THIS IS A SPECIAL NOTICE OF THE VISN 7 CONTRACTING NETWORK'S INTENT TO SOLE SOURCE. NO HARD COPY OF THE RFQ IS AVAILABLE FOR DISTRIBUTION. This notice is being published in accordance with Federal Acquisition Regulation (FAR) Part 5.101(a)(1) dissemination of information on proposed contract actions and FAR 13.106-1(b)(1) soliciting from a single source for purchases not exceeding the simplified acquisition threshold. The Government anticipates entering into sole source procurement negotiations with Mountain Whisper Light Consulting, LLC, to develop a pain intensity measure for persons with dementia and limited ability to self-report pain. Though many available instruments capture information about the pain of those with limited ability to self-report, there remain four major barriers in developing a practical and clinically relevant pain intensity measurement strategy for this vulnerable population: 1) uncertainty regarding the specificity of some behaviors typically "counted" as indicative of pain; 2) lack of a measure that goes beyond identification of pain presence to estimate pain intensity; 3) lack of an inviolable criterion or "gold standard;" and, 4) uncertainty regarding whether clinicians' global ratings of patients' pain add incremental validity as compared to using observational pain behavior checklists alone. The research proposed here addresses these barriers. This project will strongly impact VHA patient care because: (a) VHA devotes significant resources to long term care (b) the prevalence of dementia in long term care facilities is high, (c) the prevalence of dementia in the veteran population is high and is increasing, and (d) the VHA has identified pain control as a priority clinical and research area. SEE ATTACHED SOW This announcement is for services for which the Government intends to solicit and negotiate with only one source under FAR 6.302-1. Other persons may identify their interest and capability to respond to this requirement by May 15, 2015 at 2:00 PM CST. This Notice of Intent is not a request for competitive proposals. However, all interest received on or before the date and time indicated above will be considered by the Government. A determination by the Government not to open the requirement to competition based upon responses to this notice is solely within the discretion of the Government. Information received as a result of the notice of intent will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. No solicitation document is available. Statement of Work Office of Research and Development I. Title of Project: Development of a Multidimensional Pain Measure for Persons with Dementia II. Background: The goal of this study is to develop a pain intensity measure for persons with dementia and limited ability to self-report pain. Though many available instruments capture information about the pain of those with limited ability to self-report, there remain four major barriers in developing a practical and clinically relevant pain intensity measurement strategy for this vulnerable population: 1) uncertainty regarding the specificity of some behaviors typically "counted" as indicative of pain; 2) lack of a measure that goes beyond identification of pain presence to estimate pain intensity; 3) lack of an inviolable criterion or "gold standard;" and, 4) uncertainty regarding whether clinicians' global ratings of patients' pain add incremental validity as compared to using observational pain behavior checklists alone. The research proposed here addresses these barriers. This project will strongly impact VHA patient care because: (a) VHA devotes significant resources to long term care (b) the prevalence of dementia in long term care facilities is high, (c) the prevalence of dementia in the veteran population is high and is increasing, and (d) the VHA has identified pain control as a priority clinical and research area. III. Purpose of Project: The goal is to develop a multidimensional pain measure for persons with dementia. This research initiative is being carried out at four VA Medical Centers located throughout the east coast. The deliverables from this project will include a multidimensional pain measure scale. a. Description of Work: In order to meet the agency's required need, the service of an experienced biostatistician at the professor level is required. This individual should be a nationally recognized expert in the practice, teaching and research of regression in health services research. The individual would serve from 10/01/2015 through 09/30/2016 for a work effort of 100%. They will provide consultation to the PIMD PI; assist with analyses; contribute to the interpretation of the outcome data; and collaborate in manuscript writing and submission. They will attend investigator teleconference calls, and aid in the interpretation and dissemination of the results. They will advise the Team Leaders on all aspects of analysis, its application to the dementia pain population, and how to handle problems or issues in regard to the dementia pain intervention arm of the study. Mountain Whisper Light Consulting, LLC, will have the primary responsibility for guiding the analyses for this study, and will also supervise and closely work with the statistical analyst. Together they will be responsible for conducting all statistical analyses for the project with the exception of the expert panel and IRT analyses. In addition, Mountain Whisper Light Consulting, LLC will work with the Principal Investigators to develop the REMARK scannable data entry forms for data entry, will provide consultation and advice regarding appropriate data management at the TVAMC and PVAMC throughout the study, and will receive data sets and conduct data management manipulations as necessary to allow for the planned analyses. Privacy and Data Security Considerations: All information provided to Mountain Whisper Light Consulting, LLC will be de-identified data that will have no identifiable patient information. All participants enrolled in the study will have personal identifier stripped prior to being entered into the screening and tracking databases. De-identification of patient information. Prior to reaching the contractor's base, all Tuscaloosa VA Medical Center patient information is required to be de-identified and stripped of indicators such that one skilled in administering medical records could not link medical information to a specific patient. Data which has been stripped of patient identifying indicators such as patient name and address and incorporated into the contractor's comparative or benchmark databases shall cease to be patient information creates large comparative or benchmark patient satisfaction databases to help health care providers improve the efficiency and effectiveness of health care delivery. The contractor may include in their database data that has been de-identified and stripped of indicators such that one skilled in administering medical records could not link medical information to a specific patient. SECURITY CONTROLS COMPLIANCE TESTING On a periodic basis, VA, including the Office of Inspector General, reserves the right to evaluate any or all of the security controls and privacy practices implemented by the contractor under the clauses contained within the contract. With 10 working-days' notice, at the request of the government, the contractor must fully cooperate and assist in a government-sponsored security controls assessment at each location wherein VA information is processed or stored, or information systems are developed, operated, maintained, or used on behalf of VA, including those initiated by the Office of Inspector General. The government may conduct a security control assessment on shorter notice (to include unannounced assessments) as determined by VA in the event of a security incident or at any other time. b. Schedule of Deliverables: i. Period of Performance: 10/01/2015 through 09/30/2016 ii. Description of Tasks and Deliverables: Serve as a consultant analyzing and compiling data Item & Description Quantity " Data management guidance Contractor will be required to work at least 135 hours, not to exceed 300 hours. " Statistical programming " Data analysis " Statistical contributions to articles and reports " Provide consultation and advice regarding appropriate data management at the TVAMC and PVAMC throughout the study IV. Evaluation and Award Factors: a. Past Performance: Extensive background in biomedical research and statistical analysis. b. Specialized skills, expertise, and knowledge: A high level of specialized expertise and experience in the provision of bio statistical analysis is required of this co-investigator for this complex project. Given the complexities of the subject population (nursing home patients with dementia) and the complexities of the required analysis it is essential to secure an individual who is highly specialized. Please feel free to contact
[email protected] for information regarding this special notice.