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FBO DAILY - FEDBIZOPPS ISSUE OF JANUARY 31, 2018 FBO #5913
DOCUMENT

65 -- VISN 1- VA New England- Blood Products and Services - Attachment

Notice Date

1/29/2018
 

Notice Type

Attachment
 

NAICS

621991 — Blood and Organ Banks
 

Contracting Office

Department of Veterans Affairs;VAMC Manchester;718 Smyth Road;Manchester NH 03104
 

ZIP Code

03104
 

Solicitation Number

36C24118R0143
 

Response Due

2/9/2018
 

Archive Date

3/11/2018
 

Point of Contact

Jacob Linxweiler
 

E-Mail Address

4-4418<br
 

Small Business Set-Aside

N/A
 

Description

1. INTRODUCTION: This sources sought notice is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the Department of Veterans Affairs (VA). The VA is currently conducting market research to locate qualified, experienced and interested potential sources. Responses will not be considered as proposals, nor will any award be incurred by interested parties in responding to this sources sought announcement. NCO 1 Contracting is seeking interested sources for a future solicitation and procurement. At this time, no solicitation exists. 2. BACKGROUND: VISN 1 VA Healthcare System has a requirement for the following blood bank products and services: Supply blood components, plasma derivatives, and blood related services fully for VISN 1 and in the event the primary blood product supplier is unable to meet the needs for the other VISN1 Laboratories. Reference Testing Service and ancillary services are required on an as needed basis in VISN 1. VISN 1 needs the availability of reference services for red cell serology, STAT antibody identification, antigen negative units, heterologous absorption, HLA Services, Autologous and directed donor service and platelet immunology services. The blood related services include complete processing, testing, and storing which will be performed outside the VA facilities. Contractor shall furnish all labor, materials, equipment, facilities and personnel necessary for the complete drawing, processing, testing storing, delivery and recall notification of blood components, plasma derivatives, and blood related services, to the VISN 1 Medical Centers. Contractor will use due diligence to avoid repetitious denial of Rh negative red cell product from standing order. All whole blood and blood components provided to patients in VA medical centers must meet the requirements of the American Association of Blood Banks (AABB) and/or the Food and Drug Administration (FDA), Department of Health and Human Services. Allogeneic blood/blood components must be typed for ABO and Rho(D) in accordance with licensed methodologies, and must be tested for all transfusion transmitted disease markers currently required by both the FDA and AABB. All blood must be collected by the closed system under aseptic conditions, processed in appropriate solutions and the container so labeled. The label must also bear the expiration date of the contents, which must not exceed the Food and Drug Administration (FDA) allowable limit for the type of anticoagulant in which the blood component is drawn. All blood supplied must be free of hemolysis, clots, and excessive chyle. In the event that units are received and found that they are not free of hemolysis, excessive chyle, clots, and/or any other abnormal discoloration or for platelets that do not exhibit swirl, the Contractor will provide credit. Autologous blood/blood components must be typed for ABO and Rho(D) in accordance with licensed methodologies, and must be tested for all transfusion transmitted disease markers currently required by the FDA. Blood will be typed for ABO and Rh antigens in accordance with methods recommended in the current editions of Standards for Blood Banks and Transfusion Services and Technical Methods and Procedures published by the AABB. Only units negative for HBsAg, anti HBc, anti HCV, HCV RNA, anti HIV-1/2, HIV-1 RNA, anti HTLV- I/II,a serologic test for syphilis, Babesia, Zika, and WNV RNA (seasonal criteria apply) will be accepted. Donor blood with a biologic false positive for syphilis will be acceptable. This statement will not apply to autologous units. The Contractor shall supply 100% volunteer donor blood as defined in 21CFR606.121(c)(5)(ii). All blood/blood components must be collected from donors in accordance with the requirements of the AABB and the FDA. In the event of a recall, Contractor shall promptly send copies of the recall request to the Blood Bank Medical Director at the VA medical center where the blood product was issued The Contractor shall initiate recipient tracing (look back) procedures for prior seronegative units upon later discovery of a donor positive for infectious diseases such as: Human Immunodeficiency Virus (HIV); Human T Cell Lymphotropic Virus 1 & 2 (HTLV-I/II); Hepatitis C Virus (HCV); or any other requiring look back in accordance with all the applicable laws, statutes, rules and regulations such as those designated by the FDA (Title 21 Code of Federal Regulations) and Health Care Financing Administration (HFCA). Contractor shall make reference transfusion services available to all VA medical centers. The offeror must be capable of providing the blood components and specialized testing detailed in the Schedule of Supplies/Services and Prices/Costs (the Schedule) on a 24-hour per day, seven days per week basis. Contractor shall possess a registration and/or license with the Food and Drug Administration (FDA), Department of Human Services, pursuant to Section 510 of the Federal Food Drug and Cosmetic Act, 21 USC Section 260, as amended. A copy of said license shall be furnished with the offer. Contractor shall submit proof that they hold an unrevoked U.S. License which is issued by the Director, Bureau of Biologist, Food and Drug Administration (FDA) under Section 251 of the Public Health Service Act, as amended, 42 USC Section 262, as a source of supply for whole blood. Contractor shall provide upon request monthly or at minimum, quarterly Quality Control Reports that demonstrate the blood components and derivatives meet all applicable AABB and FDA criteria. VISN 1 VA Medical Centers: VA Medical Center, Providence 830 Chalkstone Avenue Providence, Rhode Island 02908 VA Boston Healthcare System West Roxbury Campus 1400 VFW Parkway West Roxbury, MA 02132 VA Connecticut, West Haven Campus, Connecticut 950 Campbell Avenue West Haven, CT 06516 VA Medical Center, Manchester, New Hampshire 718 Smyth Road Manchester, NH 03104 VA Medical Center, Togus, Maine VA Medical Center 1 VA Center Augusta, ME 04330 VA Medical Center, White River Junction, Vermont 215 North Main Street White River Junction, VT 05009 3. OBJECTIVES: VISN 1 Healthcare System is looking for small business concerns, especially Service Disabled Veteran Owned Small Business (SDVOSB) and Veteran Owned Small Business (VOSB) contractors that can provide the requested blood products and services for VA Healthcare stations within VISN 1. The current primary NAICS code is 621991 (Acoustical Engineering Consulting Services), which has a size standard of 32.5 Million. 4. SUBMITTAL INFORMATION: Contractors having the skills and capabilities necessary to perform the stated requirements should submit a response as detailed below. Companies should provide clear and unambiguous evidence to substantiate their capability to fulfill the requirements above. Interested parties shall furnish the following minimum information: 1. Company name and address ensure your company is registered in the System for Award Management (SAM) at www.sam.gov. 2. Company point of contact name, telephone number, and email address. 3. Evidence that you are a small business (if applicable): Small Business ensure you are listed as small business in SAM, reps and certifications. Provide the NAICS codes you are listed as a small business under. SDVOSB or VOSB (or in the process of certification) ensure you are certified in the veteran database at www.vetbiz.gov. Provide evidence of certification. 4. If your company holds a Federal Supply Schedule (FSS) Contract, list the Contract Number and SINs. 5. Capabilities/Qualifications: A written response providing clear and unambiguous evidence to substantiate the capacity to fulfill this requirement. Description of the capabilities/qualifications/skills your company possesses to perform services described above. 6. Past Experience: Brief summary of the company history relative to similar requirements. Response may provide information on a maximum of three similar projects for which the responder was a prime or subcontractor. It is requested that the above information be provided no later than February 9, 2018 at 4:00PM EDT. Responses should be emailed to the contracting specialist at jacob.linxweiler@va.gov.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/MaVAMC608/MaVAMC608/36C24118R0143/listing.html)
 

Document(s)

Attachment
 

File Name: 36C24118R0143 36C24118R0143.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=4046787&FileName=36C24118R0143-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=4046787&FileName=36C24118R0143-000.docx

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Record

SN04803039-W 20180131/180129231325-d5b6efe06530726a75c5c200231d06dd (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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