36C25620Q0009-000.docx

36C25620Q0009 FedBizOpps Combined Synopsis/Solicitation Notice

CLASSIFICATION CODE

SUBJECT

CONTRACTING OFFICE'S

ZIP-CODE

SOLICITATION NUMBER

RESPONSE DATE

(MM-DD-YYYY)

ARCHIVE

DAYS AFTER THE RESPONSE DATE

RECOVERY ACT FUNDS

SET-ASIDE

NAICS CODE

CONTRACTING OFFICE

ADDRESS

POINT OF CONTACT

(POC Information Automatically Filled from User Profile Unless Entered)

DESCRIPTION

See Attachment

AGENCY'S URL

URL DESCRIPTION

AGENCY CONTACT'S EMAIL

ADDRESS

EMAIL DESCRIPTION

ADDRESS

POSTAL CODE

COUNTRY

ADDITIONAL INFORMATION

GENERAL INFORMATION

PLACE OF PERFORMANCE

* = Required Field FedBizOpps Combined Synopsis/Solicitation Notice Rev. March 2010 Autologous & Directed Donations, Testing & Other related services 77030 4298 36C25620Q0009 08-29-2019 N 325412 Department of Veterans Affairs Network Contracting Office 16 Michael E. DeBakey VA Medical Center 2002 Holcombe BLVD Houston TX 77030 4298 Oney Kelly Oney.kelly@va.gov 2002 Holcombe Blvd Houston TX 77030

USA

SEE SF 1449 BELOW

PAGE 1 OF

1. REQ

UISITION 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.

DUNS:

DUNS+4:

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. 2/2012)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

OFFEROR TO COMPLETE BLOCKS 12, 17, 23,

24, & 30

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

36C25620Q0009 08-20-2019 Oney Kelly 713-791-1414 08-29-2019 Department of Veterans Affairs Network Contracting Office 16 Michael E. DeBakey VA Medical Center 2002 Holcombe BLVD Houston TX 77030 4298 X 325412 1250 Employees N/A X Department of Veterans Affairs Michael E. DeBakey VA Medical Center Receiving Warehouse Building 100 2002 Holcombe BLVD Houston TX 77030-4298 Department of Veterans Affairs Network Contracting Office 16 Michael E. DeBakey VA Medical Center 2002 Holcombe BLVD Houston TX 77030 4298

Department of Veterans Affairs Financial Service Center PO Box 149971 Austin TX 78714-9971 See CONTINUATION Page See CONTINUATION Page x X Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

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

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C256 Department of Veterans Affairs Network Contracting Office 16 Michael E. DeBakey VA Medical Center 2002 Holcombe BLVD Houston TX 77030 4298

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

3. INVOICES: Invoices shall be submitted in arrears:

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

Department of Veterans Affairs Financial Service Center PO Box 149971 Austin TX 78714-9971 ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

STATEMENT OF WORK

Purpose The Michael E. DeBakey Veterans Medical Center (MEDVAMC) located in Houston, TX requires a base (12 months) plus 4 option year contract for Autologous Donations, Directed Donations, Emergency Blood and Related Products & Services that are in accordance with standards established by recognized accrediting agencies such as the American Association of Blood Banks, the Food and Drug Administration, and the College of American Pathologists. Blood/blood components and testing must be available 24 hours per day, seven days per week regardless of holidays. Items listed below shall be drawn, processed, tested, typed and packed as specified in the following sections in suitable containers, and delivered FOB destination within consignee’s premises to the MEDVAMC, Pathology and Laboratory Medicine Service (113), Rm. 3A-121, 2002 Holcombe Blvd., Houston, TX 77030 as requested by authorized VA Blood Bank personnel. It is critical that blood products and those tests needed to ensure compatibility or blood products be available ON A STAT BASIS (immediately). The MEDVAMC is pursing this as a Firm Fixed Price Contract.

Background The Blood Utilization Committee requires the MEDVAMC to provide Directed Donations and/or Autologous Donations (if requested by the Veteran). Directed Donations are units of blood directly solicited from family or friends by the intended recipient. Some patients anticipating surgery prefer to receive blood donated by relatives or friends. Physicians initiate the order for directed donation of blood at a patient's request. The order must specify the number of units needed, transfusion date(s), and patient's ABO and Rh type. The patient should instruct his/her directed donors to donate a few days to a few weeks before the anticipated transfusion to allow adequate time for donor scheduling, blood collection, test completion, and shipping. Directed donors must have a blood type that is compatible with the recipient and meet the same donor requirements as volunteer donors. The same tests are performed on directed units as volunteer units. Generally, donors give blood only once every 8 weeks. To reduce the number of donors a patient is exposed to, special arrangements can be made to have some designated donors give more frequently. These frequent donors must continue to meet all other donor requirements each time they donate. Autologous Donations can occur if the Veteran is going to be having a surgery that will be scheduled several weeks in advance. This is a transfusion in which you receive your own blood which was drawn prior to the Veteran’s surgery. There are several benefits to receiving your own blood. There is no risk of reaction to foreign antigens. Since your body recognizes its own blood, it is readily accepted. There is also no possibility of disease being transmitted from the blood of another person. An autologous blood transfusion is only possible when the Veteran’s surgery is planned well in advance. This is not an option for emergency surgery. In addition, there are times when the MEDVAMC’s primary blood supplier is unable to provide blood/blood products due to availability &/or the rare nature of the items being requested. It is therefor critical that the MEDVAMC have an emergency alternative.

Scope of Work Autologous Donations, Directed Donations, Emergency Blood and Related Products & Services will be delivered on an as needed basis, with orders being called in by MEDVAMC’s Path & Laboratory personnel. Orders will be requested from the below listing:

Special Requirements

A) 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 the MEDVAMC under this contract.

· Selection: Donor selection must be in accordance with criteria established by the FDA and/or the American Association of Blood Banks (AABB). (www.fda.gov/ and www.aabb.org) B) 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 labeled according to “Uniform Labeling Guidelines” to include the anticoagulant used and the appropriate expiration date. 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.

C) Autologous Donations:

Autologous blood or components will be collected for patients as referred by the MEDVAMC. These units shall be tested as stated in F. Typing/Testing section below. These tests shall be performed before shipping on at least the first unit collected during each 30-day period. The patient’s physician and the patient shall be informed of any medically significant abnormalities discovered. If an autologous unit is to be shipped to another facility and the unit tests positive for any marker of transfusion-transmitted disease, the shipping facility shall notify the receiving transfusion service.

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 D 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. 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 the MEDVAMC transfusion service as soon as possible.

E) Labeling:

Blood shall be furnished labeled as to A, B, O, and Rh type and type of component. Type A Rh negative and O Rh negative must have been drawn from a donor not more than five (5) days before date on which the purchase order is filled. Types such as AB Rh positive, B Rh negative and AB Rh negative shall be supplied as fresh as possible but not over fifteen (15) days old. These limits may be adjusted if a system for exchange on credit is provided which minimizes or precludes losses due to outdating.

F) 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.

G) 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.

0. 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.

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

0. RED BLOOD CELLS LEUKOCYTES REDUCED (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.

0. 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).

0. FRESH FROZEN PLASMA (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.

0. CRYOPRECIPITATEDAHF (Cryoprecipitated Antihemophilic Factor) 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.

0. POOLED PLATELETS LEUKOCYTES REDUCED (Platelets Leukocytes Reduced Pooled) Pooled Platelets Leukocytes Reduced shall be prepared by a method known to result in a residual leukocyte count <5 × 106.

0. 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.

H) Hemolysis/Chyle/Clots:

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

I) 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.

J) Other Contractor Responsibilities:

1. Offers shall be considered only from offerors whose blood bank is currently 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: is 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. Prior to award, the offeror must submit proof that he holds 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.

1. 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.

K) Ordering:

Autologous Donations, Directed Donations, Emergency Blood and Related Products & Services will be delivered on an as needed basis, with orders being called in by MEDVAMC’s Path & Laboratory personnel.

L) Reactions:

The 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.

M) Deliveries or Performance:

Blood shall be delivered as specified within 4 hours following routine request(s). Emergency requirements are to be immediately available for delivery and/or pickup by MEDVAMC personnel.

1. Emergency Requirements:

0. 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.

0. Testing:

Reference testing such as antibody identification, blood product antigen testing, and compatibility testing must be available 24 hrs./ day, 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.

0. 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.

1. Temperature:

All blood delivered to the 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 the MEDVAMC as specified.

1. Stock:

The Contractor shall maintain an adequate stock of blood and blood products on site at the MEDVAMC and regularly maintain stock levels.

1. 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.

N) 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.

O) Inspection and Acceptance:

1. The right is reserved to thoroughly inspect and investigate the establishment ‘s facilities, records, and other qualifications of any offeror, and to reject any bid regardless of price if it should be administratively determined as lacking in any of the essentials necessary to assure acceptable standards of performance. Such inspections and investigations shall include a determination as to the offeror’s conformance with terms and conditions of this document.

1. The contractor reserves the rights to inspect conditions of blood and blood component storage at any hospital that returns blood to the Blood Center.

P) Contracting Officers’ Technical Representative (COTR):

Q) Payment:

1. The contractor shall be paid monthly in arrears following receipt of proper invoice for products delivered.

1. Invoices Shall be Submitted to the VA’s Electronic Invoice Presentment and Payment System – The FSC uses a third-party contractor, Tungsten, to transition vendor 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.

1. 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:

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

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

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

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

B.5. Special Contract Requirements

A) Services

1. The Price/Cost Schedule and Special Contract Requirements may only be changed by written modification signed by the Contracting Officer.

1. 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.

B) Qualifications:

Testing personnel assigned by the Contractor to perform the services covered by this contract shall be licensed in a State, Territory, or Commonwealth of the United States or the District of Columbia. All licenses held by the personnel working on this contract shall be full and unrestricted licenses. The qualifications of such personnel shall also be subject to review by the VA Chief of Staff and approval by the VA Facility Director. Each person assigned to work under this contract shall be licensed by the State of Texas and shall meet the testing personnel requirements of the American Association of Blood Banks for the type/complexity testing performed.

C) Work Hours:

Work Hours 24/7 including holidays.

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

Autologous Donations, Directed Donations, Emergency Blood and Related Products & Services ordered on an as needed basis by Pathology & Laboratory Personnel

LOCAL STOCK NUMBER: N/A

Autologous Donations, Directed Donations, Emergency Blood and Related Products & Services ordered on an as needed basis by Pathology & Laboratory Personnel Contract Period: Option 1 POP Begin:

POP End:

Autologous Donations, Directed Donations, Emergency Blood and Related Products & Services ordered on an as needed basis by Pathology & Laboratory Personnel Contract Period: Option 2

Autologous Donations, Directed Donations, Emergency Blood and Related Products & Services ordered on an as needed basis by Pathology & Laboratory Personnel Contract Period: Option 3

Autologous Donations, Directed Donations, Emergency Blood and Related Products & Services ordered on an as needed basis by Pathology & Laboratory Personnel Contract Period: Option 4

B.3 DELIVERY SCHEDULE

1.00

1.00

1.00

1.00

1.00

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (OCT 2018)

(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 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 32.608-2 of the Federal Acquisition Regulation 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 Contractor fails to comply with any contract terms and conditions, or fails to provide the Government, upon request, with adequate assurances of future performance. In the event of termination for cause, the Government shall not be liable to the Contractor for any amount for supplies or services not accepted, and the Contractor shall be liable to the Government for any and all rights and remedies provided by law. If it is determined that the Government improperly terminated this contract for default, such termination shall be deemed a termination for convenience.

(n) Title. Unless specified elsewhere in this contract, title to items furnished under this contract shall pass to the Government upon acceptance, regardless of when or where the Government takes physical possession.

(o) Warranty. The Contractor warrants and implies that the items delivered hereunder are merchantable and fit for use for the particular purpose described in this contract.

(p) Limitation of liability. Except as otherwise provided by an express warranty, the Contractor will not be liable to the Government for consequential damages resulting from any defect or deficiencies in accepted items.

(q) Other compliances. The Contractor shall comply with all applicable Federal, State and local laws, executive orders, rules and regulations applicable to its performance under this contract.

(r) Compliance with laws unique to Government contracts. The Contractor agrees to comply with 31 U.S.C. 1352 relating to limitations on the use of appropriated funds to influence certain Federal contracts; 18 U.S.C. 431 relating to officials not to benefit; 40 U.S.C. chapter 37, Contract Work Hours and Safety Standards; 41 U.S.C. chapter 87, Kickbacks; 41 U.S.C. 4712 and 10 U.S.C. 2409 relating to whistleblower protections; 49 U.S.C. 40118, Fly American; and 41 U.S.C. chapter 21 relating to procurement integrity.

(s) Order of precedence. Any inconsistencies in this solicitation or contract shall be resolved by giving precedence in the following order:

(1) The schedule of supplies/services.

(2) The Assignments, Disputes, Payments, Invoice, Other Compliances, Compliance with Laws Unique to Government Contracts, and Unauthorized Obligations paragraphs of this clause;

(3) The clause at 52.212-5.

(4) Addenda to this solicitation or contract, including any license agreements for computer software.

(5) Solicitation provisions if this is a solicitation.

(6) Other paragraphs of this clause.

(7) The Standard Form 1449.

(8) Other documents, exhibits, and attachments

(9) The specification.

(t) [Reserved]

(u) Unauthorized Obligations.

(1) Except as stated in paragraph (u)(2) of this clause, when any supply or service acquired under this contract is subject to any End User License Agreement (EULA), Terms of Service (TOS), or similar legal instrument or agreement, that includes any clause requiring the Government to indemnify the Contractor or any person or entity for damages, costs, fees, or any other loss or liability that would create an Anti-Deficiency Act violation (31 U.S.C. 1341), the following shall govern:

(i) Any such clause is unenforceable against the Government.

(ii) Neither the Government nor any Government authorized end user shall be deemed to have agreed to such clause by virtue of it appearing in the EULA, TOS, or similar legal instrument or agreement. If the EULA, TOS, or similar legal instrument or agreement is invoked through an “I agree” click box or other comparable mechanism (e.g., “click-wrap” or “browse-wrap” agreements), execution does not bind the Government or any Government authorized end user to such clause.

(iii) Any such clause is deemed to be stricken from the EULA, TOS, or similar legal instrument or agreement.

(2) Paragraph (u)(1) of this clause does not apply to indemnification by the Government that is expressly authorized by statute and specifically authorized under applicable agency regulations and procedures.

(v) Incorporation by reference. The Contractor’s representations and certifications, including those completed electronically via the System for Award Management (SAM), are incorporated by reference into the contract.

(End of Clause) ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS Clauses that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

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

C.2 52.217-6 OPTION FOR INCREASED QUANTITY (MAR 1989)

The Government may increase the quantity of supplies called for in the Schedule at the unit price specified. The Contracting Officer may exercise the option by written notice to the Contractor within 30 days. Delivery of the added items shall continue at the same rate as the like items called for under the contract, unless the parties otherwise agree.

(End of Clause)

C.3 VAAR 852.215-71 EVALUATION FACTOR COMMITMENTS (DEC 2009)

The offeror agrees, if awarded a contract, to use the service-disabled veteran-owned small businesses or veteran-owned small businesses proposed as subcontractors in accordance with 852.215-70, Service-Disabled Veteran-Owned and Veteran-Owned Small Business Evaluation Factors, or to substitute one or more service-disabled veteran-owned small businesses or veteran-owned small businesses for subcontract work of the same or similar value.

(End of Clause) C.4 VAAR 852.219-75 SUBCONTRACTING COMMITMENTS MONITORING AND COMPLIANCE (JUL 2018)

(a) This solicitation includes the clause: 852.215-70 Service-disabled veteran-owned and veteran-owned small business evaluation factors. Accordingly, any contract resulting from this solicitation will include the clause 852.215-71 Evaluation factor commitments.

(b) The Contractor is advised that in performing contract administration functions, the Contracting Officer may use the services of a support contractor(s) to assist in assessing Contractor compliance with the subcontracting commitments incorporated into the contract. To that end, the support contractor(s) may require access to the Contractor's business records or other proprietary data to review such business records regarding contract compliance with this requirement.

(c) All support contractors conducting this review on behalf of VA will be required to sign an “Information Protection and Non-Disclosure and Disclosure of Conflicts of Interest Agreement” to ensure the Contractor's business records or other proprietary data reviewed or obtained in the course of assisting the Contracting Officer in assessing the Contractor for compliance are protected to ensure information or data is not improperly disclosed or other impropriety occurs.

(d) Furthermore, if VA determines any services the support contractor(s) will perform in assessing compliance are advisory and assistance services as defined in FAR 2.101, Definitions, the support contractor(s) must also enter into an agreement with the Contractor to protect proprietary information as required by FAR 9.505-4, Obtaining access to proprietary information, paragraph (b). The Contractor is required to cooperate fully and make available any records as may be required to enable the Contracting Officer to assess the Contractor compliance with the subcontracting commitments.

(End of Clause)

C.5 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2018)

(a) Definitions. As used in this clause—

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

(2) Designated agency office means the office designated by the purchase order, agreement, or contract to first receive and review invoices. This office can be contractually designated as the receiving entity. This office may be different from the office issuing the payment;

(3) Electronic form means an automated system transmitting information electronically according to the accepted electronic data transmission methods and formats identified in paragraph (c) of this clause.