DOCUMENT
Q -- BLOOD PRODUCTS - Attachment
- Notice Date
- 3/12/2015
- Notice Type
- Attachment
- NAICS
- 621991
— Blood and Organ Banks
- Contracting Office
- Department of Veterans Affairs;VA Sierra Pacific Network (VISN 21);VA Northern California HealthCare System;5342 Dudley Blvd. Bldg 98 (NCO 21);McClellan CA 95652-1012
- ZIP Code
- 95652-1012
- Solicitation Number
- VA26115Q0413
- Response Due
- 3/18/2015
- Archive Date
- 4/2/2015
- Point of Contact
- Orville Landicho
- Small Business Set-Aside
- N/A
- Description
- Table of Contents PRICE/COST SCHEDULE2 Item Information2 DELIVERY SCHEDULE2 INSTRUCTIONS TO OFFERORS2 STATEMENT OF WORK4 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 NUMBERDESCRIPTION OF SUPPLIES/SERVICESQUANTITYUNITUNIT PRICEAMOUNT 1Blood Supply and Products Contract from 4/1/2015 thru 9/30/2015. Specific items are listed in the Statement of Work. 1.00LOT____________________________________ GRAND TOTAL__________________ DELIVERY SCHEDULE ITEM NUMBERQUANTITYDELIVERY DATE 1SHIP TO:Martinez Outpatient Clinic 150 Muir Road Martinez, CA 94553-4668All itemsPOP: 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) 4, 8, 26-30, 42(iii), 44, and 50 are considered checked and apply. VAAR 819.7003Class Deviation from VAAR 819.7003, Eligibility VAAR 852.203-70 Commercial Advertising (Jan 2008) VAAR 852.232-72Electronic Submission of Payment Requests (November 2012) FAR 52.252-1Solicitation 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 SECTION B - SCHEDULES OF SUPPLIES/SERVICES Contract Requirements Contractor shall provide VANCHCS, blood, blood components, and services described below for the VA Martinez OPC, 150 Muir Rd, Martinez, CA. 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) (all testing required by regulatory agencies) 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 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. All blood supplied shall be visually free of hemolysis, excessive chyle and clots. Qualification / Certifications 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. 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. 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. 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. 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. Donor Requirements 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. Donor selection shall be in accordance with criteria established by the FDA and/or the AABB. 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). Expiration Dates The contractor shall supply blood and blood components in accordance with the expiration dates specified in the AABB Standards. The contractor shall supply Red blood cell products not over 15 days from the date of collection unless agreed to by the laboratory staff. The contractor shall return for full credit any Red blood cell products that exceed 15 days from the date of collection. Blood Products The contractor shall furnish blood labeled as A, B, O and Rh type per regulatory guidelines. The contractor shall furnish an established volume of blood products for each product type and ABO Rh type per min volume agreement established by the supplier and each laboratory. The Sacramento Medical Center contractor will supply 8 O Rh negative units of PRBCs so that they have more than 10 days to the expiration date to the Sacramento Medical Center Laboratory and the Martinez OPC contractor will supply 2 O Rh negative units of PRBCs that have more than 10 days to the expiration date to the Martinez OPC laboratory to be maintained in inventory at all times. The only exception for the minimum volumes is by agreement with the laboratory staff if product availability is an issue or a short-dated unit can be utilized. The contractor shall supply whole blood, red blood cells and components in standard collection containers, with appropriate samples for laboratory work. The following tests shall be completed by Contractor prior to delivery (or as mandated by AABB and FDA): 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. 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. Special Donations Contractor shall not require pre-payment of blood processing & handling surcharges from autologous or designated blood donors for VA. 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 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 blood center. The contractor shall ship blood components at no additional expense to the VA. These units shall be shipped to VA when received. Hospital Notification 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. 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. i. Male only donors for FFP and HLA type II antibody tests for all female platelet donors (for the prevention of TRALI). j. Other services as needed, provided by the contractor. VA Martinez Requirements: Supplies and services to be delivered at VA Northern CA Health Care System, 150 Muir Road, Martinez, CA 94553. Delivery orders will be placed by phone. The type of delivery order will be specified when order is placed and Contractor shall deliver within the following times. Time begins when the delivery order is placed. STAT-------------------------------One up to (1) hour ASAP-------------------------------Four up to (4) hours Stock--------------------------------Six up to (6) hours Reference Services a. STAT reference lab specimens shall be picked up and delivered to the testing laboratory within (1) hours from the time the order was placed. b. STAT reference lab specimens shall have a progress report by the end of a work shift (eight (8) hours from the time specimen arrives) for example: most complex antibody identifications should be completed within 8 hours and most moderate antibody identifications within 4 hours. c. All results are to be initially reported to VA by telephone and a preliminary test report by fax. The final test report will be sent within five (5) working days after the preliminary report. Credit for Returned Blood (for all facilities): Credit at the rate of _100%_ shall be allowed for red blood cells returned prior to the expiration date. Credit at the rate of _100%__ shall be allowed for platelets/platelet pheresis and red cells approved for return prior to the expiration date. Credit at the rate of 100% _ shall be allowed for STAT returned prior to the expiration date. Credit at the rate of 100% shall be allowed for STAT with short dated delivery dates. Transportation Charge for STAT Orders: Delivery charge will be from the point of origin, which is the Blood Centers to the requesting VA and it will be billed separately and paid for through separate purchase orders. Delivery charge will be paid at all times except when it is delivered at the time of a normally scheduled delivery. Line Items B0001-B0005 - VA Northern California Health Care System - Martinez- Supplies Item NoDescription Base Year Est. Qty Unit Of Issue Unit Price Amount B0001Red Blood Cells - EA $ - $ - B0002Fresh Frozen Plasma, Pheresis 6 EA $ - B0003Plateletpheresis, non-HLA matched, Leukopoor 12 EA $ - B0004Leukopoor, RBC 107 EA $ - B0005Irradiated Leukopoor, RBC 87 EA $ - Irradiated Leukopoor, Plateletpheresis, non-HLA matched 12 EA $ - Sub Total $ - Line Items B0006-B0010- VA Northern California Health Care System - Martinez- Services Item NoDescription Base Year Est. Qty Unit Of Issue Unit Price Amount B0006Antibody Identification 6 EA $ - B0007Phenotyping, Genotyping whole blood or Red Cell Mass 6 EA $ - B0008CMV neg 75 EA $ - B0009Rare panel 1 EA $ - B0010Antibody screen 4 EA $ -
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/VA/VANCHCS/VANCHCS/VA26115Q0413/listing.html)
- Document(s)
- Attachment
- File Name: VA261-15-Q-0413 VA261-15-Q-0413.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1914425&FileName=VA261-15-Q-0413-000.docx)
- Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1914425&FileName=VA261-15-Q-0413-000.docx
- Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
- File Name: VA261-15-Q-0413 VA261-15-Q-0413.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1914425&FileName=VA261-15-Q-0413-000.docx)
- Place of Performance
- Address: Martinez Outpatient Clinic;150 Muir Road;Martinez, CA
- Zip Code: 94553-4668
- Zip Code: 94553-4668
- Record
- SN03666112-W 20150314/150312235200-d75eb8791b191efab16fc1b7871c784f (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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