.

4. may include deliverables and documentation associated with deliverables.

C. Requirements

1. Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

2. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

3. In accordance with 36 CFR 1222.32, the Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

4. VHA and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of VHA or destroyed except in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage, or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, the Contractor must report to VHA. The agency must report promptly to NARA in accordance with 36 CFR 1230.

5. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records, or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records, and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records, and/or equipment is no longer required, it shall be returned to VHA control or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand-carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

6. The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material, and/or records generated under, or relating to, contracts. The Contractor (and any sub-contractor) is required to abide by Government and VHA guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

7. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with VHA policy.

8. The Contractor shall not create or maintain any records containing any non-public VHA information that is not specifically tied to or authorized by the contract.

9. The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act.

10. The VHA owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which VHA shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

11. Training. All Contractor employees assigned to this contract who create, work with or otherwise handle records are required to take VHA-provided records management training. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

D. Flow down of requirements to subcontractors

1. The Contractor shall incorporate the substance of this clause, its terms, and requirements including this paragraph, in all subcontracts under this [contract vehicle], and require written subcontractor acknowledgment of same.

2. Violation by a subcontractor of any provision set forth in this clause will be attributed to the Contractor.

(End of SOW)

36C26124R0079

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SECTION C - CONTRACT CLAUSES

C.1 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):

https://www.acquisition.gov/browse/index/far https://www.va.gov/oal/library/vaar/

(End of Clause)

C.2 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2023)

(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.