Description Subject: Request for Information (RFI/Sources Sought), for repetitive Transcranial Magnetic Stimulation (rTMS) devices, for the Department of Veterans Affairs, Health Administration (VHA), Office of Mental Health Services. This source sought RFI is being published in accordance with Title 38 U.S.C. § 8127.The Veteran Health Administration (VHA), Office of Mental Health Services has identified Repetitive Transcranial Magnetic Stimulation (rTMS) as a viable candidate item for standardization. The response from this RFI may result in the issuance of a solicitation. This sources sought encourages potential contractors to submit a non-binding statement of interest and documentation substantiating they have a product they feel meets the stated Minimum Technical Requirement (MTR s). Further, it is intended to assess industry s capability to support and develop an adequate solution to the Governments continuing need(s). The Strategic Acquisition Center (SAC) is requesting responses from qualified manufacture business concerns; the qualifying NAICS code for this effort is 339112 Surgical and Medical Instrument Manufacturing. This sources sought is to gain knowledge of potential qualified sources and their size classifications (Service Disabled/Veteran-Owned Small Business (SDVOSB/VOSB), Hub Zone, 8(a), small disadvantaged, women-owned small business, or large business) relative to NAICS 339112. Responses to this notice will be used by the Government to make appropriate acquisition decisions. After review of the responses to this notice, a solicitation announcement may be published. Responses to this RFI or sources sought are not considered adequate responses to any corresponding solicitation announcement. All interested offerors will have to respond to any resulting solicitation announcement, in addition to responding to this RFI or sources sought. PLEASE INDICATE WHETHER YOU HOLD A GSA FEDERAL-SUPPLY SCHEDULE CONTRACT THAT COVERS THESE PRODUCTS AND, IF SO, THE CONTRACT NUMBER. Provide BUSINESS SIZE AND SOCIO-ECONOMIC STATUS; (a) Indicate whether your business is large or small (b) If small indicate if your firm qualifies as a small, emerging business, or small disadvantaged business (c) If disadvantaged, specify under which disadvantaged group and if your firm is certified under Section 8(a) of the Small Business Act (d) Indicate if your firm is a certified Service-Disabled Veteran-Owned Small Business (SDVOSB) or Veteran-Owned Small Business (VOSB) (g) Include the DUNS number of your firm. (h) State whether your firm is registered with the System for Award Management (SAM) at http://www.sam.gov and /or the VetBiz Registry (i) provide current commercial pricing for Audible Prescription Reading Devices (and applicable discounts or trade-in values for old equipment (j) link to the respondents General Services Administration (GSA) schedule, or attached file of same, if applicable (k) citation of any current or part customers (i.e., within the past (2) years) to include contract number, point of contact telephone number or e-mail address; and (I) other material relevant to establishing core competencies of the firm. (M) Company information on warranty and training packages for each material solution. Responses are due by 12 pm EST, April 28 2017. Please submit e-mail responses to Mr. Marlon Nibbs, Contract Specialist, at email address:
[email protected]. Your response should include the STATEMENT OF CAPABILITY, GSA SCHEDULE INFORMATION, and BUSINESS SIZE AND SOCIO-ECONOMIC STATUS information as explained above. Please place Attention: repetitive Transcranial Magnetic Stimulation (rTMS) in the subject line of your email. Disclaimer: Issuance of this RFI/sources sought is to assist the VA in completing market research, determining sources only and does not commit or bind the Government under any circumstances nor does it constitutes any obligation whatsoever on the part of the Government to procure these commodities/supplies or to issue a solicitation nor to notify respondents of the results of this notice. No solicitation documents exist at this time; The Department of Veterans Affairs is neither seeking proposals nor accepting unsolicited proposals, and responses to this RFI/sources sought cannot be accepted as offers. Any information the vendor considers proprietary should be clearly marked as such. The U.S. Government will not pay for any information or administrative cost incurred in response to this RFI/ sources sought. Repetitive Transcranial Magnetic Stimulation (rTMS) rTMS is a noninvasive procedure that uses magnetic fields to stimulate nerve cells in the brain to improve symptoms of depression (Mayo Clinic Definition). rTMS is typically used when other depression treatments haven't been effective. For many years the standard of practice for treatment resistant depression has been Electro-Convulsive Therapy. However, this treatment is not widely available and has significant negative stigma. rTMS is a safe and effective alternative that is widely used in the community, FDA-approved and is not widely available to Veterans. This purchase will fill this gap in Veterans access to this evidence-based treatment, which is timely given the epidemic of major depression and suicidal behavior in Veterans. Minimum Technical Requirements The following specifications are required. Repetitive Transcranial Magnetic Stimulation (rTMS): A device that uses an electromagnetic coil placed against the scalp. The electromagnet delivers a magnetic pulse that stimulates nerve cells in the region of the brain involved in mood control and depression. Minimum Technical Requirements for rTMS a) rTMS medical device system shall be able to deliver repeatable, reliable pulse frequency, pulse train, and time between pulse trains. Power - 120% of motor threshold as separately determined for each patient prior to treatment/sham sessions, Pulse Frequency: 10Hz, Length of Each Pulse Train: 4 seconds, Time Between Pulse Trains: 26 seconds, Length of Treatment: 37.5 minutes, Total 3,000 pulses per session, 5 days/week, 4 weeks/20 session minimum, 90,000 pulses total for 30 sessions or 60,000 pulses total for 20 sessions. b) rTMS medical device system shall have an appropriate cooling system if the coil has heating issues. c) rTMS medical device system shall have a method of accurately repositioning and maintaining the coil on the patient s head from one treatment to the next to ensure repeatable treatment location. d) rTMS medical device system shall have a comfortable chair for patients use during treatment. e) rTMS medical device system shall provide a method to minimize the possibility of scalp burns during treatment. f) rTMS medical device system shall be an Underwriters Laboratory (UL) approved or MET Lab certified medical device g) rTMS medical device system shall provide a properly grounded (shock proof) medical device. h) rTMS medical device system shall delivery and setup/install medical devices by manufacturers certified technicians. i) rTMS medical device system shall ensure all medical devices will be calibrated when initially installed and recalibrated according to manufacturer's specifications on a regular schedule by certified personnel to ensure patient safety (magnetic field strength should be defined and measurable). j) rTMS medical device system shall operate in normal room temperature environment (59°- 86°F). k) rTMS medical device system shall operate on 110 volt 60 cycle power. l) rTMS medical device will allow upgrade to include Theta burst option. m) rTMS medical device system shall have the ability to upgrade to an integrated sham system which mimics the actual rTMS system in noise and scalp sensation. n) rTMS medical device system shall allow upgradable provisions to mask (blind) the patient and treatment Administrator to the patient s actual treatment regimen (mask sound and scalp stimulations). Additional Concerns This requirement falls under FDA regulation, therefore any information/solutions provided in response to this RFI must be FDA compliant and authorized for clinical use. In addition to the information requested herein, please respond with corresponding preventative maintenance data, any/all warranty s options available and compatible accessories options and/or accessory packages. Identifying responsible and capable small business concerns. Small pool of qualified vendors Expedient delivery and implementation