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Impella Heart Pump Controllers Service Agreement


Kansas, United States
Government : Federal
RFP
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This Sources Sought Notice is for planning purposes only and shall not be considered as an invitation for bid, request for quotation, request for proposal, or as an obligation on the part of the Government to acquire any products or services. Your response to this Sources Sought Notice will be treated as information only. No entitlement to payment of direct or indirect costs or charges by the Government will arise as a result of contractor submission of responses to this announcement or the Government use of such information. This request does not constitute a solicitation for proposals or the authority to enter into negotiations to award a contract. No funds have been authorized, appropriated, or received for this effort.
The information provided may be used by the Department of Veterans Affairs in developing its acquisition approach, statement of work/statement of objectives and performance specifications. Interested parties are responsible for adequately marking proprietary or competition sensitive information contained in their response. The Government does not intend to award a contract on the basis of this Sources Sought Notice or to otherwise pay for the information submitted in response to this Sources Sought Notice.
The purpose of this sources sought announcement is for market research to make appropriate acquisition decisions and to gain knowledge of potential qualified Service Disabled Veteran Owned Small Businesses, Veteran Owned Small Businesses, 8(a), HubZone and other Small Businesses interested and capable of providing the services described below.

Documentation of technical expertise must be presented in sufficient detail for the Government to determine that your company possesses the necessary functional area expertise and experience to compete for this acquisition. Responses to this notice shall include the following: (a) company name (b) address (c) point of contact (d) phone, fax, and email (e) DUNS number (f) Cage Code (g) Tax ID Number (h) Type of small business, e.g. Services Disabled Veteran Owned small Business, Veteran-owned small business, 8(a), HUBZone, Women Owned Small Business, Small disadvantaged business, or Small Business HUBZone business and (i) must provide a capability statement that addresses the organizations qualifications and ability to perform as a contractor for the work described below.

The VA Heartland Network 15, Contracting Office located at 3450 South 4th Street, Leavenworth, KS, 66048-5055 is seeking (see Draft Statement of Work below).

Important information: The Government is not obligated to nor will it pay for or reimburse any costs associated with responding to this source sought synopsis request. This notice shall not be construed as a commitment by the Government to issue a solicitation or ultimately award a contract, nor does it restrict the Government to a particular acquisition approach. The Government will in no way be bound to this information if any solicitation is issued. Currently a total set-aside for Service Disabled Veteran Owned Small Business firms is anticipated based on the Veterans Administration requirement with Public Law 109-461, Section 8127 Veterans Benefit Act. However, if response by Service Disabled Veteran Owned Small Business firms proves inadequate, an alternate set-aside or full and open competition may be determined. No sub-contracting opportunity is anticipated. This contract shall include a base year and four one-year options. The North American Classification System (NAICS) code for this acquisition is 334510 (Electromedical and Electrotherapeutic Apparatus Manufacturing) 1,250 Employees. The small business size standard is 1,250 Employees. Notice to potential offerors: All offerors who provide goods or services to the United States Federal Government must be registered in the System for Award Management (SAM located on the web at www.sam.gov). Additionally, all Service Disabled Veteran Owned Businesses or Veteran Owned Businesses who respond to a solicitation on this project must be registered with the Department of Veterans Affairs Center for Veterans Enterprise VetBiz Registry located at http://vip.vetbiz.gov. All interested Offerors should submit information by e-mail: to Daniel.Thomas6@va.gov.

All information submissions should be received no later than 12:00 pm CST on August 20, 2018. After review of the responses to this announcement, the Government intends to proceed with the acquisition and a subsequent solicitation will be published.


DRAFT STATEMENT OF WORK

Section C - Description / Specifications

The contractor shall provide full maintenance both remotely and on site, to include all replacement parts, software updates, labor, travel expenses, tools, test equipment and other incidentals necessary to maintain or restore the listed equipment to operating specifications which meet or exceed the manufacturers specifications. Any and all parts used must be new or factory rebuilt for that model and type of device. In-house Biomedical Engineering will provide first look response to all trouble calls and will notify contractor when services are needed. The contractor must respond by telephone for diagnostic response within two (2) hours after notification, and must respond on the premises of the Kansas City VA Medical Center within one (1) business day when required for on site service call as requested by the Contracting Officer Technical Representative (COR) or a designee.

All services for this contract must meet manufacturers performance and technical specifications, Federal Regulations, FDA device certification and other specifications that may apply such as National Electric Code (NEC), Life Safety Code (LSC), the Joint Commission (JC), and VA Regulations. Also, Contractor must provide the appropriate service documentation at no additional expense. Contractor shall provide hardcopy proof, upon request by COR, that contracting entity is a certified manufacturer service provider and that technicians are current in device certification training. Contractor service representative shall attend annual safety training given at KCVA in the Facilities Management Service building on specified day and time and, wear the VA issued ID badge above the waistline at all times while on the premises.

This device does not have VPN access. As this system does not link into the VA computer systems the contractor shall not have access to the VA computer system nor shall the contractor access any e-PHI at anytime.

The contractor shall ONLY respond to service calls placed from COR or designee.

Contractor shall not perform any service that will result in additional charges without prior approval from the VA Hospital Contracting Officer. Contractor shall include all hardware and software, updates, patches, and revisions, and licenses to already purchased devices and options at no additional charge to the Kansas City VA Medical Center.

All contractor personnel must report to the COR to sign in before any work is performed on the premises of the Kansas City VA Medical Center, and to sign out after completion of assignment. The contractor must furnish a detailed field service report, or equivalent, showing work completed, listing all repairs and/or repair parts used to maintain operating efficiency of the equipment. This report must be delivered to Biomedical Engineering as the contractor signs out and leaves the facility or via email to (TBD). Payment will be withheld pending receipt of this report. The service report from the contractor must contain, at a minimum, the following information:
Date and time of the contractor s arrival on station.
Type, model, and serial number(s) of all equipment on which maintenance was performed.
Total time spent performing maintenance, excluding travel time.
Detailed narrative description of the malfunction or PM action required.
Complete list of parts replaced.
Comments as to the cause of the malfunction when applicable.
Date and time the repair or software upgrade was completed.

There is a potential for exposure to blood borne or other infectious material with equipment throughout the hospital. All maintenance persons must use the Universal Precautions (i.e. decontamination of medical equipment, wearing protective gloves, aprons, and goggles) during cleaning and maintenance/repair procedures required by this contract.

Payment will be made quarterly, in arrears, upon receipt of a properly prepared invoice, referencing the period for which payment is due, contract number and/or purchase order number assigned.

Preventive maintenance inspections shall be performed in accordance with manufacturer s literature on a semi-annual basis and must be prescheduled to avoid equipment access conflicts. Preventive maintenance inspections shall be performed in a manner which clearly demonstrates that all equipment meet or exceed all manufacturers technical performance specifications for preventive maintenance. Each preventive maintenance inspection shall include all items outlined in the manufacturers manual.

At the completion of each repair, the Contractor shall provide a written service report to the COR or his designee. This report shall clearly state the date of service, type of service performed, the model and serial number of equipment serviced, and the name of the field technician who performed the repair. Service reports will be used to verify work. Payments will not be made without service reports to document work.

Equipment Covered by the contract includes:

EE#193687, Heart Pump, Impella catheter Controller SN# IC5291
EE#193688, Heart Pump, Impella catheter Controller SN# IC5292

daniel.thomas6@va.gov

daniel.thomas6@va.gov

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