Pre-Bid Minutes QA SW COVID-19 Testing.pdf

PRE-BID SUMMARY AND Q&A

ITB NUMBER: 001IT821222 / BPM023724

COVID-19 TESTING PRODUCTS

Pre-Bid Conference Minutes

Date of Pre-Bid Conference: May 26, 2021

Date Minutes Prepared: June 8, 2021

The Pre-Bid Conference began at approximately 9:05 a.m.

Leading the conference was Charles Bailey, Procurement Officer from the Department of General Services (DGS). Also in attendance was Rachel Hershey, Procurement Coordinator with the Maryland Department of Health (MDH), and members of the COVID-19 Testing Task Force:

Jason DuBois and Sohail Qarni from MDH and Robert Scherr from the Department of Commerce.

Mr. Bailey reviewed the Information to Bidders, eMaryland Marketplace Advantage (eMMA) bid procedures, and highlighted the Invitation for Bids (IFB). Mr. Bailey summarized the requirements for submitting a bid and doing business with the State of Maryland and encouraged bidders not to wait until the deadline to submit their bids, as late bids cannot be accepted. Mr.

Bailey explained that each amendment in eMMA creates a new round, and that bids must be submitted in the final round before the bid closes so to show that all amendments have been acknowledged. Mr. Bailey also summarized the scope of work. Regarding the bid prices, Mr.

Bailey clarified that all lines on the eMMA Pricing tab for this IFB appear as optional items because bidders may choose which functional areas on which they will bid, but prices must be submitted for each year within the functional areas. Mr. Bailey, Ms. Hershey, Mr. DuBois, and Mr. Scherr answered vendor questions.

Twenty-nine potential bidders were present at the Pre-Bid Conference. Please see the attached Attendance Sheet.

End of Minutes

Questions & Answers – Round 1

1. Why is functional area 1 only PCR and functional area 2 only antigen? Are these areas locations or are areas to procure both types of tests?

Response: The functional areas refer to categories of products, not locations. Awards will be made to vendors in each category of tests.

2. If lowest bidder equals made in China, is there any consideration given to a higher price when not made in China?

Response: Per IFB Section A subsection B, awards will be made 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. To be responsive, test products and bids must meet all of the requirements in the specifications. Provided the bidder is responsible and the bid is responsive, the location of manufacture is not considered.

3. Is there any consideration given to MD based certified Diversity Vendors?

Response: Minority Business Enterprises are always encouraged to respond to a solicitation.

However, there is not an MBE subcontracting goal associated with this solicitation.

4. If I understand correctly, someone from the bidding company must reside in Maryland?

Response: If it is a foreign entity (a business organized outside the State of Maryland), a business must have a resident agent in Maryland.

5. Is it acceptable to register with the State of Maryland AFTER announcing the award and BEFORE the contract is signed?

Response: A Bidder must be registered with the State Department of Assessments and Taxation (“SDAT”) prior to entering a contract with the State of Maryland. If a Bidder is not registered to do business in the State with SDAT, a contract cannot be awarded. It is strongly recommended that any potential Bidder complete registration prior to the Bid due date and time. The Bidder’s failure to complete registration with SDAT may disqualify an otherwise successful Bidder from final consideration and recommendation for Contract award.

6. Is there any minimum quantity per shipping location?

Response: There are no minimum quantities per shipping location.

7. Will the state run the fixed and mobile sample collection centers and the contractor is responsible for sample collection supplies and testing?

Response: This IFB seeks test products only. Sample collection and testing are not requested under this solicitation.

8. In addition to lab-based molecular PCR tests and rapid POC antigen, we also offer rapid isothermic and NAAT PCR tests with 20-min TAT used widely. Is there a use case for those tests in MD?

Response: Provided the above referenced tests meet the product requirements specified in the IFB, bidders may choose to bid them for the applicable functional areas.

9. Can you please give an estimated monthly breakdown of number of test kits by estimated functional area?

Response: A monthly estimate of the number of kits by functional area is not available. Because the need and use cases vary at any time, the State cannot further estimate the need for these test products beyond the estimate provided in the IFB.

10. For Rapid POC Antigen test description, when you say "nasal swabs", does this include NP as well as anterior nasal swabs?

Response: Yes.

11. In responding to the lab PCR functional area, can the proposal include placement of instrumentation at the Baltimore central lab that could support that volume of testing and provide greatest value to the state?

Response: Specific placement of instrumentation required to use a Bidder’s PCR test is not part of this solicitation. The State does not anticipate needing instrumentation or requiring its placement outside of a Bidder’s laboratory facilities.

12. Will the State run the fixed and mobile sample collection centers and the contractor is responsible for sample collection supplies and testing?

Response: This solicitation is for the test product commodities. Diagnostic services for the tests are not part of the scope of work.

13. Could you elaborate on the requirement to provide a reporting mechanism? If we are providing "tests only," then not clear on the requirement to ALSO provide the reporting mechanism.

Response: This solicitation is for the test product commodities and any associated resulting mechanism. See IFB Section C6b for all required components for the test.

14. Can you still bid if you don't meet the following statement in Attachment S? “BIDDERS

SHALL HAVE AT LEAST THREE (3) YEARS EXPERIENCE IN PROVIDING

SIMILAR TYPE WORK AS SPECIFIED IN THIS IFB.”

Response: This statement has been removed via Amendment from the solicitation. See Amendment 2.

15. Would you accept a bid for an Antigen rapid test that has a sensitivity lower than 90%?

We have one Antigen rapid test that has a sensitivity of 87.2%.

Response: Yes. See Amendment 2.

16. Can you kindly explain the "combined sensitivity of greater than 90%" requirement? and Does the State of MD prefer the terminologies of sensitivity/specificity versus positive percent/negative percent agreements?

Response: The sensitivity and specificity standards have been revised. See Amendment 2. The State is using sensitivity and specificity standards for test products. Positive and negative percent agreements are not used for the purposes of this solicitation.

17. Is there an LOD (limit of detection) requirement? and do you want clinical sensitivity/specificity for symptomatic or asymptomatic studies?

Response: There is not a limit of detection requirement. The required sensitivity and specificity standards should align with those associated with a product’s EUA whether for symptomatic or asymptomatic studies. See also responses to Questions 15 and 16.

18. We would like additional clarification on the PCR functional area - where/how does the state anticipate PCR testing to be done if instrumentation is not being considered as part of the bid? an existing site?

Response: Instrumentation is not needed for the type of PCR tests solicited under this IFB. See Amendment 2.

19. Does the solicitation cover POC Antigen rapid tests for screening (serial testing) or diagnostic use?

Response: All use cases have not been identified. The State may use various products for either screening or diagnostic purposes.

20. Is there a timeline for award after the bid deadline?

Response: It typically takes 10-14 days after the bid deadline to award contracts resulting from an invitation for bid.

21. Are there tentative throughput requirements?

Response: There are no tentative throughput requirements.

22. When will the amendment be released?

Response: Any amendment, Q&A, and prebid conference summary is issued as soon as possible after the prebid conference. This timeline may increase or decrease depending on the number of questions received.

23. Returned Goods Section: For MD Testing Products, can or will the vendor's lab be used for PCR test kit processing if kits are provided?

Response: No, the bidder’s lab will not be used for PCR test processing. PCR test processing is not part of the scope of work for this solicitation.

24. Within product requirements, the solicitation states “Show a combined sensitivity of greater than 90% and a specificity greater than 95%;” What does combined sensitivity mean?

Response: These standards have been revised for POC tests. See Amendment 2.

25. During the pre-bid meeting, it was mentioned that “The way people are getting tested today is shifting. We are moving away from drive-up testing sites. The goal is to help meet a future need of testing method to take place.” Is the State specifically looking for point of care and/or at-home testing products?

Response: Yes, the State is looking for POC, at-home testing products, and serology tests.

26. Please clarify why the required sensitivity rate for this IFB differs from the simultaneously issued MD K-12 Testing RFP.

Response: The sensitivity rates have been revised. See Amendment 2.

27. The IFB asks for 90% sensitivity for symptomatic use. Should this requirement be adjusted to reflect FDA EUA standards?

Response: The sensitivity rates have been revised. See Amendment 2.

28. Should responses include a detailed product description in addition to all required documents provided within the IFB?

Response: While not required, a detailed description of tests may be helpful in assessing whether tests meet the IFB requirements. Accordingly, Bidders are welcome to include one.

29. Do we have to have a resident agent to participate in this bid?

Response: As explained in the IFB, if your company does not have a physical location in Maryland, it must have a resident agent.

30. Are there any preference given to providers who supply same product to the State of Maryland?

Response: There are no local preferences in this IFB. Reciprocal preferences will apply to bidders that are based in states that apply local preferences.

31. Can we provide supporting information such as clients, articles, references under vendor file?

Response: References are required in Attachment S to verify that bidders meet the minimum qualifications for this Contract. Additional supporting documents can be included as attachments with your bid.

32. How do we confirm the one percent (1%) electronic transaction fee?

Response: As with all Maryland Statewide commodities contracts, a 1% electronic transaction fee will apply to this Contract.

33. Where do we upload the attachments (C, H, K, S) under eMMA?

Response: Please review the QRG for Responding to Solicitations (IFB) for instructions about uploading bid attachments: https://procurement.maryland.gov/emma-qrgs/.

34. Do we attach our proposal to “Prepare Response” section?

Response: This is addressed in the QRG referenced in the previous response. The Prepare Response button must be clicked to begin the bid submittal process.

35. Is it enough to fill in the product/price on the site under “Pricing” section? Or Should we upload an Excel document?

Response: Yes, prices should be entered in the Pricing tab. The Excel version of the pricing tab can be used to import prices into the Pricing tab, but with only a total of 12 lines for this IFB, it may be simpler to just type responses directly into the Pricing tab.

36. Should the pricing be for 10,000 (ten thousand) tests?

Response: Estimated quantities per year for each functional area have been changed from 10,000 to 5,000 through Amendment 2.

End of Questions & Answers https://procurement.maryland.gov/emma-qrgs/