SOURCES SOUGHT
B -- REHAB-HF Study
- Notice Date
- 1/30/2015
- Notice Type
- Sources Sought
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, 6001 Executive Boulevard, Room 4211 - MSC 9559, Bethesda, Maryland, 20892, United States
- ZIP Code
- 20892
- Solicitation Number
- HHS-NIH-NIDA(SSSA)-SBSS-15-110
- Archive Date
- 2/21/2015
- Point of Contact
- Rodney E. Brooks, Phone: 3014020751
- E-Mail Address
-
rodney.brooks@nih.gov
(rodney.brooks@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- SOURCES SOUGHT NOTICE 1.Solicitation Number:HHS-NIH-NIDA(SSSA)-SBSS-15-110 2.Title: REHAB-HF Study 3.Classification Code: R499 4.NAICS Code: 541690 This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. This notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement and to determine the method of acquisition. It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes. No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. This notice is strictly for research and information purposes only. Background: The National Institute on Aging (NIA) Laboratory of Epidemiology and Populations Studies (LEPS) has a need for a project entitled "Objectively-monitored activity among participants in the REHAB-HF Study". This is a new requirement and will be nested in the Rehabilitation and Exercise Training after Hospitalization: Assessing Benefit in Acute Heart Failure (REHAB-HF) Study which is funded by a grant R01-AG045551, supported by the National Institute on Aging, Geriatrics and Clinical Gerontology Program. REHAB-HF is a multicenter, randomized trial in which patients with congestive heart failure are recruited to be randomized following hospitalization to either an exercise training (or intervention) group or to an attention control group. Both groups will continue to receive standard care. The trial will take place over five years at three clinical sites. The purpose of this new requirement is to add objective activity monitoring with accelerometry to the REHAB-HF Study. This is new work that is currently not part of the grant-funded study. Daily activity in old age can be regarded as a vital sign. Measures of endurance, such as a 6-minute walk test, and measures of function, such as a 6-meter walk, are predictive of mortality and morbidity and measures like this are included in the parent study. However, both of these tests are limited as they are performed within a clinical setting. Objective monitoring with accelerometry can be used to monitor physical activity in everyday life, including during sleep. These data yield information about the volume, duration, intensity and distribution of activity to predict health outcomes. Clinical application of monitoring for chronic disease is just beginning and there are no other studies with continuous monitoring of acute decompensated heart failure (ADHF) patients. We propose continuous objective monitoring in the REHAB-HF Study to address hypotheses about the effect of the intervention and to provide information about subclinical change in activity predictive of ADHF events. Purpose and Objectives: As the REHAB-HF Study begins recruitment and randomization, this new NIA requirement has three objectives: OBJECTIVE 1: Data Collection -- All participants in REHAB-HF, regardless of group, will be entered into the accelerometry substudy except those who refuse participation. Participants will be given an accelerometer to wear for the entire time they are participating in the trial. Arrangements will be made for exchange of the accelerometers over the course of the study to prevent battery failure and loss of data. OBJECTIVE 2: Data Processing -- All raw data from the accelerometry will be downloaded at the clinical sites and set to the Laboratory of Epidemiology and Population Sciences at the National Institute on Aging. There the data will undergo additional quality control, transformation, and calculation of standardized variables. The calculated variables will be transmitted back to the REHAB-HF data center where they will be joined to the master dataset. OBJECTIVE 3: Data Analysis -- The Laboratory of Epidemiology and Population Science at the National Institute on Aging will combine accelerometer data with clinical data from the parent study (REHAB-HF) to conduct hypotheses testing. For this purpose, standard statistical and epidemiologic methods will be used. Scope of Work: The grant-funded REHAB-HF Study will recruit 360 patients at least 60 years of age and who have been hospitalized with ADHF to participate in a trial of a multi-domain rehabilitation, including endurance, mobility, strength, and balance. Participants will be randomized to exercise intervention or attention control groups. After screening, recruitment, and randomization, 180 participants will have their first session of training prior to discharge and thereafter have three sessions a week as an outpatient for three months. Participants in the attention control arm will receive all services ordered by their physicians and will be contacted bi-weekly by study staff. Evaluations of endurance, physical function, and quality of life will be performed at one week, one month, and three months in the trial. Clinical events will be monitored for three additional months with phone calls every month. Through this new requirement from NIA LEPS, all randomized REHAB-HF Study participants will be asked to wear accelerometers continuously for the six months that they are enrolled in the study. The purpose of this study is to collect objective activity measurements in the two arms (or patient groups) of the trial during a six-month period. Physical activity and sedentary behavior will be evaluated from the accelerometer recordings. Comparison of the patterns of activity between the intervention group with the control group will provide new insight into the broader lifestyle and health effects of the different rehabilitation courses. Activity monitoring will also be evaluated as a potential new risk indicator of rehospitalization or other events requiring emergency medical care. The Contractor shall be responsible for distributing the accelerometers to all REHAB-HF participants at recruitment, tracking of instruments, coordinating exchange of devices when batteries are depleted, downloading data from the devices, securely transferring the data to the NIA LEPS, and providing requested data for analysis at NIA. The Contractor shall be responsible for protection of any personal identifying information (PII) that is obtained from participants in the REHAB-HF Study. No PII is required in the transfer of accelerometer data to NIA LEPS. The following three goals shall satisfy NIA's requirement for this project: 1)Support all data collection activities. 2)Conduct data management, maintenance, and distribution of data files. 3)Enable analysis of the data integrating the accelerometry data with the trial data. The Contractor shall provide: Data Collection, Management & Processing Data collection consists of initialization of accelerometers, distribution of devices to participants, tracking of the devices, and timely exchange to avoid loss of data. The Accelerometry Operations Manual in Appendix 1 includes instructions for initialization of the devices, a standardized script for participant contact to explain the device and its purpose, accelerometer wear instructions, a trouble-shooting guide, and tracking forms. Clinic staff training and certification will be conducted at each clinic site by NIA personnel. The ActiGraph GTX3+ wrist-worn accelerometers will be used during the entire six-months of the trial to assess activity measures including intensity, duration, and distribution in addition to sleep parameters. Accelerometers objectively assess activity with minimal participant burden and good compliance. ActiGraph accelerometers have been primarily manufactured for research purposes, with uses including monitoring patient populations. The GT3X+ has a rechargeable battery life of approximately 4 weeks, collecting data at 30Hz. Previous accelerometry studies conducted by NIA LEPS have used the ActiGraph GTX3+ monitors and specialized quality control and data processing programs have been designed specifically for data from these monitors. The Contractor will purchase the ActiGraph GTX3+ monitors for use in this requirement. All randomized participants in the REHAB-HF Study will be recruited to wear accelerometers continuously for six months, following the schedule below for distribution, device return, and redistribution: a)The data collection shall begin with the first distribution of accelerometers when participants are still in the hospital. All study participants, regardless of randomization assignment, will wear the accelerometer from the time of randomization to the one month visit. This will capture recovery activity in the first month after hospitalization. For the purposes of NIA LEPS's project, the first two weeks of accelerometry measurement will be the baseline against which further gains or declines are measured. b)Intervention group participants will return their devices and receive new devices with a full battery charge at their first and third follow-up clinic visits and during a rehabilitation session for month 2. c)Control group participants will return their devices and receive new devices with a full battery charge at their first and third follow-up clinic visits and during a home visit at month 2. d)During the three months of post-intervention monitoring, all participants will return their devices and receive new devices with a full battery charge during home visits at months 4, 5, and 6. At the end of the month 6, data collection for the participant is complete and a new device will not be issued. At each contact with participants, the Contractor shall collect data on episodes of dyspnea relieved by medication at home, episodes requiring seeing a physician under usual care, an episode requiring use of emergent care but not requiring hospitalization, and hospitalizations. These data will later be used in analysis of objective monitoring to assess signals of subclinical and clinical deterioration as identified by everyday motion. Data management responsibilities in this study involve tracking of accelerometers, downloading data from returned devices, transferring data to NIA LEPS, and responding to quality control queries from the NIA LEPS Project Office. The Accelerometry Operations Manual in Appendix 1 includes instructions for downloading data from the devices and transferring the data securely to NIA LEPS. The Contractor shall provide data collection forms for monitor tracking, refusal tracking, complaint tracking, and relevant medical events. All data from these sources shall be entered into a single database. The Contractor shall institute measures to minimize data entry errors and time spent correcting the data. The Contractor shall track all accelerometers given to the participants and shall record any complaints from participants regarding their wearing the accelerometers. Tracking distribution and receipt of the accelerometers will be closely tied to the participant's scheduled visits and contact for the main Study. Serial numbers will be recorded and battery level will be noted. Tracking of participant refusals or drop-out will be recorded and included in data delivered to NIA LEPS. Quality control measures will include training and certification of Field Center staff on the accelerometer distribution protocol and administering questionnaires. Training and certification shall be done by NIA LEPS staff and will consist of reading of the manual of operations, review of the data collection forms, and practicing the standardized scripts and distribution of monitors to participants. Periodic checks of the data in the Laboratory of Epidemiology and Population Sciences will serve as quality control assessments with feedback as needed for staff. For further quality control and assurance, the Contractor will conduct quarterly conference calls with the Field Centers and the NIA Project Office to discuss and resolve issues related to data quality and management. From the NIA LEPS Analysis Center, the raw accelerometer data files and the analysis variables created from the participant data will be sent to the REHAB-HF trial so that this material can be incorporated into the final parent study dataset. The raw data files will serve as an archive since with development of new algorithms for analysis, new analytic strategies may emerge. Other variables may be added. The Contractor shall be responsible for ensuring that all data released is de-identified to HIPAA and Privacy Act standards. De-identified raw data files will reside at the NIA as well as at Wake Forest. Section 508 This language is applicable to Statements of Work (SOW) or Performance Work Statements (PWS) generated by the Department of Health and Human Services (HHS) that require a contractor or consultant to (1) produce content in any format that could be placed on a Department-owned or Department-funded Web site; or (2) write, create or produce any communications materials intended for public or internal use; to include reports, documents, charts, posters, presentations (such as Microsoft PowerPoint) or video material that could be placed on a Department-owned or Department-funded Web site. Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d) requires Federal agencies to purchase electronic and information technologies (EIT) that meet specific accessibility standards. This law helps to ensure that federal employees with disabilities have access to, and use of, the information and data they need to do their jobs. Furthermore, this law ensures that members of the public with disabilities have the ability to access government information and services. There are three regulations addressing the requirements detailed in Section 508. The Section 508 technical and functional standards are codified at 36 CFR Part 1194 and may be accessed through the Access Board's Web site at http://www.access-board.gov. The second regulation issued to implement Section 508 is the Federal Acquisition Regulation (FAR). FAR Part 39.2 requires that agency acquisitions of Electronic and Information Technology (EIT) comply with the Access Board's standards. The entire FAR is found at Chapter 1 of the Code of Federal Register (CFR) Title 48, located at http://www.acquisition.gov. The FAR rule implementing Section 508 can be found at http://www.section508.gov. The third applicable regulation is the HHS Acquisition Regulation (HHSAR). Regardless of format, all Web content or communications materials produced for publication on or delivery via HHS Web sites - including text, audio or video - must conform to applicable Section 508 standards to allow federal employees and members of the public with disabilities to access information that is comparable to information provided to persons without disabilities. All contractors (including subcontractors1) or consultants responsible for preparing or posting content intended for use on an HHS-funded or HHS-managed Web site must comply with applicable Section 508 accessibility standards, and where applicable, those set forth in the referenced policy or standards documents below. Remediation of any materials that do not comply with the applicable provisions of 36 CFR Part 1194 as set forth in the SOW or PWS, shall be the responsibility of the contractor or consultant retained to produce the Web-suitable content or communications material. The following Section 508 provisions apply to the content or communications material identified in this SOW: •36 CFR 1194.21 (all) •36 CFR 1194.22 (all) References: HHS Policy for Section 508 Electronic and Information Technology (E&IT) (January 2005): http://www.hhs.gov/od/Final_Section_508_Policy.html HHS Section 508 Web site: http://508.hhs.gov/ HHS ASPA Web Communications Division Web site: http://www.hhs.gov/web/policies/index.html US General Services Administration (GSA) Section 508 Web site: http://www.section508.gov/index.cfm A.Required Reports/Deliverables The Contractor shall prepare and submit the reports described below. Reports should be submitted to the Contracting Officer (CO) and COTR as electronic documents in either Microsoft Word or PDF format. 1)Quarterly Progress Reports The Contractor shall submit quarterly reports that describe the activities conducted during the reporting period. Each quarterly report shall include number of participants recruited, number of contacts per participant for the accelerometer distribution or return, summary of refusals, complaints, other pertinent information from participant interactions with clinic staff, and a report on devices stability in terms of device failures, lost data, and devices which are lost or broken. A quarterly report shall not be required in the final year of the contract, as it is replace by the Final Report described below. 2)Final Report A Final Report is due one month prior to the contract expiration date. This report shall include all of the same information required in the Quarterly Progress Reports, as well as a summary report on the completion of the study with regard to the Tasks outlined herein. Anticipated period of performance: March 1, 2015 through February 28, 2018. Capability statement /information sought. Interested organizations must provide clear and convincing documentation of their capability of providing the item(s) specified in this notice. Interested organizations that believe they possess the ability to provide the required items must submit specific documentation of their ability to meet each of the project requirements to the Contract Specialist. Interested organizations must provide their Company Name, DUNS number, Physical Address, and Point of Contact Information. Interested organizations are required to identify their type of business, applicable North American Industry Classification System (NAICS) Code, and size standards in accordance with the Small Business Administration. The Government requests that no proprietary or confidential business data be submitted in a response to this notice. However, responses that indicate the information therein is proprietary will be properly safeguarded for Government use only. Capability statements must include the name and telephone number of a point of contact having authority and knowledge to discuss responses with Government representatives. Capability statements in response to this market survey that do not provide sufficient information for evaluation will be considered non-responsive. When submitting this information, please reference the solicitation notice number. The respondent must also provide their DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HubZone, etc.) pursuant to the applicable NAICS code and any other information that may be helpful in developing or finalizing the acquisition requirements. One (1) copy of the response is required and must be in Microsoft Word or Adobe PDF format using 11-point or 12-point font, 8-1/2" x 11" paper size, with 1" top, bottom, left and right margins, and with single or double spacing. The information submitted must be must be in and outline format that addresses each of the elements of the project requirement and in the capability statement /information sought paragraphs stated herein. A cover page and an executive summary may be included but is not required. The response is limited to ten (10) page limit. The 10-page limit does not include the cover page, executive summary, or references, if requested. The response must include the respondents' technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses. All capability statements sent in response to this Sources Sought Notice must be submitted electronically (via email) to Rodney E. Brooks, Contract Specialist, at rodney.brooks@nih.gov in MS Word format by or before the closing date of this announcement. All responses must be received by the specified due date and time in order to be considered. Facsimile responses are NOT accepted. The response must be received on or before February 6, 2015 12 pm, eastern time. "Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a presolicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s)." Contracting Office Address: 31 Center Drive Room 1B59 Bethesda, Maryland 20892 Primary Point of Contact.: Rodney E. Brooks Rodney.brooks@nih.gov
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