10.03 - SOW - Consulting Services.doc

Solicitation No. 270-23-0615

Attachment 1

Implementation of the Opioid Treatment Program (OTP) Regulations Consulting Services Statement of Work (SOW)

A. BACKGROUND

Under the Substance Abuse and Mental Health Services Administration (SAMHSA)

Regulation (42 CFR Part 8) compliance with narcotic treatment standards are monitored and enforced through a process of on-site surveys and inspections by accrediting bodies. Under this Regulation, an Opioid Treatment Program (OTP) shall be considered for certification by SAMHSA if the program is accredited by a SAMHSA-approved accreditation body. Accreditation, along with additional information, serves as the basis by which SAMHSA will make the determination the opioid treatment services are provided by qualified individuals and that the OTP is in compliance with standards that address the medical use of opioid drugs.

For-cause inspections are directed toward programs that are suspected of violating established Federal opioid standards, accreditation elements, providing substandard treatment, threatening the public health or being a possible source of diverted medications. In carrying out these responsibilities, the consultant supports the Director of the Division of Pharmacologic Therapies (DPT), and the Regulatory Programs Branch Chief in CSAT, SAMHSA regarding programs and services of national importance. Understanding of the substance abuse and health delivery systems is essential as well as knowledge of medication-assisted treatment.

B. PURPOSE

The purpose of this purchase order is to obtain expert consultation to CSAT to help assure that CSAT’s regulation of OTPs is consistent with the experience from the past. DPT seeks assistance in facilitating implementation and interpretation of regulations, guidelines, inspectional findings, and proposed compliance actions:

· Reviews individual patient exceptions and treatment program exemptions on site five days/week. Advises higher management within DPT on said exceptions and exemptions.

· Reviews reports from State, Federal inspections and provides advice on appropriate follow-up actions.

· Reviews existing emergency medication distribution plans to develop a DPT strategy on emergency medication distributions programs.

· Trains incoming and incumbent staff of DPT on compliance activities.

· Conduct site visits (up to six per year) to treatment programs for cause.

· Provides technical assistance to new treatment program; and

· Provides guidance on compliance with Federal regulations.

C. SCOPE OF WORK

A.

General Requirements

All reports, and materials produced under this project shall be the property of the Federal Government, which includes SAMHSA. SAMHSA may utilize, print, or disseminate such material without further charge.

B.

Specific Requirements

Task 1

The contractor shall submit a draft work plan to the Project Officer for comment and revision. The contractor shall then submit a final work plan for approval. The work plan shall describe major projects and associated timelines, suggested participants and treatment provider organizations to be involved, and description of products to be developed.

Anticipated level of effort is 200 hours Task 2

Consult with DPT staff in the provision of technical assistance and materials development to assist States in providing treatment services.

A. Review of patient exceptions and program exemptions in accordance with established Review Checklist.

1. The consultant will maintain and facilitate an intensive collaborative process between DPT and the OTPs, for the purpose of continuing an exception review checklist for OTPs, and DPT staff involved in review and approval of OTP patient exceptions.

B. Assist CSAT in a series of consultations with treatment providers to implement and administer the Regulation.

1. The contractor will draft updated standards for on-site inspections. The contractor shall revise the draft report in response to the Project Officer’s comments and submit a final report containing revisions.

Anticipated level of effort is 600 hours

Task 3

Provide consultation to DPT staff for implementation and administration of the Regulation.

A.

Provide consultation to DPT in convening and facilitating training sessions with Federal staff from DPT, other Federal Agencies, and non-federal participants to address issues identified in the SAMHSA

Regulations, including new modifications, and reporting issues.

B.

The contractor will submit a draft report of the recommendations of the Federal training sessions (reference in A. above), with specific plans including recommended participants, products, delivery schedule.

The contractor will revise the draft report in response to Project Officer comments and submit a final report containing revisions.

Anticipated level of effort is 400 hours

D. SCHEDULE OF DELIVERABLES

Task 1

The contractor will submit a draft work plan to the Project Officer for comment and revision. The contractor shall then submit a final work plan for approval. The work plan shall describe major projects and associated timelines, suggested participants and treatment provider organizations to be involved, and description of products to be developed.

Deliverable Due Date - 4 Weeks After Award Task 2

A. Consult with CSAT and DPT in the provision of technical assistance and materials development in the coordination of training to assist States and counties in providing treatment services in new treatment programs (OTPs). The contractor shall revise the draft report in response to Project Officer comments and submit a final report containing revisions. The contractor shall revise the draft report in response to the Project Officer comments and submit a final report containing revisions. The consultant will provide a draft plan for identifying OTPs not submitting patient exceptions (Item 3, A,1) to the Project Officer for comment.

B. Review of patient exceptions and program exemptions using established Review Checklist.

C. Assist CSAT in a series of consultations with treatment providers to implement and administer the Regulation.

D. The contractor will submit a draft report on the desirability and feasibility of developing standards for site inspections. The contractor will revise the draft report in response to the Project Officer comments and submit a final report containing revisions.

Deliverable Due Date - 8 Weeks After Award Task 3

Provide consultation to DPT staff for implementation of the modified regulations, guidelines, and field advisories.

A.

Provide consultation to CSAT in convening and facilitating training sessions with Federal Staff from DPT to address current issues related to the Regulation.

B. The contractor will submit a draft report of the recommendations of the Federal consultation sessions, with specific plans including recommended participants, products, and delivery schedule. The contractor will revise the draft report in response to the Project Officer comments and submit a final report containing revisions.

C. Consult with CSAT and DPT in the provision of technical assistance and materials development in the coordination of training to assist States and counties in providing treatment services in new treatment programs (OTPs). The contractor shall revise the draft report in response to Project Officer comments and submit a final report containing revisions.

Deliverable Due Date - 12 Weeks After Award E.

REQUIRED SKILLS AND KNOWLEDGE

Personnel Preferred Qualifications:

1) The contractor is preferred to have at least 10 years of experience in Federal regulatory oversight of medications for opioid use disorder (MOUD), Federal and state decision making, and a background in investigative and compliance methods.

2) The contractor is preferred to have at least 10 years of experience with investigative techniques, compliance methods, and intensive knowledge of monitoring OTPs to ensure their compliance with Federal and state narcotic regulations.

3) The contractor must exhibit knowledge skills and ability to influence, mediate, and negotiate in sensitive highly controversial areas with Federal, state, public, and private organizations.

Personnel Qualifications:

You must have 10 years specialized experience to successfully perform the following duties:

Analyzing or evaluating the effectiveness of public health programs and develop recommendations for improvements to policies and operations AND collecting, compiling, and interpreting public health data from a variety of sources, and preparing summary statements, briefings, and reports of recommendations for senior management.

F.

TRANSITION PHASE-IN/OUT PLAN

1. Upon request from the COR, in accordance with this requirement, the contractor shall provide a plan for outgoing transition for transitioning work from an active award to a follow-on award or to a Government entity. This transition may be to a Government entity, another contractor, or the incumbent contractor under a new award. The contractor shall assist the Government in planning and implementing a complete transition from the award issued under this RFQ to the follow-on entity.

2. A transition phase-in plan is required to ensure minimum disruption to vital Government business and must be completed within 30 calendar days after award. Upon completion of the phase-in period the contractor shall be fully staffed and prepared to begin full performance under the requirements of the Task Order. The contractor shall ensure that there will be no service degradation during phase-in. The contractor shall propose a phase-in approach in their management approach and it will be discussed at the Task Order Kick-Off Meeting.

(a) The transition phase-in plan must address the following:

· How the successor contractor will work with the incumbent contractor to facilitate an orderly transition.

· How the successor contractor will work with the incumbent contractor to continue performance without interruption.

· How the successor contractor will furnish phase-in training.

· The phase-in period of performance.

· The personnel involved in the phase-in.

· Cost estimate for the phase-in period.

3. A transition phase-out plan is required to facilitate a seamless transition from the incumbent to incoming contractor or government personnel at the expiration of the award. The contractor shall provide a phase-out plan not later than ninety (90) calendar days prior to expiration of the award. The contractor shall identify how it will coordinate with the incoming Contractor and/or Government personnel to transfer knowledge regarding the following:

(a) Project management processes

(b) Points of contact

(c) Location of technical and project management documentation

(d) Status of ongoing technical initiatives

(e) Appropriate contractor to contractor coordination to ensure a seamless transition

(f) Transition of all Personnel

(g) Identify schedules and milestones

(h) Identify actions required of the Government

(i) Establish and maintain effective communication with the incoming contractor/Government personnel for the period of the transition via status meetings

(j) How the incumbent contractor will work with the successor contractor to facilitate an orderly transition.

(k) How the incumbent contractor will work with the successor contractor to continue performance without interruption.

(l) How the incumbent contractor will furnish phase-out training and a date for transferring responsibilities for each level of work of the requirement.

(m) The phase-out period of performance

(n) The personnel involved in the phase-out.

(o) Cost estimate for the phase-out

4. At the end of the award, if deemed necessary by the Government, the contractor shall provide similar phase-in/phase-out training and support to the successor contractor, in accordance with FAR 52.237-3, Continuity of Services (Jan 1991).