At-home Testing Due Diligence Notice~1.docx

Renewed 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 Vault Medical Services, P.A. (“Offeror”) as a vendor available to Eligible Entities from which to purchase the services described in this Notice and the services and rates set forth in Appendix A.

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.

To provide Eligible Entities 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 under a Master Agreement for at-home and on-site self-administered COVID-19 testing and related services. Specifically, the Offeror will be contracted to provide the following services to Eligible Entities who choose to purchase from the Offeror:

· Physician-ordering of COVID-19 tests;

· Delivering COVID-19 testing kits individually or in bulk to a single or multiple locations;

· Collecting specimen materials from tests that may be self-administered by non-clinical individuals, with or without in person or virtual clinical supervision;

· Providing transportation logistics for collected specimens to and from various testing sites to qualified processing laboratories

· Processing collected specimens in a laboratory to determine the presence of SARS-CoV-2;

· Registering the information of individuals seeking a test and delivering testing results digitally directly to the individual;

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

· Adhering 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;

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

· Ensuring COVID-19 test results are delivered as described above within 72 hours of delivery of the specimen to the lab, as a condition of payment.

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 Eligible Entities who choose to purchase from them. Any contract entered into pursuant to this Notice does not guarantee any products or services will be purchased by the Eligible Entities.

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.

Eligible Entities All state agencies, municipal entities, and school districts under the Department of Elementary and Secondary Education’s authority, including charter schools, special education schools, and private schools, are eligible users of the contracts created by this Notice and may purchase services from any vendor contracted with EOHHS pursuant to this Notice. EOHHS reserves the right to expand the list of eligible entities at any point through the duration of the contract.

EOHHS accepts responsibility of contract management on behalf of other Eligible Entities. Each Eligible Entity is responsible for the execution of purchase orders or other engagement-specific documents and their retention, retrieval, archiving, and disposal; however, Eligible Entities may not enter into contracts that absolve the contractors of any obligations contained in the EOHHS contract.

Privacy and Security All interested vendors and Offerors (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 the Eligible Entities. 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.

Further, each Eligible Entity reserves the right to add any requirement to any purchase order or other engagement-specific document that it determines is necessary to ensure compliance with all applicable statutes, orders, agreements, and regulations pertaining to the privacy or security of PII, including any applicable law. The Bidder acknowledges that this may include privacy and security obligations that are required as the result of an Eligible Entity having entered into an agreement with a third party (such as the Department of Public Health, the Department of Revenue, or the Centers for Medicaid and Medicare Services). The Bidder’s failure to amend any purchase order or other engagement-specific document in accordance with the foregoing shall be considered a breach of a material provision.

Bidders are notified that any Eligible Entity meeting the definition of a Covered Entity under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) will include in any purchase order, amendment, or other engagement-specific document sufficient language establishing the Bidder’s contractual obligations, if any, that the Eligible Entity will require in order for the Eligible Entity to comply with HIPAA and the privacy and security regulations promulgated thereunder (45 CFR Parts 160, 162, and 164) (the Privacy and Security Rules). For example, if the Eligible Entity determines that the Bidder is a business associate performing functions or activities involving protected health information, as such terms are used in the Privacy and Security Rules, then the Eligible Entity will include in the purchase order, amendment, or other engagement-specific document, a sufficient description of business associate’s contractual obligations regarding the privacy and security of the protected health information, as listed in 45 CFR 164.314 and 164.504 (e), including, but not limited to, the Bidder's obligation to: implement administrative, physical, and technical safeguards that reasonably and appropriately protect the confidentiality, integrity, and availability of the protected health information (in whatever form it is maintained or used, including verbal communications); provide individuals access to their records; and strictly limit use and disclosure of the protected health information for only those purposes approved by the Eligible Entity.

Bidders are notified that access to any Eligible Entity’s 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 EOHHS originally posted this Notice on August 12, 2020. EOHHS is renewing this posting to announce its intent to contract with the Offeror and 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.

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 Tuesday, September 22, 2020. Vendors that have been selected for contracting as a result of EOHHS’ prior Notice, of August 12, 2020, are not required to respond again.

If, after the posting 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 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 Offerors 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 Offerors 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 Offerors 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

Vault Medical Services, P.A., working together with RUCDR Infinite Biologics (collectively “Vault”) will be contracted to perform all of the services listed in the Description. These services may be performed with a different combination of shipping logistics and supervision format (“Service type”) at the discretion of the purchaser, at the following prices:

· Sample collection supervised by teleconference

· Kits will include individual prepaid envelopes to return samples to the lab

· Sample collection supervised by teleconference

· Kits will include prepaid envelopes to return samples to the lab

· Sample collection supervised by teleconference

· Vault Medical will coordinate bulk return shipment of samples to lab

· Training provided for staff to supervise specimen collection; staff not required to be clinical staff

· Sample collection supervised by on-site staff trained by Vault

· Vault Medical will coordinate bulk return shipment of samples to lab

Appendix B: Response Requirements The Vendor 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 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 are able to meet Vendor Requirements listed below. Following the submission of a response, EOHHS may request any supporting documentation necessary to validate the Vendor’s response.

☐ ☐ Vendor provides an FDA-approved (i.e., EUA) at-home or on-site testing kit which can be self-administered by non-clinical individuals (with or without supervision).

☐ ☐ Vendor has the capability to collect PII (including demographics) through an online registration portal.

☐ ☐ Vendor provides physician orders for tests purchased, including for asymptomatic individuals who are not close contacts of COVID-19 cases.

☐ ☐ Vendor provides shipping logistics for both delivering test kits and returning collected specimens to a qualified processing laboratory.

☐ ☐ Vendor processes or arranges for processing of collected specimens in a CLIA-certified, FDA-approved processing lab.

☐ ☐ Vendor can report testing results directly to the patient and additional third parties (e.g., employers) using appropriate PII sharing process, which may require consent and/or compliance with HIPAA.

☐ ☐ Vendor can secure PII through recognized industry standards for administrative, physical and technical security.

☐ ☐ Vendor can deliver results into the Massachusetts Virtual Epidemiologic Network (MAVEN).

☐ ☐ Vendor commits to a turnaround time of no more than 72 hours from the time a specimen is received at the laboratory to the time results are received, as a condition of payment.

☐ ☐ Neither the Vendor nor any subcontractor have any interest that will conflict with the performance of services requested.

D. Service Detail and Cost Response The Vendor should submit Attachment A: Service Detail and Cost Response Template, in accordance with the instructions specified therein.