SOLICITATION NOTICE
B -- REHAB-HF Study
- Notice Date
- 2/10/2015
- Notice Type
- Presolicitation
- 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)-2015-PSOL110
- Archive Date
- 3/7/2015
- Point of Contact
- Samantha A. Kelly, Phone: 3015941571, Rodney E. Brooks, Phone: 3014020751
- E-Mail Address
-
samantha.kelly2@nih.gov, rodney.brooks@nih.gov
(samantha.kelly2@nih.gov, rodney.brooks@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a pre-solicitation non-competitive (notice of intent) synopsis to award a contract without providing for full or open competition (including brand-name). THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR PROPOSAL. A SOLICITATION WILL NOT BE ISSUED AND PROPOSALS WILL NOT BE REQUESTED. The solicitation number is HHS-NIH-NIDA(SS-SA)-2015-PSOL110 and the solicitation is issued as a pre-solicitation notice of intent to award a non-competitive order to Department of Internal Medicine, Cardiology and Geriatrics, Wake Forest School of Medicine, Medical Center Boulevard, Winston-Salem, NC, 27157-1045. This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures, Subpart 13.106-1 (b) (1), Soliciting from a single source and is not expected to exceed the simplified acquisition threshold. Contracts awarded using FAR Part 13-Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6-Competition Requirements. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-05-73, dated April 29, 2014. A notice regarding any set-aside restrictions, the associated NAICS 541690 code and the small business size standard is fifteen million dollars ($15M). This acquisition is being conducted in accordance with the procedures of FAR Part 13-Simplified Acquisition Procedures, FAR Subpart 13.5-Test Program for Certain Commercial Items, and FAR Part 12-Acquisition of Commercial Items. The National Institutes of Health, National Institutes of Drug intends to procure on a sole source basis a service agreement for an inclusive service agreement for the whole head CTF MEG system for a period of 12 months. Purpose and Objectives: 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". 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 where both groups will continue to receive standard care. The purpose of this NIA requirement is to add objective activity monitoring with accelerometry to the REHAB-HF 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. 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. DESCRIPTION OF REQUIREMENT: 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 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 3. TECHNICAL REQUIREMENTS (WORK TO PERFORM): A.Tasks Task 1. Data Collection 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. Task 2. Data management and processing 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 B.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. In addition the Contractor must have a randomized clinical trial in place, funded by another source, with active recruitment of elderly heart failure patients. The existing trial must have an exercise intervention group and a control group. The follow-up period for participants must be at least six months, with at least monthly interactions between staff and participants. This trial must be registered in ClinicalTrials.gov. Place of Performance: Department of Internal Medicine, Cardiology and Geriatrics, Wake Forest School of Medicine Medical Center Boulevard Winston-Salem, NC, 27157-1045 The provision of FAR clause 52.212-1, Instructions to Offerors - Commercial Items (July 2013), applies to this acquisition. The provision of FAR clause 52.212-2, Evaluation - Commercial Items (January 1999), applies to this acquisition. The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The Offeror must include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications - Commercial Items (August 2013), with its offer. The FAR clause is located at http://www.acquisition.gov/far/. FAR clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items (September 2013), applies to this acquisition. There are no additional contract requirement(s) or terms and conditions determined by the contracting officer to be necessary for this acquisition and consistent with customary commercial practices. The Defense Priorities and Allocations System (DPAS) is not applicable to this requirement. This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov." A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement. Respondents that believe that they are manufacturers or authorized resellers of the brand-name product specified in this announcement must provide, as part of their response: (a) product, catalog, model, and/or part number(s); (b) product description; (c) all relevant information and documentation that the item(s) offered meets the salient physical, functional, or performance characteristics as specified in the purchase description; quantity; estimated price or cost; shipping, handling, and/or installation charges; and delivery date after receipt of order. All responses must be received by February 20, 2015 at 12:00pm EST and must reference number HHS-NIH-NIDA(SS/SA)-2015-PSOL110. Responses may be submitted electronically to rodney.brooks@nih.gov and samantha.kelly2@nih.gov or by U.S. mail to the National Institute of Drug Abuse (NIDA), Station Support / Simplified Acquisition Branch (SS/SA), Attention: Rodney Brooks and Samantha Kelly. Fax responses will not be accepted. "All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency."
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIDA-01/HHS-NIH-NIDA(SSSA)-2015-PSOL110/listing.html)
- Record
- SN03638562-W 20150212/150210235028-e3e62f2147fa8db00f152c220ae0b202 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |