QA 2 SW COVID-19 Testing.pdf

Q&A

ITB NUMBER: 001IT821222 / BPM023724

COVID-19 TESTING PRODUCTS

Questions & Answers – Round 2

(Questions 1 - 36 answered in Round 1)

37. I am wondering if standard RT-PCR tests will still be considered for this solicitation.

Did the bid change to only at home PCR tests? Should we still provide a proposal for standard PCR tests?

Response: The State intends to purchase PCR, POC, molecular, rapid antigen and serology tests that can be administered at home or for use at a test site, with rapid tests providing results at the location where they are administered with other tests sent to a lab to be processed and results returned to the client.

38. We plan to offer two standard PCR products from the same manufacturer at different price points. The RFP indicates that there cannot be an alternate bid. I am wondering if having two PCR products be considered as an alternate bid. I would be grateful if you clarify the meaning of alternate bid.

Response: Bidders can bid one product in each Functional Area and should bid their best offering and price for it. Additional products or additional pricing for the same product bid within the same Functional Area would be considered multiple bids.

39. We plan to present proposals for PCR and Antibody tests. Should we expect each product to be evaluated separately?

Response: Each functional area will be awarded separately. Awards will be made to lowest-priced responsible bidders with responsive bids offering different products.

40. What is the estimated volume by site? Of volume, how much is PCR COVID testing?

Response: Estimates beyond those in the IFB cannot be provided.

41. What is the definition of jurisdiction? Geography or location (lab, site)?

Response: “Jurisdictions” as used in IFB Section C.2 “Background and Purpose” means Maryland’s 23 counties and Baltimore City.

42. How many physical lab locations are there?

Response: The number of physical laboratories is irrelevant for this IFB.

43. How many sites are there? How many locations will have on-site testing?

Response: The number of sites and locations for these products is irrelevant. See Amendment 2 for changes to the IFB eliminating any need for site or location information.

44. What is the testing model for public health lab? Where is the testing being conducted (e.g., multiple sites, shipping to specific hospitals)?

Response: As only at-home and clinically-observed PCR, molecular, antigen, and POC tests and serology tests are requested under the IFB there is no need for location information.

45. What is a mobile community based testing site?

Response: A mobile community based testing site is a non-permanent, movable testing site targeting specific geographic areas.

46. Do sites carry specific accreditation that affect CLIA status? Is customer concerned with CLIA status (waived vs. moderately complex) of instruments?

Response: CLIA status is relevant only as it relates to those RT-PCR tests performed at a laboratory. In those circumstances, the laboratory needs to have the relevant CLIA certificate commensurate with performing RT-PCR testing.

47. Menu beyond COVID? Is this only for COVID or are other tests included? Potential estimated annual volumes around flu, c diff, strep A, and RSV?

Response: This IFB is only for COVID-19 test products.

48. Will preference be given to a solution that offers only COVID testing vs. multiplex testing on the same instrument?

Response: This solicitation is an Invitation for Bids, meaning price alone will determine the apparent awardees provided they are responsible bidders with responsive bids. As such, there will be no evaluation of offers.

49. IFB mentions 5,000 tests annually, but requests that vendor be ready to ship 50,000 tests at any time. How many tests should we bid on in our pricing?

Response: Please use the estimate contained in Attachment B, the Bid Form.

50. Can you distinguish how the stated volume of tests (15,000 - 66,000 daily) are broken down by functional area?

Response: Estimates beyond that provided in the IFB cannot be provided.

51. Is the vendor required to supply test kits and reagents only, or also perform the test processing?

Response: Bidders are to bid only on the commodities described in the IFB. No test processing is to be included for this solicitation.

52. For at-home/mail-in RT-PCR testing options, is virtual telehealth observation of specimen collection processes a requirement?

Response: No

53. Maryland State has issued two other RFPs recently for mobile (OPASS 21_19217) and community (OPASS 21-19050) COVID-19 testing. Can you elaborate on the difference between this RFP and the prior ones?

Response: This solicitation is for test products only. The other referenced solicitations are to provide mobile testing solutions services (21-19217) and COVID-19 laboratory services (21- 19050).

54. Functional Area 2 Rapid Point-of-Care (Antigen Diagnostic) COVID-19 tests Question: As you know, there are both over the counter ("OTC") non-prescription rapid antigen tests and point of care ("POC") prescription rapid antigen tests that must be administered by trained staff. Is this contract specifically seeking OTC non-prescription rapid antigen tests, POC prescription rapid antigen tests, or both? If this contract is awarded on price only, it will be difficult to win with the OTC which is generally more expensive.

Response: The State has amended the description of Functional Areas 1 and 2 as Functional Area 1: At Home Tests and Functional Area 2: Clinically Observed Tests in response to this question. Please see Amendment X for description and definition of Functional Areas.

55. In the IFB Section C(2) it states: "Statewide testing volumes may range from more than 15,000 tests per day during off-peak testing to more than 66,000 tests per day during peak testing periods." How many or what percentage of the 15,000 to 66,000 tests per day will be allocated to Functional Area 2 Antigen Diagnostic tests? If awarded the contract for Functional Area 2, I'm trying to get a realistic estimate for the number of antigen tests that Maryland will require per month. Obviously, the higher the number of antigen tests needed per month, the better pricing Maryland will receive.

Response: No additional estimates can be provided at this time.

56. The IFB Section C – Specifications, Item 6, Subitem b) Product Requirements, No. 5 refers to an Attachment B “Contractor’s per test price. Question: Is there an Attachment B for this solicitation?

Response: Yes, Attachment B is the bid form. Attachment B is contained in the separately attached Excel spreadsheet. See Amendment X for the updated price form.

57. Under Section B – Terms and Conditions, Item 4. Delivery and Acceptance, the IFB specifies that “the materials listed in the bid or proposal shall be delivered FOB the point or points specified to or on the date specified in the bid or proposal.” Where are the locations for delivery?

Response: Most shipments will be directed to a Maryland Department of Health warehouse (location is likely in the Baltimore metro area). Some shipments may be directed to a MDH local health department location or point of care facility. These locations are distributed around the state.

58. Under Section C – Specifications, Item 6, Subitem b Product Requirements, No. 7, states that the home and mail-in testing option with virtual telemedicine guidance for specimen collection, and pre-registration using an online portal and telephone if offering at-home COVID-19 tests and includes pre-registration using an online portal and telephone if offering testing kiosk, cubes, mobile labs, or similar testing solutions and Item 7 – Shipping, Delivery, Inventory, and Storage Requirements, Subitem 6 states: “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”. Question: Is there an estimate regarding at-home testing quantities? service? As this requires individual mailing and return postage prepaid envelopes, shouldn’t a separate price be incorporated in the bid / proposal?

Response: The Contractor should pass through shipping costs for same- or next-day delivery if requested to the State with no markup. See Amendment X.

59. Under Section C – Specifications: Item 6, Subitem b Product Requirements, No. 5, “the resulting mechanism that is able to connect to HL-7 for reporting test results…”.

Question: Who will manage the database for the test results?

Response: Test results submitted via the HL-7 mechanism are processed into our National Electronic Disease Surveillance System (NEDSS) and are managed by the NEDSS IT and Division of Infectious Disease Surveillance team at the Maryland Department of Health.

60. Under Section C – Specifications, Item 11: “Contractor must have the capacity to store at least 250,000 tests at a time for the Contract, with readiness to ship at appropriate notice, and the ability to keep at least 50,000 tests in stock at any given time as part of the State’s inventory reserve;” Is the State purchasing the inventory to be stored by the Contractor?

Response: No, the State is not committing to purchase the inventory. It is requiring the Contractor to have the indicated warehouse and reserve capacity.

61. Does the bidder have any flexibility to redline any terms; some are restrictive and outside of our process and would be unduly labor intensive to implement; as well as some are adding additional costs or penalties involving fees to charge us for mistakes.

Response: Bidders could raise exceptions to terms and conditions prior to the Q&A deadline;

however, the State does not intend to accept alteration to the contract terms and conditions. See IFB Section A, subsection F. After Bid Opening, any exceptions to the bid specifications may not be accepted or considered. Changes to the solicitation or the Terms and Conditions made by the Bidder may result in Bid rejection.

62. Because of the EUA approval, Abbott needs the ability to allocate during a pandemic, can we add any language to protect Abbott for such need?

Response: Bidders may include with their bids any FDA required language to be passed through to purchasers of the tests pursuant to a test’s Emergency Use Authorization, as provided in Amendment X. Additionally, provision 40 provides force majeure protections to the Contractor in the provision of goods under the Contract.

63. Please explain whether we are considered a non-resident if we are national/worldwide company, but our headquarters is out of state. If so, please provide the attachment referenced in Section A,H1(6) needing review soon.

Response: A firm organized outside the State of Maryland is considered a foreign firm for the purposes of this section. In the event reciprocal preference applies, the referenced attachment would be sent to the bidder.

64. We will need to add pass-through termination language via EUA, Emergency Use Authorization, how can we add this via the portal? We do not have option to delete it because of EUA. Please let us know how we can do this via the portal.

Response: Bidders may include with their bids any FDA required language to be passed through to purchasers of the tests pursuant to a test’s Emergency Use Authorization, as provided in Amendment X.

65. Will the Purchase Order have additional terms at any time that we have not reviewed?

Can we review a PO in advance for terms and conditions?

Response: The contracts to be awarded will not include terms that have not been disclosed to the bidders. The blanket purchase orders/contracts may include partial listings of the terms and conditions, mainly for the benefit of using agencies viewing the documents on the DGS website.

66. Terms and Conditions Provision 4 and 26 appear to be for services; are they mandatory for purchase of goods?

Response: Provision 26 is mandatory. Provision 4 is part of the State’s standard commodities terms and conditions. The State does not intend to negotiate either for this solicitation.

67. Regarding Provision 26, is there any language that can determine the scope of the changes in “Work Order” or define its parameters, this seems quite restrictive? Will the State consider changes to or removing provisions>?

Response: The State does not intend to alter its standard terms and conditions for this solicitation.

68. Is there any language that Maryland can add to Provision 29 to state prices have been reviewed and is determined as accurate, complete, and current; or we agree to firm fix pricing which supersedes this language?

69. For provision 38, how do we determine whether or not an entity is under Maryland’s BIDS system if Abbott is awarded? Are there specific codes/or other specific information that we can rely on to prove the alignment with Maryland?

Response: If an entity meets the definition of qualifying entities stated in Provision 38 then an entity may qualify to purchase under the Contract.

70. We are not set up for this type of process for Usage Reports provided in Provision 46.

Does Maryland have any language we can add to waive this or are there alternatives we can provide to accommodate this request?

71. Can we add any language that alleviates Abbott of the fee in terms and conditions Provision 47? We do not accept transaction fees, as a business rule.

End of Questions & Answers