Reference Laboratory Testing for Laboratory Medicine

Amendment 0001: RFP Question/Answer and Clarifications are added to solicitation (See Attachment 12)

The question period has been extended from November 19, 2021. Additional questions regarding the RFP must now be received by November 29, 2021, 3:00PM eastern

The Department of Health and Human Services, National Institutes of Health (NIH) is issuing a Request for Proposal (RFP) Single Award, Firm Fixed Price (FFP) Indefinite Delivery Indefinite Quantity (IDIQ) Contract pursuant to FAR Part 12- Acquisition of Commercial Items in conjunction FAR Part 15. The National Institutes of Health (NIH) Clinical Center (CC) is a 200-bed biomedical research hospital with several large on-site outpatient clinics.  The CC’s Department of Laboratory Medicine (DLM) processes approximately two million (2,000,000) standard, esoteric and specialized laboratory tests per year.  Off-site reference laboratory services are required to support ongoing clinical research and clinical trials through the performance of unique or unusual tests.  The incumbent off-site reference laboratory performs approximately 43,000 tests per year.

The contractor shall provide commercial laboratory services to collect, test, and report results of patient specimen. A full outline of the requirement can be found in the Performance Work Statement (PWS) and Specimen Test List -Attachment 3 located in this announcement. Because of the research focus, it is imperative that changes in reference ranges and methodologies be limited during the length of the contract because the laboratory results will be used in clinical trials. 

The North American Industry Classification System (NAICS) code for this acquisition is 621511 with a size standard of $32.5 million. This is NOT A SMALL BUSINESS SET ASIDE. The resulting contract will be for a twelve (12) month base year estimated to begin on or around (January 1, 2022) and four (4) twelve month option periods to include FAR 52.217-8, Option to Extend Services. All options will be evaluated. The complete RFP package with eleven (11) attachments is included in this announcement. 

By submitting a proposal, the vendor is self-certifying that neither the requestor nor the principal corporate officials and owners are currently suspended, debarred, or otherwise ineligible to receive contracts from any federal agency. Failure to do so may represent grounds for refusing to accept the offer. By submission of an offer, the contractor acknowledges the requirement that a prospective awardee must be registered in the System for Award Management (SAM) database prior to award, during performance, and through final payment of any contract resulting from this solicitation, except for awards to foreign vendors for work to be performed outside the United States. Lack of registration in the SAM database will make a contractor ineligible for award.

Contractors may obtain information on SAM registration and annual confirmation requirements by calling 866-606-8220, or via the Internet at https://www.sam.gov. Please direct all questions regarding this requirement via e-mail to the POC identified in this synopsis.

All questions regarding this solicitation must be received in writing at dehnerm@cc.nih.gov by November 29 2021, 3:00PM eastern. All resonses to RFP questions or clarifications will be posted in writing under this announcement.

The Department of Health and Human Services, National Institutes of Health (NIH) is issuing a Request for Proposal (RFP) Single Award, Firm Fixed Price (FFP) Indefinite Delivery Indefinite Quantity (IDIQ) Contract pursuant to FAR Part 12- Acquisition of Commercial Items in conjunction FAR Part 15. The National Institutes of Health (NIH) Clinical Center (CC) is a 200-bed biomedical research hospital with several large on-site outpatient clinics.  The CC’s Department of Laboratory Medicine (DLM) processes approximately two million (2,000,000) standard, esoteric and specialized laboratory tests per year.  Off-site reference laboratory services are required to support ongoing clinical research and clinical trials through the performance of unique or unusual tests.  The incumbent off-site reference laboratory performs approximately 43,000 tests per year.

The contractor shall provide commercial laboratory services to collect, test, and report results of patient specimen. A full outline of the requirement can be found in the Performance Work Statement (PWS) and Specimen Test List -Attachment 3 located in this announcement. Because of the research focus, it is imperative that changes in reference ranges and methodologies be limited during the length of the contract because the laboratory results will be used in clinical trials. 

The North American Industry Classification System (NAICS) code for this acquisition is 621511 with a size standard of $32.5 million. This is NOT A SMALL BUSINESS SET ASIDE. The resulting contract will be for a twelve (12) month base year estimated to begin on or around (January 1, 2022) and four (4) twelve month option periods to include FAR 52.217-8, Option to Extend Services. All options will be evaluated. The complete RFP package with eleven (11) attachments is included in this announcement. 

By submitting a proposal, the vendor is self-certifying that neither the requestor nor the principal corporate officials and owners are currently suspended, debarred, or otherwise ineligible to receive contracts from any federal agency. Failure to do so may represent grounds for refusing to accept the offer. By submission of an offer, the contractor acknowledges the requirement that a prospective awardee must be registered in the System for Award Management (SAM) database prior to award, during performance, and through final payment of any contract resulting from this solicitation, except for awards to foreign vendors for work to be performed outside the United States. Lack of registration in the SAM database will make a contractor ineligible for award.

Contractors may obtain information on SAM registration and annual confirmation requirements by calling 866-606-8220, or via the Internet at https://www.sam.gov. Please direct all questions regarding this requirement via e-mail to the POC identified in this synopsis.

All questions regarding this solicitation must be received in writing at dehnerm@cc.nih.gov by November 19, 2021, 10:00AM eastern. All resonses to RFP questions or clarifications will be posted in writing under this announcement.