Amendment 6 SW COVID-19 Testing.pdf

AMENDMENT #6

DATE: JULY 2, 2021

STATE OF MARYLAND

DEPARTMENT OF GENERAL SERVICES

OFFICE OF STATE PROCUREMENT

ITB NUMBER: 001IT821246 / BPM024037

STATEWIDE – COVID-19 TESTING PRODUCTS

This Amendment is issued to clarify, add to, delete from, correct and/or change the BID documents to the extent indicated and is hereby made a part of the said BID documents on which the contract will be based. This Amendment becomes part of the bid package. COMAR

21.05.02.08 requires all Amendments issued to be acknowledged.

Issued by:

State of Maryland Department of General Services Office of Procurement and Logistics 301 W. Preston Street, Room M-4 Baltimore, Maryland 21201

Charles W. Bailey Charles W. Bailey, CPPB, CMPO DGS Procurement Officer

Acknowledgment Signature Date

AMENDMENT #6

ITB NUMBER: 001IT821246 / BPM024037

STATEWIDE – COVID-19 TESTING PRODUCTS

1. Amend due date to July 16, 2021 at 2:00 PM Local Time.

2. Amend IFB Section C3b) to add as follows:

b) It is the State's intention to make up to 10 awards in each of two functional areas based on COVID-19 test type. Functional Area 1 will be for Polymerase Chain Reaction (PCR) or Molecular Amplification Diagnostic COVID-19 tests, that are EUA-issued, packaged, and sold for at-home use where the collected sample(s) are mailed to a lab or the test provides results at home (“at-home PCR test”). Functional Area 2 will be for Rapid Point-of-Care (Antigen Diagnostic) COVID-19 tests.

Functional Area 3 will be for COVID-19 serology tests that can be collected at home and sent to a lab for resulting. Bidders may bid on one, two or three functional areas. It is the State's intention to make up to 10 awards in each of three functional areas based on COVID-19 test type.

Functional Area 1 will be for antigen, POC, PCR, or molecular COVID-19 tests for which the FDA’s (Food and Drug Administration’s) Emergency Use Authorization is for tests packaged and sold for at-home use where the collectedsample(s) are mailed to a lab or the test provides results at home (“At-Home Tests”). Functional Area 2 will be for antigen, POC, PCR, molecular COVID-19 tests that are for which the FDA’s Emergency Use Authorization is for tests for clinically-observed use where the collected sample(s) are mailed to a lab or the test provides results on site (“Clinically-Observed Tests”). Functional Area 3 will be for FDA Emergency Use Authorized COVID-19 serology tests that can be collected at home and sent to a lab for resulting. Bidders may bid on one, two or three functional areas, but each Bidder must bid only a single test product for all five years per functional area. If a Bidder’s COVID-19 test product has FDA-required pass through language pursuant to its EUA, that language must be included in the Bidder’s bid. Such language may be included as an exhibit to the State contract, which would be subordinate to the State contract and provided it does not conflict with the State contract.

3. Amend IFB Section C6b)(1) and 4)as follows:

1) Is an At-Home or Clinically-Observed PCR, molecular, antigen, or rapid point-of-care (POC) COVID- 19 test (see definition in IFB Section C3b) meeting the description of the applicable test types found in Table 1 (below) for Functional Areas 1 and 2, respectively; or an FDA EUA-serology test that meets the criteria specified in this IFB Section C6b.

4) Produce results in 30 minutes or less for rapid PCR or POC antigen diagnostic tests and 48 hours or less for standard PCR or molecular tests;

4. Amendment IFB Section C7(6) and (7) as follows:

6) At-home rapid POC tests must be available for same- or next-day delivery to any part of the State of Maryland and include a pre-paid mailing envelope, if requested by the State.

7) All shipping charges must be incorporated in the Contractor’s per test price, except those for the prepaid next day or same day mailing envelopes referenced in IFB Section C7(6), costs for which will be passed through to the State for reimbursement with no additional markup.

END OF AMENDMENT #6

Attachments:

1. Q&A Round 2