Q301--Germline Genetic Lab Testing Services_VHA_National Oncology Program Amendment 0001 - Post Answers to Vendor Questions

No.

Question/Statement

Solicitation Reference

Answer/Comments

1

Is RNA sequencing a requirement?

36C10X22Q0164

RNA sequencing is preferred but not required.

2

It's mentioned that the contractor should, "Analyze samples and report within a turn-around time of ~2 weeks." The majority of our test are completed within 18 calendar days on average (some may be longer, e.g.: WES and WGS turnaround times are 28 calendar days on average). Is that acceptable?

36C10X22Q0164

~ 2 weeks is the expectation for small panels and 18 calendar days would fall within that rough estimate. That said, VA's preference is as short of a turnaround time as possible for return of results. It is understandable that WES or WGS may be longer than 2 weeks. In the proposal, please specify if the laboratory can provide some test results more urgently than the 18 day turnaround and if so, would there be an additional cost associated with expedited sample processing.

3

It's mentioned that the contractor should, "Offer ordering provider created custom gene panels (ability to add/subtract genes from already curated panels) at no additional cost." Addition of genes to a panel and pricing will depend largely on the number of genes added and the difficulty involved with analyzing those genes. Often times, adding genes may not affect pricing, but there are cases in which it may. Is that acceptable?

36C10X22Q0164

Please provide examples of when adding genes to a curated panel will be feasible at no additional cost and when it will come with an added cost in the proposal. It is understandable that large additions to a custom gene panel could incur additional cost however addition or subtraction of a few genes from a panel should not incur a charge. VA will need to better understand the situations where these changes to a panel's number of genes trigger an additional charge.

4

Is it okay if a limited number of genes from the PWS Germline pricing schedule are not included?

36C10X22Q0164

It is preferred that all genes on the gene list are included. The proposal should include a comparison of vendor gene panel lists to the VA's list and highlight any differences. VA will use this information to evaluate the significance of the missing lists in our evaluation.

5

If not, is there a quality threshold on what percentage need to be included?

36C10X22Q0164

No.

6

Would a phlebotomy service be used rarely or frequently?

36C10X22Q0164

We estimate that about 15% of all test requests might benefit from a mobile phlebotomy service.

7

How often would the contractor be expected to deliver specimen kits to patient homes?

36C10X22Q0164

About 50% of orders would involve shipment of specimen kits to patient homes

8

Is it descualifying for a laboratory focused on Oncology genetic testing, not to offer the total of mandaroty tests? Specifically those that are not related to Oncology.

36C10X22Q0164

It is a mandatory requirement that test offerings span oncology and other disease areas listed in the Performance Work Statement. Oncology only test offerings would not fulfill this requirement.

9

Being this an Oncology focused program. Is it possible to remove the limitation to process samples no related to Oncology testing by an associated laboratory (not fully owned subsidiaries) and reported by the contractor ?

36C10X22Q0164

It is a mandatory requirement that test offerings span oncology and all other disease areas listed in the Performance Work Statement.

10

What percent of overlap is expected between the list genes for each example and our panels?

36C10X22Q0164

It is preferred that all genes on the gene list are included. The proposal should include a comparison of vendor gene panel lists to the VA's list and highlight any differences. VA will use this information to evaluate the significance of the missing lists in our evaluation. There is no specified overlap requirement outlined in the Performance Work Statement.

11

Is it expected that the contractor ships kits in bulk to the different VA centers or is expected that the contractor ships individual kits to patients homes on request?

36C10X22Q0164

Both are expected. The vendor will need to ship to VA facilities kits used for blood, saliva and/or buccal swab collection. The vendor will need to ship kits for saliva and/or buccal swab collection to patients' homes as well.

12

Since we are running DNA testing, the patient signature is needed, would the provider's attestation be covering the patient consent?

36C10X22Q0164

Patient signature will not typically be obtained on lab requitision form. Obtaining and documenting informed consent is a VA best practice. As such, ordering clinciians will be attesting to the patients' consent for testing.

13

When is the estimated starting date for this contract?

36C10X22Q0164

30-Sep-22

14

Is there an incumbent contractor for this solicitation?

36C10X22Q0164

No