Amendment 1 W911QY24R0020_07.30.2024.pdf

Amendment 1

Questions Regarding Solicitation W911QY-24-R0020

• Combined Synopsis Solicitation Submission Requirements 5. 2nd paragraph sates “Proposals may be submitted in Word or PDF format only.” Section 3. Requires the price proposal to be submitted as an excel sheet/file. Can the government clarify that Offerors should submit the narrative in PDF or WORD and that the price proposal can be a separate document submitted in Excel format? Yes narrative in word or PDF. Yes price/cost proposal is acceptable in a separate document in Excel format.

• Combined Synopsis Solicitation Provision 52.212-3 Offeror Representations and Certifications states “…specific requirements for providing Offeror Representations and Certifications with its offer are included in SUBMISSION REQUIREMENTS paragraph 4 above.” Paragraph 4 requires evidence of capabilities and does not reference 52.212-3.

o Can the government clarify requirements for submitting 52.212-3?

▪ For instance, can this be included with the Narrative proposal but not included in the page count? Yes

• Combined Synopsis Solicitation 1. Technical Requirements, the govt statement that: a) The Offeror must be able to prove that they have the ability to provide the required analysis stated in the SOW. What will the govt accept as proof of ability to perform the work? Without a specific defined requirement this technical requirement is meaningless.

Response: This can include one or more of the following: 1) laboratory certifications (e.g., ISO 17025, CLIA, CAP) and accreditations that demonstrate adherence to industry standards; 2) staff qualifications including education and/or certifications for conducting assays; 3) detailed description of in-house standard operating procedures (SOPs) including quality control measures, assay validation, and analysis methods; 4) information about laboratory facilities and the availability of in-house specialized equipment; 5) prior experience performing assays including case studies, publications, and/or testimonials from prior clients.

• Combined Synopsis Solicitation 1. Technical Requirements, the govt statement that: a) The Offeror must be able to prove that they have the ability to provide the required analysis stated in the SOW. In the clinical world proof of ability is determined objectively by satisfying requirements of the FDA. Will the government accept as technically meaningful proof of ability certification by FDA under CLIA for performing these assays in saliva routinely?

Response: See above response (1) regarding laboratory certifications.

• Volume of saliva is a critical determinant of how the assay must be performed. What is the average and minimum volume of saliva samples in mls?

Response: As noted in the initial solicitation, saliva samples are collected using the Salimetrics SalivaBio Oral Swab (SOS) method. According to documentation, the volume of sample recovered from the swab typically varies between 200-1000 microliters. Full details can be found in the Salimetrics documentation of this sampling method: https://salimetrics.com/collection-method/oral-swab-saliva-collection-device/

• The collection devices vary with respect to the complexity and time required to prepare a sample prior to analysis by ELISA. What is the name and model of the collection device used?

Response: As noted in the initial solicitation, saliva samples are collected using the Salimetrics SalivaBio Oral Swab (SOS) method. Full details can be found in the Salimetrics documentation of this sampling method:

https://salimetrics.com/collection-method/oral-swab-saliva-collection-device/

• A01 SOW 2. b, page 1 : ‘ (2) Conduct cortisol and alpha amylase assays on up to 400 unique saliva samples. (3) Conduct cortisol assays for up to 500 unique saliva samples.’ Are we supposed to bid 400 samples tested for alpha a and cortisol AND 500 samples for cortisol or something else. How many samples with be alpha + cort and how many samples just cort?

Response: Offeror can expect up to a total of 900 samples. As noted in the quoted language, of those 900 samples: there will be up to 400 samples that are “alpha + cort,” and up to 500 samples that are “just cort.”

• A01 SOW 2 b. 2 & 3 – Can the government clarify if the sample quantities are per period of performance?

o For instance, can the Offeror expect to analyze the stated quantities for each period of performance?

o If not, what are the expected quantities for the base year and what are the expected quantities for the option year?

Response: Offeror will receive and process up to 900 samples during the base period. For the option year, the offeror will receive and process up to 500 samples for cortisol only analysis.

https://salimetrics.com/collection-method/oral-swab-saliva-collection-device/ https://salimetrics.com/collection-method/oral-swab-saliva-collection-device/ https://salimetrics.com/collection-method/oral-swab-saliva-collection-device/ https://salimetrics.com/collection-method/oral-swab-saliva-collection-device/

• AO1 SOW 7. Government Furnished Equipment/Information/Computer Utilization states “The Government shall have prepared saliva test samples for analysis delivered to the contractor.”

o Will all samples be delivered to the contractor in one shipment?

Response: No, this is unlikely.

o If not, can the government clarify the expected frequency of the deliveries and quantity of samples per shipment to the contractor for the base year period of performance and the option year?

▪ For instance:

• X amount per week or month or quarter, etc. in the base year.

• X amount per week or month or quarter, etc. in the option year.

Response: It is likely that the contractor will receive samples in 2-4 shipments over the course of the base period (on an approximately quarterly basis), and 2-4 shipments over the option period.