RFP 36C10X24R0051 0001.pdf

5. PROJECT NUMBER (if applicable)

CODE7. ADMINISTERED BY

2. AMENDMENT/MODIFICATION NUMBER

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6. ISSUED BY

8. NAME AND ADDRESS OF CONTRACTOR

4. REQUISITION/PURCHASE REQ. NUMBER3. EFFECTIVE DATE

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10A. MODIFICATION OF CONTRACT/ORDER NUMBER

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Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

E. IMPORTANT:

is extended,

(a) By completing Items 8 and 15, and returning __________ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY is not extended.

12. ACCOUNTING AND APPROPRIATION DATA

(REV. 11/2016)

is required to sign this document and return ___________ copies to the issuing office.is not, A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

15C. DATE SIGNED

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER

Contractor

16C. DATE SIGNED

14. DESCRIPTION OF AMENDMENT/MODIFICATION

16B. UNITED STATES OF AMERICA

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER 16A. NAME AND TITLE OF CONTRACTING OFFICER

15B. CONTRACTOR/OFFEROR

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Prescribed by GSA - FAR (48 CFR) 53.243

(Type or print) (Type or print)

(Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

(Number, street, county, State and ZIP Code)

(If other than Item 6)

(Specify type of modification and authority)

(such as changes in paying office, appropriation date, etc.)

(If required)

(SEE ITEM 11)

(SEE ITEM 13)

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13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

(Signature of person authorized to sign) (Signature of Contracting Officer)

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36C10X

Strategic Acquisition Center - Frederick Department of Veterans Affairs

5202 Presidents Court, Suite 103 Frederick MD 21703

36C10X

Strategic Acquisition Center - Frederick Department of Veterans Affairs

5202 Presidents Court, Suite 103 Frederick MD 21703

To all Offerors/Bidders

36C10X24R0051

08-16-2024

X

X

23 August 2024 at 12:00PM ET

The purpose of this amendment to RFP 36C10X24R0051 is to provide responses to questions received regarding RFP 36C10X24R0051.

See Continuation Page for complete details.

Jacky Jean-Jacques Contracting Officer

CONTINUATION PAGE:

Page

RFP

Section

Reference Question Answer

1.) Our existing Pharmacogenomics (PGx) panel does not include all of the genes requested currently in the RFP. Given the FDA’s recent decision on enforcement discretion for review of Laboratory Developed Tests (LDTs), which covers all PGx Lab Providers in the U.S., this adds complexity to adding additional assays or platforms to PGx panels that were not on market by FDA’s May 2024 deadline. Given the FDA approval process for new PGx panel approvals, it will take substantial time to add assays to cover them as all with a sufficient level of quality and completeness as some genes may require over 100 alleles to be assayed (i.e. RYR1).

This said, can we offer testing with our existing panel that covers most genes at the outset of the contract period and add other genes in phases during the 5-year term of the agreement to allow sufficient time for FDA 510(k) &/or NY CLEP submission and approval of the panel requested?

Please propose only those tests that will be available at the start of the contract period.

2.) Or, is the VA exempt from the FDA enforcement discretion of LDTs and if so will we be able to get a copy of the requirements of VA for PGx panel approvals, if any?

Vendors providing laboratory testing to VA are not exempt from the FDA enforcement discretion of LDTs.

1.3.3, 2.6.1.6., 2.1.3

3.) The contract requires fairly significant customizations in the PGx gene panel (1.3.3), results report, clinician portal (2.6.1.6.), as well as provider-created custom gene panels at no cost (2.1.3). Are you open to seeing multiple pricing options – for example, one pricing option that includes those custom development costs and one pricing option without custom development costs but with higher tests costs to recoup that custom development investment?

We expect all costs of testing (including any needed development for customization) to be included in the unit cost of each test.

4.) Customization in both panel design and user interface adds cost and complexity for both vendor and VA to design and implement.

Would it be sufficient for VA expert leaders to select a few options rather than open customization?

No, VA requires the level of customization specified in the PWS

N/A 5.) Will there be a pre-submission meeting or live question review? No.

N/A

RFP Is there an existing VA contract for Germline PGx Molecular testing or is this a new solicitation

There is not one contract that provides all of the requirements listed within the PWS for this solicitation, but the VA does currently have germline contracts with

Fulgent Therapeutics and Prevention Genetics for similar, smaller-scale work.

27-37

RFP If this is a recompete would you be able to provide the contract number, name of incumbent, contract value and dollar amount obligated.

This is not a recompete contract.

Past Performance

Is the VAlooking for a lab that has a track record of handling the projects for the same modalities that are listed on the RFP?

Yes.

1.3.2 Is the Sanger sequencing mandatory for all

the positive mutations? We perform germline screening (Full Gene Sequencing) for all the NGS tests.

Sanger is not mandatory for all positive variants detected on NGS, unless the laboratory determins that additional analysis is needed to resolve the variant interpretation.

2.3.3.1 We are CLIA certified and COLA accredited

lab. We don't have CAP and TJC. Would that fit into the eligibility criteria?

No, VA requires CAP or TJC accreditaion as specified in the PWS (2.3.3.1).

2.3.3.2 We don't have NY business license, but we

are willing to perform tests for the Veterans Health Administration as a federal entity, regardless of any state requirements. Would that be acceptable?

Yes, as stated in the PWS (2.3.3.2 and 1.2), this is acceptable.

1.2 We report pathogenic and likely pathogenic

variants. Is reporting VUS mandatory?

Yes, reporting VUS is needed in all medical and cancer genetics reports n/a

2.5.3 STAT Testing - What TAT are they expecting

for STAT testing? Will this be a single gene analysis? or they have a custom gene panel for STAT testing?

As stated in the PWS (2.5.3), expectations for

STAT testing are no more than 1 week turnaround time. Please indicate in the Attachment A which tests have STAT testing availability.

n/a

2.16 What access do they need for their field team? Virtual customer service access to support all 170 VISNs is appropriate.