FDA-RFQ-1238058 COVID Testing QA.pdf

FDA-RFQ-1238058

Q&A

QUESTIONS AND ANSWERS

The following are the questions submitted prior to receipt of quotes/proposals and their corresponding answers.

Question 1: Could you please tell me if this is a new requirement, or if there is a current or previous contractor who has performed similar services? If available, can you please send along the incumbent contract or task order number?

Response: This is a new requirement.

Question 2: I was curious if this was a follow-on requirement. If so, would it be possible for you to provide the incumbent information (we need the contract number and contractor).

Response: This is not a follow-on requirement.

Question 3: Does the FDA have an anticipated maximum daily volume of tests? Or an average daily volume?

Response: FDA has no way of determining this as people request on their own schedules.

Question 4: If employee/contractor opts into testing, will there be a standard testing cadence?

(weekly testing, bi-weekly testing, etc.? Or will all tests be ordered individually? on-demand?

Response: FDA employees/contractors may request a test bi-weekly or less frequently. This is managed by an internal approval process. After approval the test is ordered by an OHS physician.

Question 5: What proportion of kits are required to be sent to P.O. boxes as opposed to individuals’ addresses?

Response: Personnel must provide an actual address on the test request. No PO boxes will be allowed. (The SOW does reference “PO Box” but this reference is incorrect and will be removed from the SOW upon award).

Question 6: Is it required for the contractor to send kits via P.O. Box? Can the contractor send directly to the individual addresses?

Response: Personnel must provide an actual address on the test request. No PO boxes will be allowed. (The SOW does reference “PO Box” but this reference is incorrect and will be removed from the SOW upon award).

Question 7: For kits that are not returned within 7 days, will this be for kits that are in the process of specimen collection or will this be for kits held by the individual? (there is a requirement to flag kits that are not returned within 7 days. Is this within 7 days of the order being made, 7 days of the kit arriving at the individual’s address, or 7 days of the individual activating the kit online? Also, will we be notifying the individual or the FDA of the 7-day mark?)

Response: 7 days from the k it arriving to the individual’s address; The FDA would be the one notified, not the individual.

Question 8: What time and date are the monthly reports needed?

Response: Negotiable

Question 9: What time of the day is the daily report needed?

Response: Negotiable

Question 10: How would the FDA want the daily and monthly reports delivered to them (secure file transfer, email, etc.)?

Response: The reports would just be an aggregate summary of numbers and can be sent via email or through a provider portal.

Question 11: If we are not subcontracting, how detailed do we need to be for attachment 2 (Small Business Subcontracting Plan)?

Response: Attachment 2 is very clear in stating the Agency’s goals for small business subcontracting and at the bottom of page 1 states: “For this procurement, or modification, HHS expects all proposed subcontracting plans to contain at a minimum the aforementioned percentages.” Offerors/quoters who are not planning to meet those goals must submit a detailed justification outlining their efforts to seek out and source each subcategory of small business to support this effort.

Question 12: For the ordering process where FDA’s OHS will submit physician orders for test kits, is there a particular workflow the FDA has in mind or will that be at the discretion of the contractor?

Response: FDA would like a web portal where the OHS physician can upload the orders either in a bulk manner or individually. This portal should be available at the time of award, allowing FDA to connect in a timely manner following award.

Question 13: Does the FDA OHS require kit delivery within 48 hours for kits ordered on the weekend?

Response: Yes, all requested kits should be delivered within 48 hours of being ordered.

Question 14: What information is provided on the physician order from the FDA’s OHS? Will there be adequate information so the contractor can reach out to the individual for registration and coordination of kit delivery?

Response: Yes, there will be adequate information provided so that the contractor can register and send k its to FDA’s staff members. At a minimum, FDA would provide the mailing address and email address for each staff member requesting a test.

Question 15: The RFQ calls for unsupervised COVID at home tests. Would there be an interest or amendment for an added fee, in a COVID coach concierge solution as part of the testing process for employees? The COVID coach experience assists with guiding the employee through the entire testing process. This support includes, inventory and data management, COVID coach virtual to assist with completion of test kits and mailing instructions, portal for system tracking and employee notifications.

Response: No, FDA is seek ing at home, unsupervised tests.

Question 16: Based on the SOW, both saliva and nasal specimens appear to be acceptable methods of specimen collection, however, does the FDA have a preference of the two options?

Response: Saliva is preferred, but both are acceptable.

Question 17: Also, Pooling is mentioned -- is that an acceptable? or preferred? process?

Response: Pooling is an acceptable approach.

Question 18: Please kindly provide the exact specifications of the home collection kits required for the fulfillment of this requisition.

Response: All details are contained in the documents which have already been posted to the web.

Question 19: Please list the U.S. Territories where FDA Employees and Contractors will need Tests.

Response: FDA has staff throughout the United States including Puerto Rico that could request an at-home test kit.

Question 20: Is there a specific Format that needs to be used for the submission?

Response: Please see response to question 22.

Question 21: Other than Attachments 2 and 3 are there specific forms that need to be completed?

Response: See response to question 11 regarding Attachment 2. As well, besides including a price per test in paragraph 6, there are also some check-mark fill-ins in the solicitation provisions that must be completed and returned (example: FAR 52.204-24 / FAR 52.204-26).

Question 22: Can vendors submit their own proposal and complete the applicable sections of the FAR Representations and Certifications-Commercial Items in the RFQ? In other words: as long as we complete the representations and certifications as part of the FAR, can we submit our proposal in our own format?

Response: There is no requirement for a particular format. If you will look at the RFQ itself, paragraph 6 includes a space to input price per test; however, if you have a particular proposal/quote format your company uses that is fine. You can simply also input the price per test into the RFQ’s paragraph 6, as well.

Question 23: Does the pricing need to be submitted in a specific format or on a specific form?

Response: See response to question 22.

Question 24: Is there a specific requirement or format of the electronic, interactive portal?

Response: Portal must be secure, and results should be accessible by FDA’s provider(s) as well as to each individual staff member. This portal should be available at the time of award, allowing FDA to connect in a timely manner following award.

Question 25: Is the requirement limited to at home testing or will the government also require group testing onsite at government facilities?

Response: FDA is seeking at home, unsupervised tests.

Question 26: Will the government provide medical authorization, or is it expected that the contractor through its physician will need to provide medication authorization?

Response: As stated in the SOW, the contractor shall Provide an ordering process whereby FDA’s Occupational Health Services (OHS) will submit the physician and/or other authorized practitioner’s order for the test kit to the contractor electronically either in a bulk manner or individually.

Question 27: Will the government accept any other type of test other than listed in the requirement

(NAAT)?

Response: No.

Question 28: Does the government require a) telehealth-based monitoring of patient conducting self-collection at home, b) a contractor’s representative either collecting or observing in-person at the patient’s home, or c) self-collection will take place without any monitoring of collection by anyone?

Response: FDA is seek ing at home, unsupervised tests.

Question 29: Can the government confirm it requires delivery of at home collection kit to FDA employees/contractor within 48 hours of government request?

Response: Confirmed.

Question 30: What is the anticipated (based on current CDC guidelines and FDA needs) volume of tests for FDA employees and contractors per month?

Response: Approximately 3000 per month, but subject to change.

Question 31: Is it acceptable that the request/ordering of the test occur on contractor website or order tool?

Response: As stated in the SOW, the contractor shall Provide an ordering process whereby FDA’s Occupational Health Services (OHS) will submit the physician and/or other authorized practitioner’s order for the test kit to the contractor electronically either in a bulk manner or individually.

Question 32: What is the acceptable delivery of test results to the government? For example, a) electronic file transfer daily in Excel, b) an electronic interface between contractor’s reporting system and government system? If an electronic interface is required, can the government provide detail sufficient to estimate implementation of this interface, c) via accessing/logging into contractor’s electronic portal where authorized government representative(s) may view and extract reports?

Response: Both A and C are sufficient. Data will be aggregated with no PII information and therefore may be sent via email as well.

(End of Q&A)