SOURCES SOUGHT
A -- Protocol in the Prevention of Pressure Ulcers during En Route Care
- Notice Date
- 4/13/2015
- Notice Type
- Sources Sought
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- US Army Medical Research Acquisition Activity, ATTN: MCMR-AAA, 820 Chandler Street, Frederick, MD 21702-5014
- ZIP Code
- 21702-5014
- Solicitation Number
- W81XWH-15-ISRPRESSUREULCERSTUDY
- Response Due
- 4/23/2015
- Archive Date
- 6/12/2015
- Point of Contact
- Colleen Bowers, 301-619-9599
- E-Mail Address
-
US Army Medical Research Acquisition Activity
(colleen.m.bowers3.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- 1. RFI Number: W81XWH-15-ISRPressureUlcerStudy 2. RFI / Sources Sought Title: USAISR Protocol in the Prevention of Pressure Ulcers during En Route Care 3. Agency: United States Army Institute of Surgical Research) (USAISR) 4. Office: United States Army Institute of Surgical Research) (USAISR) 5. Contracting Office: U.S. Army Medical Research Acquisition Activity (USAMRAA), Fort Detrick, Frederick, MD 6. Location: Place of performance will be at the vendor location. 7. Synopsis: In accordance with Federal Acquisition Regulation (FAR) 15.201 quote mark Exchange with industry before receipt of proposals quote mark and (FAR) 52.215-3, quote mark Request for information or Solicitation for Planning Purposes, quote mark this RFI is for information and planning purposes only at this time and shall not be construed as a solicitation or as an obligation or commitment by the Government nor will the Government pay for information solicited. The Government anticipates issuing a Request for Proposal (RFP) within the next few months. This RFI does not restrict the Government to an ultimate acquisition approach. No evaluation letters and/or results will be issued to the respondents. At this time, no solicitation exists; therefore, please do not request a copy of the solicitation. NO PHONE CALLS PLEASE. Offerors not responding to this RFI will not be precluded from responding to the solicitation. When the solicitation is released, it will be synopsized in Federal Business Opportunities (FedBizOpps) at https://www.fbo.gov. It is the responsibility of any potential Offeror to monitor this site for the release of any solicitation or synopsis. 8. Background: USAISR is part of the U.S. Army Medical Research and Materiel Command (USAMRMC). The USAISR is dedicated to both laboratory and clinical trauma research. Its mission is to provide requirements - driven combat casualty care medical solutions and products for injured soldiers from self-aid through definitive care cross the full spectrum of military operations; provide state-of -the art trauma, burn, and critical care to Department of Defense beneficiaries around the world; and provide Burn Special Medical Augmentation Response Teams. 9. Scope and Purpose: The University/Company shall support the USAISR in development of evidence-based checklist for en-route care. Under conditions simulating Role I-Role II/III transport in healthy subjects describe skin interface pressure and transcutaneous oxygen (tcPO2) over bony prominences (sacrum and heel) that are high risk for pressure ulcer development. The specific aim of the study is develop innovative strategies that can be immediately implemented to alleviate the risk of pressure ulcer development in this austere environment. 9.1. Subjects will be positioned, supine or supine with 30 degree backrest, on the NATO litter with standard aeromedical evacuation mattress and multiple physiological parameters will be recorded along with the collection of subject demographic information. Skin Interface Pressure - is the pressure at the interface between a bony prominence, the overlaying skin, and a support surface is called the interface pressure. Peak interface pressure, which is the highest measured pressure for each body region will be measured using a specialized mattress system that is placed between the subject and the mattress. Transcutaneous oxygen (tcPO2) - transcutaneous oximetry measures oxygenation under loaded and unloaded conditions and will be the method to measure ischemia. Demographic information - height, weight, calculated BMI 9.2. Environment conditions will be normalized to control for the effect of ambient temperature cutaneous blood flow. The ambient temperature of a controlled exercise lab will be adjusted to 70-73 F. 9.3. Fifteen healthy volunteers, between the ages of 18 and 55 will be enrolled to meet the stratification scheme. Males and females will be included. Subjects will have weight and height measurements as well as body frame size determination obtained. Height and weight are measured using a standard up-right scale. Body frame size measurement is accomplished by using a standard caliper over the elbow. Subjects will be asked to lie on the NATO litter with mattress in two different positions. (Total time on litter 2 hours.) Skin interface pressures will be obtained non-invasively using a thin sensor mat placed between the subject's body and the support surface. The interface pressure mat uses extremely low voltage current and is electrically grounded. In addition tcPO2 electrodes will be placed on the sacrum, heels, and occiput to measure pressure and tissues oxygenation. 9.4. Statistical Plan - This analysis will allow us to inform future research by describing individual variability in physiological parameters over time, to identify appropriate periods for analysis (i.e., can we obtain reliable and valid data with a 20 test period compared to a 45 minute test period) and the feasibility of the methods (i.e., can an individual lie motionless for 45 minutes) For each individual by area and tcPO2 electrode, descriptive statistics will be used to describe skin interface pressure and tcPO2 over time. For each individual, by body area, descriptive plots of interface pressure and tcPO2 over time will be generated. Time series analysis will be conducted to describe within and across person variability in tcPO2 over time. To address the primary hypothesis of this study, a linear mixed model will be used. For this analysis, the data will be collapsed to five minute intervals. For each individual, time and location (sacrum, heels, and occiput) will be analyzed separately with pressure as a covariate. For the sacrum and heels the tcPO2 will be the outcome variable. This analysis will allow for evaluation of the main effect (pressure- tcPO2), time (trend in pressure and tcPO2 over time) and the interaction between pressure and time on tissue oxygenation (tcPO2). This method of analysis has been previously used in a similar study evaluating pressure and tcPO2 in healthy subjects in supine position on a hospital bed and seated positions (wheelchair). Qualitative information to evaluate the feasibility of the design in terms of subject comfort and ability to remain motionless will also be analyzed. A graphical exploration of differences in tcPO2 patterns between subjects who did and did not move during a given study period will be shown. 9.5. Final Report - Final report analyzing differences in skin interface pressure, and indicators of tissue perfusion (transcutaneous oxygen and skin temperature) under baseline conditions. These results will inform the design of intervention trials to evaluate strategies to mitigate risk factors for pressure ulcer development 10. Draft Performance Work Statement (PWS). A Draft PWS dated 13 April 2015, Version 1 (Attachment A) is included with this RFI for informational purposes and identifies the scope of work. The final PWS will be released with the solicitation. 11. North American Industry Classification System (NAICS) Code. The NAICS code for this requirement is 5411712 with a size standard of 500. 12. Capability Statement. The Government encourages all firms to submit a comprehensive and fully integrated Capability Statement that addresses the scope of work in the PWS. The Capability Statement should demonstrate the Offeror's experience, knowledge of, and participation of support services required in the Draft PWS. The Offeror shall state the need to subcontract and approach. The Offeror shall include with the Capability Statement relevant experience from three (3) contracts within in the last five (5) years that demonstrate relevant past experience in similar size, scope, and complexity. 13. Anticipated period of performance: June 2015 through June 2016 14. Response Due Date: Interested parties are requested to submit the Capability Statement in response to this RFI electronically by 3:00 pm (EST) 23 April 2015 via e-mail to Colleen Bowers at colleen.m.bowers3.civ@mail.mil. NO PHONE CALLS PLEASE. 15. Questions: All questions pertaining to the RFI are due by 1:00 pm (EST) 20 April 2015. Only one set of questions per vendor will be accepted. Telephone requests will not be entertained. 16. Instructions to Responders: 16.1. The Government appreciates responses from all interested parties. 16.2. The subject header of the e-mail for submission of questions and/or the RFI response shall be: USAISR Protocol on Prevention of Pressure Ulcers. 16.3. Interested firms should submit up to a ten (10) page response (Capability Statement) that demonstrates the Offeror's ability to perform the scope of work in the Draft PWS. 16.3.1. The Capability Statement should adhere to the following formatting and outline instructions: 16.3.1.1. Capability Statement shall not exceed ten (10) typed pages; additional sheets for cover page, table of contents, tables, and charts will not be counted toward page limitation. 16.3.1.2. Format specifications include 12 point font, single spaced, single sided, 8.5 by 11 inches paper with 1 inch margins. All submissions must be made electronically (as described above) and in one of the following formats: Microsoft Word or Adobe PDF. a. Cover Page (1 page) i.Title ii.Organization iii.Responders technical and administrative points of contact (names, addresses, telephone, fax number and e-mail addresses) iv.Topic area(s) addressed b. Current Technical Expertise, Knowledge, and Management Capability i.Executive Summary ii.Discussion of capabilities / challenges / approach iii.Technical Expertise response, the breadth of disciplines and experience, relevance of Offeror's expertise that demonstrates a full understanding of the specialized and unique nature of all functional technical task requirements to be performed as applied to the mission of USAISR. iv. Management Capability response, the basis of the processes and methodologies required to manage an effort of this size, techniques and managerial skills to perform the scope of work. c.Brief summary of relevant experience from three (3) contracts within the last five (5) years pertaining to the requirement, could be Government or commercial. 16.4. Complete the below table and submit with response to this RFI / Sources Sought. QuestionAnswer Solicitation Number Company Name Company Address Point of Contact Telephone Number E-mail Address Tax Identification Number (TIN) DUNS Company Web Page Company Location(s) Company is / is not a 8(a) Small Business Company is / is not registered in SAM Other Classifications (e.g. HubZone, Woman-Owned, Veteran-Owned, Service-Disabled Veteran-Owned) 17. Disclaimer and Important Notes: The purpose of this RFI notice is to gain market knowledge. 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 solution and 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, the Government anticipates releasing a pre-solicitation synopsis and solicitation published in FedBizOpps at https://www.fbo.gov; however, responses to this notice will not be considered adequate responses to a solicitation. 18. Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in the Offeror's response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s). Attached in Word format
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/USAMRAA/DAMD17/W81XWH-15-ISRPRESSUREULCERSTUDY/listing.html)
- Place of Performance
- Address: US Army Medical Research Acquisition Activity ATTN: MCMR-AAA, 820 Chandler Street Frederick MD
- Zip Code: 21702-5014
- Zip Code: 21702-5014
- Record
- SN03697441-W 20150415/150413234609-d37c100bf96533e63d915a7bce006d89 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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