Amendment 9 SW COVID-19 Testing.pdf

AMENDMENT #9

DATE: JULY 30, 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 #9

ITB NUMBER: 001IT821246 / BPM024037

STATEWIDE – COVID-19 TESTING PRODUCTS

1. Amend IFB Section Ab1 as follows:

1) A Contract shall be awarded to the responsible Bidder(s) in each Functional Area submitting a responsive Bid with the most favorable bid price or most favorable evaluated bid price (as referenced in COMAR 21.05.02.13) for providing the goods and services as specified in this IFB. Bidders must bid all line items for each Functional Area. Bidders may bid on one, two or twothree both Functional Areas. Partial or incomplete bids will be rejected unless otherwise stated in the solicitation. See IFB Section 6 for Bid evaluation and award information.

2. Amend IFB Section C1 as follows:

1) The Department intends to make up to 10 awards in botheachboth of the twothreetwo functional areas for the work under this IFB. See IFB Section B, Item B – Basis of Award for more Contract award information.

3. Amend IFB Section C1 to remove references to Functional Area 3 as follows:

b) The Department intends to make up to 10 awards in both of the twothreetwo functional areas for the work under this IFB. See IFB Section AB, Item B – Basis of Award for more Contract award information.

4. Amend IFB Section C3b) to remove references to serology tests and Functional Area 3 as follows:

b) It is the State's intention to make up to 10 awards in each of twothree 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, or two or three functional areas, but each Bidder must bid only a single test product for all fourfive 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.

5. Amend IFB Section C6b)(1) 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; or an FDA EUA-serology test that meets the criteria specified in this IFB Section C6b.

6. Amend IFB Section C6b)3) to remove the reference to serology tests as follows:

3) All PCR tests used under the Contract must meet the following standards: Sensitivity ≥ 90% and Specificity ≥ 95%. All POC rapid antigen tests used under the Contract must meet the following standards: Sensitivity ≥ 84% and Specificity ≥ 95%. All serology tests must meet the following standards: ≥ 97.5% and Specificity ≥ 99.3%.;

7. Amend IFB Section C6b)4) to remove reference to serology tests as follows:

4) Produce results in 30 minutes or less for rapid PCR or POC antigen diagnostic tests and 48 hours or less for standardat-home PCR and serology tests;

8. Amend IFB Section C6b) Table 1 as follows:

Table 1: Description of Test Types for FA 1 and FA2

9. Amend the eMMA Pricing Tab to remove the following lines for FA3: I1_9, I1_10, I1_11, and I1_12.

END OF AMENDMENT #9

4) Produce results in 30 minutes or less for rapid PCR or POC antigen diagnostic tests and 48 hours or less for standardat-home PCR and serology tests;