Consultation on CSAT Implementation of the Opioid Training Program (OTP) Regulations

Description: Consultation on CSAT Implementation of the Opioid Training Program (OTP) Regulations The Program Support Center, plans to award a sole source Simplified Acquisition Procedures to Elsworth Dory Support Systems. 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 Team Leader of the Certification and Waiver Team, DPT, CSAT, and SAMHSA in programs and services of national importance. Understanding of the substance abuse and health delivery systems is essential, as is knowledge of pharmacologic treatment. OBJECTIVE The objective 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 three days/week and off-site via extranet at least two 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 distribution programs. - Trains incoming and incumbent staff of DPT on compliance activities; - Conducts inspections (up to six per year) to treatment programs for cause; and - Provides technical assistance to new treatment programs. - Provides guidance on compliance with Federal confidentiality and privacy regulations. SCOPE OF WORK A. General Requirements 1. Independently, and not as an agent of the Government, the contractor shall exert its best efforts and furnish the necessary personnel, facilities, equipment, materials and supplies, and perform the work set forth below. 2. All work under this project shall be monitored by the Government Project Officer (GPO). 3. 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 GPO for comment and revision. The contractor shall then submit a final work plan for approval. The work plan shall describe major projects and associated time lines, suggested participants and treatment provider organizations to be involved, and description of products to be developed. Task 2 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 GPO comments and submit a final report containing revisions. Task 3 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. The consultant with identify at least 20 OTPs who do not submit exceptions, investigate how the programs are complying with patient needs without accessing the exception process. B. Assist CSAT in a series of consultations with treatment providers and State Authorities to implement and administer the Regulation. 1. The consultant will prepare background materials and facilitate a series of OTP inspections. On-site inspections will be to OTPs on the basis of "For Cause." The consultant will identify and recommend at least four OTPs per quarter for inspections, and conduct at least 5 direct inspections per year. The recommendations should be based upon a qualitative review of State Inspection Reports, Accreditation Reports, patient complaints, and other information. 2. The contractor will draft updated standards for on-site inspections. The contractor will revise the draft report in response to GPO comments and submit a final report containing revisions. SCHEDULE OF DELIVERABLES Task 1 The contractor will submit a draft work plan to the GPO for comment and revision. The contractor will then submit a final work plan for approval. The work plan shall describe major projects and associated time lines, suggested participants and treatment provider organizations to be involved, and description of products to be developed. DUE 4 WEEKS AFTER AWARD Task 2 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. There will be one in service training every two months. B. The contractor will submit a draft report of the recommendations of the Federal consultation sessions, with specific plans including recommended participants, products, delivery schedule. The contractor will revise the draft report in response to GPO 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 will revise the draft report in response to GPO comments and submit a final report containing revisions. DUE 6 WEEKS AFTER AWARD Task 3 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 will revise the draft report in response to GPO 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 GPO 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 and State Authorities to implement and administer the Regulation. D. The consultant will prepare background materials and facilitate a series of site visits (proposing at least 2 visits per quarter, and conducting no less than 5 per year) to OTPs. Site visits will be to OTPs on the basis of "For Cause." E. The contractor will submit a draft report on the desirability and feasibility of developing contracting standards for site visits. The contractor will revise the draft report in response to GPO comments and submit a final report containing revisions. FIRST THRU ELEVENTH MONTH Period of performance: From May, 21, 2011 through May 20, 2012 Interested firms may identify their interest and capability to respond to the requirement or submit proposals. This notice of intent to award is not a request for competitive proposals. A determination to compete this proposed contract based on responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement.