Questions and Responses.pdf

Questions and Responses 36C25721Q0710 Page 1 of 5

1. Who will we be testing - patients of the VA Health System?

Response: The contractor will test veteran patients and VA employees.

2. Will the VA be able to provide a space for us to lease for the drive-through testing site, such as the VA Health System’s parking space? Can we set up a kiosk instead of a drive-through (smaller footprint) within the VA Health System’s parking space?

Response: No space will be provided at a VA facility for the contactor to perform the services. The contractor must provide the drive-through testing site within Bexar County.

3. Does the laboratory need to be within Bexar County, or can it be in an adjacent county?

Response: (SOW has been revised)

4. Can you provide further clarification on “must be a local laboratory for patient access”? Our main lab is located in ( ) and we will certainly be able to exceed the 24-48 HR TAT because of this. You would like a location were patients could go from 9-5 essentially, in addition to the drive through sites?

Response: (SOW has been revised)

5. The RFP states that testing will be conducted “at the Contractor’s facility in

Bexar County for patient access.” With Bexar County being the 4th largest county in Texas covering over 1200 miles, does the Government anticipate requiring multiple test sites with drive-through capability?

Response: Proximity to the VA medical center is optimal. Multiple sites would be helpful; however, only if specimen integrity and security is maintained.

6. Is the Government requiring a physical, permanent building or lab facility with drive-thru capability? Our solution is a mobile lab provider with CLIA certification with the ability to establish a fixed-site deployment with drive-through capability and onsite lab processing for certain tests. We provide all the equipment and personnel and can establish a single or multiple fixed sites anywhere in Bexar County based on the Governments requirements. Does this approach meet the Governments requirements?

Response: A permanent building is required for testing. In addition to CLIA accreditation, the laboratory must be accredited by the College of American Pathologists (CAP).

36C25721Q0710 Page 2 of 5

7. “Must be able to perform Inhouse RT-PCR for SARS-CoV-2 and FLU A&B testing and be an approved testing site by the CDC.” Can you please clarify the requirements for being a CDC-approved testing site?

Response: Review the requirements listed at the CDC website:

Frequently Asked Questions about Coronavirus (COVID-19) for Laboratories | CDC

8. “Must be able to perform in-house RT-PCR for SARS-CoV-2 and FLU A&B testing and be an approved testing site by the CDC.” We have CMS (CLIA) license as a clinical lab and have been on FDA website among the labs conducting COVID testing since March 31st. Together, do these account for " approved testing site by the CDC"?

Response: Refer to the answers listed at the CDC website (see #7 above).

9. “Must have EUA (Emergency Use Authorization) from FDA for RT-PCR SARS

CoV-2 testing.” Our COVID test is based on CDC protocol and reagents. FDA issued a laboratory Developed Test label when EUA was submitted. Does that satisfy the EUA parameter?

Response: Yes

10.“Certified by the Joint Commission, American Associates of Blood Banks (AABB).” Do we still need to be certified by AABB even though we will not be collecting or handling blood samples?

Response: Joint Commission certification and membership in the AABB is not required (SOW has been revised).

11. Is a membership in AABB an absolute requirement? Additionally, the requirement to have previously interfaced with the VA?

Response: Membership in the AABB is not required (SOW has been revised).

Previous interface with the VA is preferred.

12. Statement of Work, Page 8: “Provide documentation of successful interfacing with a minimum of 2 VA references (not within VISN 17) and 2 private sector, other federal agency, state, or local government agencies/ institutions.”

Is it required that the bidder’s past experience include interfacing with 2 VA systems or is it acceptable that the bidder document past interfaces with other Government entities or with commercial entities. Is the absence of past experience interfacing with a VA system a disqualifier? i.e. Only previous VA vendors are eligible to bid? If yes, we respectfully request the government consider broadening the requirement so vendors such as (us), who have extensive interface experience with commercial customers and large laboratories, can offer the government a more competitive landscape and https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Flab%2Ffaqs.html%23General-Guidance-and-Regulatory-Requirements&data=04%7C01%7C%7C553a243818194b89509508d913d0414a%7Ce95f1b23abaf45ee821db7ab251ab3bf%7C0%7C0%7C637562607427172024%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C1000&sdata=uosjNBwv108Phu9r0ayrWBlxUrNiPfnm9Q4TbqrvY8k%3D&reserved=0

36C25721Q0710 Page 3 of 5 superior product/service offering. We ask that you please advise on this point.

Response: Due to the complexity of obtaining interfacing privileges, it is preferred to have an established connection with the VA (SOW has been revised). Other government references will be accepted.

13. Is the VA interested in billing any testing to insurance?

Response: No, not at this time.

14. Can the testing site also provide testing for the general population (billed separately from VA-provided testing)?

15. Will the VA be providing staffing for the sample collection?

Response: No

16. Can the Government provide estimates for daily and weekly testing volume?

Response:

Test CPT Code(s) Est. Annual

Quantity Est. Monthly Quantity

Est. Weekly Quantity

SARS-CoV-2

(RT-PCR) W/

Collection

U00003, G20023

21406 1784 412

SARS-CoV-2

(RT-PCR) W/O

Collection

U00003 8152 679 157

SARS-CoV-2 +

FLU (RT-PCR)

W/ Collection

U00003, G2023 & 87502 x 2

2816 235 54

17. Based on the estimated volume, the assumption is 80-100 patients per day.

Is this a fair assumption or would you have a more accurate expected volume per day?

Response: A list of test appointments will be sent to the contractor daily.

18. The Statement of Work references the “ordering healthcare provider.” Can the Government clarify the workflow? That is, will the ordering healthcare provider essentially write a prescription or complete an order to give to the patient who then registers with the test vendor to select and schedule the prescribed test?

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Response:

1. VA provider follows proposed COVID test ordering algorithm and a Drive-Thru test order is generated.

2. MAS (Medical Administration Service) receives order and sets up an appointment for the veteran.

Non-count clinic has been created “ALM LAB COVID Test NC-X” Appointments are set up incrementally according to estimated 80 to 100 patients a day 8:30 AM – 4:30 PM (Monday – Friday), Saturdays occasionally.

3. By 4:30 PM the prior day, MAS will send completed appointment list by secure facsimile. List contains full name, full SSN, DOB and ZIP code. Contractor will use this list to validate with the veteran’s identification at the collection site.

19. Will the VA provide the prescribing authority?

Response: All patients will have an order from a VA provider.

20. Is supervised self-collection an acceptable form of patient collection?

Response: No

21. We can provide appointment scheduling. Is the expectation to have a majority of the patients have a set appointment or is the preference for a first come first serve model?

Response: Will be done by appointment only.

22. For the Price/Cost Schedule in attachment S02, item 002, in what situation would testing be provided without sample collection services?

Response: For Line Item 0002, the situation is where the VA has collected a sample at a VA facility and transported it the contractor’s collection site, for the sample to be tested by the contractor.

23. Will there be a guaranteed minimum testing volume, or minimum pricing, to ensure that the operational costs are covered?

Response: The solicitation was published in the form for the award of a single contract or purchase order. In the event the resultant award has to be terminated for the convenience of the government, the awardee would need to propose starting load costs, which were not fully absorbed, in their termination settlement proposal.

24. Are you open to vendor partnerships bidding on this opportunity? If so, is any type of partnership acceptable—e.g. prime/sub, JV, GSA-style Contractor Teaming Arrangement (CTA)? If the response is ‘yes’, would like to confirm

36C25721Q0710 Page 5 of 5 whether it is acceptable for either the prime or the sub to hold the quals (i.e.

the previous experience interfacing with a VA system)? And in a JV or Contractor Teaming Arrangement, is it acceptable that only one member of the team hold the quals?

Response: Solicitation 36C25721Q0710 is published as an unrestricted, full, and open competition. The laboratory performing the testing services must have the qualifications to perform the services. If selected as the apparent successful offeror, the prime vendor must submit a subcontracting plan to be negotiated with the Contracting Officer.

25. Are there any guidelines / restrictions around format and length of the technical response (i.e. point size, margins, max number of pages)?

Response: There are no restrictions on format of the technical response.

Due to VA email limitations, it is requested that email correspondence be no larger than 7 MB.

26. SF 1449, Page 36: “Past performance will be evaluated with the information provided in the offer and by review of past performance information found in government past performance systems.”

In the absence of data found in government past performance systems (due to past projects having been executed in the commercial space or as a sub in the Gov space), would reference letters and/or customer satisfaction surveys be acceptable as evidence of past performance?

27. What is the timeframe for the RFP to be rewarded once submitted? Is the expected start date for services 06/01/2021?

Response: Yes, the expected start date for the services is 6/1/2021.

28. Can ( ) receive an extension of one week to complete the RFP making the due date 05/20/2021?

Response: Due to the delay in providing the solicitation responses to questions, the solicitation is extended.