RFP 36C25622R0003 - Blood and Blood Products - MEDVAMC.pdf

PAGE 1 OF 81 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

580-23-1-057-0001

36C25623R0003 11-09-2022

Steven A. Berkeley, Contract Specialist 713-791-1414 ext. 21345 12-09-2022

16:00 CST

36C256

Department of Veterans Affairs

Network Contracting Office 16

5075 Westheimer Road, Suite 750

Houston TX 77056-5643

X

325414

1,250 Employees

N/A

X

36C580

Department of Veterans Affairs

Michael E. DeBakey VA Medical Center

(MEDVAMC)

2002 Holcombe Boulevard

Houston TX 77030-4298

36C256

Department of Veterans Affairs

5075 Westheimer Road, Suite 750

Houston TX 77056-5643

N/A

FSC e-Invoice Payment http://www.fsc.va.gov/fsc/einvoice.asp

Invoice Setup Information 1-877-489-6135

Invoice must be submitted electronically

1-877-489-6135 N/A

See CONTINUATION Page

This solicitation is a request for proposal (RFP) for Blood &

Blood products in support of MEDVAMC. The Government intends to award a fixed price Indefinite Delivery Indefinite Quantity

(IDIQ)contract.

See B.2 Price/Cost Schedule/B.4 Statement of Work (SOW)pages

5 through 29 for RFP details.

See Addendum to 52.212-1 Instructions to Offerors for

Instructions for proposal submission pages 50 through 58

This solicitation is unrestricted.

This acquisition is in accordance with Federal Acquisition

Regulation (FAR) 15 and 16.504.

See CONTINUATION Page

X X

X 1 (One)

Reuben A. Zepeda

Contracting Officer

36C25623R0003

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

B.3 Statement of Work (SOW)

SECTION C - CONTRACT CLAUSES

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

AND COMMERCIAL SERVICES (NOV 2021)

C.2 52.216-18 ORDERING (AUG 2020)

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

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

C.5 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.6 VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA

ACQUISITION OF COMMERCIAL ITEMS (APR 2020)

C.7 VAAR 852.219-75 SUBCONTRACTING COMMITMENTS MONITORING AND

COMPLIANCE (JUL 2018)

C.8 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020)

C.9 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.10 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (MAY 2022) (JUL 2020) (DEVIATION)

C.11 SUPPLEMENTAL INSURANCE REQUIREMENTS

C.12 52.232-19 AVAILABILITY OF FUNDS FOR THE NEXT FISCAL YEAR (APR 1984)

C.13 MANDATORY WRITTEN DISCLOSURES

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

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

COMMERCIAL SERVICES (NOV 2021)

E.2 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

E.3 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

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

E.5 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.6 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.7 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (NOV 2021)

E.8 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (MAY 2022) (JUL 2020)

(DEVIATION)

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: POC Name: _________________ Address: ___________________ Phone: _____________________ Email: ______________________ UEI Number: ______________ Tax ID Number: ______________

b. GOVERNMENT: Reuben A. Zepeda, Contracting Officer 36C256

5075 Westheimer Road, Suite 750

Houston TX 77056-5643

Phone: 832-450-0008

E-mail: Reuben.zepeda@va.gov

Steven A Berkeley, Contract Specialist 36C256

5075 Westheimer Road, Suite 750

Houston TX 77056-5643

Phone: 713-791-1414

E-mail: Steven.berkeley@va.gov

Contracting Officer Representative (COR):

Peter L. Basten, Pathology & Laboratory Medicine

Department of Veterans Affair

Michael E. DeBakey VA Medical Center

2002 Holcombe Boulevard

Houston, TX 77030-4298

Phone: 713-791-1414 ext.24392

Email: Peter.basten@va.gov

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 [] mailto:Reuben.zepeda@va.gov mailto:Steven.berkeley@va.gov mailto:Peter.basten@va.gov

b. Semi-Annually []

c. Other [X] Payment for supplies provided under the terms of this contract will be made in arrears within (30) days. Invoices shall be submitted no later than the 10th the following month.

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.

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

AMENDMENT NO DATE

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

Estimated quantities listed for each Contract Line Item are estimates of the total requirement for the described product. The Government may place orders at quantities less than the estimated total quantity as stated in the schedule of items. There is no express or implied guarantee that the quantities will be ordered regularly.

This is a five (5) year firm fixed price IDIQ and list overall 5-year period of performance. The

Government anticipates issuing a single order covering each ordering period below. However, the possibility exist the Government may issue multiple orders during each ordering period at the rates established for a period. Each order or combination of order “may” exceed the ordering period grand total; however, all orders shall not exceed the stated IDIQ maximum.

Guaranteed Minimum for the contract is $1,000.00.

Maximum Amount for the life of the contract is $16,000,000.00

Six (6) Month Extension: As indicated in contract clause FAR 52.217-8, the Government will have the option to extend the performance of the contract up to an additional six (6) months when the contractor is provided written notice. Six (6) Months extension pricing will be based on the current ordering period the six (6) months extension is exercised. For purposes of the award of this contract, the Government intends to evaluate the option to extend service under FAR 52.217-8 as follows: The evaluation will consider the possibility that the option can be exercised at any time and can be exercised in increments of one (1) to six (6) months, but for no more than a total of six (6) months during the life of the contract. The evaluation will assume that the prices for any option exercised under FAR 52.217-8 will be at the same price as those in effect under the contract at the time/period the option is exercised. This evaluation will not obligate the Government to exercise any options under FAR 52.217-8.

***Note*** (Period of Performance for Ordering periods are based on a twelve (12) month period, effective date and end date may change depending on when an award will be made but will be based on a twelve (12) month period).

Order Period: 1 POP Begin: 02-01-2023 End: 01-31-2024

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

30.00 EA __________________ __________________

Adsorption (Allo, Auto, Cold, HPC, OEG, PEG, Rest and Warm)

LOCAL STOCK NUMBER: 86978

15.00 EA __________________ __________________

Cell Separation

LOCAL STOCK NUMBER: 86972/REF15

350.00 EA __________________ __________________

CMV Antibody negative component

LOCAL STOCK NUMBER: C6I

1,600.00 EA __________________ __________________

Cryoprecipitate AHF, Single

LOCAL STOCK NUMBER: E5165V00

Donath-Landsteiner Test

LOCAL STOCK NUMBER: 86941

36.00 EA __________________ __________________

Elution

LOCAL STOCK NUMBER: 86860

20.00 EA __________________ __________________

Neutralization

LOCAL STOCK NUMBER: 86977

40.00 EA __________________ __________________

Panel

LOCAL STOCK NUMBER: 86870

1.00 EA __________________ __________________

Leukocyte Red Blood Cell-Irradated

LOCAL STOCK NUMBER: EO332V00

160.00 EA __________________ __________________

Leukoreduced Red Blood Cell-Irradated, CMV negative

10.00 EA __________________ __________________

Packed Human Red Blood Cells Deglycerolized

LOCAL STOCK NUMBER: E4521D00

Patient Antigen Typing

LOCAL STOCK NUMBER: 86906

Patient Antigen Typing (Rare)

LOCAL STOCK NUMBER: 86905

Plasma Fresh Frozen

LOCAL STOCK NUMBER: EO701V00

1,700.00 EA __________________ __________________

Plasma Frozen within 24 hours

LOCAL STOCK NUMBER: E2555V00

Plasma, Apheresis

LOCAL STOCK NUMBER: E7644V00

100.00 EA __________________ __________________

Plasma, Cryoprecipitate Reduced

1,820.00 EA __________________ __________________

Platelets

LOCAL STOCK NUMBER: E8340V00

Pretreatment of Patient's RBC for Testing (Enzyme Treatment)

LOCAL STOCK NUMBER: 86971

Pretreatment of Patient's Serum for Testing

LOCAL STOCK NUMBER: 86975

240.00 EA __________________ __________________

Red Blood Cell O neg. (surcharge)

LOCAL STOCK NUMBER: O_NRBC

6,000.00 EA __________________ __________________

Red Blood Cells Leukoreduced (10-20% O neg. required)

LOCAL STOCK NUMBER: EO316V00

Red Blood Cells, Frozen

LOCAL STOCK NUMBER: E5085V00

Red Blood Cells, Washed

LOCAL STOCK NUMBER: E5169V00

2.00 EA __________________ __________________

Whole Blood, Leuko-Reduced

LOCAL STOCK NUMBER: EOO33V00

125.00 EA __________________ __________________

SHP-Stat/Priority

LOCAL STOCK NUMBER: Y8B

400.00 EA __________________ __________________

SHP-Unscheduled

LOCAL STOCK NUMBER: J8B

GRAND TOTAL __________________

Order Period: 2 POP Begin: 02-01-2024 End: 01-31-2025

NUMBER

DESCRIPTION OF

Order Period: 3 POP Begin: 02-01-2025 End: 01-31-2026

NUMBER

DESCRIPTION OF

Order Period: 4 POP Begin: 02-01-2026 End: 01-31-2027

NUMBER

DESCRIPTION OF

Order Period: 5 POP Begin: 02-01-2027 End: 01-31-2028

NUMBER

DESCRIPTION OF

B.3 Statement of Work (SOW)

SOW for Blood & Blood Products in support of MEDVAMC Diagnostica & Therapeutic Care Line

Houston TX

Overview of Supplies and Services

The Contractor shall provide Blood and Blood Products in accordance with the terms and conditions stated herein. This procurement provides Blood and Related Blood Products & Blood Services for the Department of Veterans Affairs, MEDVAMC in Houston, TX. This contract is required to ensure an adequate, readily available supply of blood and/or blood components and related blood services that are in accordance with standards established by recognized accrediting agencies such as the American Association of Blood Banks (AABB), the Food and Drug Administration (FDA), and the College of American Pathologists. Blood/blood components and blood testing must be available 24 hours per day, seven days per week regardless of holidays to ensure an adequate blood supply at all times. Items listed below shall be drawn, processed, tested, typed and packed as specified in the following sections in suitable containers, and delivered f.o.b. destination to MEDVAMC, Pathology and Laboratory Medicine Service Line Blood Bank (113), located in room number 3A-121, 2002 Holcombe Boulevard., Houston, TX 77030. It is critical that blood products and those blood tests needed to ensure compatibility or blood products be available ON A STAT BASIS (immediately).

Credits & Incentives for MEDVAMC

• Credits for damaged, recalled or withdrawn blood, outdated, short-dated products shall be issued in accordance with industry standards.

Scope of Work/Special Requirements

The contractor shall provide the following Blood and Related Blood Products:

Descriptions

Adsorption (Allo, Auto, Cold, HPC, OEG, PEG, Rest and Warm)

Plasma Frozen within 24 hours

Cell Separation Plasma, Apheresis

CMV Antibody negative component Plasma, Cryoprecipitate Reduced

Cryoprecipitate AHF, Single Platelets

Donath-Landsteiner Test Pretreatment of Patient's RBC for Testing (Enzyme Treatment)

Elution Pretreatment of Patient's Serum for Testing

Neutralization Red Blood Cell O neg. (surcharge)

Panel Red Blood Cells Leukoreduced (10-20% O neg.

required)

Leukocyte Red Blood Cell-Irradated Red Blood Cells, Frozen

Leukoreduced Red Blood Cell-Irradated, CMV negative Red Blood Cells, Washed

Packed Human Red Blood Cells Deglycerolized Whole Blood, Leuko-Reduced

Patient Antigen Typing SHP-Stat/Priority

Patient Antigen Typing (Rare) SHP-Unscheduled

Plasma Fresh Frozen Internationally let blank

The period of performance (POP) – five (5) 12-month ordering periods

Ordering Period 1 02/01/2023 – 01/31/2024

Ordering Period 2 02/01/2024 – 01/31/2025

Ordering Period 3 02/01/2025 – 01/31/2026

Ordering Period 4 02/01/2026 – 01/31/2027

Ordering Period 5 02/01/2027 – 01/31/2028

A. Sources of Donor Blood:

Offers shall be considered only from blood banks that are able to provide the VA with 100% “volunteer donor” blood in accordance with the most current FDA regulations. Definition of a “Volunteer Donor”- “A volunteer donor is a person who does not receive monetary payment for his blood donation. Benefits, such as monetary time off from work, membership in blood assurance programs and cancellations of non-replacement fees that are not readily convertible to cash, do not constitute monetary payment.”

B. Donor Records and Selection:

• Lists: the contractor must maintain readily available blood donor lists including names, addresses and unique identifying numbers. Such lists shall indicate whether and on what date the blood of a particular donor was furnished to MEDVAMC under this contract.

• Selection: Donor selection must be in accordance with criteria established by the FDA and/or the AABB. (www.fda.gov and www.aabb.org)

C. Collection of Blood/Blood Components:

• The contractor shall collect all blood by a closed system under aseptic conditions and shall be processed in appropriate solutions and the container(s) labeled according to “Uniform Labeling Guidelines” to include the anticoagulant used and the appropriate expiration date. (Reference websites United States Industry Consensus Standards for Uniform blood and blood components www.fda.gov/BiologicsBloodVaccines and CFR Title 21, Food and Drug part 210, part 211 www.accessdata.fda.gov/.../cfcfr/cfrsearch.

The venipuncture site shall be prepared so as to minimize risk of bacterial contamination. Green soap shall not be used. At the time of collection or component preparation, the integral donor tubing shall be filled with anticoagulated blood and sealed in such a manner that it will be available for subsequent compatibility testing. The integral donor tubing segments shall be separable from the container without breaking the sterility of the container. At the time of collection, if additional blood is collected for laboratory tests, containers shall be properly labeled before or at the time of collection, shall accompany the blood container, and shall be re-identified with the blood container immediately after filling. Storage of samples before testing shall meet the requirements stated in the manufacturer’s written instructions for the test being performed. The volume of blood to be drawn shall be proportional to the amount of anticoagulant/preservative solution in the collection container.

http://www.fda.gov/ http://www.aabb.org/ http://www.fda.gov/BiologicsBloodVaccines http://www.accessdata.fda.gov/.../cfcfr/cfrsearch

D. Typing/Testing of Donor blood/blood components:

Contractor shall perform typing/testing in accordance with methods recommended in the most current edition of Standards for Blood Banks and Transfusion Services and the Technical Manual of the American Association of Blood Banks. The tests required include but are not limited to the following:

• The ABO group shall be determined for each collection by testing the red cells with anti- A and anti-B reagents and by testing the serum or plasma for expected antibodies with A1 and B reagent red cells.

• The Rh type shall be determined for each collection with anti-D reagent. If the initial test with anti-D is negative, the blood shall be tested using a method designed to detect weak D. When either test is positive, the label shall read “Rh POSITIVE.” When the tests for both D and weak are negative, the label shall read “Rh NEGATIVE.”

• Serum or plasma from donors with a history of transfusion or pregnancy shall be tested for unexpected antibodies to red cell antigens. Methods for testing shall be those that demonstrate clinically significant red cell antibodies. A control system appropriate to the method of testing shall be used.

• The cost of all testing for infectious diseases and tests as required by state or federal agencies (i.e., FDA, AABB, Code of Federal Regulations (CFR), etc.) shall be included in the offered prices in the B.3 Price/Cost Schedule. No additional fees will be paid for blood testing. However, when new special requirements for blood testing or packaging are approved and/or mandated by a state or federal agency, contract pricing may be amended by written agreement of the parties, and only to the extent of cost recovery by the contractor. As a minimum, this includes testing for HBsAg, anti-HBc, anti-HCV, HCV RNA, anti-HIV-1/2, HIV-1 RNA, anti-HTLV-I/II, and a serologic test for syphilis. Blood components shall not be distributed or issued for transfusion unless the results of these tests are negative, except in the case of a test for syphilis that has been shown to have a biological false-positive result. Units with biological false-positive results shall be labeled in accordance with FDA requirements.

• If, due to urgent need, blood or components are distributed or issued before completion of these tests, a notation that testing is not completed shall appear conspicuously on an attached label or tie tag. Required tests shall be completed and results reported to MEDVAMC transfusion service as soon as possible.

E. Apheresis Collection Requirements:

The process used in performing a phlebotomy and processing the blood shall be designed to ensure safe reinfusion of the autologous non-retained components.

• Leukapheresis Collection not required.

• Therapeutic Phlebotomy and Apheresis Therapeutic phlebotomy and apheresis shall be performed only when ordered by a physician. Units drawn as therapeutic phlebotomies shall not be used for allogeneic transfusion unless the indication for therapeutic phlebotomy is hereditary hemochromatosis and the therapeutic phlebotomy is performed at no expense to individuals with hereditary hemochromatosis. The program must have received a variance from the FDA.

F. Preparation/Processing of Components:

Methods that ensure the quality and safety of components, including aliquots and pooled components, shall be employed. If the seal is broken during processing, components shall be considered to have been prepared in an open system and expiration times specified for such components apply. If a sterile connection device is used to produce sterile welds between two pieces of compatible tubing, the weld shall be inspected for completeness. If the integrity of the weld is complete, the component shall retain original expiration dates or have storage times approved by the FDA. If the integrity of the weld is incomplete, the container shall be considered an open system and may be sealed and used with a component expiration as indicated for an open system. At the time of preparation of a final red-cell containing component intended for transfusion, the integrally connected tubing shall be filled with an aliquot of the component and sealed in such a manner that it will be available for subsequent compatibility testing.

• Leukocyte Reduction

➢ Leukocyte-reduced blood and components shall be prepared by a method known to reduce the leukocyte number to <5 × 106 for Apheresis Platelets and Red Blood Cells and to <8.3 × 105 for whole-blood-derived Platelets. Validation and quality control shall demonstrate that at least 95% of units sampled meet this criterion.

• Irradiation

➢ Irradiated blood and components shall be prepared by a method known to ensure that irradiation has occurred. A method shall be used to indicate that irradiation has occurred with each batch. The intended dose of irradiation shall be a minimum of 25 Gy (2500 cGy) delivered to the central portion of the container. The minimum dose at any point in the components shall be 15 Gy (1500 cGy). Alternate methods shall be demonstrated to be equivalent.

Verification of dose delivery shall be performed using a fully loaded canister.

Records shall be maintained as follows:

1) Annually for cesium-137 as a radiation source.

2) Semi-annually for cobalt-60 as a radiation source.

3) Periodically, as recommended by the manufacturer for alternate sources of radiation.

4) Upon installation, major repairs, or relocation of the irradiator.

• Pooling

➢ For pooled components, the preparing facility shall maintain records of the identification number and collecting facility for each unit in the pool.

• Red Blood Cells Leukocytes Reduced

➢ Red Blood Cells Leukocytes Reduced shall be prepared by a method known to retain at least 85% of the original red cells and contain <5 × 106 residual leukocytes per unit.

• Apheresis Red Blood Cells Leukocytes Reduced (Red Blood Cells Pheresis Leukocytes Reduced) Apheresis Red Blood Cells Leukocytes Reduced shall be prepared by a method known to ensure a final component containing a mean hemoglobin of ≥51 g (or 153 Ml red cell volume) and <5 × 106 residual leukocytes per unit. At least 95% of units sampled shall have >42.5 g of hemoglobin (or 128 Ml red cell volume).

• Fresh Frozen Plasma

➢ Fresh Frozen Plasma shall be prepared from a whole blood or apheresis collection and placed at ≤–18 C within the time frame required for the anticoagulant or collection process. If a liquid freezing bath is used, the container shall be protected from chemical alteration.

• Cryoprecipitated Antihemophilic Factor (Cryoprecipitated AHF)

➢ Cryoprecipitated AHF shall be prepared by a method known to separate the cold insoluble portion from Fresh Frozen Plasma and result in a minimum of 150 mg of fibrinogen and a minimum of 80 IU of coagulation Factor VIII. In tests performed on pooled components, the pool shall contain a minimum of 150 mg of fibrinogen and 80 IU of coagulation Factor VIII times the number of components in the pool.

• Platelets Leukocytes Reduced Pooled

➢ Pooled Platelets Leukocytes Reduced shall be prepared by a method known to result in a residual leukocyte count <5 × 106.

• Apheresis Platelets Leukocytes Reduced (Platelets Pheresis Leukocytes Reduced) Validation and quality control shall demonstrate that 90% of units sampled contain ≥3.0 × 1011 platelets and that at least 90% of units have a Ph ≥6.2 at the end of allowable storage. FDA criteria apply. At a minimum, 95% of units sampled shall contain a residual leukocyte count <5 × 106.

G. Hemolysis/Clots:

➢ All RBCs supplied will be free of hemolysis, and clots.

H. Storage:

➢ Immediately after collection, the red blood cell components shall be stored in a monitored (alarm and recording chart) refrigerator between 1 and 6 degrees Celsius. If transportation of the blood is necessary, it shall be transported in clean shipping containers provided with refrigeration sufficient to hold at 1–10 degrees Celsius, preferably 1–6 degrees while in transit. Plasma is maintained at -18 degrees Celsius or below in a monitored (alarm and recording chart) freezer. Platelets are stored between 20-24 degrees Celsius in a monitored (alarm and recording chart) incubator or other environment that is stable.

I. Contractor Requirements:

• The Contractor shall be registered and/or licensed with the Food and Drug Administration (FDA), through the Department of Health and Human Services pursuant to Section 510 of the Federal Food, Drug and Cosmetic Act as amended, 21 USC Section 260.

• The offeror must hold an unrevoked U.S. License which is issued by the Center for Biologics, Evaluation and Research, Food and Drug Administration (FDA), hereinafter referred to as FDA under Section 351 of the Public Health Service Act, as amended, 42 USC Section 262, as a source of supply for blood and blood products complying with FDA regulations.

• Contractor shall be inspected and accredited by the American Association of Blood Banks; and participates in a proficiency testing program that is recognized as meeting the requirements of the American Association of Blood Banks, especially in terms of frequency and tests challenged.

• The contractor’s transfusion reference laboratory shall:

I. Hold a Certificate of Compliance or Certificate of Accreditation from the Centers for Medicare and Medicaid Services as meeting the requirements of the Clinical Laboratory Improvement Amendments of 1988.

or

II. Is accredited by regulatory agency(s) with deemed status from the Centers for Medicare & Medicaid Services, e.g., the College of American Pathologists and/or other state regulatory agencies, as appropriate, and as mandated by federal and state statutes.

J. Contractor Requirements:

• The contractor shall obtain all necessary licenses and/or permits required to perform this work. He/she shall take all reasonable precautions necessary to protect persons and property from injury or damage during the performance of this contract. He/she shall be responsible for any injury to himself/herself, his/her employees, as well as for any damage to personal or public property that occurs during the performance of this contract that is caused by his/her employee's fault or negligence and shall maintain personal liability and property damage insurance having coverage for a limit as required by the laws of the State of Texas. Further, it is agreed that any negligence of the Government, its officers, agents, servants and employees, shall not be the responsibility of the contractor hereunder with the regard to any claims, loss, damage, injury and liability resulting therefrom.

➢ Insurance Requirements: In accordance with VAAR 852.237-7 Indemnification and

Medical Liability Insurance the following minimum liability insurance coverage levels shall apply to this contract:

➢ General Liability of not less than: $1,000,000.00 per occurrence.

• The Contractor must present to the Contracting Officer, evidence of general liability insurance without any exclusionary clauses that would void the general liability coverage

K. Order Procedures:

• Delivery Orders will be issued by the Contracting Officer and orders will be placed by Contracting Officer Representative (COR), or designee, through telephone, fax, or on-line on an as needed basis, twenty-four hours a day, seven days per week. Names of Lab personnel authorized to place, accept, or reject orders will be provided to the Contractor upon request. Purchase orders to the contractor shall be placed through the following: (Contractor to complete)

Michael E. DeBakey VA Medical Center, Houston, TX:

✓ Vendor’s Contact Person: TBD

✓ Telephone Number: TBD

✓ Fax Number: TBD

✓ On-line Address: TBD

✓ Physical Address: TBD

✓ Emergency order may be placed 24 hours per day 7 days per week by calling: TBD

✓ Emergency Telephone Number: TBD

✓ Fax Number: TBD

L. Interstate Shipment:

• If interstate shipment of blood or blood components is involved, the contractor must submit with the offer a statement that such approval has been authorized under Section 251 of the Public Health Act, as amended, 42 USC Section 262. Contractors that are only registered may not participate in interstate shipments according to federal regulations.

M. Reactions:

• MEDVAMC will report all hemolytic transfusion reactions immediately after occurrence.

Any occurrence of jaundice or other blood-transmitted disease in patients subsequent to blood transfusion shall also be reported.

N. Quality Assurance/Performance Improvement:

• The contractor shall follow the current edition of Standards for Blood Banks and Transfusion Services and the Technical Manual of the American Association of Blood Banks. The contractor shall be licensed by the Food and Drug Administration (FDA), Department of Health and Human Service. The Contractor shall be accredited by the American Association of Blood Banks (AABB).

• Any incident of contractor non-compliance as evidenced by the monitoring procedures shall be reported immediately by the Contracting Officer Representative (COR) to the Contracting Officer.

• The COR will furnish a statement in writing to the Contracting Officer at the close out of the contract to include summary of contractor actions and a statement that all requirements of the contract were fulfilled as agreed.

• A summary evaluation of contractor performance, based upon the compliance or noncompliance of contract requirements as evidenced under the monitoring procedures shall be forwarded by the monitoring official to the Contracting Officer prior to exercising any option.

O. Deliveries or Performance:

• Emergency Requirements:

1) Transportation of specimens to lab for testing:

➢ Emergency (STAT) requests for transportation of patient sample to reference laboratory for reference blood bank testing shall be available with a 1-hour response time. Delivery of blood products for transfusion to MEDVAMC, shall be made within two (2) hours of completion of testing and location of a suitable product.

2) Testing:

➢ Reference testing such as antibody identification, blood product antigen testing, and compatibility testing must be available 24 hrs/ 7 days per week regardless of holidays. In a STAT situation, this testing must be started within 30 minutes of receipt of the specimen to ensure rapid blood product availability. In the event that multiple STAT orders are received at one time, testing will be started as soon as feasible.

3) Delivery of blood products in STAT situations:

➢ The contractor agrees to expedite urgent requests for blood and blood products and to exhaust every possibility to respond to medical emergencies on a prompt and timely basis. A prompt and timely manner is considered to be a maximum of one (1) hour for pick-up of a sample for testing, if necessary, and two hours response/delivery time for suitable blood for transfusion for MEDVAMC unless delays are encountered due to complexity of testing and/or locating compatible products.

• Temperature:

➢ All blood delivered to MEDVAMC under this contract shall be properly packed and insulated in such a way as to ensure that 1-10 degree Celsius is maintained during shipment between the Contractor’s place of business and MEDVAMC as specified.

• Transportation:

➢ The contractor agrees to furnish all transportation for its products, including delivery and pick up. All deliveries must be made to the laboratory’s blood bank MEDVAMC, Houston, TX.

P. Patient/Recipient Testing:

• Identification of allogenic antibodies in recipient blood specimens, antigen typing of blood/blood components, investigation of blood group discrepancies, and compatibility testing (including investigation of incompatibilities) may be requested for VA patients in order to supply compatible blood/blood products. This testing must be performed in compliance with AABB and CAP standards.

Q. Inspection and Acceptance:

• The Contracting Officer’s Representative (COR) shall make inspection of blood products. The COR has the authority to inspect quality, quantity and verify adherence by the contractor to the technical and delivery requirements of the contract.

R. Contracting Officers’ Representative (COR):

• A list will be provided with the award document of authorized laboratory personnel from MEDVAMC, Houston, TX, that may place orders against the contract.

S. Payment:

• The contractor shall submit invoices monthly in arrears covering the services performed under this contract to the VA’s Electronic Invoice Presentment and Payment System (IPPS) – The FSC uses a third-party contractor, Tungsten, 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:

➢ 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.

➢ 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).

➢ The Contractor shall provide an itemized invoice to the required VA invoicing address or submission online through the appropriate website no later than the 10th of the following month services were provided. The invoices shall contain the following information at a minimum:

• Contract Number http://www.x12.org/

• Purchase Order Number

• Line-Item Number (LIN)

• Quantity

• Price

T. Special Contract Requirements:

The contractor agrees to provide blood and blood products in accordance with the terms and conditions stated herein, to the Department of Veterans Affairs Medical Center at the prices specified in the Section entitled Schedule of Supplies/Services of this contract.

• Services:

1) The services specified in the Section entitled Price/Cost Schedule and Special Contract Requirements may only be changed by written modification signed by the Contracting Officer.

2) The services to be performed by the contractor will be performed in accordance with VA policies and procedures and the regulations of the medical staff bylaws of the VA facility.

• Out of Stock Products:

➢ In the event the contractor is out of stock of a particular blood product, the contractor is required to deliver the product(s) to MEDVAMC by obtaining the products from an alternative source.

• Performance Period:

➢ Five (5) Year Ordering Period. The contractor shall perform no services after the end of one performance period until the Contracting Officer authorizes such services in writing.

• Work Hours:

1) The services covered by this contract shall be furnished by the contractor as requested by authorized Laboratory staff.

2) The following terms have the following meanings:

➢ Work Hours: 24-hour/7 days a week

➢ National Holidays observed by the Federal Government are:

New Year’s Day Labor Day Martin Luther King’s Day Columbus Day Presidents’ Day Veterans Day Memorial Day Thanksgiving Independence Day Christmas Juneteenth AND

➢ Any other day specifically declared by the President of the United States to be a national holiday.

• Personnel Policy:

➢ The contractor shall be responsible for protecting the personnel furnishing services under this contract. To carry out this responsibility, the contractor shall follow all Laws and mandates as guided by the Department of Labor.

➢ The parties agree that the contractor, its employees, agents and subcontractors shall not be considered VA employees for any purpose.

• Record Keeping:

➢ MEDVAMC shall establish and maintain a record keeping system that will record products/services provided by the contractor.

U. Changes to Statement of Work:

➢ The Contracting Officer is the only person authorized to approve changes or modify any of the requirements under this contract and such changes will be executed bi-laterally in accordance with FAR 52.212-4(c). The Contractor shall communicate with the Contracting Officer on all matters pertaining to contract administration. Only the Contracting Officer is authorized to make commitments or issue changes, which will affect price, quantity, or quality of performance of this contract. In the event the contractor effects any such change at the direction of any person other than the Contracting Officer, the change shall be considered to have been made without authority and no adjustment will be made in the contract price to cover any increase in costs incurred as a result thereof.

V. Participate in a Post-Award Conference:

➢ This meeting shall provide an introduction between the Contractor personnel and Government personnel who will be involved with the contract. The meeting shall provide the opportunity to discuss technical, management and security issues. The Post Award Conference will aid both the Government and Contractor in achieving a clear and mutual understanding of all requirements and identify and resolve any potential issues. The Contractor shall be prepared to discuss any items requiring clarification and gather information as necessary to support each deliverable. The VA will provide the Contractor with a written summary of the Post-Award Conference.

(End of SOW)

SECTION C - CONTRACT CLAUSES

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

COMMERCIAL SERVICES (NOV 2021)

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

Government must exercise its post-acceptance rights—

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

and

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

(b) Assignment. The Contractor or its assignee may assign its rights to receive payment due as a result of performance of this contract to a bank, trust company, or other financing institution, including any Federal lending agency in accordance with the Assignment of Claims

Act (31 U.S.C. 3727). However, when a third party makes payment (e.g., use of the

Governmentwide commercial purchase card), the Contractor may not assign its rights to receive payment under this contract.

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

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

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

(f) Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without its fault or negligence such as, acts of God or the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, unusually severe weather, and delays of common carriers. The Contractor shall notify the

Contracting Officer in writing as soon as it is reasonably possible after the commencement of any excusable delay, setting forth the full particulars in connection therewith, shall remedy such occurrence with all reasonable dispatch, and shall promptly give written notice to the

Contracting Officer of the cessation of such occurrence.

(g) Invoice.

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

(i) Name and address of the Contractor;

(ii) Invoice date and number;

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

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

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

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

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

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

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

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

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

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

Electronic Funds Transfer—Other Than System for Award Management), or applicable agency procedures.

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

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

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

(i) Payment.—

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

(2) Prompt payment. The Government will make payment in accordance with the Prompt

Payment Act (31 U.S.C. 3903) and prompt payment regulations at 5 CFR part 1315.

(3) Electronic Funds Transfer (EFT). If the Government makes payment by EFT, see 52.212-

5(b) for the appropriate EFT clause.

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

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

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

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

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

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

(D) Contractor point of contact.

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

Officer.

(6) Interest.

(i) All amounts that become payable by the Contractor to the Government under this contract shall bear simple interest from the date due until paid unless paid within 30 days of becoming due. The interest rate shall be the interest rate established by the Secretary of the

Treasury as provided in 41 U.S.C. 7109, which is applicable to the period in which the amount becomes due, as provided in (i)(6)(v) of this clause, and then at the rate applicable for each six-month period as fixed by the Secretary until the amount is paid.

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

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

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

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

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

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

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

(A) The date fixed under this contract.

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

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

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

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

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

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

(j) Risk of loss. Unless the contract specifically provides otherwise, risk of loss or damage to the supplies provided under this contract shall remain with the Contractor until, and shall pass to the Government upon:

(1) Delivery of the supplies to a carrier, if transportation is f.o.b. origin; or

(2) Delivery of the supplies to the Government at the destination specified in the contract, if transportation is f.o.b. destination.

(k) Taxes. The contract price includes all applicable Federal, State, and local taxes and duties.

(l) Termination for the Government's convenience. The Government reserves the right to terminate this contract, or any part hereof, for its sole convenience. In the event of such termination, the Contractor shall immediately stop all work hereunder and shall immediately cause any and all of its suppliers and subcontractors to cease work. Subject to the terms of this contract, the Contractor shall be paid a percentage of the contract price reflecting the percentage of the work performed prior to the notice of termination, plus reasonable charges the

Contractor can demonstrate to the satisfaction of the Government using its standard record keeping system, have resulted from the termination. The Contractor shall not be required to comply with the cost accounting standards or contract cost principles for this purpose. This paragraph does not give the Government any right to audit the Contractor's records. The

Contractor shall not be paid for any work performed or costs incurred which reasonably could have been avoided.

(m) Termination for cause. The Government may terminate this contract, or any part hereof, for cause in the event of any default by the Contractor, or if the…