SPECIAL NOTICE
A -- NASEM Hannon Act for the study of opioids and benzodiazepine on Veterans in fulfillment of the Hannon Act Statute. Notice of intent to Sole Source
- Notice Date
- 9/20/2022 4:30:15 AM
- Notice Type
- Special Notice
- NAICS
- 541714
— Research and Development in Biotechnology (except Nanobiotechnology)
- Contracting Office
- RPO EAST (36C24E) PITTSBURGH PA 15212 USA
- ZIP Code
- 15212
- Solicitation Number
- 36C24E22R0038
- Archive Date
- 10/20/2022
- Point of Contact
- Ann Marie Stewart, Contracting Officer, Phone: 401-919-0878
- E-Mail Address
-
annmarie.stewart@va.gov
(annmarie.stewart@va.gov)
- Awardee
- null
- Description
- Special Notice Page 4 of 4 Special Notice Special Notice Page 1 of 4 Presolicitation Notice of Intent to Sole Source Pre-Solicitation Notice for notice of intent to award a sole source contract. This is not a solicitation. The Veteran s Administration (VA) Office of Research and Development, Regional Procurement Office East in Pittsburgh, PA intends to negotiate on a sole source basis with the National Academies of Sciences, located at 2101 Constitution Ave NW, Washington DC, 20418 to work on a study to evaluate the effects of opioids and benzodiazepine on all-cause mortality of veterans. Section 204 of the Hannon Act requires the VA to work with NASEM to evaluate the effects of opioids on all-cause mortality of veterans, including suicide, regardless of whether information relating to such deaths has been reported by the Centers for Disease Control and Prevention per the Congressionally mandated requirements from Section 204 of the Commander John Scott Hannon Veterans Mental Health Care Improvement Act (2020). (https://www.congress.gov/116/plaws/publ171/PLAW-116publ171.pdf). This requirement is in response to, and in fulfillment of, the Hannon Act statute. NAS is chartered by Congress under 36 U.S.C. Chapter 1503 as a private, non-profit, non-governmental organization to advise the government on scientific and technological matters. Scope The scope of this contract is to provide services as detailed in the Hannon Act Section 204. The project evaluation should seek to quantify the effects of opioid and benzodiazepine prescribing on risk of death among Veterans who received care from the Veterans Health Administration between 2007 - 2019. Because opioids are more lethal than benzodiazepines when either is taken alone, the treatment patterns of greatest clinical importance are: (a) the effect of opioid prescribing for pain, relative to alternative non-opioid pain treatments, (b) the effects of higher doses relative to lower doses of opioids and (c) the effect of co-prescribing a benzodiazepine among patients already receiving opioids, relative to alternative treatments for anxiety and other indications for benzodiazepines. (d) the effect of initiating opioids among patients already taking benzodiazepines. Specific Tasks. For every task, the contractor and any of its subcontractors (hereafter referred to solely as contractor) will identify in writing all the necessary tasks and subtasks (if any), associated costs by task, and together with associated sub-milestone dates. All written deliverables will be phrased in layperson language. Statistical and other technical terminology will not be used without providing a glossary of terms. VHA will receive a copy of the report in final form at the end of the contract. The contractor, and any of its subcontractors, conducting the data analyses shall have experience with: Accessing, using, and analyzing VA data sources, including health care, mental health and pharmacy data Data analysis and data analysis tools, including SAS and SQL. Querying, cleaning, managing, and interpreting data Task 1 Management Task 1, Subtask 1 Develop Draft and Final Workplan. Create a detailed draft workplan that will describe in greater detail than the proposal: How the tasks will be completed, the timeline, and the key personnel, including contractors/consultants How the committee will interact with the VHA subject matter experts (task 3) and support the required analyses and report How it will address the considerations described in the background section above. The plan and timeline for initiating the request for data access, which shall be initiated as early as possible upon award. The proposed number, timing, and purpose of each committee meeting. The proposal shall include a preliminary workplan for how the offeror plans to meet the task requirements and deliverable schedule specified. Task 1, Subtask 2 Monthly Reporting and Calls. Provide a progress report to accompany each invoice that describes the work conducted, challenges/barriers and proposed solutions, and any significant deviations to the original workplan. Monthly calls shall also be conducted to provide project updates and discuss any challenges/barriers. Task 2 - Project Committee. Task 2, Subtask 1 Committee Establishment. Establish a project committee tasked with completing the requirements under this contract. Any committee which participates in conducting the assessments and formulating the recommendations required by this contract will include at least one former official of the Veterans Health Administration (VHA) with expertise in mental health care and at least two former providers of mental health care in the Veterans Health Administration, at least one of whom has experience in pharmacy practices and pharmacoepidemiology. These individuals shall provide the unique perspective for how care, including mental health care, is delivered in the VA, as well as how data is captured and recorded within the VA. VHA may nominate individuals for consideration. Task 2, Subtask 2 Committee Meetings. Schedule, coordinate, and conduct committee meetings to meet the requirements under this contract. The number, timing, and purpose of each meeting shall be specified in the project workplan (Task 1.1) Task 3 Consultation with VHA subject matter experts The contractor shall consult with VHA subject matter experts and hold a minimum of 2 meetings with VHA subject matter experts. Task 3, Subtask 1 VHA Meeting 1. Hold a meeting between Committee members and staff and VA subject matter experts and VA program office leads from the Office of Research and Development and Office of Mental Health and Suicide Prevention to clarify questions of scope, deliverables, and methodology and help inform development of the Task 4.1 project protocol. Collect information on relevant VA policy changes that may be associated with changes in prescribing practices over time. Obtain suggestions of external reviewers for draft report. Task 3, Subtask 2 VHA Meeting 2. Hold a meeting with VHA subject matter experts to present protocol design to receive input on data elements, data quality and limitations, population numbers and power, and any other barriers to completing design as proposed. Task 4 Assessment of the Effects of Opioid and Benzodiazepine Prescribing on Mortality Task 4, Subtask 1 Develop Draft and Final Project Protocol. Subsequent to input from VHA subject matter experts, the research team will develop a comprehensive protocol to assess the mortality impacts of opioid and benzodiazepine prescribing in the period. The protocol shall specify the operational definitions for the analyses, including variables, inclusion/exclusion criteria, comparators, etc. Task 4, Subtask 2 Request and Obtain access to relevant VHA and Medicare data. Analysts working with VA data will obtain appropriate permission as contractors to access data and complete all required onboarding and training. The initial request for data access shall be initiated as early as possible upon award. Task 4, Subtask 3 Draft Report for Technical Review and External Review. Develop draft report and circulate report to at least 5 non-VA external reviewers. Develop draft report for technical review by the VA prior to prepublication. Task 4, Subtask 4 Prepublication Report, Final Report. Submit pre-publication report. The report shall include the study and analytical findings, the context of the findings and current VA practice and policy, overall conclusions, and any recommendations related to current practices in VA prescribing relative to those outlined in current VA policy. Note: VA is fulfilling the Congressional mandate to work with NASEM for this requirement. NASEM provides unique services and skillsets that are highly valuable to the VA in helping improve the health of veterans. This requirement is in response to and in fulfillment of the Hannon Act statute, therefore no other contractor could fill this role. Since the intent is to procure this on a sole source basis, no solicitation will be posted to FedBizOps (FBO). The applicable NAICS code is 541715 with a 1,000 employees size standard. The PSC is AN11. The authority for this action is FAR 6.302-5 Authorized or Required by Statute per 41 USC ยง3304(a)(5). The requirement will take place at the National Academies of Sciences. This notice of intent is not a request for competitive proposals, however; any responsible source who believes it is capable of meeting the requirement may submit a capability statement and supporting documentation for an equal/better service based on the specifications to the contracting office. Solicitation notice 36C24E22Q0169 was posted for this requirement. 36C24E22R0038 is being posted due to a system error in order to post the award notice. Interested persons may contact the Contracting Officer via email at annmarie.stewart@va.gov regarding this procurement. The determination to conduct a competitive procurement based on responses to this notice is solely within the discretion of the Contracting Officer.
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- Record
- SN06471834-F 20220922/220920230119 (samdaily.us)
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