H265--VHA VISN 10 INR Patient Self Testing

The purpose of this solicitation amendment is to provide answers to questions from industry.

Questions are listed below, and the corresponding responses are below each question in red.

We would like to know if this a brand new contract OR if there is (was) an incumbent performing these services.

There was a pilot program for a limited number of facilities that was previously awarded (36C25022P1056). However, this is considered a new contract due to the increased participation, and several changes to the Statement of Work.

Please clarify what documentation is needed for certification of device.

VA Directive requires Proof of quality checks and the device must be FDA-approved for CLIA-waived testing.Â

Are rechargeable batteries required for the devices, or will VA accept regular batteries if recommended by manufacturer?

Rechargeable batteries are highly preferred.

Please clarify what is meant by supplies required for quality control. Would this be the code chips that come in every box of strips?

This depends on what the quality control process entails. The quality control process should be the internal process used to ensure that the meter and strips work appropriately. Vendor must describe their quality process and if other supplies are needed to perform this process (i.e., code chips, liquid controls, etc.), these must be provided to the Veteran.

VAMC required quality control testing, if regularly scheduled maintenance intervals are deemed too infrequent please clarify what VAMC would need in this situation.

If the VA requires that additional quality controls be performed, the vendor will provide the supplies to perform the testing. Additional quality controls would be performed for troubleshooting purposes. Frequency of testing depends on the meter specifications.

RE: Results communication: Can you please clarify which method is preferred? Test results should be sent via encrypted email, fax, and/or phone; All test results outside of specified parameters will be communicated to the facility via a phone call to the facility POC in addition to the email and fax.

Please refer to the solicitation, page 7 (paragraph Results Communication) - INR results shall be transmitted from the device to the vendor via Bluetooth or some type of automatic downloading capabilities. This is the preferred method, however, patient may self-report via an online portal system or phone call to the vendor is acceptable if downloading/Bluetooth is not available.

The phone call is in addition to the routine communication method if the results are outside the specified parameters.

Please clarify what SaaS approval is.

Software as a Service A VA information security requirement.

VA Office of Information Technology, Privacy, and Security will review the system to determine the risk and provide approval or additional steps needed to be compliant.

RE: Billing If the veteran does not test within the calendar month, how should we invoice for that veteran?

The VA should be billed per month for each active Veteran enrolled in the program. The monthly price should be all-inclusive of supplies and testing.

RE: Billing Does the VA expect an invoice for the meter and supplies?

The monthly price should be all-inclusive of supplies and testing.

What are your expectations for quality control outside of manufacturer guidelines?

Please refer to the Quality Control section of the solicitation. The quality controls must meet FDA and CLIA-approved requirements.

RFP states The vendor shall have a system in place to provide summary reports or information in an organized fashion of any quality control completed should it be needed for audits, governing body reviews, VA lab requirements, etc. Please clarify what is needed to meet this requirement.

Please refer to the Quality Control section of the solicitation. The quality controls must meet FDA and CLIA-approved requirements.

Please define what the Government s Quality Control Program is and the requirements of the quality assurance plan.

Vendor must be able to provide documentation in an organized fashion of the quality controls conducted.

What formula is required for unity price and estimated amount on CLINs 0001, 1001, 2001, 3001, and 4001 if unit is 1 yr?

CLINs 0001, 1001, 2001, 3001, and 4001 will be the total of all of the SLINs for the year, and you are not required to enter those amounts. Our system will automatically total the SLINs and place the total in the designated CLIN. It is possible the highlights didn t come through Contract Opportunities, but we did not highlight the CLINs in our original because we do not require an entry. Additionally, the entries in the SLINs Unit Price should be price per patient per month.

Decision factors The Evaluation Commercial Products & Commercial Services section on page 63 references a price schedule .xls attachment. The preparation instructions do not reference a spreadsheet attachment or that vendor must create the price proposal in xls format. There isn t anything in SAM either. Can VA provide the Price Schedule.xls attachment or clarify that it is just the Price/Cost Schedule in section B3 that needs to be completed?

Reference to the xls document was in error. Please complete the Price/Cost Schedule in section B3 and include with your submission.