Amendment 7 SW COVID-19 Testing.pdf

AMENDMENT #7

DATE: JULY 16, 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 #7

ITB NUMBER: 001IT821246 / BPM024037

STATEWIDE – COVID-19 TESTING PRODUCTS

1. Amend due date to July 23, 2021 at 2:00 p.m. Local Time.

2. Amend Term of Contract (for clarification) as follows: Notice to Proceed (NTP) through June 30, 2025

3. Amend IFB Section C3b) to add as follows: [was not fully legible in Amendment #6]

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 collected sample(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 Attachment N – Contract Affidavit with updated version:

Click link to download a fillable copy of the Contract Affidavit: https://procurement.maryland.gov/wp-content/uploads/sites/12/2020/03/Attachment-N-Affidavit.pdf

[current versions of all attachments can be located at https://procurement.maryland.gov/rfp/]

4. Amend title of Functional Area 1 on eMMA Pricing tab as follows: At Home PCR, Molecular, POC, or Antigen Tests

5. Amend title of Functional Area 2 on eMMA Pricing tab as follows: Clinically Observed PCR, Molecular, POC, or Antigen Tests

END OF AMENDMENT #7

https://procurement.maryland.gov/wp-content/uploads/sites/12/2020/03/Attachment-N-Affidavit.pdf https://procurement.maryland.gov/wp-content/uploads/sites/12/2020/03/Attachment-N-Affidavit.pdf https://procurement.maryland.gov/rfp/