36C26120Q0969.docx

36C26120Q0969

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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.

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

570-21-1-223-0010 36C26120Q0969 11-24-2020 Deborah Sosa 916-923-4564 11-27-2020

8AM

PST

612MCP

Department of Veterans Affairs VA Sierra Pacific Network (VISN 21) VA Northern California HealthCare System 5342 Dudley Blvd, Bldg 209 McClellan

CA

95652-2609 X 621991 $35 Million N/A X VA Central California Health Care System 2615 E. Clinton Ave Fresno, CA 93703

612MCP

Department of Veterans Affairs VA Northern California HealthCare System 3230 Peacekeeper Way, Bldg. 209 McClellan

CA

95652-1012

Department of Veterans Affairs FMS VA-9(101) Financial Services Center PO Box 149971 Austin

TX

78714-9971 See CONTINUATION Page This is a request for quote for blood and blood products, see Section B for Statement of Work, Description and dellivery. No partial quotes will be accepted or considered See CONTINUATION Page X Deborah Sosa SECTION B – INDEFINITE DELIVERY, INDEFINITE QUANTITY (IDIQ) CONTRACT ADMINISTRATION DATA AND STATEMENT OF WORK

B.1 IDIQ CONTRACT ADMINISTRATION:

1. All IDIQ administration matters will be handled by the following individuals:

0. CONTRACTOR:

0. GOVERNMENT: Contracting Officer (CO): Deborah Sosa Department of Veterans Affairs Network Contracting Office (NCO) 21 McClellan, CA 95652 deborah.sosa@va.gov

1. OFFEROR REMITTANCE ADDRESS: See Section B.2.12 for details.

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

B.2 DESCRIPTION OF CONTRACT

1. SCOPE OF WORK: The contract will be an indefinite delivery, indefinite quantity (IDIQ) with a term of up to five years. All Delivery Orders will be placed against the IDIQ contract on an as-needed basis with an initial order amount of no less than $25,000.00 and no order to exceed $2,500,000. The quantity and size of the items needed over the life of the contract are listed below and could vary in each delivery order.

1. INTENT: In the spirit of the Federal Acquisition Streamlining Act and pursuant to Federal Acquisition Regulation (FAR) Part 12 – Acquisition of Commercial Items and FAR Part 8 – Required Sources of Supplies and Services, it is the intent of the Department of Veterans Affairs (VA), Veterans Integrated Service Network (VISN) 21, VA Central California Healthcare System (VACCHCS) (VA FRESNO) to establish a Single Award contract for Blood and Blood Products as described within this solicitation. The Contractor shall provide all the necessary supplies to perform for VASNHCS as outlined within this solicitation.

1. TERMS OF AGREEMENT: This contract shall be for a five (5) year term, In Accordance With (IAW) FAR Part 13.303-3. This contract will be reviewed at least annually to ensure the terms are met, to assess current market conditions and to determine price reasonableness IAW FAR Part 13.303-6. Additional discounts maybe requested by NCO 21 at any time. If the Contractor fails to perform in a manner satisfactory to the Contracting Officer, this contract may be canceled with a thirty (30) days written notice to the Contractor by the Contracting Officer. The contract shall not exceed sixty (60) months from the effective date.

1. PRICES: This requirement contract is a pricing agreement and does not obligate any funds. Pricing shall be established based on the estimated quantities listed in this solicitation.

1. DELIVERY ORDERS: The Government is obligated only to the extent of authorized any Delivery Orders (DO) issued under the contract by authorized individuals. DOs shall be identified by the contract Number, To Be Determined (TBD) and DO Number (TBD). DOs may include options, if it is determined that options would be in the best interest of the Government. Any DO issue during the effective term of this contract shall be completed by the Contractor within the time specified in the DO, including any option periods. The Contractor shall accept the price, terms and conditions of an issued DO as long as they do not conflict with the terms set forth in the contract.

NOTICE TO CONTRACTORS: The awarded Contractor is advised that only the Contracting Officer, acting within the scope of the contract has the authority to make changes which affect the contract in terms of quality, quantity, price or delivery, unless otherwise specified within this solicitation. In the event the Contractor initiates any such change at the direction of any person other than the Contractor Officer, the change shall be considered to have been made without authority and no adjustment shall be made in the contract price to cover any increase of costs incurred as a result thereof.

1. ORDERING METHOD: Designated primary facility Points of Contact (POCs) shall place orders against valid DOs signed by the Contracting Officer. POCs may coordinate delivery quantities and schedule via Electronic Data Interchange (EDI), telephone, facsimile, email or other written communication, identifying the products by number, quantity, purchase price, address for delivery, and any special instructions.

1. PARTICIPATING FACILITIES: This IDIQ covers VA Central California Healthcare System (VA Fresno).

1. CONTRACT PROGRAM MANAGER: The Contractor shall provide a primary Program Manager who shall be responsible for the performance of the work under the contract. In addition, the Program Manager shall act as the main focal point of communication between the Contracting Officer and the Contractor. The name of this person shall be designated in writing to the Contracting Officer. The Program Manager shall have full authority to act on behalf of the Contractor on all contractual matters relating to daily operation of the contract.

1. ORDERING CONTACTS: The Contractor shall list in the spaces below the name(s) and address(es) of customer service departments with whom the Government facilities shall place orders. Additional tables may be inserted, if needed.

1. DELIVERY: The Contractor shall deliver all supplies and services identified in the schedule to the locations identified in each delivery order. The delivery location is subject to change as required by the designated authority or authorized personnel at the receiving facility. The primary facility POC shall be required to notify the Contractor when delivery locations have been changed.

All deliveries shall be accompanied by a delivery ticket or sales slip which shall contain: Contractor name, contract number, DO number, VISTA obligation number, date of order, date of delivery, itemized list of products furnished, including product description and quantity shipped.

All deliveries shall be made during normal working hours from 8:00 a.m. to 4:00 p.m., unless specified otherwise. Standard orders shall be delivered within no more than 3-5 working days after receipt or placement of order.

No product substitutions shall be made by Contractor without prior approval of the treating facilities primary POC. However, if substitution would further obligate the Government, the Contractor shall have approval of a warranted Contracting Officer.

1. PACKAGING: All supplies shall be adequately packaged to prevent damage during shipping, handling and storage. Bags or packages shall be whole, intact, and not otherwise torn or damaged. Upon delivery, the Government shall examine all packages. The Contractor shall be required to replace unacceptable or damaged products at the Contractor’s expense.

1. INVOICE AND PAYMENT: An itemized invoice shall be submitted at least monthly, whichever occurs first, for all deliveries made during a billing period and for which payment has not been received. These invoices need not be supported by copies of delivery tickets. Invoices shall be submitted to WWW.TUNGSTEN-NETWORK.COM in accordance with FAR Part 52.232-34, Payment by Electronic Funds Transfer and Veterans Affairs Acquisition Regulation (VAAR) Part 852.232-72.

The following information shall be listed on all invoices submitted: (failure to comply may result in refusal of an invoice resulting in delayed payment at the fault of the Contractor)

0. Facility’s Name and address where service was provided

0. Contract Number (For Example: VA261-21-A-0001)

0. Purchase Order/Delivery Order Number (For Example: 36C261-21-N-0000)

0. VISTA Obligation Number (For Example: 654-C19001)

0. Itemized list of products provided, to include quantity, unit price and extended price

0. Include the period of time that is being invoiced for in the invoice

0. Contract Holder’s Internal Contract number (if applicable)

0. Contractor company name, address, and phone number including a POC for concerns and questions, Invoices shall name a specific person, the phone number and email

In the event of an inconsistency between the terms and conditions of this contract and the Contractor's invoice, the terms and conditions of this contract will take precedence.

SECTION B - DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK

36C26120Q0969

STATEMENT OF WORK

1. INTRODUCTION:

1.1. The Vendor shall furnish and deliver the blood and blood products listed in “Attachment 1 – Price-Cost Schedule for Estimated Usage” on an “AS NEEDED” basis, in appropriate containers, to VA Central California Health Care System (VACCHCS):

VACCHCS Blood Bank 2615 East Clinton Ave Fresno, CA 94703 POC: Eileen Khanania

1.2. Authorized personnel from the VACCHCS will order supplies furnished under this contract on an “AS NEEDED” basis. VA personnel authorized to place orders will be identified after award.

1.3. The Vendor shall provide blood and blood products as available when ordered, and VACCHCS shall purchase blood and blood products according to the appropriate pricing listed in “Attachment 1 – Price-Cost Schedule for Estimated Usage”.

1.4. All blood will be tested as required by the Food and Drug Administration (FDA), the American Association of Blood Banks (AABB), all applicable state regulatory agencies, laws, rules and regulations. The Vendor and the VACCHCS shall maintain standards in accordance with FDA, AABB, all applicable state regulatory agencies, laws, rules and regulations, including Occupational Safety and Health Administration (OSHA) Blood borne Pathogen Exposure Final Rule 29 Code of Federal Regulations (CFR) Part 1910.1030, effective March 2, 1996, and any subsequent revisions thereof.

1.5. All blood shall be collected by the closed system under aseptic conditions and shall be stored in currently approved, appropriate solutions and the container shall be correctly labeled. The label shall also bear the expiration date of the contents which shall not exceed 42 days from date of collection of source blood when collected and stored with anti-coagulant citrate phosphate, dextrose adenine solution (AS) or 35 days from date of collection of source blood, when collected and stored with anti-coagulant citrate phosphate dextrose adenine solution (CPDA1).

1.6. All blood supplies shall be free of hemolysis, and clots, based on The Vendor’s visual inspection of such blood prior to delivery.

1.7. Prior to award The Vendor must submit proof that they hold an unrevoked US license which is issued by the Director, Bureau of Biologics, FDA under Section 351 of the Public Health Service Act, as amended, 42 USC Section 262, as a source of supply for Leukoreduced Red Blood Cells. Vendor shall maintain licensure and accreditation throughout contract period. The Vendor shall comply with the requirements outlined below with respect to donors, containers, delivery, etc.

1.7.1. Vendor shall provide VACCHCS with 100% “volunteer donors” blood in accordance with the latest FDA rules and regulations.

1.7.1.1. Definition of a “volunteer donor”: “A volunteer donor is a person who does not receive monetary payment for blood donation. Benefits, such as monetary time off from work, membership in blood assurance programs and cancellations on non-replacement fees that are not readily convertible to cash, do not constitute monetary payment.”

1.7.2. Blood and blood products shall be delivered to the VACCHCS Blood Bank within two (2) hours for STAT/Emergency orders and four (4) hours for stock orders from the time the order is placed with The Vendor. All Fresh Frozen Plasma shall have expiration dates at least nine (9) months in advance when shipped. The VACCHCS has in place the suitable temperature-monitored freezer and refrigerator for appropriate storage of the products.

2. CRITERIA FOR DONOR SELECTION:

2.1. The Vendor shall maintain a blood donor list with unique identifier numbers. Such list shall indicate the date the blood of a volunteer donor was furnished to the VACCHCS. Donor selection shall be in accordance with criteria established by the FDA and or American Association of Blood Banks.

2.2. Blood samples testing positive during unit screening shall not be used for transfusion if the results are outside the established limits by FDA and or ABB. When FDA or AABB requires a new test, it shall be performed.

3. COLLECTION, PROCESSING AND TYPING OF BLOOD:

3.1. Blood shall be typed for ABO & Rh antigens and labeled in accordance with the methods recommended in the current editions of “Standard for Blood Banks and Transfusion Services and Technical methods and Procedures,” published by the AABB.

3.1.1. If there is an error by The Vendor in the blood typing, The Vendor shall pick up the errant blood immediately.

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

3.2.1. 21 days from the date of collection of source blood; or:

3.2.2. 35 days from the date of collection of source blood if when collected, is stored with anti-coagulant citrate phosphate, dextrose adenine solution (CPDA1).

3.2.3. 42 days from date of collection for blood collected in Adsol.

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

4. QUALIFICATIONS:

4.1. All blood and blood products shall be collected, processed, labeled, tested, packaged and shipped in accordance with all regulations of the FDA, Center for Biological Evaluation and review, as described in CFR Title 21, Parts 600, 601, 606, 607, 610, 640, and 660, and the Department of Health and Human Services (DHHS). Also, The Vendor shall maintain a current license with the FDA and the DHHS and maintain accreditation with the AABB. The Vendor shall be accredited by The Joint Commission (JC) or meet JC standards and maintain the accreditation or standards. The Vendor shall provide current documentation of above licenses and accreditation to the Contracting Officer (CO) with the proposal, and annually or upon organizational change. The Vendor shall immediately inform the CO concerning any threatened or actual revocation, suspension, or termination or material modification of a certification or licensure.

5. SPECIFICATIONS:

5.1. Volunteer blood donors shall make all donations. The Vendor shall use reasonable efforts to supply the VACCHCS with related service needs. In the event modification of testing of blood for safe usage, as mandated by FDA, Vendor shall provide the CO with 30 days written notice and the CO shall issue a modification.

5.2. Should the Vendor be unable to provide blood components from its inventory to fill an order, The Vendor shall seek other approved sources to obtain such blood components to complete the order. In the event The Vendor fails to fill an order within the estimated timeframe given at the time the order is placed, Vendor shall notify VACCHCS within 30 minutes, and the Government may obtain the item/s elsewhere.

5.3. Vendor shall provide the most current version of the Circular of Information for the use of human blood and blood components to the VACCHCS at no additional charge to the Government.

5.4. Vendor shall not require pre-payment of blood processing & handling surcharges from autologous or designated blood donors for VA. The Vendor shall direct autologous or designated blood donors for VA patients to a facility as decided by VA and the blood center after coordination with COR. In the event a facility for autologous or designated blood donors for VA patient is not feasible for the donor, a community blood center may be used. Shipping fees of blood components shall be incurred by The Vendor. The Vendor shall ship blood components at no additional expense to the VA. These units shall be shipped to VA when received. Autologous donors that have units drawn at The Vendor’s collection sites shall not be required to pay any charges.

5.5. Reference laboratory reports shall be provided to VACCHCS, as soon as testing is completed, by telephone, as this shall provide transfusion records to the patients. A written report shall be issued within seven (7) business days following telephone report. Both telephone and written reports shall be submitted to VACCHCS Blood Bank Technical Specialist, or her/his designee.

5.6. Complex cases may take longer to report and shall be handled on a case by case basis. Mutually agreeable reporting date shall be determined between the VACCHCS Blood Bank Technical Specialist and The Vendor.

6. ORDERING: Orders shall be placed by fax or telephone on an “As Needed” basis by a VACCHCS Blood Bank Technologist at the VACCHCS Blood Bank, VACCHCS.

7. PACKAGING: Blood components shall be labeled in accordance with all FDA requirements, including kind of component, blood group and type (ABO/Rh), expiration date, unique donor unit identification, and storage and handling. Blood components shall be packaged for shipping and transport to ensure the FDA required temperature ranges are maintained: red cell components (1-10◦C), frozen plasma components (below <-20◦C), and platelet components (20-24◦C).

8. DELIVERIES:

8.1. There shall be no additional delivery charges for blood and blood products. Delivery charges shall be included in the overall price of the blood and blood product. Vendor shall make every effort to make routine deliveries during the time of day suitable to, and as requested by, the VACCHCS.

8.2. The Vendor shall have sole responsibility of the proper care and handling of all blood and blood components, until delivered to the designated VACCHCS Blood Bank in accordance with FAR Clause 52.247-35, F.O.B. destination, within consignee’s premises. All deliveries shall be delivered to the VACCHCS on an “AS NEEDED” basis.

8.2.1. STAT: STAT ordering shall be utilized when products are needed immediately. VACCHCS shall order STAT and expect delivery within two (2) hours. Deliveries shall be seven (7) days per week, twenty-four (24) hours per day “As Needed”.

8.2.2. VACCHCS shall make reasonable efforts to minimize the frequency of STAT deliveries.

8.2.3. No additional charge shall be incurred by the Government for STAT orders.

8.2.4. Vendor shall make every effort to ensure delivery of autologous blood components are made prior to the scheduled surgery. Deglycerolized cells shall be delivered to hospitals within four (4) hours of preparation to assure adequate dating.

8.2.5. Each shipment shall be properly packaged and be accompanied by an itemized shipping list.

9. INSPECTION AND ACCEPTANCE: Upon receipt, VACCHCS shall properly inspect the blood and blood products and maintain proper refrigeration and storage facilities for the blood in compliance with all regulations, as well as the standards of the AABB, as applicable.

9.1. Inspection of Facilities: VACCHCS reserves the right to thoroughly inspect and investigate the establishment, facilities, and other qualifications of The Vendor.

9.2. Reference Lab Services: Reference lab services for red cell antibody identification must be available twenty-four (24) hours per day and seven (7) days per week, and must provide results within four (4) hours for urgent and seven (7) days per week, and must provide results within four (4) hours for urgent clinical situations, and within twenty-four (24) hours in non-urgent situations.

9.3. Plasmapheresis/cytopheresis services must be available twenty-four (24) hours per day and seven (7) days per week and must be available within four (4) hours for urgent clinical situations.

9.4. Plasmapheresis/cytopheresis services are therapeutic procedures performed on patients that have appropriate clinical indications. Automated equipment is used to perform these procedures.

9.5. All pheresis equipment, personnel that operate the equipment and supervisory physicians must satisfy the appropriate regulatory agency guidelines (FDA, AABB, etc.). All pheresis procedures must be under the supervision of a qualified physician.

10. IDENTIFICATION, PARKING, SMOKING, AND VA REGULATIONS: Vendor employees shall wear visible company identification at all times while on VACCHCS property. It is the responsibility of The Vendor employees to park in the appropriate designated parking areas. Information of designated parking areas is available from the VA Police Service. VACCHCS will not invalidate or make reimbursement for parking violations of The Vendor under any conditions. Smoking is prohibited on VACCHCS property, except in designated areas. Possession of weapons, illegal drugs or alcohol is prohibited. Enclosed containers, including tool kits, shall be subjected to search. Violations of VACCHCS regulations may result in citation answerable in the United States Federal District Court, not a local district, state, or municipal court.

11. HOURS OF OPERATION

Workdays: VACCHCS Normal Business Hours are Monday thru Friday, 7:30 AM until 4:30 PM; however, the VACCHCS laboratory is staffed twenty-four (24) hours a day, seven days a week.

Federal Holidays: The following holidays are observed by the Department of Veterans Affairs:

New Year’s Day President’s Day Martin Luther King’s Birthday Memorial Day Independence Day Labor Day Columbus Day Veterans Day Thanksgiving Christmas The payment for any leave, including sick leave or vacation time, is the responsibility of The Vendor. Periods of any absences are not paid by the VA.

12. COVERAGE:

12.1. Twenty-four (24) hour coverage shall be provided by The Vendor to fill emergency needs when these needs are ordered by VACCHCS. Coverage includes filling blood and blood component orders as requested.

12.2. VACCHCS Blood Bank shall maintain properly monitored temperature refrigeration storage of blood components, and shall abide by directives dictating handling, storage and shipping of blood components and related documentation.

12.3. VACCHCS Blood Bank shall make available, on an as needed basis, its inventory of blood components. Any excess of VACCHCS blood bank immediate patient requirements may be made available for distribution to other hospitals, with approval from the VA Blood Bank. Vendor shall work with the VACCHCS to provide blood component to replenish blood inventory.

12.4. The Vendor shall own, control and solely be responsible for any loss, destruction or damage to the blood until delivered or received and accepted. After such delivery or receipt and acceptance, the VACCHCS shall own the blood. The VACCHCS also agree and acknowledge that no blood components supplied by The Vendor, including part and or derivatives thereof, shall be sold, bartered, traded or exchanged by the VACCHCS without prior authorization from The Vendor.

12.5. The VACCHCS Blood Bank shall prioritize the use of appropriate blood components with the shortest dating period and provide to The Vendor after award to ensure optimal utilization of blood components and thereby avoid loss by outdating.

13. ADVERSE EVENT REPORTING: VACCHCS will notify The Vendor of any possible infectious disease or other serious complication associated with transfusion that may have resulted from any of the blood, including suspected post-transfusion hepatitis, transfusion-associated HIV or HTLV infection, and any other transfusion-associated infections (malaria, babesiosis, bacterial contamination or infection) and death. VACCHCS will make available to The Vendor information concerning transfusions to include product names, lot identifications and quantities, any therapeutic adverse effects, complaints or other pertinent information relating to the blood.

14. REJECTED GOODS: The Vendor shall remove rejected products within 48 hours after notice of rejection.

15. RETURNS: Credit for returned, unacceptable, transferred, recalled, withdrawn, or rotated blood components shall be included on the billing statement within 30 days of the return.

15.1. Full credit shall be given by The Vendor if for a technical reason the blood component cannot be used, regardless of expiration, provided the Government notifies The Vendor within twenty-four (24) hours of discovery and the VACCHCS Blood Bank completes appropriate documentation.

15.2. Full credit shall be given by The Vendor for any Red Blood Cell product returned/exchanged within ten (10) days or greater from the expiration date. If blood is shipped to the transfusion service with ten (10) days or less remaining before expiration date, full credit will be given to VACCHCS if it is returned to The Vendor no later than five (5) days after the expiration date. Full credit will be given to the VACCHCS for Red Blood Cell products not rotated due to an inventory shortage by The Vendor upon return.

15.3. Vendor shall assist with and facilitate the transfer of all blood components to ensure their use. This includes irradiated and other transferrable blood components.

15.4. Red Cells. Vendor shall notify VACCHCS and VACCHCS shall approve Red Blood Cells unit with seven (7) days or less shelf-life remaining prior to delivery.

15.5. Single donor plateletpheresis are returnable and credit will be given if unit is returned with twenty-four (24) hours of shelf life, provided the unit has been continuously stored within 20-24°C with continuous gentle agitation, and the maximum time without agitation is less than twenty-four (24) hours or less, and is unable to use, full credit will be given in the event of expiration date.

16. TRANSFUSION REACTION: VACCHCS Blood Bank shall report to The Vendor within twenty-four (24) hours by telephone any life threatening adverse reactions and if appropriate, make arrangements to have specimen of patient’s blood and the remaining portion of blood component in question sent to Vendor for testing at no additional charge to the Government. VACCHCS Blood Bank shall report to Vendor and assist in investigation of cases of suspected adverse transfusion reactions, including post transfusion hepatitis, post transfusion HTVL-1, and transfusion associated HIV infection within a reasonable period of time not exceeding seven (7) days after learning of the adverse reaction.

17. RECORDS MANAGEMENT: VACCHCS Blood Bank shall maintain thorough and complete records of the recipients of all vendor products to facilitate investigation of transfusion reaction or product recalls. Patient privacy and security safeguards shall be in effect at all times throughout performance of this contract to prevent the loss of sensitive patient data/information and PHI/PII IAW local VA policy.

18. INVOICE AND PAYMENT:

Itemized invoices rendered by The Vendor to VACCHCS for service furnished under this task order shall be invoiced in full for each month in which services were performed. All payments made under this order shall be made monthly in arrears in accordance with FAR Clause 52.212-4. No advance payments will be authorized.

All invoices applicable to this agreement must be submitted no later than thirty (30) days after the end of the contract period. Any problems regarding unpaid invoices should be directed to the CO.

Invoices will be submitted for services, on a monthly basis. At a minimum, each invoice must contain the following:

Invoice number and date Customer Number Payment terms – 1.5/15 net 30 Tax ID Accounts receivable phone number Selling Unit Purchase Order Number Invoice Date Description of services performed, or products supplied Quantity delivered and/or returned Unit cost billed Credit Total Amount All invoices must include the name, title and phone number of person to be notified in the event of defective invoicing.

Invoices must be submitted electronically to:

Department of Veterans Affairs FMS-VA-2 (101) Financial Services Center PO Box 149971 Austin, TX 78714-9971

Fees charged by vendor shall be itemized as processing costs or blood services and are not charges for blood components. Note: Payment of invoices may be delayed if required information listed above and in FAR 52.212-4(g) is not included on the invoice.

All incremental costs during the period of the agreement as a result of additional donor tests mandated by the state, federal agency, and industry practice, shall be the responsibility of the VACCHCS as long as Vendor provides thirty (30) days written notice of such cost, and a bilateral modification is executed by CO. Payment may be retroactive to the 1st day after the 30th day written notification is provided by The Vendor.

19. VACCHCS RESPONSIBILITIES:

19.1. The CO is the only person authorized to approve changes or modify any of the requirements of this contract. The Vendor shall communicate with the CO on all matters pertaining to contract administration. Only the CO is authorized to make commitments or issue any modification to include (but not limited to) terms affecting price, quantity or quality of performance of this contract.

19.2. The CO shall resolve complaints concerning Vendor relations with the Government employees or patients. The CO is final authority on validating complaints. In the event The Vendor effects any such change at the direction of any person other than the CO without authority, no adjustment shall be made in the contract price to cover an increase in costs incurred as a result thereof.

19.3. COR Responsibilities: The COR for this contract is:

Merna White Pathology and Laboratory Medicine Service Administrative Officer 2615 E. Clinton Avenue (570/113) Fresno, CA 93703 The COR shall be the VA official responsible for verifying contract compliance. After contract award, any incidents of Vendor noncompliance as evidenced by the monitoring procedures shall be forwarded immediately to the CO.

The COR will be responsible for monitoring The Vendor’s performance to ensure all specifications and requirements are fulfilled.

20. NOTIFICATIONS: With respect to Vendor supplied blood, if a blood donor originally test negative at the time of donation but then during a later donation, tests repeatedly reactive for the HIV antibody, The Vendor shall provide the VACCHCS with the results of follow-up testing required or recommended by the FDA. Vendor shall complete the follow-up testing within thirty (30) days after the donor’s repeatedly reactive screening test. Under no circumstances shall Vendor ever reveal the identity of the blood donor.

Vendor shall promptly notify VACCHCS when new information indicates that blood provided may adversely affect transfusion recipient, provided that vendor shall not reveal the identity of the blood donor.

Upon discovery, VACCHCS shall report to The Vendor any blood lost or missing due to shipping error, and or possible infectious disease or other serious complication associated with transfusion which may have resulted from the blood, including without limitation, suspected post transfusion hepatitis, transfusion associated HIV or HTLV infection, and any other transfusion associated infections such as malaria, babesiosis, bacterial contamination or infection, and death due to adverse event. VACCHCS shall cooperate with vendor’s investigation of any adverse event and provide information regarding recipient of blood, upon forms provided by vendor, to the extent permissible under the applicable regulations of patient confidentiality.

21. DOCUMENTATION REQUIREMENTS: VACCHCS shall keep complete and accurate records of patients supplied with blood including product name, lot identifications and quantities, any therapeutic adverse effects, complaints and any pertinent information relating to the blood. Patient privacy and security safeguards shall be in effect at all times throughout performance of this contract to prevent the loss of sensitive patient data/information and PHI/PII IAW local VA policy.

22. NOTICES: All notices given or required in the contract shall be provided to each of the parties in writing and delivered by certified or registered U.S. first class mail, return receipt requested, or by recognized national overnight courier service which provides proof of delivery, to the names and addresses set forth in the signature block. Unless otherwise specified in this solicitation, all references to “days” are calendar and not business days.

23. The Vendor shall not employ any person who is an employee of the United States Government if the employment shall create a conflict of interest. The Vendor shall not employ any person who is an employee of the Department of Veterans Affairs unless such person seeks and receives approval in accordance with VA Regulations and public law. Nor shall The Vendor employ any person who is a member of the immediate family of a VA employee employed at VACCHCS, if the employment of that family member shall create a conflict of interest or the appearance of a conflict of interest, particularly with regard to influencing the contract negotiations, terms of the contract or the work carried out under this contract. In any such case, VACCHCS must review the matter and provide approval in accordance with agency ethics regulations.

24. SECURITY CONTROLS COMPLIANCE TESTING: On a periodic basis, VA, including the Office of Inspector General, reserves the right to evaluate any or all of the security controls and privacy practices implemented by The Vendor under the clauses contained within the contract. With ten (10) working-days’ notice, at the request of the government, The Vendor must fully cooperate and assist in a government-sponsored security controls assessment at each location wherein VA information is processed or stored, or information systems are developed, operated, maintained, or used on behalf of VA, including those initiated by the Office of Inspector General. The government may conduct a security control assessment on shorter notice (to include unannounced assessments) as determined by VA in the event of a security incident or at any other time.

25. HIPAA COMPLIANCE: Under HIPAA Privacy and Security Rules, The Vendor providing services under this contract is considered to be a “covered entity,” and thus is not required to enter into a Business Associate Agreement with VA. However, The Vendor must observe Public Law 104-191 and all respective regulations implementing this law while providing services under this contract.

26. POLICIES/HANDBOOKS: The Vendor shall be subject to the following policies, including any subsequent updates during the period of performance:

VA Directive 1663: Health Care Resources Contracting ‐ Buying http://www1.va.gov/vapubs/viewPublication.asp?Pub_ID=347 VHA Directive 2006‐041 “Veterans Health Care Service Standards” (expired but still in effect pending revision) https://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1443 VHA Handbook 1100.17: National Practitioner Data Bank Reports http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=2135 VHA Handbook 1100.18 Reporting and Responding to State Licensing Boards http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1364 VHA Handbook 1100.19 Credentialing and Privileging http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2910 VHA Handbook 1907.01 Health Information Management and Health Records:

http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=2791 Privacy Act of 1974 (5 U.S.C. 552a) as amended http://www.justice.gov/oip/foia_updates/Vol_XVII_4/page2.htm VHA Handbook 1106.1: Pathology and Laboratory Medicine Service (P&LMS) Procedures (29JAN2016) http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=3169

27. DEFINITIONS/ACRONYMS: Terms used in this contract shall be interpreted as follows unless the context expressly requires a different construction and/or interpretation. In case of a conflict in language between the Definitions and other sections of this contract, the language in this section shall govern.

Contracting Officer (CO): The person executing this contract on behalf of the Government with the authority to enter into and administer contracts and make related determinations and findings.

Contracting Officer’s Representative (COR): A person appointed by the CO to take necessary action to ensure The Vendor performs in accordance with and adheres to the specifications contained in the contract and to protect the interest of the Government. The COR shall report to the CO promptly any indication of non‐compliance in order that appropriate action can be taken.

HIPAA: Health Insurance Portability and Accountability Act POP: Period of Performance QASP: Quality Assurance Surveillance Plan VISTA (Veterans Integrated Systems Technology Architecture): A PC based system that will capture and store clinical imagery, scanned documents and other non‐textual data files and integrates them into patient’s medical record and with the hospital information system.

Veterans Affairs Medical Center (VAMC): Unless identified with the name of a different VA medical Center, for purposes of this contract, this term shall mean VA Central California Healthcare System.

VACCHCS: Veterans Affairs California Healthcare System FDA: Food and Drug Administration DHHS: Department of Health and Human Services CFR: Code of Federal Regulations

[END OF STATEMENT]

B.1 PRICE/COST SCHEDULE

ITEM INFORMATION

Annual Contract with Central CA Blood Center to provide blood components to VACCHS for patient blood transfusions.

Contract Period: Base POP Begin: 12-01-2020 POP End: 11-30-2021

Annual Contract with Central CA Blood Center to provide blood components to VACCHS for patient blood transfusions.

Contract Period: Option 1 POP Begin: 12-01-2021 POP End: 11-30-2022

Annual Contract with Central CA Blood Center to provide blood components to VACCHS for patient blood transfusions.

Contract Period: Option 2 POP Begin: 12-01-2022 POP End: 11-30-2023

Annual Contract with Central CA Blood Center to provide blood components to VACCHS for patient blood transfusions.

Contract Period: Option 3 POP Begin: 12-01-2023 POP End: 11-30-2024

Annual Contract with Central CA Blood Center to provide blood components to VACCHS for patient blood transfusions.

Contract Period: Option 4 POP Begin: 12-01-2024 POP End: 11-30-2025

B.2 DELIVERY SCHEDULE

VA Fresno 2615 E Clinton Ave Fresno, CA 93703

USA

559-225-6100 ext 4653 merna.white@va.gov

VA Fresno 2615 E Clinton Ave Fresno, CA 93703

USA

1.00

VA Fresno 2615 E Clinton Ave Fresno, CA 93703

1.00

VA Fresno 2615 E Clinton Ave Fresno, CA 93703

1.00

VA Fresno 2615 E Clinton Ave Fresno, CA 93703

1.00

SOW - CCBC Page 17 of 62

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…