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FBO DAILY - FEDBIZOPPS ISSUE OF JULY 04, 2014 FBO #4605
DOCUMENT

Q -- Hospital Blood Services-Blood Infectious DesienceTesting - Attachment

Notice Date

7/2/2014
 

Notice Type

Attachment
 

NAICS

621991 — Blood and Organ Banks
 

Contracting Office

Contracting Office (90C);Department of Veterans Affairs;Ralph H. Johnson VA Medical Center;325 Folly Road, STE 300;Charleston SC 29412
 

ZIP Code

29412
 

Solicitation Number

VA24714I1031
 

Response Due

7/11/2014
 

Archive Date

7/16/2014
 

Point of Contact

Janica Francis-Hunter
 

E-Mail Address

H
 

Small Business Set-Aside

N/A
 

Description

SOURCES SOUGHT NOTICE Blood Infectious Disease Testing DESCRIPTION: This is a sources sought to determine the availability of potential sources having the skills and capabilities necessary to provide the SPECIFIED REQUIREMENT. All interested vendors are invited to provide information to contribute to this market survey/sources sought including commercial market information. THIS IS NOT A SOLICITATION ANNOUNCEMENT. This is a sources sought synopsis only. No solicitation will be made. Provide only the requested information below. The purpose of this synopsis is to gain knowledge of potential qualified sources and their size classifications (Service Disabled/Veteran Owned Small Business (SDVOSB/VOSB), Hub zone, 8(a), small, small disadvantaged, woman owned small business, FSS/GSA contract schedule holders or large business) relative to NAICS 621991, Blood and Organ Banks (size standard $30.0 Million). Responses to this synopsis will be used by the Government to make appropriate acquisition decisions in the future. SPECIFIED REQUIREMENT: Network Contracting Office 7, Charleston, SC is seeking sources for a potential contractor to perform the following type of service: Blood Infectious Disease Testing: Blood establishments must test each donation of human blood or blood components intended for allogeneic use or intended for use as a component of a medical device for the following, unless otherwise excluded under 21 CFR 610.40(c): "Human Immunodeficiency Virus, types 1 & 2 (anti-HIV and HIV-1 Antigen (HIV-1 Ag)) "Hepatitis B Virus (HBsAg and anti-HBc) "Hepatitis C Virus (anti-HCV) "Human T-Cell Lymphotropic Virus, types I and II (anti-HTLV-I/II) "Syphilis [required under 21 CFR 640.5(a)] These testing requirements are also applicable to autologous donations that may be used for allogeneic transfusion. Blood establishments may also test for other infectious agents, for example, antibody to Cytomegalovirus (anti-CMV). A blood establishment must do further testing on each reactive donation using supplemental tests approved for such use unless otherwise excluded under 21 CFR 610.40(e). The blood establishment may do its own testing or may contract part or all of the testing. Only a testing laboratory that registers with FDA and that is certified by the Centers for Medicare and Medicare Services for infectious disease testing may perform testing on blood donations. The laboratory testing must comply with 21 CFR 610.40 (a), (b), (e) and (f). 21 CFR 610.40(c) identifies exceptions to required testing. Testing must be performed using licensed test kits, with the exception of the serological test for syphilis. Although not licensed, the serological test for syphilis must be labeled for use in donor screening. A list of currently licensed HIV and hepatitis test kits is on the Internet at http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/BloodDonorScreening/InfectiousDisease/ucm080466.htm. A manufacturer that contracts infectious disease testing must ensure the contract laboratory is registered with FDA. SPECIFICATIONS i.All blood shall be tested as required by the Food and Drug Administration (FDA) and the American Association of Blood Banks (AABB). a)All blood shall be collected by the close 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, not to exceed the established AABB guidelines for: ACD/CPD/CP2D of 21 days, CPDA-1 of 35 days, AS-1/AS-3/AS-5 of 42 days. b)All blood supplied shall be free of hemolysis, clots, and excessive chyle. ii.Offers shall be considered only from offerors whose blood bank is currently registered and/or licensed with the Food and Drug Adminsitration (FDA), in accordance with the 21 USC Section 360. iii.Prior to award the offeror must submit proof that he holds an unrevoked US license which is issued by the Director, Bureau of Biologics, FDA under Section 251 of the Public Health Service Act, as amended, 42 USC Section 262. iv.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 as indicated under section 42 USC 262. v.The offeror shall certify that he will comply with the requirements outlined below with respect to donors, containers, delivery, etc. vi.Offers will be considered only from blood banks who are able to provide the VA with 100% "volunteer donors" blood in accordance with the latest FDA rules and regulations. Definition of "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." vii.Donor Requirements: a)The offeror shall maintain readily available blood donor listing which include names, addresses and social security numbers of the donors; along with the date the donor(s) blood or blood components is furnished to the medical center under this contract. All donor information, including without limitation, information in the donor database, is confidential and proprietary to the contractor. b)Donor selection shall be in accordance with criteria established by FDA and/or the AABB. viii.The contractor shall make every reasonable effort to confirm consultation results within twenty-four (24) hours of sample shipment. ix.Subject to availability, voluntary blood donations and absence of force majeure events, emergency shipments shall be delivered within two (2) hours. b.PERFORMANCE, DELIVERY, INSPECTION AND ACCEPTANCE i.Packaging and Marking a)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. b)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). REQUESTED INFORMATION: (1) STATEMENT OF CABABILITY: Submit a brief description, five (5) pages or less, that demonstrates how your company has the license, supervision, facilities, labor and experience to conduct Blood Infectious Disease Testing. Blood establishments must test each donation of human blood or blood components intended for allogeneic use or intended for use as a component of a medical device for the following, unless otherwise excluded under 21 CFR 610.40(c): Human Immunodeficiency Virus, types 1 & 2 (anti-HIV and HIV-1 Antigen (HIV-1 Ag)); Hepatitis B Virus (HBsAg and anti-HBc); Hepatitis C Virus (anti-HCV); Human T-Cell Lymphotropic Virus, types I and II (anti-HTLV-I/II); and Syphilis [required under 21 CFR 640.5(a)]. (2) BUSINESS SIZE AND SOCIO-ECONOMIC STATUS: (a) Indicate whether your business is large or small (b) If small, indicate if your firm qualifies as a small, emerging business, or small disadvantaged business (c) If disadvantaged, specify under which disadvantaged group and if your firm is certified under Section 8(a) of the Small Business Act (d) Indicate if your firm is a certified Hub-zone firm (e) Indicate if your firm is a woman-owned or operated business (f) Indicate if your firm is a certified Service-Disabled Veteran Owned Small Business (SDVOSB) or Veteran Owned Small Business (VOSB) (g) Include the DUNS number of your firm. (h) State whether your firm is registered with the System for Award Management (SAM) at https://www.sam.gov/portal/public/SAM/ and/or the VetBiz Registry at http://vip.vetbiz.gov/. If not, please (i) NOTE that any future solicitation could only be awarded to a contractor who is registered in SAM and to receive award based on VOSB or SDVOSB status you must be registered in the VetBiz Registry. Responses must be emailed to Janica.Francis@va.gov no later than 4:00pm EST, Friday, July 11, 2013. Your response should include both the STATEMENT OF CABABILITY and BUSINESS SIZE AND SOCIO-ECONOMIC STATUS information as explained above. Please place "Attention: Blood Infection Disease Testing" in the subject line of your email. This notice is to assist the VA in determining sources only. A SOLICITATION WILL NOT BE ISSUE.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/ChaVAMC/VAMCCO80220/VA24714I1031/listing.html)
 

Document(s)

Attachment
 

File Name: VA247-14-I-1031 VA247-14-I-1031.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1472904&FileName=VA247-14-I-1031-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1472904&FileName=VA247-14-I-1031-000.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: Ralph H Johnson VAMC;Department of Veteran Affairs;109 Bee Street;Charleston, SC

Zip Code: 29403
 

Record

SN03412942-W 20140704/140703001730-708f66d714a2eb8b983a043b27192a17 (fbodaily.com)
 

Source

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

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