Table of Contents PRICE/COST SCHEDULE 3 Item Information 3 DELIVERY SCHEDULE 3 INSTRUCTIONS TO OFFERORS 3 STATEMENT OF WORK 5 This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation, proposals are being requested, and a written solicitation will not be issued. The proposed contract action is for supplies or services for which the Government intends to solicit Blood Centers of the Pacific. Interested persons may submit offers, and all eligible offers received prior to March 18, 2015 at 1000 AM PST will be considered by the Government. The NAICS code is 621991 and the size standard is $32.5 Million. This is an open market competitive. This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-78 effective, December 26, 2014. PRICE/COST SCHEDULE Item Information ITEM NUMBER DESCRIPTION OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT 1 Blood Supply and Products Contract from 4/1/2015 thru 9/30/2015. Specific items are listed in the Statement of Work. 1.00 LOT __________________ __________________ GRAND TOTAL __________________ DELIVERY SCHEDULE ITEM NUMBER QUANTITY DELIVERY DATE 1 SHIP TO: VA San Francisco Medical Center 4150 CLEMENT ST. BUILDING 203 SAN FRANCISCO ,CA 94121 All items POP: 04/01/2015 - 09/30/2015 INSTRUCTIONS TO OFFERORS Only electronic offer will be accepted. Offers are due by 10:00 AM PDT March 18, 2015. FAR 52.212-2 EVALUATION--COMMERCIAL ITEMS (Oct 2014) (a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factor shall be used to evaluate offers: The Government will award to the lowest priced, responsible, technically acceptable offeror. The following factor shall be used to evaluate offers: Price, Past Performance and technical capability. All evaluation factors, other than price, when combined are approximately equal to price. 1.Technical Capability: Offeror's technical capability shall be evaluated based on compliance with the statement of work (See SOW below). (End of Provision) ADDITIONAL SOLICITATION PROVISIONS/CONTRACT CLAUSES: FAR 52.252-2 Clauses Incorporated by Reference (Feb 1998) For the purpose of this clause, the fill-ins are http://www.acquisition.gov/far/index.html (FAR) and http://www1.va.gov/oamm/oa/ars/policyreg/vaar/index.cfm (VAAR), respectively. FAR 52.212-4 Contract Terms and Conditions -- Commercial Items (Dec 2014). FAR 52.212-5 Contract Terms and Conditions Required To Implement Statutes Or Executive Orders -- Commercial Items (MAR 2015) For the purposes of this clause, items (b) 1, 4, 8, 26-30, 32, 33, 34, 44, and 50 are considered checked and apply. VAAR 819.7003 Class Deviation from VAAR 819.7003, Eligibility VAAR 852.203-70 Commercial Advertising (Jan 2008) VAAR 852.232-72 Electronic Submission of Payment Requests (November 2012) FAR 52.252-1 Solicitation Provisions Incorporated by Reference (FEB 1998) http://www.acquisition.gov/far/index.html (FAR) and http://www.va.gov/oamm/oa/ars/policyreg/vaar/index.cfm(VAAR) FAR 52.212-1 Instructions to Offerors - Commercial Items (APR 2014). FAR 52.212-3 Offeror Representations and Certifications -- Commercial Items (DEC 2014): Offerors must return this provision with their proposal. They may either (1)complete all relevant portions of the provision or (2) complete paragraph (b) of the provision and indicate that it has completed the annual representations and certifications electronically via the SAM website accessed through https://www.acquisition.gov. ? STATEMENT OF WORK DESCRIPTIONS/SPECIFICATIONS/WORK STATEMENT VA San Francisco A.1 Contract Requirements A.1.1 Contractor shall provide VAMC San Francisco, 4150 Clement Street, San Francisco, CA 94121, blood, blood components, and services described in Schedule B. A.1.2 Blood shall be typed for ABO and Rh antigens in accordance with methods recommended in the current edition of Standards for Blood Banks and Transfusion Services and the Technical Manual of the American Association of Blood Banks (AABB) (available from the AABB website: http://www.aabb.org/content). Contractor shall provide services and products in accordance with the regulations and requirements of the Food and Drug Administration (FDA), the laws and regulations of the State of California and the Standards of the American Association of Blood bank. A sample of blood from each donation shall be tested for syphilis. Whole blood and/or components (non-autologous) shall not be used for transfusion unless the test is non-reactive. In addition, only blood testing negative for antibody to human immunodeficiency virus (HIV), for hepatitis B surface antigen (HBsAg), for anti-hepatitis B core antigen (Anti-HBc), for hepatitis C virus (anti-HCV), and for human T cell leukemia virus (anti-HTLV) shall be used for transfusion. Blood and components shall not be used for transfusion if the results are outside established limits. Testing must also include the following: a. Nucleic Acid Test (NAT) for HIV and HCV RNA b. ALT and HIV P24 optional A.1.3 All blood shall be collected in a closed system under aseptic conditions, processed in appropriate solutions and the container so labeled. The label shall indicate the expiration date of the contents from the date of collection of the source blood. Source blood collected and stored with anticoagulant of CPD has a shelf life of 21 days, CPDA-1 35 days and ADSOL 42 days. This is with in guidelines of blood container manufactures, Food and Drug Administration (FDA) and AABB regulations. A.1.4 All blood supplied shall be visually free of hemolysis, excessive chyle and clots. A.2 Qualification / Certifications A.2.1 The contractor shall supply 100% "volunteer donor" blood in accordance with FDA rules and regulations effective May 15, 1978 or latest revision. Definition of a "volunteer donor"-- A volunteer donor is a person who does not receive monetary payment for blood donation. Benefits, such as monetary times 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. A.2.2. Registration/Licensures/Certifications. The Contractor shall be registered and/or licensed with the Food and Drug Administration (FDA), through the Department of Health and Human Services pursuant to Section 510 of the Federal Food, Drug and Cosmetic Act, as amended, 21 USC Section 260; is inspected and accredited by the American Association of Blood Banks; is a member in good standing in the California Hospital Associations, and participates in a proficiency testing program. A.2.3. License. The Contractor shall submit proof that he holds an unrevoked U.S. License which is issued by the Center for Biologics, Evaluation and Research, Food and Drug Administration, hereinafter referred to as FDA under Section 351 of the Public Health Service Act, as amended, 42 USC Section 262, as a source of supply for blood and blood products complying with FDA regulations. A.2.4. The Contractor shall ensure testing personnel assigned to perform the services covered by this contract are licensed in a State, Territory, or Commonwealth of the United States or the District of Columbia. All licenses held by personnel working on this contract shall be full and unrestricted licenses. The qualifications of such personnel shall also be subject to review by the VAMC Chief of Staff and approval by the VA Facility Director. Each person assigned to work under this contract shall be licensed by the State of California and shall meet the testing personnel requirements of the American Association of Blood Banks for the type/complexity testing performed. A.2.5. The Contractor shall obtain all necessary licenses and/or permits required to perform this work. The Contractor shall take all reasonable precautions necessary to protect persons and property from injury or damage during the performance of this contract. The Contractor shall be responsible for any injury to himself/herself, his/her employees, as well as for any damage to personal or public property that occurs during the performance of this contract that is caused by his/her employee's fault of negligence, and shall maintain personal liability and property damage insurance having coverage for a limit as required by the laws of the State of California. Further it is agreed, that any negligence of the Government, its officers, agents, servants and employees, shall not be the responsibility of the Contractor hereunder with the regard to any claims, loss, damage, injury and liability resulting therefrom. A.3 Donor Requirements A.3.1 The contractor shall maintain readily available blood donor lists including names, addresses and Social Security number. Such lists shall indicate whether, and on what date, blood of a particular donor was furnished to the VA . A.3.2 Donor selection shall be in accordance with criteria established by the FDA and/or the AABB. A.3.3 Immediately after bleeding, the blood shall be stored in accordance with criteria established by the Food and Drug Administration (FDA) and/or American Association of Blood Banks (AABB). A.4 Expiration Dates A.4.1 The contractor shall supply blood and blood components in accordance with the expiration dates specified in the AABB Standards. A.4.2 The contractor shall supply Red blood cell products not over 15 days from the date of collection. A.4.3 The contractor shall return for full credit any Red blood cell products that exceed 15 days from the date of collection. A.5 Blood Products A.5.1 The contractor shall furnish blood labeled as A, B, O and Rh type. Type A Rh negative and O. Rh negative must have been drawn from donor not more than five (5) days before date on which purchase order is filled. Types such as AB Rh positive, B. Rh negative and AB Rh negative will be supplied not over fifteen (15) days old. These time limits may be adjusted if a system for exchange on credit is provided which minimizes or precludes losses due to outdating. A.5.2 The contractor shall supply whole blood, red blood cells and components in standard collection containers, with appropriate samples for laboratory work. A.5.3 The following tests shall be completed by Contractor prior to delivery: a. ABO Grouping b. RHo(D) -- Testing c. Syphilis --- Testing d. Irregular Red Blood Cell Antibody Detection e. Hepatitis B Surface Antigen (HBsAg) f. HCV Antibody g. HIV Antigen and Antibody h. Hepatitis B Core Antibody i. HTLV Antibody j. Nucleic Acid Test for HCV and HIV RNA k. Other tests as may be included for licensure by the Office of Biologics/Food and Drug Administration. A.5.4 Other than in the case of emergency, the above work shall be completed on all blood and its components prior to shipment. In such emergencies, products may be released with a "statement of justifications for request of incompletely tested blood components, signed by the veteran's physician. A.6 Special Donations A.6.1 Contractor shall not require pre-payment of blood processing & handling surcharges from autologous or designated blood donors for VA. A.6.2 The contractor shall direct autologous or designated blood donors for VA patients to a facility as decided by VA and the blood center after coordination with COTR. A.6.3 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. A.6.4 Shipping fees of blood components shall be incurred by the blood center. The contractor shall ship blood components at no additional expense to the VA. These units shall be shipped to VA when received. A.7 Hospital Notification A.7.1 If it is determined by the Contractor that a blood component potentially infectious with HIV, HCV, or HTLV I/II may have been provided to Dept. of Veterans Affairs Health Care Systems, contractor shall notify the VA. This notification process will comply with the requirements as defined by the U.S. Food and Drug Administration. Where required or allowed by law, notification to the VA Health Care Systems may be provided through a State Department of Health or similar governmental agency. A.8 Description of the required services a. Screening for negative blood per antigen - Testing donor units for RBC antigens and select units negative for a given antigen. b. Irradiate units - Treat units with gamma irradiation to prevent lymphocyte proliferation. c. Screening for CMV negative blood - Testing units for antibody to cytomegalovirus and select negative units. d. Freezing and storing autologous - Freeze blood donated by the patient for his or her own use and store it until needed. e. Thawing and deglycerolizing autologous blood - Thaw and wash frozen blood. f. Plateletpheresis, crossmatched - Compatibility test between recipient serum and donor platelets. g. Crossmatched Platelet Donor Recruitment - Recruit a donor known from previous testing to be compatible with a recipient. h. Antibody Identification, enzyme panel, select cell panel, absorption/elution with panel, inhibition panel, chloroquine treatment, extended phenotype and phenotyping, genotyping whole blood or red cell mass - Samples to identify antibodies when detected by antibodies screening. A.9 Delivery of Orders Supplies and services to be delivered at VA Medical Center, Building 200, Room 2B111, 4150 Clement Street, San Francisco, CA 94121. Delivery orders may be placed by phone, fax, or online. The type of delivery order will be specified when the order is placed and the Contractor shall deliver within the following times. The time begins when the authorized official places the delivery order. STAT/Emergency------------------------------One (1) hour ASAP--------------------------------------------Two (2) hours Stock---------------------------------------------Six (6) hours A.10 Distance and Impediments for deliveries during disasters or traffic congestion Due to the important nature of STAT or emergency delivery requests for blood and blood products, the distribution center must be located within 10 miles of the SFVAMC and the courier cannot be required to cross a bridge, such as the Bay Bridge, Golden Gate Bridge, or the San Mateo Bridge. SCHEDULE B - BLOOD, BLOOD COMPONENTS AND SERVICES CONTRACT: Contract Award through September 30, 2015 Est. Unit Est. Description Qty Unit Price Total Supplies B.0001 Leuko-poor RBC by Filtration 1150 ea $______ $__________ B.0002 Red Cells -- Washed 10 ea $______ $__________ B.0003 Red Cells -- Irradiated 100 ea $______ $__________ (Random Population Donation) B.0004 Red Cells - Autologous 10 ea $______ $__________ Per unit surcharge B.0005 Red Cells - Thawed 5 ea $______ $__________ B.0006 Red Cells -- Directed 3 ea $______ $__________ Per unit surcharge B.0007 Fresh Frozen Plasma 500 ea $______ $__________ B.0008 Platelet SD Apheresis 250 ea $______ $__________ B.0009 Pooled CRYO 38 ea $______ $__________ B.0010 RhIg 1 ea $ ______ $__________ B.0011 Plateletpheresis, HLA matched 5 ea $_______ $__________ ? Services B.0012 Screening for negative blood 50 ea $______ $________ per antigen B.0013 Irradiate units 200 ea $______ $________ B.0014 Screening for CMV negative 10 ea $______ $________ blood B.0015 Antibody Identification 15 ea $______ $________ B.0016 Enzyme Panel 10 ea $______ $________ B.0017 Select Cell Panel 10 ea $______ $________ B.0018 Absorption/Elution with Panel 8 ea $______ $________ B.0019 Inhibition/Panel 2 ea $______ $________ B.0020 Chloroquine Treatment 2 ea $_______ $________ B.0021 Extended Phenotype 15 ea $_______ $________ B.0022 Phenotyping, Genotyping Whole 15 ea $_______ $________ Blood or Red Cell Mass B.0023 Plateletpheresis, crossmatched 5 ea $______ $________ B.0024 Screening for historically antigen 100 ea $______ $________ Negative blood per antigen B.0025 Crossmatched Platelet Donor 15 ea $______ $________ Recruitment B.0026 Transportation charge for STAT 200 trip $_______ $________ orders B.0027 STAT off-hours surcharge if an 20 hrs $_______ $________ on-call Technician has to perform special procedures or provide special products outside normal hours. Base Year Total $__________

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