SOURCES SOUGHT
65 -- Hemodynamic Monitoring System
- Notice Date
- 12/27/2017
- Notice Type
- Sources Sought
- NAICS
- 339113
— Surgical Appliance and Supplies Manufacturing
- Contracting Office
- Department of the Air Force, Air Force Materiel Command, AFLCMC/PZIO - WPAFB, 1940 ALLBROOK DRIVE, WRIGHT-PATTERSON AFB, Ohio, 45433-5309, United States
- ZIP Code
- 45433-5309
- Solicitation Number
- FA860118R0015
- Archive Date
- 1/13/2018
- Point of Contact
- Joseph Craven, Phone: 9375224565
- E-Mail Address
-
joseph.craven.1@us.af.mil
(joseph.craven.1@us.af.mil)
- Small Business Set-Aside
- N/A
- Description
- Hemodynamic Monitoring System The Government is conducting market research and identifying, as potential sources, companies that may possess the expertise, capabilities, and experience to meet the requirements as specified in the Program Description below. CAUTION: This Sources Sought is issued solely for information and planning purposes. In accordance with Part 10 of the Federal Acquisition Regulations, the U.S. Government is conducting market research. The intended purpose is to identify potential sources that may possess the expertise, capabilities, and experience to meet 88 MDSS' requirement. It does not constitute a Request for Proposal (RFP) or a promise to issue an RFP in the future. Furthermore, 88 MDSS is not at this time seeking proposals, and will not accept unsolicited proposals. Responders are advised that the Government will not pay for any information or administrative costs incurred in response to this Sources Sought. Please be advised that all submissions become Government property and will not be returned. All costs associated with responding to this Sources Sought will be solely at the responding party's expense. Not responding to this Sources Sought does not preclude participation in any future RFP, if any is issued. In accordance with Federal Acquisition Regulation 15.201(e), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. It is the responsibility of the interested parties to monitor this FedBizOpps website for additional information pertaining to this Sources Sought. INSTRUCTIONS: 1. Below is a document containing a description of the requirement and a Contractor Capability Survey, which allows you to provide your company's capabilities. 2. If, after reviewing these documents, you desire to participate in the market research, you should provide documentation that supports your company's capability in meeting these requirements. Failure to provide documentation may result in the Government being unable to adequately assess your capabilities. If you lack sufficient experience in a particular area, please provide details explaining how you would overcome the lack of experience / capabilities in order to perform that portion of the requirement (i.e., teaming subcontracting, etc.). 3. Both large and small businesses are encourage to participate in this Market Research. Joint ventures or teaming arrangements are encouraged. 4. Questions relative to this market survey should be addressed via e-mail to Mr. Joseph Craven (AFLCMC/PZIBA), joseph.craven.1@us.af.mil no later than 11:00 A.M. EST on Friday, 29 December 2017. Verbal questions will NOT be accepted. PROGRAM DESCRIPTION: The Cardiology Catheterization Laboratory at the Wright-Patterson Air Force Base (WPAFB) Medical Treatment Center (MTC) requires a Hemodynamic Monitoring System. This important and essential piece of equipment will be used to measure and monitor all hemodynamic functions of patients during cardiac catheterizations, direct current cardioversions, transesophageal echocardiograms, and cardiac implants to include pacemaker, defibrillators, bi-ventricular cardiac implants and cardiac event recorders. ESSENTIAL CHARACTERISTICS: The Hemodynamic Monitoring System houses the electrical and mechanical components and software needed to perform measuring and monitoring during cardiology procedures. The Contractor shall provide the proposed Hemodynamic Monitoring System. The Hemodynamic Monitoring System will provide real-time continuous monitoring to include four (4) invasive pressure channels, twelve (12) lead ECG, NIBP, cardiac output, SpO2, and EtCO2. The system will allow hemodynamic analysis, real-time procedure note charting along with patient and procedure detail charting as well as hemodynamic procedure report generation. The system will transmit all caseload data for final reports. CLINICAL CAPABILITIES:  The system will be used for monitoring the following: o 12 Lead ECG (electrocardiogram) o NIBP (non-invasive blood pressure) o 4 Invasive Pressure Channels o Cardiac Output o SpO2 (oxygen saturation) o EtCO2 (end-tidal carbon dioxide monitor)  The system shall include the following: o 4 Invasive Pressure Channels o 12 Lead ECG o SpO2 o NIVP o Cardiac Output o Hemodynamic Analysis o EtCO2 o Real-time procedure notes charting o Patient procedure and visit details charting o Hemodynamic procedure report generation o Cardiology review and charting station o Nurse charting solution o Medical Grade UPS o Cardiology Image and Database Server  The system shall provide the following performance measures: o 4 Invasive Pressure Channels o 12 Lead ECG o SpO2 o NIVP o Cardiac Output o EtCO2 o Hemodynamic Analysis o Real-time procedure notes charting o Patient procedure and visit details charting o Hemodynamic procedure report generation ADDITIONAL REQUIREMENTS:  The system shall have a rack mount database server with online image storage with at least 3800GB usable (300GB for database backups).  The system must be DICOM / DICAP compatible and be approved to connect to the Air Force network prior to installation.  All supplied software, operating systems, databases, etc. (excluding contractor developed application software) must be on the National Information Assurance Partnership approved products list found at https://niap-ccevs.org/ or https://www.commoncriterisportal.org. Contractor must provide proof that Supplied Software is on this approved list.  The system shall be capable of printing reports.  Contractor shall provide user training for how to configure and customize the Hemodynamic Monitoring System. Contractor shall provide a course to reinforce and advance the skills of system super-users.  Contractor shall provide Bio Med Training - providing knowledge, education, and hands-on experience to perform annual system functionality testing of the Hemodynamic Monitoring System along with hardware, network, device cabling, and troubleshooting.  The system shall have at least a one (1) year warranty. MAINTAINABILITY / MAINTENANCE SUPPORT:  The Contractor shall provide maintenance coverage equipment and software for a minimum of three (3) years. Shall provide training for BMET and USER. Contractor will provide installation and set-up of the equipment within the Wright-Patterson Air Force Base Medical Treatment Center. INFORMATION ASSURANCE (IA):  System must meet Department of Defense (DoD) Cybersecurity and Information Assurance requirements.  Contractor shall only quote items which already have an Authorization to Operate (ATO) or items for which the contractor agrees to go through the IA approval process and obtain an ATO. o If the contractor does have an ATO/ATC (Authorization to Connect), the contractor will need to provide a copy of the ATO/ATC approval and signed AF IA contract language. o If the contractor does not have an ATO/ATC, the contractor will need to complete a Joint Medical Device Risk Assessment Questionnaire v1.1 and sign the AF IA contract language.  Submitting a quote for any requirement under this initiative constitutes full agreement to all specific service IA requirements and attached IA document.  Failure to agree to Cybersecurity or attached IA requirement shall result in rejection of a contractor's proposal. Failing to disclose that a system cannot meet IA requirements, failure to meet certification timeframes or failure to receive ATO may result in termination for cause in accordance with FAR 52.212-4(m). GENERAL REQUIREMENTS:  Hemodynamic System with unsupported operating systems (i.e. Windows XP) is prohibited. Only equipment and part numbers that are FDA approved and commercially available may be offered under this requirement. Promises to upgrade the system in the future to meet Government requirements such as providing a supported operating system or IA requirements is prohibited. *Upon initial market research the Hemodynamic Monitoring System meets the above specifications. However, if the contractors are capable to produce an equal item is also being sought after. CONTRACTOR CAPABILITY SURVEY: Part I. Business Information: Please provide the following business information for your firm:  Company/Institute Name:  Address:  Point of Contact:  CAGE Code:  Phone Number:  E-mail Address:  Web Page URL: Based on North American Industry Classification System (NAICS) code 339113 - Surgical Appliance and Supplies Manufacturing, size standard of 500 employees, please circle YES or NO as to whether your company is: Small Business, (Yes / No) Small Disadvantaged Business (Yes / No) o Woman Owned Small Business, (Self-Certified or Third Party Certified) (Yes / No) o Economically Disadvantaged Woman Owned Small Business (Yes / No) o 8(a) Certified (Yes / No) o HUBZone Certified (Yes / No) o Veteran Owned Small Business (Yes / No) o Service Disabled Veteran Small Business (Yes / No) *All interested contractors must be registered in SAM in order to be eligible for award of Government contracts. The Government reserves the right to consider a small business set-aside based upon responses hereto for any subsequent action.*  Please indicate if your company is domestic or foreign owned (if foreign, please indicate the country of ownership).  Indicate if you are the manufacturer or provide the name and siz3e of the manufacturer of the product(s) you will be supplying.  Please provide a statement that the respondent will allow or will not allow the Government to release proprietary data. The Air Force will handle proprietary items in accordance with FAR 2.101 and 3.104.  Please provide information about the firm's standard warranty.  Please provide recent sales history to commercial companies in order to determine commerciality.  Please provide a statement to acceptability of the following proposed provisions and clauses, as they are determined to be consistent with customary commercial practice. No set aside decision has been made; however, the Air Force is contemplating setting this acquisition aside for Small Businesses if there is sufficient demonstrated interest and capability. Note that a key factor in determining an acquisition to be a Small Business Set Aside is that two or more small business prime contractors must be capable of performing at least 50% of the entire scope of the effort, as defined in Federal Acquisition Regulation (FAR) clause 52.219-14, Limitations on Subcontracting. The clause reads, in part, as follows: "Limitations on Subcontracting (NOV 2011)... (c) By submission of an offer and execution of a contract, the Offeror / Contractor agrees that in performance of the contract in the case of a contract for - (1) Services (except construction). At least 50 percent of the cost of Contract Performance incurred for personnel shall be expended for employees of the concern...". Provide specific details and rationale as to how compliance with FAR clause 52.219-14 would be achieved, including specific details regarding teaming arrangements, etc. If subcontracts are to be used, provide anticipated percentage of effort to be subcontracted and whether small or large businesses will be used. Teaming and / or subcontracting arrangements should be clearly delineated and previous experience in teaming must be provided. ATTENTION all potential respondents: If this acquisition is not set aside for small business, it is anticipated that the contract may contain a small business utilization requirement. Please provide feedback on what areas of this requirement are likely candidates for small business subcontracting. Part II. Capability Survey Questions: 1. Name of country where the Hemodynamic Monitoring System is manufactured.. 2. Describe briefly the capabilities of your facility and the nature of the services you provide. Include a description of your staff composition and management structure. 3. Describe your company's past experience on previous projects similar in complexity to this requirement. Include contract number and date, a brief description, agency / organization supported, and point of contact name and telephone number. 4. Are there specific requirements in the documentation that we provide that would currently preclude your product / service from being a viable solution to our requirement? 5. Are there established market prices for our requirement? If you offer this product and / or service to both U.S. Government and commercial sources, is the same workforce used for both the U.S. Government and general public? Is our requirement offered to both under similar terms and conditions? Briefly describe any differences. If your company is interested, submit your responses to joseph.craven.1@us.af.mil. E-mail responses should be received no later than 11:00 A.M. EST on Friday, 29 December 2017. All responses must be UNCLASSIFIED; no classified material will be accepted or considered with this Sources Sought Synopsis. The response to Part I. Business Information should be single spaced, 12pt font. The response to Part II. Capabilities should be limited to no more than 10 pages (8.5x11 inches), single spaced, 12pt font. In addition, identify a representative to support further Government inquiries for clarification of the information provided, if needed. Respondents should indicate which portions of their response are proprietary and should mark them accordingly. The Air Force will handle proprietary items in accordance with FAR 2.101 and 3.104. Responses to questions from interested parties will be promptly answered and posted on this FedBizOpps website, unless some release of proprietary information is involved or the answer addresses a question peculiar to a company or that company's response. Information feedback sessions may be offered to respondents after the Sources Sought assessments are completed. An Industry Day (date to be determined) with one-on-one information sessions with respondents may be offered to clarify the Government's understanding of their submittal, the capability ramifications, or to discuss their business approach. Be advised that all correspondence sent via e-mail shall contain a subject line that reads "Hemodynamic Monitoring System." If this subject line is not included, the e-mail may not get through e-mail filters at Wright-Patterson AFB. Filters are designed to delete e-mails without subject lines or with suspicious subject lines or contents. Attachments with files ending in.zip or.exe are not allowable and will be deleted. Ensure only.pdf,.doc, or.xls documents are attached to the e-mail.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USAF/AFMC/88 CONS/FA860118R0015/listing.html)
- Place of Performance
- Address: Wright-Patterson Air Force Base, Wright-Patterson AFB Medical Center, Ohio, 45433, United States
- Zip Code: 45433
- Zip Code: 45433
- Record
- SN04776393-W 20171229/171227230534-7e37ce67de2a31c5897822f0cd548c63 (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 |