S02-RFQ 36C26122Q0643-BLOOD AND BLOOD PRODUCTS-VASFMC.pdf

PAGE 1 OF 1. REQUISITION NO.

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NO. 5. SOLICITATION NUMBER 6. SOLICITATION ISSUE DATE

a. NAME b. TELEPHONE NO. (No Collect Calls) 8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY CODE 10. THIS ACQUISITION IS UNRESTRICTED OR SET ASIDE: % FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ IFB RFP

15. DELIVER TO CODE 16. ADMINISTERED BY CODE

17a. CONTRACTOR/OFFEROR CODE FACILITY CODE 18a. PAYMENT WILL BE MADE BY CODE

TELEPHONE NO. 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 123

662-23-1-061-0001

36C26122Q0643 08-05-2022

Katherine Fairley 925-372-2270 08-17-2022

4:30 PM PST

Department of Veterans Affairs VA Sierra Pacific Network (VISN 21) VA Northern California HealthCare System 150 Muir Road Martinez CA 94553-4668

X

N

621991

1250 Employees

N/A

"See Delivery Schedule"

VA Sierra Pacific Network (VISN 21) VA Northern California HealthCare System

FMS-VA-2(101) Financial Services Center

PO Box 149971 Austin TX 78714-9971

See CONTINUATION Page

THIS RFQ IS FOR THE PROCUREMENT OF BLOOD AND BLOOD PRODUCTS

FOR THE VA SAN FRANCISCO MEDICAL CENTER (VASFMC) IN

SAN FRANCISCO, CA.

Please complete block 17a above and identify the SAM UEI NO.

Please complete B. 1 "Price/Cost Schedule" and attached 36C26122Q0643 Line Items spreadsheet.

This will be a Five-Year Single Award Indefinite Delivery Indefinite Quantity (IDIQ) contract.

Ordering Period Base: 10/01/2022 - 09/30/2023 Ordering Period 1: 10/01/2023 - 09/30/2024 Ordering Period 2: 10/01/2024 - 09/30/2025 Ordering Period 3: 10/01/2025 - 09/30/2026 Ordering Period 4: 10/01/2026 - 09/30/2027 Period of Performance: 10/01/2022 - 09/30/2027

PLEASE EMAIL INFORMATION TO KATHERINE.FAIRLEY@VA.GOV

See CONTINUATION Page

Maxwell W. Derck

CONTRACTING OFFICER

36C26122Q0643

Table of Contents

SECTION A

A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

A.2 CONTRACT ADMINISTRATION DATA

SECTION B – INDEFINITE DELIVERY, INDEFINITE QUANTITY (IDIQ) CONTRACT.

INTRODUCTION AND STATEMENT OF WORK

B.1 PRICE/COST SCHEDULE

ITEM INFORMATION

SECTION C - CONTRACT CLAUSES

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

2018)

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

C.3 52.216-18 ORDERING (AUG 2020)

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

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

C.6 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.7 52.219-4 NOTICE OF PRICE EVALUATION PREFERENCE FOR HUBZONE

SMALL BUSINESS CONCERNS (SEP 2021)

C.8 52.222-19 CHILD LABOR—COOPERATION WITH AUTHORITIES AND

REMEDIES (JAN 2020) (JUL 2020) (DEVIATION)

C.9 52.216-1 TYPE OF CONTRACT (APR 1984)

C.10 VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA

ACQUISITION OF COMMERCIAL ITEMS (APR 2020)

C.11 VAAR 852.219-75 SUBCONTRACTING COMMITMENTS MONITORING AND

COMPLIANCE (JUL 2018)

C.12 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020) . 83

C.13 VAAR 852.247-71 DELIVERY LOCATION (OCT 2018)

C.14 VAAR 852.247-73 PACKING FOR DOMESTIC SHIPMENT (OCT 2018)

C.15 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (MAY 2022)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL ITEMS (SEP 2021)93

E.2 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.3 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (OCT 2020)

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

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

E.6 VAAR 852.215-72 NOTICE OF INTENT TO RE-SOLICIT (OCT 2019)

E.7 52.212-2 EVALUATION—COMMERCIAL ITEMS (OCT 2014)

E.8 ADDENDUM TO 52.212-2 EVALUATION—COMMERCIAL ITEMS (OCT 2014) 105

E.9 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL ITEMS (FEB 2021)

A.2 CONTRACT ADMINISTRATION DATA

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

a. CONTRACTOR:

[Company Contact Person’s Name]:

[Company]:

[Street Address]:

[City, State, Zip]:

[Phone number]:

[Email address]:

[CAGE Number]:

[DUNS Number]:

b. GOVERNMENT: Contracting Officer 36C261 – Maxwell W. Derck Contract Specialist – Katherine E. Fairley

Department of Veterans Affairs VA Sierra Pacific Network (VISN 21) VA Northern California HealthCare System

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

[X] 52.232-33, Payment by Electronic Funds Transfer—System For Award Management, or

[] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] Monthly

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 FMS-VA-2(101) Financial Services Center PO Box 149971 Austin TX 78714-9971

Invoicing:

All invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

VA’s Electronic Invoice Presentment and Payment System – The FSC uses a third-party contractor, Tungsten, to transition vendors from paper to electronic invoice submission. Please go to this website: http://www.tungsten-network.com/US/en/veterans-affairs/ to begin submitting electronic invoices, free of charge.

More information on the VA Financial Services Center is available at http://www.fsc.va.gov/einvoice.asp.

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

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

AMENDMENT NO DATE

http://www.tungsten-network.com/US/en/veterans-affairs/ http://www.fsc.va.gov/einvoice.asp mailto:VA.Registration@Tungsten-Network.com mailto:vafsccshd@va.gov

SECTION B – INDEFINITE DELIVERY, INDEFINITE QUANTITY (IDIQ)

CONTRACT. INTRODUCTION AND STATEMENT OF WORK

1. INTRODUCTION: Blood and Blood Products

1.1 The intent of this solicitation is to locate a source that can provide blood and blood products to the Department of Veterans Affairs (VA) VA San Francisco Medical Center

(VASFMC).

1.2 The Contractor shall furnish and deliver the blood and blood products listed in B.1 Price/Cost Schedule and Attachment 1 36C26122Q0643 Line Items spreadsheet for Estimated Usage” on an “AS NEEDED” basis, in suitable containers, to the VASFMC Division:

VA San Francisco Medical Center (VASFMC)

4150 Clement Street

San Francisco, CA 94121-1545

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

1.4 The Contractor shall provide blood and blood products as available when ordered, and the VASFMC shall purchase blood and blood products according to the appropriate pricing listed in the B.1 Price/Cost Schedule and “Attachment 36C26122Q0643 Line Items spreadsheet” for Estimated Usage”.

1.5 The Contractor shall complete “Attachment 1 36C26122Q0643 Line Items spreadsheet in Section D for Estimated Usage” and submit it with their proposal.

1.6 All blood shall 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 Contractor and the VASFMC 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 CFR Part 1910.1030, effective March 2, 1996, and any subsequent revisions thereof.

1.7 All blood shall be collected by closed system under aseptic conditions and shall be stored in currently approved, appropriate solutions and the container shall be correctly labeled. The label shall also bear the expiration date of the contents which shall not exceed 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).

1.8 All blood supplies shall be free of hemolysis, and clots, based on the contractor’s visual inspection of such blood prior to delivery.

1.9 All cellular blood products (platelets and RBC) shall be leuko-reduced. If a leuko-reduced product is not available, VASFMC Transfusion Service shall be notified.

1.10 Offers shall be considered only from offerors whose blood bank is currently registered and/or licensed with the FDA, Department of Health and Human Services pursuant to Section 510 of the Federal Food, Drug and Cosmetic Act, as amended, 21 USC Section 260. Prior to award the offeror must submit proof that it holds 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 Leuko-reduced Red Blood Cells. Contractor shall maintain licensure and accreditation throughout contract period. If interstate shipment of blood or blood component is involved, the offeror must submit with the offer a statement that such approval has been authorized under Section 251 of the Public Health Service Act, as amended, 42 USC Section 262. The offeror shall certify that they will comply with the requirements outlined below with respect to donors, containers, delivery, etc.

Offers will be considered only from blood banks that are able to provide the VA with 100% “volunteer donors” blood in accordance with the latest FDA rules and regulations. 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.”

For local delivery, as applicable, products shall be delivered to the VASFMC Blood Bank within 1 hour for STAT/Emergency orders, 2 hours for ASAP orders and 6 hours for Stock orders from the time the order is placed with the contractor.

All Fresh Frozen Plasma shall have expiration dates at least nine (9) months in advance when shipped.

The VASFMC has in place the suitable temperature-monitored freezer and refrigerator for appropriate storage of the products.

2. PERIOD OF PERFORMANCE: The contract will be an indefinite delivery, indefinite quantity (IDIQ) contract with a term of up to five years. All Delivery Orders will be placed against the IDIQ contract on an as needed basis. The quantity of the items needed over the life of the contract are listed in the B.1 Price/Cost Schedule and could vary in each delivery order.

Base Year Period: 10/1/2022 – 09/30/2023 Ordering Period 1 10/1/2023 – 09/30/2024 Ordering Period 2 10/1/2024 – 09/30/2025 Ordering Period 3 10/1/2025 – 09/30/2026 Ordering Period 4 10/1/2026 – 09/30/2027

3. PLACE OF PERFORMANCE:

VA San Francisco Medical Center (VASFMC)

4150 Clement Street

San Francisco, CA 94121-1545

4. CRITERIA FOR DONOR SELECTION:

a. The offeror shall maintain a blood donor list with unique identifier numbers. Such list shall indicate the date the blood of a particular donor was furnished to the VASFMC.

Donor selection shall be in accordance with criteria established by the FDA and or American Association of Blood Banks.

b. 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 American Association for Blood Banks. When FDA or American Association of Blood Banks requires a new test, it shall be performed by the contractor

5. COLLECTION, PROCESSING AND TYPING OF BLOOD:

a. 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.

i. If there is an error by the vendor in the blood typing, the vendor shall pick up the errant blood immediately.

b. 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 (per FDA approved expiration dates):

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

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

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

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

c. All platelets shall be manufactured according to FDA Guidance to mitigate the risk of septic transfusion reactions caused by bacterial contamination of platelets stored at room temperature before being shipped (e.g., using a large-volume delayed sampling strategy or pathogen reduced technology).

6. QUALIFICATIONS:

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

7. SPECIFICATIONS:

a. Volunteer blood donors shall make all donations. The contractor shall use reasonable efforts to supply the VASFMC with related service needs. In the event modification of testing of blood for safe usage, as mandated by FDA, Contractor shall provide the Contracting Officer (CO) with 30 days written notices and the Contracting Officer (CO) shall issue a modification.

b. Should the contractor be unable to provide blood components from its inventory to fill an order, the contractor shall seek other approved sources to obtain such blood components to complete the order. In the event the contractor fails to fill an order within the estimated timeframe given at the time the order is placed, contractor shall notify VASFMC without delay within reasonable time, of not being able to fill order, and the Government may obtain the item/s elsewhere.

c. Contractor shall provide the most current version of the Circular of Information for the use of Human blood and blood components to the VASFMC at no additional charge to the Government.

d. Autologous donors that have units drawn at the contractor’s collection sites shall not be required to pay any charges. Contractor shall bill VASFMC for the unit of blood and apply a handling fee for an overall charge. Handling fee is same as below. All charges are billed to - VASFMC and not the donor.

e. For autologous blood donors that have units collected at other than the contractor’s site may have their blood delivered to the contractor for shipment to VASFMC. The contractor may charge a processing and handling fee in accordance with schedule of supplies.

f. Reference laboratory reports shall be provided to VASFMC, as soon as testing is completed, by telephone, secure fax or secure email, 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 VASFMC Blood Bank Supervisor, or designee.

g. 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 VASFMC Blood Bank Supervisor and the Contractor.

8. ORDERING:

Orders shall be placed by fax, telephone, or online on an “As Needed” basis by a VASFMC Blood Bank Technologist at the VASFMC Blood Bank.

9. 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 degrees Celsius), frozen plasma components (below minus 20 degrees Celsius), and platelet components (20-24 degrees Celsius).

10. DELIVERIES:

a. There shall be no delivery charges for routine deliveries. Contractor shall make every effort to make routine deliveries during the time of day suitable to, and as requested by, the VASFMC.

b. The Contractor shall have sole responsibility of the proper care and handling of all blood and blood components, until delivered to the designated VASFMC 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 VASFMC on an “AS NEEDED” basis.

c. VASFMC requires two (2) stock deliveries on a daily basis Monday – Friday. The first stock delivery shall be delivered before 12:00pm pacific. The second stock delivery shall be delivered before 6:00pm pacific. VASFMC also requires one (1) stock delivery if needed on Saturday and Sunday and Holidays before 12:00pm Pacific.

(1) STAT: STAT ordering shall be utilized when products are needed immediately.

VASFMC shall order STAT and expect delivery within one (1) hour. Deliveries shall be seven (7) days per week, twenty-four (24) hours per day “As Needed”. Due to the high level of emergency services, cardiac surgeries, hematology/oncology/ transplant patients at the VASFMC, the contractor’s blood bank must be located within an area where the route for deliveries of blood and blood products to meet the timeline for STAT orders (see 1.10).

(a) VASFMC shall make reasonable efforts to minimize the frequency of STAT deliveries.

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

ii. Contractor 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.

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

11. INSPECTION AND ACCEPTANCE:

a. Upon receipt, VASFMC shall properly inspect the blood and maintain proper refrigeration or other proper storage facilities for the blood in compliance with all regulations, as well as the standards of the American Association of Blood Banks, as applicable.

b. Inspection of Offerors Facilities:

(1) The right is reserved to thoroughly inspect and investigate the establishment and facilities and other qualifications of any offeror, and to reject any offer regardless of price, if it should be administratively determined as lacking in any of the essentials necessary to assure acceptable standards of performance.

c. Reference Lab Services:

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

(2) Screening for negative blood per antigen – Testing donor units for RBC antigens and select units negative for a given antigen.

(3) Irradiate units – Treat units with gamma irradiation to prevent lymphocyte proliferation Pathogen-reduced products approved by FDA to prevent transfusion-associated graft-vs-host disease are acceptable in place of irradiated units.

(4) Screening for CMV negative blood – Testing units for antibody to cytomegalovirus and select negative units.

(5) Plateletpheresis, crossmatched or HLA-matched – Compatibility test between recipient serum and donor platelets.

(6) Crossmatched or HLA matched Platelet Donor Recruitment – Recruit a donor known from previous testing to be compatible with recipient.

(7) Antibody Identification, enzyme and DTT panels, select cell panel, absorption/elution with panel inhibition panel, chloroquine treatment, extended phenotyping and genotyping.

(8) Volume reduced or washed RBC and platelets.

(9) Full list of Reference Lab services:

Supplies:

Red Cells, Washed

Red Cells, Irradiated

Red Cells, CMV Negative

Red Cells, Thawed

Red Cells, Volume Reduced

Plateletpheresis, Volume Reduced

Plateletpheresis, Crossmatched (unit)

Plateletpheresis, HLA matched (unit)

Services:

Screening for negative blood per antigen

Screening for historically antigen Negative blood per antigen

Irradiate Units

Screening for CMV negative blood

Antibody Identification

Enzyme Panel

Select Cell Panel

Absorption/Elution with Panel

Inhibition/Panel

Chloroquine Treatment

Extended Phenotyping

Phenotyping, Whole Blood or Red Cell Mass

Crossmatched Platelet or HLA Donor Recruitment

Transportation charge for STAT orders

STAT off hours surcharge

DTT (Dithiothreitol) screen

DTT (Dithiothreitol) panel

RBC Genotype (HEA BeadChip Assay or similar)

Drug study

Direct Antiglobulin Test

Adsorption Auto

Adsorption Allo

Adsorption REST (cold auto)

ABO/Rh grouping

Antibody Screen

PLT Crossmatch (test)

PLT Antibody screen

HLA Antibody screen

Patient HLA (A,B) typing for HLA PLT selection

HPA-1a Antigen screen

Molecular genotype (HPA)

12. ADVERSE EVENT REPORTING:

VASFMC will notify the Contractor 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.

VASFMC will make available to the Contractor information concerning transfusions to include product names, lot identifications and quantities, any therapeutic adverse effects, complaints or other pertinent information relating to the blood.

13. REJECTED GOODS:

The contractor shall remove rejected products within 48 hours after notice of rejection.

14. RETURNS:

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

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

2) Full credit shall be given by the contractor for any Red Blood Cell product returned/exchanged within ten (10) days or greater from the expiration date.

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

4) Red Cells. Contractor shall notify VASFMC, and VASFMC shall approve Red Blood Cells unit with seven (7) days or less shelf-life remaining prior to delivery.

5) Platelets: Contractor shall notify VASFMC, and VASFMC shall approve platelet units with less than 24 hours shelf-life remaining prior to delivery.

15. COVERAGE:

a. Twenty-four (24) hour coverage shall be provided by the Contractor to fill emergency needs when these needs are ordered by VASFMC. Coverage includes filling blood and blood component orders as requested.

b. VASFMC 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.

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

d. The Contractor 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 VASFMC shall own the blood. After such delivery or receipt and acceptance, the VASFMC shall own the blood. The VASFMC also agree and acknowledge that no blood components supplied by the contractor, including part and or derivatives thereof, shall be sold, bartered, traded or exchanged by the VASFMC without prior authorization from the contractor.

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

16. TRANSFUSION REACTION:

VASFMC Blood Bank shall report to the contractor 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 Contractor for testing at no additional charge to the Government.

VASFMC Blood Bank shall report to Contractor 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:

VASFMC Blood Bank shall maintain thorough and complete records of the recipients of all contractor 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:

a. Payment: Payment will be made in arrears, upon receipt of a properly prepared invoice. The Contractor shall submit all invoices via electronic invoice submission to the VA Financial Services Center through OB10 Electronic Invoicing Services, or alternative service as declared by the VA.

b. Contractor shall provide invoices for VASFMC every 30 days in arrears showing all services provided and components shipped, returned, or transferred. VASFMC reserves the right to request hard copy of invoices. Invoices shall be sent to the address specified in paragraph c below.

c. Properly completed invoices shall be submitted electronically for certification to:

VA San Francisco Medical Center (VASFMC)

ATTN: Accounts payable

Department of Veterans Affairs

Financial Services Center (FSC)

Box 149971 Austin, TX 78714

Invoice shall be itemized to include the following information:

(1) Invoice number and date.

(2) Customer Number

(3) Payment terms – 1.5/15 net 30

(4) Tax ID

(5) Accounts receivable phone number

(6) Selling Unit

(7) Purchase Order Number

(8) Invoice Date

(9) Description of services performed, or products supplied.

(10) Quantity delivered and/or returned

(11) Unit cost billed

(12) Credit Total Amount

d. Fees charged by contractor shall be itemized as processing costs or blood services and are not charges for blood components.

e. 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.

f. 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 VASFMC as long as Contractor provides thirty (30) days written notice of such cost, and a bilateral modification is executed by Contracting Officer.

Payment may be retroactive to the 1st day after the 30th day written notification is provided by the Contractor.

19. NOTIFICATIONS:

a. With respect to Contractor supplied blood, if a blood donor originally tests negative at the time of donation but then during a later donation, tests repeatedly reactive for the HIV antibody, the Contractor shall provide the VASFMC with the results of follow-up testing required or recommended by the FDA. Contractor shall complete the follow-up testing within thirty (30) days after the donor’s repeatedly reactive screening test.

Under no circumstances shall Contractor ever reveal the identity of the blood donor.

b. Contractor shall promptly notify VASFMC when new information indicates that blood provided may adversely affect transfusion recipient, provided that contractor shall not reveal the identity of the blood donor.

c. Upon discovery, VASFMC shall report to the contractor any blood lost or missing due to shipping error, and or possible infectious disease or other serious complication associated with transfusion which may 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. VASFMC shall cooperate with contractor’s investigation of any adverse event and provide information regarding recipient of blood, upon forms provided by contractor, to the extent permissible under the applicable regulations of patient confidentiality.

20. DOCUMENTATION REQUIREMENTS:

VASFMC 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.

21. 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.

22. ENTIRE CONTRACT AND MODIFICATION(S):

This solicitation and resulting contract is the entire agreement between the parties with respect to the supply of blood and services, and replaces all prior agreements and undertaking, both written and oral, between the parties with respect to the provision to the blood, blood products and services. The contractor shall not employ any person who is an employee of the United States Government if the employment shall create a conflict of interest. The contractor 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 Contractor employ any person who is a member of the immediate family of a VA employee employed at VASFMC, 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, VASFMC must review the matter and provide approval in accordance with agency ethics regulations.

23. POST AWARD PERFORMANCE CONFERENCE

The Contracting Officer shall schedule a post award performance conference with the Contractor if deemed necessary for contract orientation purposes.

24. INFORMATION SECURITY:

MARCH 12, 2010 VA HANDBOOK 6500.6 APPENDIX C

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE

FOR INCLUSION INTO CONTRACTS, AS APPROPRIATE

1. GENERAL

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

2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

a. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.

b. Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness.

c. Custom software development and outsourced operations must be located in the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor.

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

3. VA INFORMATION CUSTODIAL LANGUAGE

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

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

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

d. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract.

e. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed.

f. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12.

g. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship.

h. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140- 2 validated.

i. The contractor/subcontractor’s firewall and Web services security controls, if applicable, shall meet or exceed VA’s minimum requirements. VA Configuration Guidelines are available upon request.

j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA’s prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response.

k. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above-mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response.

l. For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COTR.

4. INFORMATION SYSTEM DESIGN AND DEVELOPMENT

a. Information systems that are designed or developed for or on behalf of VA at non- VA facilities shall comply with all VA directives developed in accordance with FISMA, HIPAA, NIST, and related VA security and privacy control requirements for Federal information systems. This includes standards for the protection of electronic PHI, outlined in 45 C.F.R. Part 164, Subpart C, information and system security categorization level designations in accordance with FIPS 199 and FIPS 200 with implementation of all baseline security controls commensurate with the FIPS 199 system security categorization (reference Appendix D of VA Handbook 6500, VA Information Security Program). During the development cycle a Privacy Impact Assessment (PIA) must be completed, provided to the COTR, and approved by the VA Privacy Service in accordance with Directive 6507, VA Privacy Impact Assessment.

b. The contractor/subcontractor shall certify to the COTR that applications are fully functional and operate correctly as intended on systems using the VA Federal Desktop Core Configuration (FDCC), and the common security configuration guidelines provided by NIST or the VA. This includes Internet Explorer 7 configured to operate on Windows XP and Vista (in Protected Mode on Vista) and future versions, as required.

c. The standard installation, operation, maintenance, updating, and patching of software shall not alter the configuration settings from the VA approved and FDCC configuration. Information technology staff must also use the Windows Installer Service for installation to the default “program files” directory and silently install and uninstall.

d. Applications designed for normal end users shall run in the standard user context without elevated system administration privileges.

e. The security controls must be designed, developed, approved by VA, and implemented in accordance with the provisions of VA security system development life cycle as outlined in NIST Special Publication 800-37, Guide for Applying the Risk Management Framework to Federal Information Systems, VA Handbook 6500, Information Security Program and VA Handbook 6500.5, Incorporating Security and Privacy in System Development Lifecycle.

f. The contractor/subcontractor is required to design, develop, or operate a System of Records Notice (SOR) on individuals to accomplish an agency function subject to the Privacy Act of 1974, (as amended), Public Law 93-579, December 31, 1974 (5 U.S.C. 552a) and applicable agency regulations. Violation of the Privacy Act may involve the imposition of criminal and civil penalties.

g. The contractor/subcontractor agrees to:

i. Comply with the Privacy Act of 1974 (the Act) and the agency rules and regulations issued under the Act in the design, development, or operation of any system of records on individuals to accomplish an agency function when the contract specifically identifies:

1. The Systems of Records (SOR); and

2. The design, development, or operation work that the contractor/subcontractor is to perform;

ii. Include the Privacy Act notification contained in this contract in every solicitation and resulting subcontract and in every subcontract awarded without a solicitation, when the work statement in the proposed subcontract requires the redesign, development, or operation of a SOR on individuals that is subject to the Privacy Act; and

iii. Include this Privacy Act clause, including this subparagraph (3), in all subcontracts awarded under this contract which requires the design, development, or operation of such a SOR.

h. In the event of violations of the Act, a civil action may be brought against the agency involved when the violation concerns the design, development, or operation of a SOR on individuals to accomplish an agency function, and criminal penalties may be imposed upon the officers or employees of the agency when the violation concerns the operation of a SOR on individuals to accomplish an agency function. For purposes of the Act, when the contract is for the operation of a SOR on individuals to accomplish an agency function, the contractor/subcontractor is considered to be an employee of the agency.

a) “Operation of a System of Records” means performance of any of the activities associated with maintaining the SOR, including the collection, use, maintenance, and dissemination of records.

b) “Record” means any item, collection, or grouping of information about an individual that is maintained by an agency, including, but not limited to, education, financial transactions, medical history, and criminal or employment history and contains the person’s name, or identifying number, symbol, or any other identifying particular assigned to the individual, such as a fingerprint or voiceprint, or a photograph.

c) “System of Records” means a group of any records under the control of any agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual.

i. The vendor shall ensure the security of all procured or developed systems and technologies, including their subcomponents (hereinafter referred to as “Systems”), throughout the life of this contract and any extension, warranty, or maintenance periods. This includes, but is not limited to workarounds, patches, hotfixes, upgrades, and any physical components (hereafter referred to as Security Fixes) which may be necessary to fix all security vulnerabilities published or known to the vendor anywhere in the Systems, including Operating Systems and firmware. The vendor shall ensure that Security Fixes shall not negatively impact the Systems.

j. The vendor shall notify VA within 24 hours of the discovery or disclosure of successful exploits of the vulnerability which can compromise the security of the Systems (including the confidentiality or integrity of its data and operations, or the availability of the system). Such issues shall be remediated as quickly as is practical, but in no event longer than days.

k. When the Security Fixes involve installing third party patches (such as Microsoft OS patches or Adobe Acrobat), the vendor will provide written notice to the VA that the patch has been validated as not affecting the Systems within 10 working days. When the vendor is responsible for operations or maintenance of the Systems, they shall apply the Security Fixes within days.

l. All other vulnerabilities shall be remediated as specified in this paragraph in a timely manner based on risk, but within 60 days of discovery or disclosure.

Exceptions to this paragraph (e.g. for the convenience of VA) shall only be…