SOURCES SOUGHT
65 -- Cryocath Ablation System
- Notice Date
- 10/23/2017
- 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
- FA8601-18-R-0002
- Archive Date
- 11/21/2017
- Point of Contact
- Paula Williams, Phone: 9375224646
- E-Mail Address
-
paula.williams.4@us.af.mil
(paula.williams.4@us.af.mil)
- Small Business Set-Aside
- N/A
- Description
- Cryocath Ablation System Sources Sought 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 Regulation, 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 source 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 encouraged to participate in this Market Research. Joint ventures or teaming arrangements are encouraged. 4. Questions relative to this market survey should be addressed via email to Ms. Paula Williams (AFLCMC/PZIBA), paula.williams.4@us.af.mil no later than 10:30 A.M. EST on 06 November 2017. Verbal questions will NOT be accepted. PROGRAM DESCRIPTION: The Cardiology Catheterization Laboratory at Wright-Patterson Air Force Base (WPAFB) requires a Cryocath Ablation System. This is important and essential piece of equipment will assist the physicians in performing delicate cardiac ablations of the heart. During a cardiac ablation procedure, pressurized liquid nitrous oxide (N2O) is delivered from a tank in the Cryocath Ablation System. The liquid refrigerant travels in an ultra-fine tube through the coaxial umbilical and the shaft of the cryoablation catheter to the tip of the catheter. The liquid refrigerant vaporizes as it is sprayed into the tip. As it vaporizes, it absorbs heat from the surrounding tissue, thereby cooling and freezing the target tissue. The warmed refrigerant is vacuumed back to the Cryocath Ablation System through a large lumen within the shaft of the catheter and coaxial umbilical. The Cryocath Ablation System discharges the vapor into the hospital scavenging system. ESSENTIAL CHARACTERISTICS: The Cryocath Ablation System houses the electrical and mechanical components and software needed to perform cryoablation procedures. It controls the delivery, recovery, and disposal of cryoablation refrigerant safely and efficiently. The Cryocath Ablation System encompasses the electrical and mechanical components and proprietary software for controlling a cryotherapy procedure with the Arctic Front Advance and Freezor MAX catheters. It stores and controls the delivery of the liquid refrigerant (N20) through the coaxial umbilical to the catheter, recovers the refrigerant vapor from the catheter under constant vacuum, and disposes of the refrigerant through the hospital scavenging system. Multiple features are built into the catheters and the Cryocath Ablation System to promote safety. TECHINCAL REQUIREMENTS (for the Cryocath Ablation System Device): • Height (min & max): 126cm - 157 cm • Depth: 59 cm • Width: 55cm • Weight: 131 kg (without nitrous oxide tank) • Power input parameters: 110/120/230V • Operational parameters: 15-30 Celsius; maximum of 75% humidity • Refrigerant: Liquefied Nitrous Oxide (N2O); 99.5% purity with humidity level < 50ppm ACCESSORY REQUIREMENTS: • Auto Connection Box • Footswitch • ECG Cable • White Scavenging Hose 6.0m / 20ft • N2O Refrigerant Tank (full) • North American Power Cord *Upon initial market research the CryoConsole System meets the above specifications. However, if the vendors are capable to produce an equal item is also being sought after. INSTRUCTIONS: 1. The information below provides a "Contractor Capability Survey" to allow you to document your company's capabilities in meeting these requirements. 2. If, after reviewing these documents, you desire to participate in the market research, please complete and return the Contractor Capability Survey below. Response format and due date information is specified at the bottom portion of this notice. Failure to provide a complete response 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 encouraged to participate in this Market Research. Joint ventures or teaming arrangements are encouraged. Questions relative to this market survey should be addressed via email to Ms. Paula Williams, AFLCMC/PZI, at paula.williams.4@us.af.mil. 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:  Email 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 size 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. At this time the following non-commercial clauses and provisions are being considered for inclusion in the solicitation package: FAR 52.203-6 Alt I, Restrictions on Subcontractor Sales to the Government FAR 52.203-18, Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements or Statements-Representation FAR 52.204-4, Printed or Copied Double-Sided on Postconsumer Fiber Content Paper FAR 52.204-7, System for Award Management FAR 52.204-13, System for Award Management Maintenance FAR 52.204-16, Commercial and Government Entity Code Reporting FAR 52.204-18, Commercial and Government Entity Code Maintenance FAR 52.209-7, Information Regarding Responsibility Matters FAR 52.228-5, Insurance - Work on a Government Installation FAR 52.229-3, Federal, State, and Local Taxes FAR 52.232-39, Unenforceability of Unauthorized Obligations FAR 52.233-2, Service of Protest FAR 52.242-13, Bankruptcy FAR 52.252-1, Solicitation Provisions Incorporated by Reference FAR 52.252-2, Clauses Incorporated by Reference FAR 52.252-5, Authorized Deviations in Provisions FAR 52.252-6, Authorized Deviations in Clauses DFARS 252.203-7002, Requirement to Inform Employees of Whistleblower Rights DFARS 252.204-7000, Disclosure of Information DFARS 252.204-7003, Control of Government Personnel Work Product DFARS 252.204-7004 Alt A, System for Award Management DFARS 252.209-7004, Subcontracting with Firms that are Owned or Controlled by the Government of a Country that is a State Sponsor of Terrorism DFARS 252.225-7002, Qualifying Country Sources as Subcontractors DFARS 252.225-7048, Export-Controlled Items DFARS 252.243-7001, Pricing of Contract Modifications AFFARS 5352.201-9101, Ombudsman AFFARS 5352.223-9000, Elimination of Use of Class I Ozone Depleting Substances (ODS) AFFARS 5352.223-9001, Health and Safety on Government Installations Attention Small business respondents who are interested in submitting a proposal as the prime contractor for this effort: 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 Cryocath Ablation 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 paula.williams.4@us.af.mil. E-mail responses should be received no later than 10:30 A.M. EST on 06 November 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 and requests 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 "Cryocath Ablation 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 emails 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 email.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USAF/AFMC/88 CONS/FA8601-18-R-0002/listing.html)
- Place of Performance
- Address: Medical Materiel, Bldg. 830 Area A, 4881 Sugar Maple Dr., WPAFB, Ohio, 45433, United States
- Zip Code: 45433
- Zip Code: 45433
- Record
- SN04719954-W 20171025/171023230650-235ddcbb36d498b82d1e2c586b8b35c8 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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