RFR 264827_HCV POC RFR_Re-Opened~1.docx

APPLICATION FOR GRANTS AND SUBSIDIES (PP OBJECT CLASS)

Key RFR Information All Potential Bidder’s must readCOMMBUYS REGISTRATION It is the responsibility of the prospective Bidder and awarded Contractor to maintain an active registration in COMMBUYS and to keep current the email address of the Bidder’s contact person and prospective contract manager, if awarded a contract, and to monitor that email inbox for communications from the Purchasing Department, including requests for clarification. The Purchasing Department and the Commonwealth assume no responsibility if a prospective Bidder’s/awarded Contractor’s designated email address is not current, or if technical problems, including those with the prospective Bidder’s/awarded Contractor’s computer, network or internet service provider (ISP) cause email communications sent to/from the prospective Bidder/Awarded contractor and the Purchasing Department to be lost or rejected by any means including email or spam filtering. To register review the COMMBUYS Job Aide COMMBUYS Vendor Registration or go to www.COMMBUYS.com.

QUOTE SUBMISSION

This BID requires the submission of electronic quotes. All Bidders are advised to allow adequate time for submission of their quotes by considering potential online impediments like Internet traffic, Internet connection speed, file size, and file volume. DPH is not responsible for delays encountered by Bidders or their agents, or for a Bidder’s local hardware failures, such as computers or related networks, associated with bid compilation or submission. Bids submitted via COMMBUYS are time stamped by the COMMBUYS system clock which is considered the official time of record.

If you plan to submit a quote to this RFR “No Bid” should not be checked anywhere in your quote in COMMBUYS. This includes on the General Screen and the Items tab. Checking No Bid sends your quote to a different location in COMMBUYS than the rest of the quotes for that Bid and you run the risk of the Department not receiving your response. The department will not guarantee that a bid received with a “No Bid” checked will be reviewed.

Title of Grant RFR: Using Point-of-Care Diagnostic Strategies to Advance Elimination of Hepatitis C Infection DPH RFR Document File Number: 264827 COMMBUYS BID Number: BD-27-1031-ADMIN-ADM07-132007 Contact Name: Ciara Williams, Liisa Randall E-mail: Ciara.Williams@mass.gov, liisa.randall@mass.gov

Section A: Procurement Overview

A1: Procurement Description or purpose This procurement is being reopened to allow for additional applicants, to broaden geographic and setting representation. Previously posted as BD-26-1031-BID00-BID05-124094.

The Bureau of Infectious Disease and Laboratory Sciences (BIDLS), Massachusetts Department of Health (DPH) is making resources available to support enhancement and expansion of hepatitis C virus (HCV) testing and linkage to curative treatment in high impact health care and social service settings serving people who use injection drugs. This will be accomplished by use of a test system which enables diagnosis of current HCV infection at point-of-care (POC). Currently, one such test system, the Cepheid GeneXpert system, is approved for use in the United States. BIDLS intends to award approximately $70,660 to support 2 awards, (approximately $35,000 per selected agency). Past awardees from BD-26-1031-BID00-BID05-124094 are not eligible to apply, although past applicants who were not awarded may. Resources are to be used to purchase the Cepheid GeneXpert system, test cartridges, controls, and testing supplies. These are one-time resources and will not be renewed.

A2: Program Background Information Hepatitis C (HCV) infection remains a significant health threat in Massachusetts. DPH estimates approximately 250,000 residents are currently infected with hepatitis C. Hispanic/Latine individuals are infected with HCV at 1.3 times, Black individuals at 1.2 times, and American Indian/Alaska Native individuals at 1.1 times the rate of White individuals. Persons who use drugs (PWUD), particularly those who inject drugs (PWID), face an elevated risk for acquiring HCV infection, and for other infections including HIV, hepatitis A, hepatitis B, and bacterial infections. In Massachusetts 95% of confirmed cases of HCV reported to DPH between 2016 and 2020 with a known exposure mode reported having injected drugs.

Hepatitis C infection is curable with a short course of oral medications. Testing to identify current HCV infection is an essential first step to treatment. However, too few people are receiving timely and/or consistent testing to identify current HCV infection. Among those who do receive appropriate testing and are identified with current HCV infection, only about 4 of 10 receive treatment within one year of diagnosis.

DPH’s goals and strategies for reducing HCV infections and associated health disparities, and improving health outcomes for persons diagnosed with and at risk for HCV infection are articulated in the Massachusetts Hepatitis C Elimination Plan. Testing and prompt engagement in curative treatment are key strategies articulated in the Plan. This procurement will support the use of point-of-care (POC) RNA testing for hepatitis C infection and to understand how this tool can effectively expand uptake of testing and engagement in curative treatment for HCV infection in health care settings serving PWUD, particularly persons who use injection drugs.

Section B: Procurement Information B1: Applicable Procurement Law

Executive Branch Goods and Services

B2: Anticipated Payment Methodology:

B3. Whether Single Or Multiple Grantees Are Required For Grant(s) Check One (“X”):

B4. Expected Duration of Grant (Initial Duration and Any Options to Renew) (Subject to appropriation or the availability of sufficient non-appropriated funds under the grant funding authority)

year(s)

B4: Anticipated Expenditures, Funding Or Compensation For Expected Duration

Dollar Amount

Will Federal Funds be used to fund any part of Contract(s)?

*Additional information for contracts with Federal Dollars:

Sub-Recipient: Grantees receiving federal grant funds will be considered sub-recipients for federal grant purposes and will be required to comply with applicable federal requirements, including but not limited to sub-recipient audit requirements under OMB Circular A-133.

Capital Budget Items: The funds received in advance of expenditure by a grantee for a capital budget item must be held in a segregated non-interest bearing account and must be expended within 60 days (for policy information on spending capital funds see: Office of the State Comptroller, State Grants and Federal Sub-grants: 815 CMR 2 (mass.gov)

Unique Entity Identifier: On April 4, 2022, the unique entity identifier used across the federal government changed from the DUNS Number to the Unique Entity ID also known as UEI or SAMS number. Any entity that wants to apply for federal contracts or wants to receive federal funds must register with SAM. Entities that use SAM include for profit businesses, nonprofits, government contractors or subcontractors, as well as state and local governments.

Registering with SAM.gov is free and is required for your organization to receive federal funds. Your organization can submit an application to this RFR without being registered on SAM, however if awarded your organization will need to have an active SAM account prior to contract execution.

Unspent Funds: Any funds from Capital, Trust and/or Federal Accounts designated in the budget that are unspent in any fiscal year will not be available for expenditure in the subsequent fiscal year.

Section C: Performance and Contract Specifications

C1: Eligibility Health care and social service organizations serving PWUD, particularly people who inject drugs, are eligible to apply for funding available under this procurement. Eligible organizations may include correctional facilities, syringe service programs, substance use treatment facilities, health centers, and other facilities providing low threshold medical services and serving populations impacted by HCV. Applicant organizations must have the capacity to provide or facilitate access to treatment for HCV infection, with same day or next day treatment initiation expected. Organizations currently funded by BIDLS under RFR BD-26-1031-BID00-BID01-126159, (RFR# 271928 HIV/HCV/STI/TB Prevention, Testing, Linkage, and Retention in Care and Treatment) are eligible to apply, but proposed activities and outcomes must complement and may not supplant activities and outcomes supported under that procurement. Applicants do not currently need to be funded through RFR# 271928 to be eligible to apply for funding under this procurement.

C2: Scope of Services The goal of this procurement is to increase testing and engagement in curative treatment for HCV infection in populations experiencing hepatitis C-related health disparities, consistent with the epidemiology of HCV infection in Massachusetts. There will be two awards of approximately $35,000 per award, to purchase the Cepheid GeneXpert Xpress testing instrument and related supplies for an initial 500 HCV point of care tests per applicant organization. Organizations will be required to work directly with BIDLS/DPH to provide testing, linkage services, and administrative data for 18 months following purchase and implementation of the instrument.

Organizations receiving funding under this procurement must purchase the GeneXpert Xpress system testing reagents, controls, and other supplies directly from the manufacturer Cepheid. DPH does not make and disclaims any representations or warranties (including but not limited to warranties of merchantability) regarding Cepheid, the GeneXpert Xpress system testing reagents, controls, and other supplies purchased from Cepheid. DPH shall not be a party to and shall not have any duties, rights, or obligations, pursuant to any contract, purchase order, or the like between organizations receiving funds under this procurement and Cepheid.

Applicants must meet required instrument standards for operation per manufacturer and must be able to clearly articulate sustainability plans as they relate to ongoing testing and treatment, maintenance of the instruments and purchasing of supplies after the contracted scope of work ends, as there are no options to renew on this contract.

Successful applicants will describe a plan to test at least 500 individuals within the contract period. The description must include how individuals at high risk of HCV infection, particularly PWID, will be engaged in testing and treatment. Applicants who intend to provide POC testing in a mobile setting or otherwise off-site should describe how they will maintain instrument conditions as required by the manufacturer.

Bidder Requirements:

Applicants must have current experience providing HCV testing, the demonstrated ability to link individuals that test positive for hepatitis C infection to treatment on the same day or next day after testing, and a plan to support individuals through the course of treatment to cure. Applicants should describe how POC testing will be integrated into their existing HCV testing and treatment process and how individuals who test negative will be supported in ongoing efforts to prevent HCV infection. This should include additional supported referral to services inclusive of syringe service programs and substance use disorder (SUD) treatment, as appropriate.

HCV point of care testing should not replace phlebotomy-based HCV testing, and organizations should clearly document how they will determine eligibility to receive POC testing. The POC instrument should provide a result within one hour and may have an early positive result within 41 minutes. However, there may be instances where patients do not stay on site to receive their result. Applicants should describe what steps they will take to rapidly locate individuals with positive results.

Successful applicants will provide a detailed explanation of their process for linking patients to HCV treatment. Applicants must specify the treatment location (e.g. in the same office as testing, on another floor, in another location, etc.), the members of the treatment team (e.g. prescribers and nurse, prescriber, nurse and outreach worker, etc.), the process for facilitating treatment engagement, and the timeframe for the treatment visits. Applicants should describe what activities take place at the initial visit, how patients receive their medication, how frequently patients must return to the facility during treatment, and what happens at each visit. The process description should include how uninsured patients will be enrolled in insurance and how patients will be supported in navigating engagement with mail-order and specialty pharmacies if applicable. In describing how patients receive their medication, applicants should specify their ability to directly deliver medication to patients and if medications can be stored on-site for individuals experiencing homelessness or for those that are otherwise unable to carry and store medication. Priority will be given to organizations that demonstrate strong infrastructure and established networks and treatment pathways.

Successful applicants will collaborate with BIDLS/DPH to report HCV infection consistent with 105 CMR 300.000. Organizations will collaborate with BIDLS/DPH to articulate and document implementation processes and outcomes of using POC HCV RNA testing and strategies to engage individuals in treatment for HCV infection, to assist BIDLS/DPH in examining the effectiveness of this testing strategy.

Contract Performance Expectations:

Organizations are expected to plan to administer 500 tests within the contract period. Organizations will need to independently coordinate and ensure maintenance of the instrument occurs as needed, working directly with the manufacturer Cepheid. Organizations must abide by all applicable law concerning conducting POC testing, including but not limited to obtaining a CLIA waiver and ensuring instrument conditions and maintenance for optimal performance. Organizations must prioritize and facilitate same day or next day treatment initiation for patients testing positive for active HCV infection. Organizations will be expected to attend monthly contract meetings to discuss performance, challenges, and opportunities for technical assistance. Organizations will be expected to provide BIDLS/DPH with timely, accurate, and complete data relevant to use of the POC instrument and linkage to HCV treatment.

Performance dates and deadlines:

· Testing instruments must be ordered, delivered, and fully functional within 90 days of contract start date.

Applicants must agree to 18-month reporting period of programmatic, service, and administrative data from contract start date.

C3: Performance Requirements and Contract Monitoring An optimal response to HCV and the needs of people who use drugs involves coordination between DPH and providers. Organizations must comply with applicable law including 105 CMR 300.00.

Successful bidders must agree to adhere to all requirements mandated by DPH and its federal funders. These requirements address compliance with rules, regulations, and policies; the comprehensiveness, accuracy, and quality of reporting; responsiveness to standards of care/service; and the timeliness of demonstrating compliance.

DPH will monitor contracts through monthly contract meetings, analysis of data submissions, and additional mechanisms as appropriate. In addition to reporting otherwise required by applicable law, successful bidders will be required to report information as determined by DPH which may include frequency of tests performed and days from test result to treatment initiation. DPH will monitor service quality and health outcomes both at an organizational level and at a systems level. DPH will assess organizations’ respective contributions toward system-level goals by reviewing the following types of data: number of tests, number of positives, number of patients referred to treatment, time to treatment initiation, number of patients currently in treatment, and number of patients who have completed treatment. DPH may add additional data collection and reporting requirements during the contract period.

C4: Contract Invoicing This will be a one-time, upfront lump sum payment of approximately $35,000 per organization to purchase the instrument and supplies for the first 500 tests only, and will not be renewable.

Payment through Electronic Funds Transfer (EFT) is required for any contract awarded through this solicitation. If awarded a contract vendors not already enrolled will be required to sign up for EFT as a contract requirement by completing and submitting the Authorization for Electronic Funds Transfer Form to the Department. Additional information will be sent at the time of contract.

Section D: RFR Evaluation D1: Evaluation Criteria All proposals will be scored on the following criteria:

· Expertise and experience providing HCV testing and treatment

· Experience serving priority populations that are disproportionately impacted by HCV

· Integration of targeted testing and capacity to enable same day or next day treatment

· Organizational capacity to house the Cepheid GeneXpert Xpress HCV POC instrument and provide services as described in RFR

· Proposal for implementation and sustainability planning including total number of patients planned to be tested and anticipated number of patients diagnosed with HCV infection during the contract period

Technical Review: The quality of the response to each question in the narrative is evaluated by a team of objective reviewers who score each question according to criteria related to that question. Reviewers are instructed to evaluate each question for content, comprehensiveness, and clarity of each answer.

Section E: Estimated Procurement Calendar

RFR Release Date August 4, 2026

Deadline for Submission of RFR Q&A.1

Deadline for Submission of Responses Also known as the BID Opening Date in COMMBUYS

Anticipated Contract Start Date

November 1, 2026

1All Questions must be received in writing. Questions can be sent by email no later than the date and time indicated in the Procurement Calendar. All questions should be sent to the email listed in the calendar and should include the RFR title and number in the subject of the email. All Questions with answers will be posted on the COMMBUYS Attachment section for this procurement.

Section F: Instructions for Submission of Responses

F1: Bidder Response Requirements Organizations should submit a response to this RFR that answers the following questions:

1. What is your organization’s mission, vision, purpose and brief history? What populations and geographic areas do you serve?

2. What is your organization’s existing HCV testing and linkage to care capacity and experience serving PWID? Please include organization’s ability to handle the scope of medical care associated with HCV treatment. Please provide the approximate annual volume of patients served, PWID served, volume of HCV tests performed, and percentage of patients diagnosed with HCV infection, and number of patients treated for HCV infection.

3. How will your organization engage priority populations disproportionately impacted by HCV in HCV testing and treatment? Include a plan to identify eligible patients for POC testing, including total number of patients planned to be tested during the contract period. Describe the extent to which implementing POC testing is expected to increase the volume of patients tested, diagnosed, and treated for hepatitis C infection.

4. What is your organization’s implementation plan for housing and maintaining a Cepheid HCV POC instrument? Include location and conditions for the POC instrument.

5. What will be the sustainability plan for POC testing and treatment, including maintaining the instrument (i.e. instrument maintenance, future purchases of supplies), and other expenses outside the scope of this contract?

6. How will same and next day treatment for HCV infection be facilitated at your organization and/or with local collaborators? Attach current HCV treatment protocol, including information on location, treatment visits and timing, staffing, medication storage, insurance navigation, specialty pharmacy, etc.

7. Please include staffing documents for staff that will be working directly with the instrument and with patients receiving testing and treatment.

8. How will you ensure training and workflow integration, quality assurance and data management and reporting associated with point of care HCV testing?

F2: COMMBUYS Submission Instructions All responses are to be submitted electronically using the online submission tools available to Vendors registered in COMMBUYS. There is no charge to register in COMMBUYS. To Register go to www.COMMBUYS.com and click on the “Register” link on the front page. COMMBUYS Vendor Registration Job Aide is also available.

All Quotes must be received by the Department of Public Health before the specified date, month, year and time of the Bid Opening Date displayed on COMMBUYS. Times are Eastern Standard/Daylight Savings (US), as applicable.

All Bidders are advised to allow adequate time for submission by considering potential online submission impediments like Internet traffic, Internet connection speed, file size, and file volume. DPH is not responsible for delays encountered by Bidders or their agents, or for a Bidder’s local hardware failures, such as computers or related networks, associated with bid compilation or submission. Bids submitted via COMMBUYS are time stamped by the COMMBUYS system clock which is considered the official time of record.

Bidders are encouraged to upload attachments well in advance of the Bid Opening Date. This will help to reduce disqualified submissions that can occur if upload is not fully completed or if an attachment is missing at the deadline. Prior to the Bid Opening Date listed in the Procurement Calendar above, documents can easily be deleted and revised versions can be uploaded. If you wish to revise or delete a quote after submission, you may do so prior to the bid opening date. Please review the Withdraw, Reopen, and Resubmit a Quote in COMMBUYS Job Aide for additional instructions.

No Bid in COMMBUYS Quote If you plan to submit a quote to this RFR “No Bid” should not be checked anywhere in your quote in COMMBUYS. This includes on the General Screen and the Items tab. Checking No Bid sends your quote to a different location in COMMBUYS than the rest of the quotes for that Bid and you run the risk of the Department not receiving your response. The department will not guarantee that a bid received with a “No Bid” checked will be reviewed.

Electronic Signatures Quotes submitted via COMMBUYS must be signed electronically by the Bidder or the Bidder’s Agent by accepting the terms and conditions of the bid on the “Terms & Conditions” tab in COMMBUYS. Bidders do this by selecting “Save & Continue” on the “Terms and Conditions” tab after accepting the terms and conditions of the bid. By agreeing to this the submitter attests that s/he is an agent of the Bidder with authority to sign on the Bidder’s behalf, and that s/he has read and assented to each document’s terms.

File Format and Naming Conventions Scanned documents will be accepted and must be scanned in such a way that they can be read on a computer monitor and printed on 81/2” x 11” paper, unless otherwise specified. Attachments must be uploaded individually and cannot be combined in a zipped file.

DPH is requiring that all response attachments that are uploaded in COMMBUYS include the company name of the Bidder, the RFR number and the name of the document. (e.g. Company Name _ RFR Number _Doc Name).

F3: RFR Attachments To assist bidders in identify the purpose of the attachments for this procurement; the forms posted on the COMMBUYS attachment section have a prefix according to the following chart:

F4: COMMBUYS Support

A link to a job aid on How to Submit a Quote on COMMBUYS COMMBUYS Resource Information at www.mass.gov/osd/commbuys Email: Send inquiries to the COMMBUYS OSD Help Desk at OSDHelpDesk@mass.gov Telephone: Call the COMMBUYS Help Desk at 1-888-627-8283 or 617-720-3197. 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.

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

Bidders are advised that COMMBUYS will be unavailable during regularly scheduled maintenance hours of which all users will be notified.

Section G: Other Requirements Pertaining to this RFR Additional RFR requirements can be found in the document “Additional Requirements for Grants” found in the READ folder in the attachments section of COMMBUYS for this RFR.

Fraud Risk Management and Reporting Requirements: Fraud is defined as any intentional illegal act characterized by deceit, concealment, or violation of trust, committed by an individual or organization to obtain money, property, or services; to avoid payment or loss of property or services; or to secure personal or business advantage.

DPH requires that all providers have a zero-tolerance policy for fraud. All DPH providers must maintain internal fraud risk management policies and procedures that include regular risk assessments, internal controls, and a process for reporting and investigating incidents of suspected fraud. Such policies and procedures shall be made available to DPH for review upon written request.

Additionally, in connection with their work for DPH, providers are required to comply with the following obligations related to incidents of suspected fraud:

· Notification to DPH. Written notification of any incident of suspected fraud must be made as soon as possible, but no less than 5 business days, following discovery to your DPH program contract manager.

· Responsibility for Personnel. Providers are solely responsible for the actions of any individuals or entities it employs, contracts with, or otherwise uses in connection with the provision of the work under this RFR to DPH, including, without limitation, any actions by such personnel that may result in an incident of suspected fraud and/or misuse and/or abuse of Commonwealth funds.

· Cooperation. Irrespective of any actions taken by the provider, providers are expected to cooperate fully in any investigation, litigation, or other action deemed necessary by the Commonwealth in connection with an incident of suspected fraud.

· Corrective Measures. Immediately upon becoming aware of an incident of suspected fraud, the provider shall, at its own expense, take all reasonable and appropriate action necessary to mitigate, to the extent practicable, any harmful effect of the incident. Upon request, the provider, at its own expense, shall take such further actions as the Commonwealth may reasonably request, or shall take such additional action to assist the Commonwealth to further mitigate any harmful effect of the incident and prevent recurrence, including, without limitation, strengthening internal controls.

Failure to report incidents of suspected fraud in a timely manner may result in adverse consequences, including, but not limited to, any of the following: recoupment of funds, suspension of payments, required corrective action plans, suspension/termination of program participation and/or any contract with DPH, or civil or criminal penalties.

MDPH use of DocuSign for Execution of Contracts: Contracts and Engagements for the Department are sent through DocuSign. Vendors will be able to use DocuSign to electronically sign and return all applicable contract forms to DPH. A web browser and valid email are all that are needed to access the documents through DocuSign. A DocuSign account is not required. Contracted vendors will be expected to keep their contract contact information updated through the life of their contract with the Department. The Job Aide “How to Sign MDPH Contracts and Engagements” is available in the attachment section for this RFR on COMMBUYS.

MBTA Communities Compliance Grant Policy: The receipt of grant funds is contingent upon the grantee being able to certify that it will comply with the Massachusetts General Laws, including G.L. c. 40A, § 3A, the MBTA Communities Act. Compliance with the MBTA Communities Act is determined by the Executive Office of Housing and Livable Communities.”

Public Records: All information, documents, and attachments submitted as a response to this RFR are considered a public document subject to the Massachusetts Public Records Law, M.G.L., c. 66, s. 10, and to c. 4, s. 7, ss. 26. Please be aware that checking the “confidential” box in COMMBUYS does not bar these documents from being released as a public record pursuant to these statutes once the procurement is awarded, unless statutorily exempt from disclosure.

Vendor Activation Requirements: To receive a contract with state an awarded vendor must be active in The Massachusetts Management Accounting and Reporting System (MMARS). MMARS is the official accounting system of the Commonwealth and once registered a vendor will be issued a Vendor Code number or a “VC” number. This VC number is used for all contracts that a vendor has with state agencies. An organization with existing state contracts or a vendor who has had state contracts with any state agency in the past has been registered in MMARS and does not need to re-submit paperwork again unless existing information in MMARS will need to be updated. Upon notification of a contract award to this RFR, awarded vendors not already registered in MMARS will be sent the required paperwork to be completed before a contract will be awarded which includes a W-9 form, Electronic Funds Transfer (EFT) and Contractor Authorized Signatory Listing.

Virtual Gateway Business Services: The Executive Office of Health and Human Services (EOHHS) operates a number of online business services through the Virtual Gateway. These include but are not limited to, Provider Data Management (PDM), Common Intake (IE&R), Enterprise Invoice / Service Management (EIM/ESM), Home and Community Service Information System (HCSIS), Senior Information Management System (SIMS) Service and Transition Planning System (STARS).

These services permit users to access a variety of EOHHS programs and services. Virtual Gateway business services are accessible by end users with web browsers such as Internet Explorer (6.0 or above), and a broadband Internet connection that is capable of high-speed data transmission, such as a Local Area Network (LAN), a cable modem, or DSL.

PP RFR Template 1-2023