ATTACHMENT 1-Questions and Answers for Combined Synopsis-Solicitation W91YTZ21R0061x.pdf

ATTACHMENT 1

Questions and Answers for Combined Synopsis/Solicitation W91YTZ21R0061

1. Can you tell me if these services are currently being performed by a contractor? If so, could you please provide the incumbent name as well as the contract number?

GHCB Answer: The services are currently being performed by a contractor. Contractor and Contract Number information must be requested through Freedom of Information Act (FOIA). www.foia.gov.

2. Regarding the Whole Blood Panel Testing/Confirm. Item 0001

a. The antibody screen identifies positives. Positives antibody screens would then be automatically reflexed by the reference lab and the antibodies identified for the additional charge.

b. Please advise if I can provide you a separate price for the Antibody Identification listed under the

Whole Blood Panel Testing/Confirm.

c. If so, please estimate how many Antibody Identification Test you will require.

d. Additionally, CMV is listed as part of the WB testing panel and again is requested in item

0002. Usually CMV it’s not part of the WB default panel; we can price it individually. Please advise.

Answer: We do not require Antibody Identification only Antibody screening. We only require POS or NEG Antibody screens. CMV is only needed under 0002. We require approximately 450-500 CMV screens per year.

3. Regarding (IRL) Blood Donor Reference Lab Testing. Item 0003

a. The quantity for this item is 50,000, without any indication of which tests need to be performed. Can you provide more specifics?

b. We currently test under the Blood Donor Reference Lab (IRL) the following tests:

i. Low Titer Whole Blood /Plasma Testing (ISO AGGLUTIN TITER aka Anti-A, B Titer

ii. HLA Class I and HLA Class II Antibody Panel

iii. Antibody Identification

c. Please let me know if we are allowed to place these tests under the IRL -Item 0003 and how many tests you would be required.

Answer: We require ISO Agglutin titers, HLA I and II only. We do not require AB identification. These test can be placed under 0003. We perform approximately 3,700 ISO Titers and HLA test per year.

4. Regarding Zika Testing. Item 0007

a. This is only for your information. The FDA has discontinued Zika testing since 14-MAY-2021.

b. Some customers would like to keep this test as part of the panel in case things change in the future.

c. I will be sending you a quote

Answer: ZIKA can be removed. The FDA guidance was issued after the PWS and PR had been created.

We could not remove that language. You can provide a quote but we will not utilize ZIKA testing so I would exclude that from any pricing or add that pricing separately.

The Zika CLIN has been removed, price accordingly.

5. Would you please send me the missing page? Or please help me locate it?

a) Price Schedule-(Base and four options years). Offerors must round the unit and total price to the penny.

b) Complete and sign SF 1449, page 1, Block 17a& b, 30a, b & c.

c) Signed amendments (if any).

d) Representations and Certifications found at FAR 52.212-3 Alt, 52.204-24, and 52.209- 7 MUST be completed GHCB Answer: b) Please disregard those instructions to complete and sign SF 1449 page 1, Block 17a&b, 30a, b &c. Instead, please be sure to complete page 2 and sign. Language updated in red to reflect changes.