36C24826R0066.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

36C24826R0066 12-12-2025

Susan Rodriguez-Perez 407-646-4004 01-12-2026 11:00 am EST

36C248 Department of Veterans Affairs Network Contracting Office 8 (NCO 8) Orlando VA Healthcare System 13800 Veterans Way Orlando FL 32827

X

621991

$40 Million

N/A

X

Department of Veterans Affairs Orlando VA Healthcare System 13800 Veterans Way

Orlando FL 32827

36C248

Department of Veterans Affairs Network Contracting Office 8 (NCO 8) Orlando VA Healthcare System

Department of Veterans Affairs Financial Services Center

P.O. Box 149971 Austin TX 78714-9971

(877) 353-9791 (512) 460-5429

See CONTINUATION Page

Solicitation for Whole Blood Products and related services for VISN 08 facilities.

All requests for clarification are due no later than December 24,2025 at 11:00 am EST.

See CONTINUATION Page

X X

X 1

36C24826R0066

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- (SEE ATTACHMENT D.1)

B.3 DELIVERY SCHEDULE

B.4 STATEMENT OF WORK (SOW)

SECTION C - CONTRACT CLAUSES

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

AND COMMERCIAL SERVICES (NOV 2023)

C.2 52.201-1 ACQUISITION 360: VOLUNTARY SURVEY (SEP 2023)

C.3 52.216-18 ORDERING (AUG 2020)

C.4 52.216-19 ORDER LIMITATIONS (OCT 1995)

C.5 52.216-22 INDEFINITE QUANTITY (OCT 1995)

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) ...35

C.8 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

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

2018)

C.10 VAAR 852.246-71 REJECTED GOODS (OCT 2018)

C.11 VAAR 852.247-71 DELIVERY LOCATION (OCT 2018)

C.12 VAAR 852.247-73 PACKING FOR DOMESTIC SHIPMENT (OCT 2018)

C.13 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (JAN 2025)

C.14 MANDATORY WRITTEN DISCLOSURES

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

D. 1 ATTACHMENT 1 – PRICE/COST SCHEDULE_BAY PINES

D. 2 ATTACHMENT 2 – PRICE/COST SCHEDULE_MIAMI

D. 3 ATTACHMENT 3 – PRICE/COST SCHEDULE_ORLANDO

D. 4 ATTACHMENT 4 – PRICE/COST SCHEDULE_TAMPA

D. 5 ATTACHMENT 5 – PRICE/COST SCHEDULE_WPB

D. 6 ATTACHMENT 6 – PRICE/COST SCHEDULE_NFSG

D. 7 ATTACHMENT 7 - PAST PERFORMANCE QUESTIONNAIRE

SECTION E - SOLICITATION PROVISIONS

E.1 INSTRUCTIONS TO OFFERORS—COMMERCIAL ITEMS

E.2 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

E.3 52.204-29 FEDERAL ACQUISITION SUPPLY CHAIN SECURITY ACT

ORDERS—REPRESENTATION AND DISCLOSURES (DEC 2023)

E.4 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

E.5 52.216-1 TYPE OF CONTRACT (APR 1984)

E.6 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.7 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.8 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)

E.9 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (NOV 2021)

E.10 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (MAY 2024)

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 36C248 Ferdinand Rodriguez;

Email: Ferdinand.Rodriguez@va.gov

Contract Specialist Susan Rodriguez-Perez;

Email: Susan.Rodriguez-Perez@va.gov.

Department of Veterans Affairs Network Contracting Office 8 (NCO 8) Orlando VA Healthcare System

1.1.2 Each VA Facility may have its own COR. The primary COR(s) under this proposal is/are:

COR: (to be provided upon award)

1.1.3 Each VA facility may have its own secondary/alternate COR(s). The secondary/alternate COR(s) under this proposal is/are:

Alt COR: (to be provided upon award)

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

1.1.4.1 Promise, award, agree to award, or execute any contract, contract modification, or notice of intent that changes or may change this contract;

1.1.4.2 Waive or agree to modification of the delivery schedule;

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

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

1.1.4.5 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.

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

1.1.6 The contractor shall provide the CO information copies of all correspondence to the COR(s).

1.2. POST AWARD PERFORMANCE CONFERENCE

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

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 upon acceptance of goods/services.

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.

http://www.tungsten-network.com/US/en/veterans-affairs/

5. FSC MANDATORY ELECTRONIC INVOICE SUBMISSION INSTRUCTIONS: Contractors are required to submit payment requests in electronic form in accordance with the submission instructions below.

TUNGSTEN ELECTRONIC INVOICE SUBMISSION

FSC e-INVOICE PROGRAM THRU AUSTIN PORTAL

FSC MANDATORY ELECTRONIC INVOICE SUBMISSION FOR AUSTIN PAYMENTS

Vendor Electronic Invoice Submission Methods:

Facsimile, e-mail, and scanned documents are not acceptable forms of submission for payment requests. Electronic form means an automated system transmitting information electronically according to the accepted electronic data transmission methods below.

a) 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 begin submitting electronic invoices, free of charge.

b) A system that conforms to the X12 electronic data interchange (EDI) formats established by the Accredited Standards Center (ASC) chartered by the American National Standards Institute (ANSI). The X12 EDI Web site (http://www.x12.org)

Vendor e-invoice Set-Up Information:

Please contact Tungsten 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 Tungsten, please contact the FSC at the phone number or email address listed below.

a) Tungsten e-Invoice Setup Information: 1-877-489-6135

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

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

d) FSC e-invoice email: vafsccshd@va.gov

6. The Contractor is advised that only the Contracting Officer, acting within the scope of the contract and his/her duties and responsibilities and after advice and consultation with the point of contact has the authority to make changes that will affect contract prices, quantity, quality, delivery terms and conditions, or the term of the contract. In no event shall any understanding or agreement, modification, change order, or other matters in deviation from the terms of this contract between Contractor and a person other than the Contracting Officer be effective or binding upon the Government. All such actions must be formalized by the proper contractual document executed by the Contracting Office.

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- (SEE ATTACHMENT D.1)

The quantities are estimated quantities only and shall be considered nonbinding.

The guaranteed minimum for the fiscal year in which the contract was awarded shall be $1,000.00.

The total maximum amount of services acquired under this contract shall not exceed $49,000,000.00.

B.3 DELIVERY SCHEDULE

ITEM

NUMBER

SHIPPING INFORMATION QUANTITY DELIVERY DATE

0001 SHIP TO:

Department of Veterans Affairs

VISN CONTRACT ALL

STATIONS

USA

See B.2 Price/Cost Schedule

3/01/26-02/28/27

FOB: DESTINATION

1001 SHIP TO:

Department of Veterans Affairs

VISN CONTRACT ALL

Schedule

3/01/27-02/29/28

2001 SHIP TO:

Department of Veterans Affairs

VISN CONTRACT ALL

Schedule

3/01/28-02/28/29

FOB: DESTINATION

3001 SHIP TO:

Department of Veterans Affairs

VISN CONTRACT ALL

Schedule

3/01/29-02/28/30

FOB: DESTINATION

4001 SHIP TO:

Department of Veterans Affairs

VISN CONTRACT ALL

Schedule

3/01/30-02/28/31

FOB: DESTINATION

B.4 STATEMENT OF WORK (SOW)

Blood and Blood Products The VISN 8: Veterans Administration (VA) Sunshine Healthcare Network in Florida (hereinafter “VA” or “Government”), which includes: Bay Pines Healthcare System, North Florida/South Georgia Veterans Health System, Miami VA Healthcare System, Orlando VA Medical Center, James A. Haley Veterans’ Hospital and West Palm Beach VAMC has an ongoing requirement for the delivery of whole blood and blood products provided by an active Food and Drug Administration (FDA) registered or licensed blood bank entity, community(non-hospital) blood bank nonprofit corporation, accredited by AABB (American Association of Blood Banks), The College of American Pathologists (CAP), or the Joint Commission.

The Contractor shall provide products, any other blood related services, and therapeutic services to attain a blood product that will be compatible and safe for a patient’s condition(s). These blood products shall be provided in accordance with the terms and conditions of this contract as stated in the Supplies/Services listing below.

SUPPLIES/SERVICES- CONTRACT LINE-ITEM NUMBER QUANTITY

Contractor shall supply each site with all whole blood and blood components daily and maintain an emergency supply of each group, type of blood and blood components. Whole blood and blood products shall be furnished to multiple hospital facilities within Veterans Integrated Service Network (VISN 8) in accordance with the specifications of this contract. All quantities are estimated per annum. This requirement is for products and services required in Network Contracting Office 8 (NCO8). The initial requirement may only include the stations stated in the below primary delivery locations. HOWEVER, the government reserves the right to increase the requirement area to include more stations in the VISN 8 catchment area.

The Government reserves the right to include products and services later at additional locations.

Terms Defined SC= Sickle Cell CBC= Complete Blood Count SC Cryopreservation requires storage of product includes 1 year. Thereafter additional years of storage are charged separately CD- Cluster of differentiation.

HLA- Human Leukocyte Antigens HLA-DR Human Leukocyte Antigens Related D HPC- hematopoietic progenitor cell WBC -White Blood Count RBC- Red Blood Count ABO- Blood Types (group) CMV- Cytomegalovirus LUI- Technique for eluting antibodies from red cells NAT- Nucleic Acid Test QC- Quality Control ABO -Blood Type Rh- Blood group system RBC -Red Blood Group

SECTION I - WHOLE BLOOD AND BLOOD COMPONENTS

Whole blood and blood components, are to be delivered F.O.B. destination in packaging of protective quality that are suitable to maintain temperature for component transportation and ensure that component is undamaged during handling within consignee's premises, to each of the designated VISN 8 sites, for the period of the contract, in such quantities and at such times as may be required in accordance with all terms, conditions, provisions and the Schedule contained in this statement of work.

A. COLLECTION, PROCESS AND TYPING OF BLOOD

1. Blood shall be typed for Blood groups ABO and Rh antigens and screened for red cell antibodies in accordance with methods recommended in the current edition of Standards for Blood Banks and Transfusion Services and the Technical Manual of the American Association of Blood Banks (AABB).

Blood shall be collected, processed, and stored in accordance with the Food and Drug Administration (FDA) Regulations (21CFR) and applicable contractor standard operating procedures under contractor’s “U.S.

License”.

2. Contractor agrees that all components shipped will have been tested and found non-reactive for current testing requirements from the FDA and AABB Standards.

3. All blood and components are to be collected by a closed system under aseptic conditions and shall be processed in appropriate solutions and the containers labeled. The label shall also bear the expiration date of the contents. The expiration date shall not exceed 42 calendar days from the date of manufacture, which is the date of bleeding the donor, unless the type of preservative used is approved by the FDA for a longer interval.

4. All blood supplied shall be grossly free of hemolysis, excessive chyle and clots.

5. All blood must be leukocyte reduced.

6. Blood shall include at least ten (10) properly labeled and originally attached segments of the blood to be used in cross matching.

7. All platelets will be tested for bacterial contamination and pathogen reduction with manufacturer instruction using FDA approved instrumentation and AABB approved methods. AABB guidelines shall be followed for plasma components to reduce the risk of (Transfusion Related Acute Lung Injury) TRALI. Other screening will be performed on cellular components when requested and or required.

8. All plasma for allogeneic transfusion should be from males, females who have not been pregnant, or females who have been tested since the most recent pregnancy and results interpreted as Negative for HLA antibodies.

B. PACKAGING AND MARKING

1. Blood shall be labeled as to A, B, O, AB, and Rh type.

2. All blood components must use bar code labels (ISBT-128) conforming to International Council for Commonality in Blood Bank Automation, Inc. (ICCBBA) will be legible on all blood components.

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

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

C. SPECIALIZED SERVICES

1. Contractor shall provide consultation services prior to delivery under the direction of the contractor’s Medical Director(s) to aid in the identification of difficult irregular antibodies, problem crossmatches and any such matters. Contractor shall provide Tissue TypiFng Services, Flow Cytometric Services, in house Therapeutic Apheresis Services, and other such services requested by the hospital. The contractor blood bank shall investigate all donors implicated in TRALI after notification by a VA site.

2. 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 including federal holidays.

3. The contractor blood bank provides reference laboratory services and esoteric components within one hour of receipt of specimen at their reference testing laboratory if ordered statim (STAT) or 4 hours if ordered as routine.

D. DELIVERIES AND PERFORMANCE

1. Blood products shall be delivered at the time specified when the order is placed. Routine stock orders are to be delivered within 12 hours of orders placement. In an emergency, contractor/courier service shall provide delivery within one (1) hour of request packed red blood cells to maintain an adequate blood supply and meet VA standard/regulations. Contractor shall deliver standard products at no extra charge (3) times a day, seven days a week.

2. Blood shall be transported in such a way as to ensure the integrity of blood components remain safe for use and not compromised. Contractor shall comply with all accreditation and regulatory standards as defined by the FDA and AABB.

3. Contractor shall provide all supplies necessary for shipment of blood components and specimens.

Contractor shall provide any special preservatives for specimen preservation. Frozen specimens and components shall be shipped on dry ice provided by contractor.

4. Contractor shall provide a copy of their emergency Contingency Plan in Facilitating and coordinating an appropriate response in the event of a local domestic threat or disaster that affects the provision of a safe and adequate blood supply.

E. DELIVERY/TRANSPORTATION

1. 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.

2. Contractor shall transport all requested blood and blood products to VA blood bank labs within the agreed upon timeframes.

The delivery locations are as follows:

The PRIMARY delivery locations are as follows:

a. C.W. Bill Young VA Medical Center

Bay Pines VA Healthcare System Pathology & Laboratory Medicine Services (113) 10000 Bay Pines Blvd.

Building 100, Room 2B-111 (2nd Floor Lab) Bay Pines, Florida 33744

b. Miami VA Healthcare System Pathology & Laboratory Medicine Services (113) 1201 N.W. 16th Street Miami, FL 33125 Blood Bank- Room A305B 3rd floor 305-575-7000 ext. 4293/4294

c. Orlando VAMC Laboratory (113)

Orlando, FL 32827 Blood Bank – D&T building 2nd floor Room 2J500 407-631-2606/07

d. James A Haley Veterans Hospital

13000 Bruce B. Downs Tampa, FL 33612 Blood Bank Lab- Room 1D-175 (1st floor) 813-972-2000ext4276

e. West Palm VAMC Laboratory (113) 7305 N Military Trail West Palm Beach, FL 33410 Room 4A203 inside of 4A201 561-422-6303

f. Malcolm Randall VAMC NF/SG Health System

1601 S.W. Archer Road Gainesville, FL 32608 Blood Bank- Room E126 1st floor 352-374-6023

F. LICENSE: The contractor shall possess a current, unrevoked U.S. License which is issued by the Director, Bureau of Biologics, Food and Drug Administration (FDA) under Section 351 of the Public Health Service Act, as amended, 42 USC Section 262 (http://www.law.cornell.edu/uscode/text/42/262), as a source of supply for whole blood.

G. INTERSTATE SHIPMENT: If interstate shipment of blood or blood component is involved, the contractor must submit prior to award a statement that such approval has been authorized under Section 251 of the Public Health Service Act, as amended 42 USC Section 262.

H. CERTIFICATION: The contractor certifies that he/she complies and will remain in compliance with the requirements outlined with respect to donors, containers, and delivery of blood products for the duration of the contract.

I. BLOOD DONATION: The contractor shall provide the VA only with one hundred (100%) "volunteer donor" blood in accordance with 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. Definition of a "volunteer donor" - A volunteer donor is a person who does not receive monetary payment for blood donation. Benefits, such as monetary time off from work, membership in blood assurance programs and cancellations on non-replacement fees that are not readily convertible to cash, do not constitute monetary payment.

J. DONOR LIST:

1. The contractor shall maintain readily available blood donor lists including names, addresses, and social security numbers. Such lists should indicate on what date blood of a particular donor was furnished to the VA under this contract period.

2. Donor selection must be in accordance with criteria established by the FDA and/or the AABB.

K. AUTOLOGOUS COLLECTION AND UNITS:

Autologous blood units shall be tested for infectious agents per FDA and AABB regulations. Contractor will draw, test and return autologous unit with provider order and contractor director approval.

L. ORDERING:

1. Orders shall be categorized into two (2) types: routine and STAT. These categories are defined as follows:

a. Routine – Shipments of blood products to maintain minimum inventory levels or blood products ordered to fulfill a standing request.

b. STAT – A 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 sixty (60) minutes. Additional emergency requirements may be placed and the shipper shall arrange for delivery in one hour or less (including orders during evenings and nights).

c. Ordering shall be conducted in accordance with applicable laws and resulting contract. Supplies and/or services may be ordered via email, facsimile (fax), telephone, in hardcopy format, electronic means including vendor websites or in any other manner consistent with accepted commercial business practices. No sensitive data will be transmitted.

M. INSPECTION OF CONTRACTOR’S FACILITIES:

The government reserves the right to thoroughly inspect and investigate the establishment, and facilities and verify other qualifications of any contractor.

N. NOTIFICATION AND REPORTING REQUIREMENTS:

In accordance with 21 CFR 610.46, 610.47 & 610.48, VA transfusion service shall be notified of any subsequent positive viral donor test results discovered by contractor after delivery. Contractor shall contact affected VA within 3 calendar days if supplied blood and blood components collected from a donor who tested negative at the time of donation but tests reactive for evidence of HIV or HCV.

SECTION II – THERAPEUTICS APHERISIS SERVICES

The contractor agrees to provide inpatient and outpatient therapeutic apheresis procedure. Procedures must be available seven days a week and must be provided within a 24-hour period of request for regularly scheduled cases. Emergency/STAT response time shall be within 4 hours once a patient and products are ready. The contractor warrants that all therapeutic apheresis services shall be provided by qualified and experienced personnel who shall be Registered Nurses or Licensed Practical Nurses.

Contractor shall provide evidence of all education, professional licenses and or certifications, training, competency assessments and performance evaluations of all nursing staff utilized to perform these procedures. For purposes of this contract, all such personnel shall hereinafter be referred to as "Apheresis Nurses".

The contractor shall provide all equipment and disposables necessary to accomplish therapeutic apheresis procedures once vascular access has been established by VA personnel, and comply with the federal, state and local regulations for disposal of such supplies and waste products. It is preferable that contractor utilizes portable equipment that will allow the Apheresis Nurses to perform therapeutic procedures at the patient’s bedside. Contractor will provide documentation of the therapeutic procedure when completed to VA staff to be included into the patient’s medical record.

Contractor shall provide all maintenance and service records on equipment that will be used to perform these procedures. Contractor is responsible in ensuring that equipment maintenance is kept up to date and complies with manufacturer instructions. Contractor must ensure that all equipment is safe for usage and provide evidence of staff training and competency on equipment.

SECTION III - REFERENCE TESTING

The contractor shall provide highly specialized testing for all levels of transfusion testing needed to help determine which type of blood component is compatible and suitable for patients with rare blood types, or for patients who exhibit an unusual combination of antibodies against certain blood components. Contractor shall resolve complex antibody identification problems; help select compatible donors and perform genetic screening for blood group and platelet antigen.

SECTION IV – OTHER CONDITIONS

A. THE JOINT COMMISSION, VETERANS HEALTH ADMINISTRATION (VHA) AND OTHER

STANDARDS:

1. The contractor shall perform the required work in accordance with The Joint Commission, OSHA, VHA HIPAA, FDA, AABB and/or any other regulatory standards. The contractor shall comply with all annual updates as issued.

2. Contractor shall maintain the minimum acceptable service, reporting systems and quality control as specified herein. Failure to comply with the specified terms and conditions and/or adverse reports from external monitoring agencies, which indicate poor quality of care or/and any other noncompliance issues, are grounds for termination of the contract. Immediate notification (within 24 hours shall be given to VA regarding adverse reports and action by a regulatory agency.

3. The requirements of the contract may be changed by written modification and agreement of the parties. All modifications will be approved and prepared by the VA Contracting Officer.

4. The contractor shall furnish the supplies specified in this contract to VA when authorized by the Contracting Officer Representative (COR).

B. TERM OF CONTRACT:

1. This contract is for one base period with four option periods.

2. The contractor is required to begin providing supplies and services in accordance with the schedule, effective on the date of contract award.

C. QUALIFICATIONS:

1. The contractor shall have a blood bank currently registered and/or licensed with the Food and Drug Administration (FDA), Department of Health, Education and Welfare pursuant to Section 510 of the Federal Food, Drug and Cosmetic Act, 21 USC Section 301. Contractor’s Medical Director shall be a board-certified physician in Clinical Pathology/Blood Bank Transfusion Medicine. The government will only enter a legally binding contract with contractors who are regularly established in the business called for and who, in the judgment of the Contracting Officer, are financially responsible and able to show evidence of their responsibility, ability, experience, equipment, facilities, and personnel directly employed or supervised by them to render prompt and satisfactory supplies in the volume required for all items under this contract. By signing the contract, the contractor certifies that he/she shall meet all requirements of Federal, State, or local laws, codes, and/or regulations regarding the operation of this type of business.

2. The VA may inspect the establishment, facilities, business reputation, and other qualifications of any contractor and reserves the right to reject any offer, irrespective of price, that shall be administratively determined by the Contracting Officer to be lacking in any of the essentials judged necessary to assure acceptable standards of performance.

3. Any sub-contractor utilized by the contractor for the provision of supplies required under this contract must meet the same qualifications specified herein for the contractor. The contractor must obtain approval from the Contracting Officer for any sub-contractor to be utilized for the provision of supplies required under this contract.

4. Thirty (30) days prior to contract expiration date, the contractor shall certify in writing to the Contracting Officer that all licenses and registrations of personnel employed under this contract are valid and current and shall be renewed as necessary during any option period.

D. PERSONNEL POLICY:

The Contractor shall assume full responsibility for the protection of its personnel furnishing services under this contract, in accordance with the personnel policy of the Contractor, such as providing worker’s compensation, professional liability insurance, health examinations, income tax withholding, and social security payments. The parties agree that the contractor, its employees, agents, and subcontractors shall not be considered VA employees for any purpose.

E. CONFIDENTIALITY:

1. The VA will provide the contractor with access to pertinent patient medical information, within the existing privacy rules and regulations. Contractor shall ensure the confidentiality of all patient information and shall be held liable in the event of the breach of confidentiality.

2. The contract is subject to the Privacy Act of 1974. The Contractor is not authorized to release any VA medical record information. The VA is the sole entity authorized to release this information upon written request from the patient.

F. PAYMENTS, INVOICING AND CREDIT:

1. Charges should be inclusive of all transportation charges as defined in Deliveries and Performance, except those charges incurred and authorized by Pathology & Laboratory Medicine Service.

2. There will be no additional fees for autologous donations for transfusions at VA Health Care System (HCS).

3. All unsatisfactory units (broken Fresh Frozen Plasma (FFP), clots in red cells, etc.) shall be returned and full credit given to VA.

4. Full credit will be provided for returned units. Full credit shall be provided for blood products returned 24 hours prior to expiration date.

5. All invoices will be paid monthly in arrears upon receipt and certification of invoice. Each invoice must indicate the month in which the items were delivered and the appropriate obligation number.

6. 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.

7. Invoices shall be matched against VA bill validation report to verify supplies were delivered in accordance with the contract.

8. The VA will review the invoice against its record. VA will notify the contractor of invoice discrepancies. Upon the resolution of the discrepancies, contractor shall submit a revised invoice; the VA will verify revised invoice and make payment accordingly.

G. OTHER/APPLICABLE POLICIES AND REGULATIONS: The Contractor shall perform in accordance with policies and procedures set forth in VHA Handbook 1106.01, Pathology and Laboratory Medicine Service Procedures the handbook can be located at the following web address:

www.va.gov/vhapublications/viewpublication.asp?pub_id=1779 United Stated Department of Health and Human Service (HHS) / Office of Inspector General (OIG): To ensure that the individuals performing under the contract have not engaged in fraud or abuse regarding Sections 1128 and 1128A of the Social Security Act regarding federal health care programs, the contractor is required to check the Health and Human Service – Office of Inspector General, List of excluded individuals/entities on the OIG Website (www.hhs.gov/oig) for each person providing services under this contract. Further the contractor is required to certify in its proposal that all persons listed in the contractor’s proposal have been compared against the OIG list and are not listed. During the performance of this contract the Contractor is prohibited from using any individual or business listed on the List of Excluded Individuals/Entities.

“Contractor shall provide health care to patients seeking such care from or through VA. As such, contractor is considered part of the Department health activity for purposes of the following statues and the VA regulations implementing these statues: the Privacy Act, 5.U.S.C. § 552a, and 38 U.S.C. §s 5701, 7705 and 7332. Contractor and its employees may have access to VA patient medical records to the extent necessary for the contract or to perform this contract. Notwithstanding any other provision of this contract, contractor and its employees shall disclose patient treatment records only pursuant to explicit disclosure authority for VA. Contractor and its employees are subject to the penalties and liabilities provided statutes and regulations for unauthorized disclosures of such records and their contents.”

“Records created by the contractor in the course of treating VA patients under this agreement are the property of the VA and shall not be accessed, released, transferred or destroyed except in accordance with applicable federal law and regulations.” “Upon the expiration of this contract or termination of the contract, the contractor shall promptly provide the VA with the VA patient treatment records.”

HIPAA COMPLIANCE: “Contractor must adhere to the provisions of Public Law 104-191, Health Insurance Portability and Accountability Act (HIPAA) of 1996 and the National Standards to Protect the Privacy and Security of Protected Health Information (PHI). A business associate agreement is not required in this case.

H. CONTRACTING OFFICER REPRESENTATIVE (COR):

All work coordination shall be made through the COR. The Contractor shall be provided a copy of the letter of delegation, authorizing the COR at the commencement of the term of this agreement. No other person shall be authorized to act in such capacity unless appointed in writing by the Contracting Officer.

The COR will be the VA official responsible for verifying contract compliance. After contract award, any incidents of contractor noncompliance as evidenced by the monitoring procedures shall be forwarded immediately to the Contracting Officer.

I. SERVICES CHARGES TO VA BENEFICIARIES:

VA beneficiaries shall not under any circumstances be charged nor their insurance companies charged for services rendered by the contractor even if VA does not pay for those services. This provision shall survive the termination or ending of the contract.

J. REQUIRED REGISTRATION WITH CONTRACTOR PERFORMANCE ASSESSMENT SYSTEM

(CPARS):

1. As prescribed in Federal Acquisition Regulation (FAR) Part 42.15, the VA evaluates contractor past performance on all contracts that exceed $100,000 and shares those evaluations with other Federal Government contract specialists and procurement officials. The FAR requires that the contractor be provided an opportunity to comment on past performance evaluations prior to each report closing. To fulfill this requirement VA uses an online database, CPARS, which is maintained by the Naval Seal Logistics Center in Portsmouth, Virginia. CPARS has connectivity with the Past Performance Information Retrieval System (PPIRS) database, which is available to all Federal agencies. PPIRS is the system used to collect and retrieve performance assessment reports used in source selection determinations and completed CPARS report cards transferred to PPIRS. CPARS also includes access to the federal awardees performance and integrity information system (FAPIIS). FAPIIS is a web-enabled application accessed via CPARS for contractor responsibility determination information. REVIEW

2. Each contractor whose contract award is estimated to exceed $100,000 is required to register with CPARS database at the following web address: www.cpars.csd.disa.mil. Help in registering can be obtained by contacting Customer Support Desk @ DSN: 684-1690 or COMM: 207-438-1690. Registration shall occur no later than thirty days after contract award, and it shall be kept current in the case that any change to the contractor’s registered representative occurs.

3. For contracts with a period of one year or less, the contracting officer will perform a single evaluation when the contract is complete. For contracts exceeding one year, the contracting officer will evaluate the contractor’s performance annually. Interim reports will be filed each year until the last year of the contract, when the final report will be completed. The report shall be assigned in CPARS to the contractor’s designated representative for comment. The contractor representative will have thirty days to submit any comments and re-assign the report to the VA contracting officer.

4. Failure to have a current registration in the CPARS database, or to re-assign the report to the VA contracting officer within those thirty days, will result in the Government’s evaluation being placed on file in the database with a statement that the contractor failed to respond.

K. DOCUMENTING PERFORMANCE:

1. ACCEPTABLE PERFORMANCE

The Government will document acceptable as well as unacceptable performance. Any report may become a part of the supporting documentation for any contractual action.

2. UNACCEPTABLE PERFORMANCE

When unacceptable performance occurs, the Contractor Officer Representative (COR) will inform the contractor. This will normally be in writing unless circumstances necessitate verbal communication. In any case the COR will document the discussion and place it in the COR file.

When the COR determines, formal written communication is required, the COR will prepare a Contract Discrepancy Report (CDR) and present it to the contractor's program manager.

The contractor shall acknowledge receipt of the CDR in writing. The CDR will specify if the contractor is required to prepare a corrective action plan to document how the contractor shall correct the unacceptable performance and avoid a recurrence. The CDR will also state how long after receipt the contractor has to present this corrective action plan to the COR. The Government will review the contractor's corrective action plan to determine acceptability.

Any CDRs may become a part of the supporting documentation for any contractual action deemed necessary by the CO.

L. FREQUENCY OF MEASUREMENT:

1. Frequency of Measurement. During contract performance, the COR will periodically analyze whether the negotiated frequency of surveillance is appropriate for the work being performed.

2. Frequency of Performance Assessment Meetings. The COR will meet with the contractor monthly to assess performance and will provide a written assessment for the Contractor and Contracting Officer.

SECTION V- DEFINITIONS

F.O.B- An abbreviation for free on board, which means that a vendor or consignor will deliver goods on a railroad car, truck, vessel, or other conveyance without any expense to the purchaser or consignee.

Rh- Rhesus (Rh) factor is an inherited protein found on the surface of red blood cells Consignee- deliver (something) to a person's custody; send (goods) by a public carrier. A party (usually a buyer) named by the consignor (usually a seller) in transportation documents as the party to whose order a consignment will be delivered at the port of destination.

AABB- International non-profit association representing individuals and institutions involved in the field of transfusion medicine and cellular therapies. AABB has been a leader in the development of voluntary standards in blood bank blood component collection, processing, and transfusion.

ICCBBA- Enhances safety for patients by managing and promoting the ISBT 128 international information standard for use in transfusion and transplantation.

CFR- Code of Federal Regulations Apheresis- Is a medical technology in which the blood of a person is passed through an apparatus that separates out one constituent and returns the remainder to the circulation Apheresis Nurses- The Apheresis nurse performs all aspects of apheresis collection, using the centrifuge machines. The nurse monitors the machine and monitors the donor for possible reactions. The Apheresis RN will operate and manage several different apheresis blood cell separators, conduct donor medical history review and perform physical assessments to determine donor eligibility for bone marrow transplantation. The Apheresis RN will have direct patient care and be responsible for performing routine nursing functions while patients are undergoing an apheresis treatment.

TRALI Transfusion- Related acute lung injury (TRALI) is defined as new acute lung injury (ALI) that occurs during or within six hours of transfusion, not explained by another ALI risk factor.

HLA- The human leukocyte antigen (HLA) system is a gene complex encoding the major histocompatibility complex (MHC) proteins in humans. These cell-surface proteins are responsible for the regulation of the immune system in humans.

STATIM- Immediately or without delay-STAT.

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With Sensitive Data and Training

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE

ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS:

a. Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

b. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.

c. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.

d. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor’s employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination.

Contractor Personnel Security Requirements:

All contractor employees who require access to the Department of Veterans Affairs’ computer systems shall be the subject of a background investigation and must receive a favorable adjudication from the VA Office of Security and Law Enforcement prior to contract performance. This requirement is applicable to all subcontractor personnel requiring the same access. If the investigation is not completed prior to the start date of the contract the contractor will be responsible for the actions of those individuals that provide or perform work for the VA.

1. Position Sensitivity – The position sensitivity has been designated as ( low ) risk.

2. Background Investigation – The level of background investigation commensurate with the required level of access is National Agency Check (NACI) with written inquiries.

3. Contractor Responsibilities

a. The contractor shall bear the expense of obtaining background investigations. If the investigation is conducted by the Office of Personnel Management (OPM), the contractor shall reimburse the VA within 30 days.

The web site which provides information on the cost of the security investigation is:

www.opm.gov\extra\investigate – Select Federal Investigations Notices (FIN 01-01)

b. The contractor shall prescreen all personnel requiring access to the computer systems to ensure they maintain a U.S. citizenship and are able to read, write, speak, and understand the English language.

c. The contractor will provide to the Contracting Officer prior to award the following: (1) List of names of contract personnel. (2) Social security numbers of contractor personnel. (3) Home address of contractor personnel or the contractor address.

The Contracting Officer will submit the above information to the Office of Security and Law Enforcement, Washington, D.C. The Office of Security and Law Enforcement will provide the necessary investigative forms (these forms are indicated in paragraph 3.d. below) to the contractor’s personnel, coordinate the background investigations with OPM and notify the Contracting Officer and contractor of the results of the investigation.

d. The contractor shall submit or have their employees submit the following required forms to the VA Office of Security and Law Enforcement within 30 days of receipt:

(i) Standard From 85P, Questionnaire for Public Trust Positions

(ii) Standard Form 85P-S, Supplemental Questionnaire for Selected Positions

(iii) FD 258, U.S. Department of Justice Fingerprint Applicant Chart

(iv) VA Form 0710, Authority for Release of Information Form

(v) Optional Form 306, Declaration for Federal Employment

(vi) Optional Form 612, Optional Application for Federal Employment

e. The contractor, when notified of an unfavorable determination by the Government, shall withdraw the employee from consideration from working under the contract.

f. Failure to comply with the contractor personnel security requirements may result in termination of the contract for default.

VA INFORMATION CUSTODIAL LANGUAGE:

a. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1).

b. VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor’s information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA’s information is returned to the VA or destroyed in accordance with VA’s sanitization requirements. VA reserves the right to conduct onsite inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.

c. Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract.

d. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies.