High RIsk HPV typing of Thin Prep Samples for the VA Montana Health Care System
THIS IS A SOURCE SOUGHT NOTICE / RQUEST FOR INFORMATION (RFI) ONLY. THIS IS NOT A REQUEST FOR PROPOSAL AND/OR QUOTE. The Department of Veterans Affairs (VA), Veterans Integrated Systems Network (VISN) 19 and the Network Contracting Office (NCO) 19 are performing market research to determine if there are sufficient numbers of qualified (1) Service Disabled Veteran Owned Small Business; (2) Veteran Owned Small Business; or (3) Small Business to set aside a Firm Fixed Price requirement for High Risk HPV Typing Services for the VA Montana Health Care System. The Government will use responses to this notice to help make the appropriate acquisition strategy decision.
1. PURPOSE: Contractor shall provide High Risk HPV DNA Detection and HPV Genotyping of Thin Prep samples that are received from Montana VA Healthcare, 3687 Veterans Drive, Ft. Harrison, MT 59636, to the contractor s reference laboratory. The volume is an estimated workload is 30-40 specimens per month.
2. SCOPE: The Contractor(s) shall provide High Risk HPV DNA detection and reflex HPV Genotyping of Thin Prep PAP samples received from VA Montana Healthcare as ordered by VA Montana healthcare providers. The tests included in this test panel detect the E6/E7 viral messenger RNA from 14 high-risk types of human papillomavirus (HPV) in cervical specimens. The high-risk types detected by the assay include: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59,66, and 68. The nucleic acid amplification HPV assay does not discriminate between the 14 high-risk types. The contractor(s) shall be able to provide reflex HPV Genotyping to 16, 18/45 genotyping. This reflex is triggered by a negative PAP test with a positive High-Risk HPV DNA detection. The reflex HPV genotyping needs to be FDA approved test.B The HPV 16, 18/45 Genotype Assay is an in-vitro nucleic acid amplification test for the qualitative detection of E6/E7 viral messenger RNA (mRNA) of human papillomavirus (HPV) types 16, 18 and 45 in cervical specimens. The HPV 16, 18/45 Genotype Assay must provide differentiation of HPV 16 from HPV 18/45.
The Contractor(s) shall be approved to provide clinical diagnostic laboratory tests under both Medicare and Medicaid regulations and all applicable federal and state laws.
3. CONFORMANCE STANDARDS: The contractor shall meet the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI). A valid, in-date CLIA certificate must be supplied showing the address and CLIA registration number of the testing lab. The Contractor shall be HIPAA compliant.
4. REPORTING: Testing results will be supplied by a secure fax (406-447-7991) or by a secure email or web link. Results shall be returned no later than five days from receipt of the sample.
All interested firms shall submit a response demonstrating their capabilities regarding the above requirement. As stipulated in FAR 15.201, responses to this notice are not considered offers and cannot be accepted by the Government to form a binding contract. No solicitation exists; therefore, do not request a copy of the solicitation. The decision to solicit for a contract shall be solely with the Government discretion.
Firms responding should indicate whether they are, or are not, a service disabled veteran owned small business, a veteran owned small business, or any other type of small business business. The NAICS code to be used for this acquisition is 621511 (Medical Laboratories) is applicable to this acquisition, and the size standard is 32.5 milion. The Government reserves the right to consider all types of small business set-asides based upon responses hereto for any subsequent acquisition. Respondents are further requested to indicate their status as a foreign-owned/foreign-controlled firm and any contemplated use of foreign national employees on this effort.
Any information submitted by respondents to this sources-sought synopsis is voluntary. This sources-sought notice is not to be construed as a commitment by the Government, nor will the Government reimburse any costs associated with the submission of information in response to this notice. Respondents will not individually be notified of the results of any Government assessments. The Government s evaluation of the capability statements received will factor into whether any forthcoming solicitation will be conducted as a full and open competition or as a set-aside for small businesses, or any small business designation (e.g. SDVOSB, HUB Zone, 8(a), WOSB, VOSB, etc).
All prospective vendors must be registered and current within the System for Award Management (SAM). Visit www.sam.gov for details. In addition, all SDVOSBs and VOSBs must be registered and verified within VetBiz. Visit www.vetbiz.gov for details.
All responses must be received by 11-18-2019 at 3:30 pm MT
POC for this notice is Ian Boettcher / ian.boettcher@va.gov
Ian Boettcher
ian.boettcher@va.gov
Contractting Officer
