SCT Services Due Diligence Notice.docx

Due Diligence Posting of Notice of Intent to “Accept a Best Value Offer” and “Purchase a Proprietary Product or Service” During a Declared State of Emergency from the COVID-19 Pandemic

The Executive Office of Health and Human Services (“EOHHS”) of the Commonwealth of Massachusetts announces its intent to “Accept a Best Value Offer” and “Purchase a Proprietary Product or Service” pursuant to the Commonwealth’s Due Diligence Posting policy and Emergency Procurement provisions, to contract with qualified vendors for the services described herein. Pending the results of this Notice of Intent (“Notice”), EOHHS intends to contract with Color Genomics, Inc. (“Offeror”) to provide services related to testing for SARS-CoV-19, the virus which causes COVID-19.

Description Due to the COVID-19 pandemic and declared state of emergency by Governor Baker on March 10, 2020, EOHHS has been working closely with the Department of Public Health and the COVID-19 Command Center to expand access to COVID-19 testing resources across the Commonwealth in order to limit the spread of COVID-19. In continuation of these efforts, EOHHS is seeking to further expand, on an expedited basis, the routine testing of asymptomatic individuals who are not known to be close contacts of individuals with COVID-19 (“surveillance testing”) with a COVID-19 polymerase chain reaction (PCR) test or an equivalent or better technology.

To provide EOHHS access to broad-scale, convenient, and relatively low-cost access to COVID-19 surveillance testing resources, EOHHS hereby gives notice of its intent to contract with the Offeror for logistics, technology, and services related to the provision of COVID-19 testing which will be performed in partnership with the laboratory designated by the state, currently the Broad Institute (“Designated Lab”). Specifically, the Offeror will be contracted to provide the following Self-Collected Testing Services (“SCT Services”) to EOHHS, which are detailed in Attachment A: Model Contract for COVID-19 Self-Collected Testing Services:

· Collect individual patient PII through an online, digital registration portal;

· Establish an online, digital intake mechanism to register the location, contact, and other information of sites designated to receive COVID-19 tests, to which sites individual registration information can be linked for the purposes of delivering results;

· Transmit sample requisitions and supporting digital accessioning for collected samples for the laboratory designated by EOHHS, currently the Broad Institute (“Designated Lab”);

· Supply Test Kits that have an FDA EUA for collection without clinical supervision, which contain all materials necessary for collecting COVID-19 testing specimens by individuals;

· Provide shipping logistics and arrange for the delivery of all Test Kits purchased by EOHHS to the addresses specified by EOHHS and the delivery of collected specimens to the Designated Lab on the same day specimens are collected;

· Digitally transmit results to individuals, to the ordering provider, and to the individual’s respective site within 2 hours of results being available from the Designated Lab;

· Digitally transmit results to individual’s designated healthcare provider, if desired;

· Deliver results into the Massachusetts Virtual Epidemiologic Network (MAVEN);

· Provide instructions for self-isolation to any patient that tests positive;

· Provide a method through which patients can obtain information about the status of their test kit and ask general questions;

· Adhere to appropriate personally identifiable information (PII) sharing process, which may require consent and/or compliance with HIPAA, for employees to share their testing results with employers and sharing said information directly when authorized and appropriate;

· Secure PII through recognized industry standards for administrative, physical and technical security; and

· Retain the ability to perform the aforementioned services at a scale no less than 1000 tests per day, if requested by EOHHS

After the response deadline (see Response Requirement and Deadline section below), the Offeror will immediately enter into a contract with EOHHS pursuant to the Emergency Procurement and Purchase (pursuant to 801 CMR 21.05(3)) and Due Diligence Posting provisions of the Best Value Procurement Handbook to provide the services listed above at the prices specified in Appendix A to EOHHS. Any contract entered into pursuant to this Notice does not guarantee any products or services will be purchased by EOHHS.

EOHHS is posting this Notice rather than conducting a full procurement because EOHHS believes the immediate availability of these services will help address the public health emergency and this opportunity represents best value to the Commonwealth and is utilizing this Due Diligence Posting to ensure that the process is open, fair and competitive.

Privacy and Security All interested vendors and the Offeror (collectively known as “Bidders” for this section) acknowledge that they may receive PII subject to certain privacy and security requirements, including, but not limited to M.G.L. c. 66A, from EOHHS. Such PII shall, at a minimum, be safeguarded by recognized industry standards for administrative, physical and technical security. The security of PII shall mean prevention of unauthorized access, dissemination, misuse, reproduction, removal or damage to data or materials used by or in the possession of the Bidder.

Bidders are notified that access to any EOHHS IT system or application must conform with the Enterprise Information Technology Policies, Standards and Guidance promulgated by the Commonwealth or Eligible Entity’s Chief Security Information Officer.

Determination of Other Interested Vendors The intent of this posting is to determine if there are any other interested and qualified vendors. Any such vendors must submit documentation that they can provide the services listed in the Description at a comparable or better offer as those detailed in Appendix A. Vendors should respond by submitting all of the information set forth in Appendix B and must meet all Minimum Service Requirements set forth in Appendix B to qualify. Additionally, Vendors must agree to the terms set forth in Attachment A: Model Contract for COVID-19 Self-Collected Testing Services.

Response Requirement and Deadline All interested vendors and the Offeror interested in responding to this Notice, regardless of prior communications with EOHHS, must submit a Response to this posting containing evidence of their qualification and interest to provide all of the services listed in the Description, and the price(s) at which they offer those services, on a per-test basis, by submitting the information set forth in Appendix B. All required information, as set forth in Appendix B, must be submitted via COMMBUYS, the official procurement record system for the Commonwealth of Massachusetts' Executive Departments, no later than 5:00 p.m. (prevailing Eastern Time) on Wednesday, December 9, 2020.

If, after the response deadline has passed, interest is generated by this Notice, EOHHS will review all Responses and will determine whether it will: (i) withdraw the notice and not accept the Offeror’s offer to contract with EOHHS (and cancel the Notice of Intent); or (ii) accept the offer from the Offeror to contract with EOHHS; or (iii) accept an offer from another vendor offering a comparable or better value than the Offeror in their Responses; or (iv) accept the offer from the Offeror and from any other offerors offering similar or better value in their Response.

Additional Terms Required for Doing Business with the Commonwealth In addition to any specific terms set forth in this Notice and any subsequent contract resulting from this Notice, all vendors doing business with the Commonwealth must agree to additional terms and complete the additional forms required by the Commonwealth.

All Bidders responding to this Notice must agree to participate in the Commonwealth’s Electronic Funds Transfer (EFT) program for receiving payments, unless the Bidder can provide compelling proof that it would be unduly burdensome. EFT is a benefit to both Contractors and the Commonwealth because it ensures fast, safe and reliable payment directly to Contractors and saves both parties the cost of processing checks. The Electronic Funds Transfer (EFT) Authorization Agreement will be supplied by EOHHS for completion during the contracting process. If the Bidder is already enrolled in the program, it may so indicate in its Response. Because the EFT Authorization Agreement contains banking information, this form, and all information contained on this form, shall not be considered a public record and shall not be subject to public disclosure through a public records request.

All Responses and related documents submitted in response to this Notice are public records and are subject to the Massachusetts Public Records Law, M.G.L. c. 66, § 10 and M.G.L. c. 4, § 7 subsection 26. Any statements in submitted Responses that are inconsistent with these statutes will be disregarded.

Please see Appendix B for further information.

Quote Submission Method Online Quote Submission via COMMBUYS is required. All interested vendors and the Offeror must submit Quotes online using tools available only to Vendors registered in COMMBUYS. COMMBUYS provides Vendor registration functionality at no charge. To register, go to www.COMMBUYS.com and click on the “Register” link on the front page. All interested vendors and Offerors who are awarded a contract resulting from this Notice, if any, will be required to maintain an active account during the duration of the Contract, by reviewing their registration information regularly and maintaining its accuracy.

COMMBUYS Quote Submission Training and Instructions The following resources are provided to assist interested vendors and the Offeror in submitting Quotes:

· An online job aid on How to Create a Quote;

· Webcast video on How to Find Bids (Solicitations) and Submit Quotes (Responses) through COMMBUYS;

· Instructor-led trainings (ILT) and live webinar sessions on “How to Locate and Respond to Bids” may also be available. Check the OSD Training Courses schedule for Sellers/Business Entities for available locations, dates and times. Note that space is limited and pre-registration for trainings is required to attend. Follow instructions on the course schedule to register.

COMMBUYS Support Technical assistance is available during the procurement process. Every effort is made to respond to inquiries within one business day.

· Website: Go to www.mass.gov/osd/commbuys and select the COMMBUYS Resource Center link offered under Key Resources.

· Email: Send inquiries to the COMMBUYS Helpdesk at COMMBUYS@mass.gov

· Telephone: Call the COMMBUYS Help Desk at 1-888-MA-STATE (1-888-627-8283). The Help Desk is staffed from 8:00 AM to 5:00 PM Monday through Friday Eastern Standard or Daylight time, as applicable, except on federal and state holidays.

Interested vendors and the Offeror are advised that COMMBUYS will be unavailable during regularly scheduled maintenance hours of which all users will be notified.

Appendix A: Offeror’s Price Sheet

Color Genomics, Inc. (“Color”) will be contracted to perform all of the services listed in the Description. Subject to the payment terms described in Attachment A: Model Contract for COVID-19 Self-Collected Testing Services (“Model Contract”), Color will provide the services described in the Description and the Model Contract at the following prices:

$25 per Test Kit if calendar month Test Kit purchases are 25,001 or greater

Appendix B: Response Requirements Interested Vendors and the Offeror shall provide the following information in their Response:

A. Cover Letter, including:

1. A statement that the Vendor is interested in and qualified to provide the requested services, including a confirmation of the accuracy of the Vendor’s responses to the Minimum Service Requirements form;

2. Confirmation that neither the Vendor, nor any subcontractor may have any interest that will conflict with the performance of services requested. In the event the Vendor or any employee or subcontractor who shall perform work under the Contract has a possible conflict of interest, the Vendor should disclose the nature of that conflict and proposal to eliminate or mitigate such conflicting interest.

3. Confirmation that the Vendor is willing to consent to the terms established in Attachment A: Model Contract for COVID-19 Self-Collected Testing Services; and

4. Confirmation that the Vendor has read and agreed to the terms in the following forms:

B. Required Forms and Certifications The Vendor shall complete, sign and submit the following forms which may be downloaded from COMMBUYS:

C. Minimum Service Requirements Using the form below, Vendors must specify whether they have the current capacity to meet each of the Vendor Requirements listed below. Following the submission of a response, EOHHS may request any supporting documentation necessary to validate the Vendor’s response. Vendor has the current capacity to:

☐ ☐ Collect individual patient PII through an online, digital registration portal;

☐ ☐ Establish an online, digital intake mechanism to register the location, contact, and other information of sites designated to receive COVID-19 tests, to which sites individual registration information can be linked for the purposes of delivering results;

☐ ☐ Transmit sample requisitions and supporting digital accessioning for collected samples for the laboratory designated by EOHHS, currently the Broad Institute (“Designated Lab”);

☐ ☐ Supply Test Kits that have an FDA EUA for collection without clinical supervision, which contain all materials necessary for collecting COVID-19 testing specimens by individuals;

☐ ☐ Provide shipping logistics and arrange for the delivery of all Test Kits purchased by EOHHS to the addresses specified by EOHHS and the delivery of collected specimens to the Designated Lab on the same day specimens are collected;

☐ ☐ Digitally transmit results to individuals, to the ordering provider, and to the individual’s respective site within 2 hours of results being available from the Designated Lab;

☐ ☐ Digitally transmit results to individual’s designated healthcare provider, if desired;

☐ ☐ Deliver results into the Massachusetts Virtual Epidemiologic Network (MAVEN);

☐ ☐ Provide instructions for self-isolation to any patient that tests positive;

☐ ☐ Provide a method through which patients can obtain information about the status of their test kit and ask general questions;

☐ ☐ Adhere to appropriate personally identifiable information (PII) sharing process, which may require consent and/or compliance with HIPAA, for employees to share their testing results with employers and sharing said information directly when authorized and appropriate;

☐ ☐ Secure PII through recognized industry standards for administrative, physical and technical security; and

☐ ☐ Retain the ability to perform the aforementioned services at a scale no less than 1000 tests per day, if requested by EOHHS

D. Evidence of Prior Completion of Similar Services The Vendor must submit existing materials and / or a narrative repose which demonstrate or attest to competence in completing each of the services listed in the Minimum Service Requirements. Materials submitted should demonstrate or attest that the Vendor has performed or currently performs each of the services listed in the Minimum Service Requirements set forth above. The narrative portion of the response, if the Vendor determines it to be necessary, should be limited to no more than 5 pages. Following the submission of a response, EOHHS may request any additional documentation necessary to validate the Vendor’s response.

E. Cost Response The Vendor must submit its cost to perform the Minimum Service Requirements on a per-test basis. Shipping costs may be listed separately in the cost response, but must include a “not to exceed” amount for shipping on a per-test basis.