Amendment_2 _RFP_NIAID-DAIDS-NIHAI2015048.pdf

AMENDMENT #2 RFP NIAID-DAIDS-NIHAI2015048 1

Amendment No. 2

NIAID-DAIDS-NIHAI2015048

“Mycobacterium Tuberculosis (Mtb) Quality Assessment Program (TBQA)”

Solicitation Number: NIAID-DAIDS-NIHAI2015048

Amendment Number: Two (2)

Amendment Issue Date: February 24, 2016

Proposal Due Date/Time: Monday, March 7, 2016 at 3:00 PM, Local Time (Unchanged)

Issued By: John R. Manouelian

Contracting Officer

OA/DEA/NIAID/NIH/DHHS

5601 Fishers Lane, Room 3D10, MSC 9821 Bethesda, Maryland 20892-9821

Points of Contact: PRIMARY patrick.finn@nih.gov Patrick Finn, Contract Specialist Phone: 240.669.5401

SECONDARY

manouelj@mail.nih.gov John R. Manouelian, Contracting Officer Phone: 240.669.5152

Please note that we do NOT intend to extend the due date for submission of proposals as a result of this amendment. The date specified for receipt of proposals remains unchanged.

Offerors must acknowledge receipt of this Amendment by identifying the amendment number and the date of the amendment on each copy of the submitted proposal. Failure to receive your acknowledgement may result in the rejection of your proposal. Except as provided herein, all terms and conditions of the solicitation remain unchanged and in full force and effect.

The purpose of this Amendment is to: (1) provide responses to questions from potential offerors, regarding the solicitation; (2) update the threshold amount for Data Other than Certified Cost or Pricing Data, at Section L – Instructions, Conditions, and Notices to Offerors, paragraph 2., subparagraph c., item 3.b.c., Data Other than Certified Cost or Pricing Data, Subcontracted Items; and (3) update the threshold amount for a Small

AMENDMENT #2 RFP NIAID-DAIDS-NIHAI2015048 2

Business Subcontracting Plan, at Section L – Instructions, Conditions, and Notices to Offerors, paragraph 2., subparagraph c., item 6. Small Business Subcontracting Plan.

The solicitation is amended to provide the following responses from potential offerors:

Question 1

Attachment 5, Section 3.1.a) provides assumptions for the offeror’s use in developing a cost proposal. Can the government provide advice as to the average number of samples per PT panel, and the number of Mtb strains that are included per panel?

Response to Question 1

Generally, commercial proficiency testing panels include 5-10 samples. The purpose of TBQA is to provide proficiency testing panels that are not currently available commercially. The offeror is expected to propose and budget for proficiency testing panels for Mtb tests of high scientific relevance. The design of a panel should include appropriate test materials (e.g. sputum from various Mtb strains) and number of PT samples that allow for clear assessment of the ability of laboratories in various geographical areas to perform monitored tests correctly.

Question 2

Attachment 5, Section 3.1.a) Are all PT panels for any one PT shipped concurrently?

Response to Question 2

Commercial proficiency testing panels are generally shipped 2-3 times per year or are shipped all at once with the expectation that the laboratory will store all received panels and test each panel at different times throughout the year. The offeror is expected to propose and budget for an approach that takes into consideration PT sample integrity and stability, as well as cost efficiencies.

Question 3

Attachment 5, Section 3.1.d) Does the government have specific sources for the 100 drug-resistant and 50 drug-sensitive isolates that would constitute the Mtb QCM repository? Will there be a requirement for samples from suspected versus confirmed cases?

Response to Question 3

The government does not have specific sources for the drug-resistant and drug-sensitive isolates.

There is no requirement to obtain samples from suspected versus confirmed cases. It is expected that isolates provided to the TBQA from any source will be accompanied by data regarding drug resistance, and it is expected that the TBQA will confirm such data.

AMENDMENT #2 RFP NIAID-DAIDS-NIHAI2015048 3

Question 4

Statement of Work paragraph 1), Background and Introduction, states, “As needed, the TBQA Contractor will collaborate and coordinate with pSMILE activities related to the oversight of laboratories’ test performance”, but pSMILE has additional responsibilities that overlap with the Technical Requirement at Statement of Work paragraph 3)A.2 (i.e., trouble shooting and training to improve assay performance).

a. Assuming pSMILE will continue to provide this service, how does the Government anticipate the interaction between pSMILE and the TBQA contract?

b. Should the offeror assume that the TBQA contractor will also collaborate and coordinate with pSMILE on these activities?

c. Will the Government or the TBQA contractor take the lead?

d. Who is ultimately responsible for these activities?

Response to Question 4

As indicated in the Background and Introduction of the solicitation, the focus of the pSMILE contract is, and will continue to be, on standard TB testing, such as Acid Fast Bacillus and qualitative MTB cultures and resistance testing. The focus of the TBQA program is intended to be on relatively novel tests, non-standard tests for which commercial proficiency testing schemes are not available. Examples include nucleic acid-based drug susceptibility testing (DST), next-generation bacterial DNA and RNA sequencing, serial sputum colony count (SSCC) on solid media, time to positivity (TTP) in liquid culture, minimal inhibitory concentration (MIC) assessment, and host-based assays (Mtb-specific, antigen-dependent mRNA expression levels). It is possible that the TBQA will provide test proficiency oversight, including troubleshooting and training, for some of these novel tests. Because pSMILE is actively engaged with the DAIDS-supported MTB laboratories, communications between the TBQA and pSMILE will facilitate the work of the TBQA. Coordination between the activities of the two contracts (e.g. visits to site) will ensure that no duplication occurs. The Government will indicate when communication and coordination is needed and will facilitate it once the TBQA contract is awarded.

Question 5

The threshold at FAR 15.403-4(a) is currently $750,000 for certified cost or pricing data. Please confirm the $650,000 requirement on page 69 of the RFP (Section L.2.c.3.b.c, Subcontracted Items).

Response to Question 5

Section L – Instructions, Conditions, and Notices to Offerors, paragraph 2., subparagraph c., item 3.b.c. Subcontracted Items (on page 69 of the RFP), is being revised to reflect that the certified

AMENDMENT #2 RFP NIAID-DAIDS-NIHAI2015048 4

cost or pricing data threshold, at FAR 15.403-4(a), has been increased by $100,000, from $650,000 to $750,000.

Question 6

The threshold at FAR 19.702(a)(1) is currently $700,000 for a small business subcontract plan.

Please confirm the $650,000 requirement on page 72 of the RFP (Section L.2.c.6, Small Business Subcontracting Plan).

Response to Question 6

Section L – Instructions, Conditions, and Notices to Offerors, paragraph 2., subparagraph c., item

6. Small Business Subcontracting Plan (on page 72 of the RFP), is being revised to reflect that the Small Business Subcontracting Plan threshold at FAR 19.702(a)(1), has increased by $50,000, from $650,000 to $700,000.

As a result of the above, the RFP has been revised as follows:

SECTION L – INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS, paragraph 2., subparagraph c., item 3.b.c., Subcontracted Items (on page 69 of the RFP), is hereby revised to reflect that the certified cost or pricing data threshold at FAR 15.403-4(a), has been increased by $100,000, from $650,000 to $750,000, and shall read as follows:

c. Subcontracted Items

Include parts, components, assemblies, and services that are to be produced or performed by others in accordance with offeror's design, specifications, or direction and that are applicable only to the prime contract. For each subcontract over $750,000, the support should provide a listing by source, item, quantity, price, type of subcontract, degree of competition, and basis for establishing source and reasonableness of price, as well as the results of review and evaluation of subcontract proposals when required by FAR 15.404-3.

SECTION L – INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS, paragraph 2., subparagraph c., item 6., Small Business Subcontracting Plan (on page 72 of the RFP), is hereby revised to reflect that the Small Business Subcontracting Plan threshold at FAR 19.702, has been increased by $50,000, from $650,000 to $700,000.

As a result of the foregoing, the first paragraph under this item (on page 72 of the RFP) has been revised to read as follows:

AMENDMENT #2 RFP NIAID-DAIDS-NIHAI2015048 5

6. Small Business Subcontracting Plan

If the proposed contract exceeds a total estimated cost of $700,000 for the entire period of performance, the offeror shall be required to submit an acceptable subcontracting plan in accordance with the terms of the clause entitled "Small Business Subcontracting Plan," FAR Clause No. 52.219-9, incorporated herein by reference in the Solicitation, See SECTION J - LIST OF ATTACHMENTS, BUSINESS PROPOSAL ATTACHMENTS of this RFP for an example of such a plan.

As a result of the foregoing, sub-item d.9. (on page 73 of the RFP), is revised to read as follows:

9. Assurances that the offeror will include in all subcontracts the contract clause "Utilization of Small Business Concerns." Assure that all subcontractors, other than small businesses, in excess of $700,000 adopt a plan similar to the plan agreed upon by the offeror.

END OF AMENDMENT NO. 2, RFP No. NIAID-DAIDS-NIHAI2015048