SOURCES SOUGHT
Q -- HIV testing services
- Notice Date
- 9/20/2013
- Notice Type
- Sources Sought
- NAICS
- 621511
— Medical Laboratories
- Contracting Office
- Center for Health Care Contracting, ATTN: MCAA C BLDG 4197, 2199 Storage Street, Suite 68, Fort Sam Houston, TX 78234-5074
- ZIP Code
- 78234-5074
- Solicitation Number
- W81K04-RFI-HIV
- Response Due
- 10/10/2013
- Archive Date
- 11/19/2013
- Point of Contact
- Gary Hankins, (210)221-4122
- E-Mail Address
-
Center for Health Care Contracting
(gary.hankins@cen.amedd.army.mil)
- Small Business Set-Aside
- N/A
- Description
- The U.S. Army Medical Command (MEDCOM), Center for Health Care Contracting (CHCC), on behalf of the Department of the Army, has developed this Request for Information (RFI) to solicit market research information from industry to assist the Government with analysis of a Government requirement and provide commercial insight on performance-based solutions, best practices, possible contractual arrangements, and potential issues. THIS IS A REQUEST FOR INFORMATION ONLY. It is not a Request for Proposal, a Request for Quotation, an Invitation for Bids, a Solicitation, or an indication the CHCC will contract for the items contained in the RFI. This RFI is part of a Government market research effort to determine the scope of industry capabilities and interest and will be treated as information only. In accordance with FAR 15.201(e), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responses to this RFI are strictly voluntary and the government will not pay respondents for information provided in response to this RFI. Responses to this RFI will not be returned and respondents will not be notified of the result of the review. If a Solicitation is issued, it will be announced on the Federal Business Opportunities website http://www.fbo.gov at a later date, and all interested parties must respond to that Solicitation announcement separately from any response to this announcement. This RFI does not restrict the Government's acquisition approach on a future Solicitation. A description of the required services are as follows: This is a non-personal services contract to provide testing services for the detection of antigen and antibody of Human Immunodeficiency Viruses (HIV), as directed by the government. The HIV testing services will include, but is not limited to, the provision of highest quality of HIV test integrity and transparency employing best laboratory and quality practices, and fully automated (robotic), highly stringent engineering controls and work flows for maintenance of specimen chain of custody and positive specimen identification from receipt of specimens to report of results and final disposition of specimens. HIV testing services include, but are not limited to, the provision of collection supplies, specimen collection/preparation /shipment instructions and training, courier services, specimen testing (including required quality programs), result reporting, specimen storage/re-aliquot/final disposition services, required information management systems, and help desk customer support services. The Contractor shall independently, and not as an agent of the U.S. Government, provide qualified personnel, services, materials, equipment, supplies, information systems, and facilities necessary to perform testing services for the simultaneous detection of HIV antigen and anti-HIV antibody employing the most state-of-art Food and Drug Administration (FDA) approved tests, platforms, and methodologies. The Contractor shall perform initial and repeat reactive screening tests on serum and/or plasma specimens submitted by Army Military Treatment Facilities (MTFs) and/or other submitting entities, the U.S. Army Reserve (USAR) sites and U.S. Army National Guard (ARNG) sites (coordinated by the Reserve Health Readiness Program (RHRP)) and United States Military Entrance Processing Command (USMEPCOM) sites. Screening test(s) will employ state-of-art US FDA approved fourth generation microplate technology employing an Enzyme Immunoassay (EIA) methodology for simultaneous qualitative detection of HIV-1 p24 antigen and recombinant proteins and synthetic peptides for the detection of antibodies to HIV-1 (Groups M and O) and HIV-2 in human serum and/or plasma. In the event that more sensitive and/or specific FDA approved screening tests become available, the Contractor, upon the direction of the Government (HDRL) through the Contracting Officer (KO), will employ the more sensitive/specific methodology. The number of testing locations is limited to no more than three sites: one primary testing site and two contingency sites. Testing shall be executed at the Contractor's facilities, or within the limited number of sites. The Contractor shall, at a minimum, have an alternative College of American Pathologists (CAP) or Clinical Laboratory Improvement Amendment (CLIA) equivalent accredited testing site (primary or subcontractor) for use only during contingency operations and/or as required for quality assurance re-testing. The Contractor shall submit test results via a secure on-line Laboratory Information Management System (LIMS) that is in compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and other Security requirements, e.g., 1.5 and is compatible with and able to interface directly with the Composite Health Care System (CHCS), or other current Government LIMS/IS located at each Submitting Activity (SA). For non-CHCS SAs, (see paragraphs 1.2.6. and subparagraphs of the PWS); and for USMEPCOM Sas. The Contractor shall provide a secure website for the exchange of test request data and test results. The secure website shall be ready to receive information through HL7, XML, or ASCII flat file by the period of performance start date. The Contractor may receive approximately 62,000 specimens monthly from Army Active Duty MTFs; 3,000 specimens from the USAR RHRP sites; 11,600 specimens from ARNG; and 34,000 specimens from USMEPCOM sites for initial HIV EIA screening. Of those numbers, it is estimated that not more than 3 percent shall require a confirmatory testing. The Contractor shall have the capability to provide direct courier delivery services for CONUS/OCONUS sites meeting all domestic and international regulations and military facility security requirements for delivery of specimens, materials, equipment and reports. The Government desires that respondents offer their experience and recommendations on the following questions and issues related to the above requirement. When addressing these items, respondents should consider the size and scope of the requirement described herein. a. Please provide a capability statement that includes, as a minimum, the following information: company name, address, point of contact, cage code, phone number, fax number, and business size as it relates to NAICS 621511- Medical Laboratories. b. types of HIV testing performed by your company. c. total number of annual tests (including types of tests) performed by your company. d. number of testing locations (e.g., laboratories) used by your company. e. list of your laboratories certifications, licenses, etc. f. number of years your company has performed HIV testing. g. a list of the types of your major clients (i.e. governmental and commercial). h. Brief description of your quality control procedures and standards. i. what are your overall procedures for receiving specimens and submitting test results j. are there any industry standards applicable to your testing. k. what type of information management system do you use to submit test results. l. what type of courier services do you provide to your customers. m. what types of labor do you employ including personnel qualifications. n. what are some of the challenges in today's market for these testing services. Please provide e-mail responses to this RFI no later than 10 October 2013 to Ms. Yesenia Rodriquez, Contract Specialist at yesenia.c.rodriguez2.civ@mail.mil and Mr. Gary Hankins, Contracting Officer at gary.d.hankins.civ@mail.mil.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/MEDCOM/DADA10/W81K04-RFI-HIV/listing.html)
- Place of Performance
- Address: Center for Health Care Contracting ATTN: MCAA C BLDG 4197, 2199 Storage Street, Suite 68 Fort Sam Houston TX
- Zip Code: 78234-5074
- Zip Code: 78234-5074
- Record
- SN03196749-W 20130922/130920235201-bda6926c66008df936248f52751a09ce (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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