FILE | 65 | BLOOD AND PLOOD PRODUCTS LEXINGTON - Attachment

FBO DAILY ISSUE OF JUNE 12, 2011 FBO #3487
DOCUMENT

65 -- BLOOD AND PLOOD PRODUCTS LEXINGTON - Attachment

Notice Date: 6/10/2011
Notice Type: Attachment
NAICS: 621991 — Blood and Organ Banks
Contracting Office: Department of Veterans Affairs;VISN 9;1639 Medical Center Parkway, Suite 400;Murfreesboro TN 37129
ZIP Code: 37129
Solicitation Number: VA24911RI0190
Response Due: 6/13/2011
Archive Date: 6/14/2011
Point of Contact: KEN LLOYD
E-Mail Address: KENNETH.LLOYD2@VA.GOV
(Kenneth.Lloyd2@va.gov)
Small Business Set-Aside: N/A
Description: This is a SOURCES SOUGHT SYNOPSIS only. The purpose of this notice is to conduct market research and obtain information from qualified businesses. No proposals or quotes are being requested or accepted with this announcement. No Telephone calls shall be accepted as a response to this notice. The Department of Veteran Affairs, Network Contracting Activity, VISN 9 is seeking qualified Service Disable Veteran Own Business, Veteran Own Business, 8(a) firms, HubZone businesses, and Small Business firms and GSA Scheduled Contractors with the availability and capability of providing human blood components suitable for transfusion in accordance with methods stipulated in the current edition of Standards for Blood Banks and Transfusion Services and the American Association of Blood Banks (AABB) Technical. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set aside is possible for this requirement.. NAICS code is 621991 and size standard is $10 million in annual revenue. Product Estimated Annual Volume BLOOD ProductsAnnual Estimated Usage 1.RBC, ADENINE-SALINE1 ea 2.RBC, ADENINE-SALINE,LEUKO-REDUCED1750 ea 3.RBC, WASHED1 ea 4.RBC, WASHED1 ea 5.RBC, DEGLY, REJUVENATED1 ea 6.RBC,FROZEN DEGLYCEOLIZED1 ea 7.IRRADIATED/LEUKO-REDUCED PC1 ea 8.AUTOLOGOUS BLOOD1 ea 9.PLATELET, PHERESIS,LEUKO-REDUCED120 ea 10.Plt, Pheresis, Leuko-reduced, Irr. 10 ea 11.Plt, Leuko-reduced, irr.1 ea 12.PLATELETS1 ea 13.WASHED Units1 ea 14.FRESH FROZEN PLASMA,REGULAR50 ea 15.FRESH FROZEN PLASMA,REGULAR1 ea 16.FRESH FROZEN PLASMA, LARGE >600ml1 ea 17.CRYOPRECIPITATED1 ea 18.CMV SURCHARGE1 ea 19.HLA SURCHARGE5 ea 20.NATIONAL SEARCH1 ea 21.IRRADIATION CHARGE1 ea 22.STAT CHARGE50 ea 23.ANTIGEN TYPING5 ea 24.ANTIGEN SURCHARGE (1 AG)5 ea 25.ANTIGEN SURCHARGE (2 AG)5 ea 26.ANTIGEN SURCHARGE (3AG)5 ea 27.ANTIGEN SURCHARGE (4AG)1 ea 28.ANTIGEN SURCHARGE (5AG)1 ea 29.ANTIGEN SURCHARGE (6AG)1 ea 30.Pre-Pooled Cryo5 ea Vendor Qualifications All blood and derivatives provided to patients in VA facilities must meet the requirements of the Food and Drug Administration (FDA). The blood supplier must have a quality program in place that meets the requirements of the current FDA good manufacturing regulations for finished blood products. a.The contractor's blood bank must be currently registered and/or licensed by the FDA, DHHS pursuant to Section 510 of the Federal Food, Drug and Cosmetic Act, as amended, 21 U.S.C. Section 260. NOTE: If interstate shipment of blood or blood components is involved, the contractor must have an authorized approval under Section 251 of the Public Health Service Act, as amended, 42 U.S.C. Section 262. b.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 American Association of Blood Banks Technical Manual. (i)All blood and blood products will be free of gross hemolysis and clots. c.All blood/blood components shall be collected from donors in accordance with the requirements of the FDA. (i)In the event of a recall or lookback, copies of the request must be sent promptly to the Blood Bank Medical Director at the LEXINGTON VA Medical Center. (ii)The contractor will promptly notify the VA about potentially infectious blood or blood products. d.Specifically, contractor agrees that all components shipped will have been tested and found to be non-reactive for HBsAg, RPR, HBc antibody, antibodies to HIV-1, HIV-2, HCV, HTLV-1, and HIV-ag. e.Each unit of donor blood shall also be tested for alanine transferase (ALT). f.Blood and components shall not be used for transfusion if the ALT results are outside established limits. Additional tests may be implemented as appropriate. 1.References "Standards for Blood Banks and Transfusion Services American Association of Blood Banks (AABB) "Technical Manual American Association of Blood Banks (AABB) "VHA Handbook 1106.1 "College of American Pathologists (section checklist criteria) "Joint Commission Standards for Pathology & Clinical Laboratory Services "Food and Drug Administration (FDA) "HIPAA Regulations "Code of Federal Regulations (212) Section 606.120 and 606.121 Subpart G. "Code of Federal Regulations (21) Section 606.165 Subpart 1. "Code of Federal Regulations (21) Section 210 and 211. "The American Association of Blood Bank 27th Standards for Blood Bank and Transfusion Services. 2.Delivery/Location/Ordering a.The blood will be delivered to the Veteran Administration Medical Center, Lexington KY, (VAMC) laboratory in accordance with CFR (21), (212) and AABB 27th Edition as referenced above. Delivery Location: Laboratory Room B-102, Cooper Division VA Medical Center 1101 Veterans Drive Lexington, Kentucky 40502. b.Vendor's primary blood center must be geographically located be capable of delivering additional emergency platelets and all products within 1/2 hour of receiving the delivery order. -Vendor must provide routine exchange, at no extra cost, 7 days per week, of platelets to VAMC to ensure availability of product for our patients. -The rotation process of moving blood products to meet patient needs will minimize product outdating. -VAMC will be charged only for products used, with no hidden fees. -Additionally, VAMC will be credited "irradiation" fees when an irradiated product is used, but not required by the patient, due to limited inventory. -In case of emergency, the blood supplier must deliver additional platelets and all products within 1/2 hour of receiving the delivery order. c.All products must be free of gross hemolysis and be ISBT 128 coded products. d.Empty containers, blood, and equipment being returned for credit will be returned at Contractor's expense. e.The blood supplier will determine and implement a Blood Utilization Program to monitor the appropriate use of blood, promote patient safety and support cost containment. This program will be provided by vendor at no additional cost to our hospital. The contracting officer technical representative (COTR) will work with our facility to develop a process to monitor ongoing blood usage thereby, eliminating product wastage. f.The blood supplier must be available to accept delivery orders 24 hours a day, seven days a week. -Routine delivery orders will be placed by 9:00 am daily if needed. -The blood supplier will provide delivery by 2:00 pm the same day. -Additional non-routine delivery orders will be accepted as needed. g.Specimen and blood components must be transported in such a way as to ensure the integrity of specimens and blood components, and comply with accreditation standards as defined by the FDA and the American Association of Blood Banks (AABB). h.The VAMC keeps one platelet pheresis in their inventory on a daily basis. If more platelets are needed they will be ordered for STAT delivery. There will be no delivery charge for these platelet deliveries. These STAT deliveries must be within 30 minutes of the initial contact call. i.Upon award, a list of VAMC employees of Pathology Service, who are authorized to place orders, will be furnished to the Contractor in the memo of designation of Contracting Officer's Representative(s). 3.Packaging, Marking, and Storage A.Blood shall be furnished labeled as to A, B, 0 and Rh type. Type A Rh negative and 0 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 shall be supplied as fresh as possible but 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. B.Immediately after collection, unless the blood is to be used as a source for platelets, the blood shall be refrigerated between 1 and 6 degrees Celsius with fluctuation of no more than 2 degrees Celsius within this range. C. -Blood from which platelets are to be prepared shall be held in an environment maintained at a temperature range of 20 to 24 degrees Celsius until platelets are separated. -Red blood cells shall then be placed in storage, within a maximum of 8 hours of bleeding, at a temperature from 1 to 6 degrees Celsius immediately after platelets are separated. -This shall be in accordance with FDA and/or the AABB Standards for Blood Banks and Transfusion Services. -Freezing must be avoided at all times. -If public transportation of the blood is necessary, it shall be transported in clean shipping containers provided with refrigeration sufficient to hold the blood at 1-10 degrees Celsius if it has been pre-cooled. -If the blood has not been cooled, the shipping containers shall provide sufficient refrigeration to bring the temperature toward 1-10 degrees Celsius, preferably 1-6 degrees while in transit. 4.Progress and Compliance A.Offers shall be considered only from offerors whose blood bank is currently registered and/or licensed with the Food and Drug Administration (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. B.Prior to award the offeror must submit proof that he holds an unrevoked U.S. 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 whole blood. (i)In the event that the contractor is a registered facility, proof must be provided that there have been no significant adverse findings noted during the last FDA inspection. C.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. D.The offeror certifies that he will comply with the requirements outlined below with respect to donors, containers, and delivery. E.Offers shall be considered only from blood banks that are able to provide the VAMC with 100% "volunteer donor" blood in accordance with FDA rules and regulations effective May 15, 1978 or later 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 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." F.Donor Requirements: 1.Donor selection must be in accordance with criteria established by the FDA and/or the AABB. G.The Contractor shall assume complete responsibility for furnishing all blood components required by VAMC, Lexington, Kentucky. Blood components shall be drawn, processed, typed, and packed in suitable containers in accordance with all the terms, conditions, provisions, and schedule of this proposal. H.The supplies shall be provided upon receipt of an order received from an employee, authorized in writing, as a representative of the VAMC Contracting Officer. Twenty-four (24) hour daily coverage will be given by the Blood Center to fill emergency needs of the VAMC. Upon award, the names of VAMC employees authorized to place orders will be furnished to the Contractor with the designation as Contracting Officer's Representative. Anticipated Period of Performance is: Base Year Oct 1, 2011 through Sep 30, 201 1st Option Year Oct 1, 2012 through Sep 30, 2013 2nd Option Year Oct 1, 2013 through Sep 30, 2014 3rd Option Year Oct 1, 2014 through Sep 30, 2015 4th Option Year Oct 1, 2015 through Sep 30, 2016 Interested qualified small business firms responding to this announcement shall not to exceed 5 pages and should include the following information: (1) A tailored capability statement indicating the firm's ability to provide blood products and related services; (2) Name, address, phone #, and POC for your firm.; and (3) The firm's DUNS Number and (4) ORCA document (5) GSA Schedule Contract Number (if applicable) NOTE: 1.SDVOSB and VOSB must be registered and CVE verified in VetBiz Registry www.vetbiz.gov. 2.GSA Schedule Contractor must provide it Schedule contract number Please e-mail your interest with above information to Kenneth.lloyd2@va.gov with the subject line "Sources Sought Notice# VA-249-11-RI-0190 by 1:00 p.m. on June 14, 2011. DISCLAIMER AND IMPORTANT NOTES: This notice does not obligate the Government to award a contract to any firm or its affiliates or otherwise pay for the information provided in this response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any firm responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the firm small business qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. Responses to this announcement shall not be considered adequate responses to a solicitation. All information submitted in response to this announcement is voluntary; the Government will not pay for information requested nor will it compensate any respondent for any cost incurred in developing information provided to the Government.
Web Link: FBO.gov Permalink
(https://www.fbo.gov/spg/VA/NaVAMC/VAMCCO80220/VA24911RI0190/listing.html)
Document(s): Attachment; File Name: VA-249-11-RI-0190 VA-249-11-RI-0190.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=208789&FileName=VA-249-11-RI-0190-001.docx); Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=208789&FileName=VA-249-11-RI-0190-001.docx; Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
Place of Performance: Address: VA MEDICAL CENTER;LABORARTORY ROOMB-102 COOPER DIVISION;1101 VETERAN DRIVE;LEXINGTON KY; Zip Code: 40502
Record: SN02470264-W 20110612/110610235704-013df910c1b3dd8e873007ab16d25bf8 (fbodaily.com)
Source: FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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65 -- BLOOD AND PLOOD PRODUCTS LEXINGTON - Attachment