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THIS IS NOT A SOLICITATION ANNOUNCEMENT. THIS IS A REQUEST FOR INFORMATION ONLY.

This Request for Information (RFI) is intended for information and planning purposes only at this time; and shall not be construed as a solicitation or as an obligation on the part of the Department of Veterans Affairs. Because this is a Request for Information announcement, no evaluation letters and/or results will be issued to the respondents. This Sources Sought Notice is for market research purposes only and shall not be considered an Invitation for Bids, Request for Quotations, or a Request for Proposal. Do not submit a proposal or quote. This market research is issued for information and planning purposes only and does not constitute a solicitation nor does it restrict the Government as to the ultimate acquisition approach. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Additionally, there is no obligation on the part of the Government to acquire any products or services described in this sources sought notice. You will not be entitled to payment for direct or indirect costs that you incur in responding to this Sources Sought Notice. Any contract that might be awarded based on information received or derived from this market research will be the outcome of a competitive process. Interested parties are responsible for adequately marking proprietary, restricted or competition sensitive information contained in their response.

No solicitation exists. Therefore, do not request a copy of a solicitation.

See instructions on page 4.

Brand name only: Inspire s implantable respiratory pacemakers

STATEMENT OF NEED
SURGICAL SERVICES DEPARTMENT
DEPARTMENT OF VETERANS HEALTH ADMINISTRATION
CORPORAL MICHAEL J CRESCENZ VA MEDICAL CENTER
3900 WOODLAND AVE, PHILADELPHIA, PA 19104

GENERAL DESCRIPTION: The Corporal Michael J. Crescenz Veteran Affairs Medical Center (CMCVAMC) Surgical Services Department intends to establish an indefinite delivery contract to obtain the implants and equipment items needed for the CMCVAMC s Sleep Clinic. Veteran patients that come to the VAMC with sleep apnea a potentially serious sleep disorder in which breathing repeatedly stops and starts require a treatment that can ease symptoms and prevent further medical complications, such as heart disorders, stroke, and lung disease. The VAMC has witnessed much success treating Veterans with sleep apnea using Inspire s implantable respiratory pacemakers and Inspire equipment items. IAW the Joint Commission and VA policy, a physician is not authorized to perform treatment on a Veteran without having backup implants and equipment items on-hand. The Sleep Clinic s physicians continuously use Inspire products when treating Veterans; however, due to uncertain demand, limited lifespan for implants, and holding cost the VAMC has failed to faithfully maintain the backup implants required to perform treatment on a patient. The Sleep Clinic s intent is to establish an indefinite delivery contract because physicians repetitively use Inspire s implants and equipment items to treat sleep apnea on a case-by-case and as-needed basis.

SCOPE OF WORK: The awarded contractor shall provide all personnel, disposables, supplies, transportation, tools, materials, supervision, and other items and non-personal services necessary to provide the CMCVAMC Sleep Clinic with implants and equipment items on an indefinite delivery basis as defined in this SON. The contractor shall place their products within a designated area in the Sleep Clinic, and rotate stock regularly to maintain a viable product on the shelf at all times. The initial delivery and stock of implants and equipment items shall be delivered to the CMCVAMC within sixty (60) calendar days after contract award. The contractor shall be responsible for delivering replacement products to the CMCVAMC within seventy-two (72) hours of receiving a request from the Sleep Clinic. The contractor shall be responsible for ensuring the functionality and serviceability of equipment items and implants delivered to the VAMC.

IMPLANTS & EQUIPMENT:

ITEM NUMBER
DESCRIPTION OF IMPLANTS/EQUIPMENT
UNIT OF ISSUE
INITIAL PAR LEVEL
0001
Inspire's Sleep Remote for Upper Airway System
EA
3
0002
Inspire's Next-Generation Implantable Pulse Generator (IPG) Model 3028
EA
3
0003
Inspire's Leadwire Model 4063
EA
3
0004
Inspire's Respiratory Sensing Lead
EA
3

TERMS & CONDITIONS:

GENERAL: The contractor shall furnish and maintain a stock of implants and equipment items at the par/quantity levels agreed upon in the agreement Schedule. Implants shall be placed in the CMCVAMC Sleep Clinic in accordance with the terms and conditions of the indefinite delivery agreement and the terms stated herein. The Government shall be responsible for all expenses incidental to the safekeeping and use of the equipment and implants. The Government shall be responsible for furnishing the proper security for all products listed on the agreement s Schedule.

The estimated minimum par/quantity levels for the indefinite delivery agreement is outlined on the Schedule of the agreement. The minimum par/quantity levels may be adjusted based on the Sleep Clinic s need during the contract term; all changes, modifications, and/or add-ons to the indefinite delivery agreement will require a bilateral agreement from the involved contractor and the Contracting Officer.

DELIVERY TICKETS: All contractor order deliveries under this agreement must be accompanied by a delivery ticket that contains the following minimum information:
Name of Contractor
Contractor s Phone Number
Model Number/Part Number or National Stock Number (NSN) of the implant
Quantity, Unit Price, and Nomenclature of each implant or equipment item
Date of Delivery
DEFECTIVE & RECALLED PRODUCTS: The contractor must replace defective and recalled products according to the delivery schedule of the agreement at no additional cost to the Government, unless the CMCVAMC has misused or lost the product. The contractor shall be responsible for notifying the COR and/or Nurse Managers immediately of any recalls of products or other important product safety issues.

EXPIRING PRODUCTS: Implants having less than ninety (90) days sterility/expiration must be removed and replaced. The contractor shall provide a list of all the expired products to the COR. The CMCVAMC is not liable for implants that are allowed to expire while on the shelf. The removal of expired implants shall be completed at no additional cost to the Government.

TECHNICAL SUPPORT: The contractor shall provide a technical support helpline to answer end user questions and provide consultation on product technical issues. The contractor s helpline shall be available during normal business hours of Monday thru Friday from 7:00 am to 4:00 pm EST. The contractor shall return the CMCVAMC s calls for assistance within one (1) hour of a call being placed.

SCHEDULE: This requirement may be solicited for pricing to cover a five year contract term. The contractor shall provide a firm-fixed price for all implants and equipment items listed when solicited. Currently only seeking sources for a responsibility determination.

Base Year: August 1, 2023 July 31, 2024
1ST Option Year: August 1, 2024 July 31, 2025
2ND Option Year: August 1, 2025 July 31, 2026
3RD Option Year: August 1, 2026 July 31, 2027
4TH Option Year: August 1, 2027 July 31, 2028

DELIVERY: Implants and equipment shall be delivered to the Corporal Michael J. Crescenz Veteran Affairs Medical Center (CMCVAMC) located at 3900 Woodland Avenue, Philadelphia, PA 19104. The contractor shall absorb all transportation costs and transportation related costs associated with the delivery of products to the CMCVAMC. Placement in the Sleep Clinic shall be coordinated with the CMCVAMC s Nurse Managers and Assistant Nurse Managers.

JUST-in-TIME DELIVERY: This delivery method allows product that are not present in stock to be requested and delivered in a timely manner to be used for Veteran treatment. At times, the attending physician may decide a different size or model of product is necessary for a particular patient. Under these conditions, all attempts at a reasonable amount of lead time will be given to the contractor for requested product to be ordered and/or delivered to the CMCVAMC for use. Product shall arrive pre-packaged and pre-sterilized (ready to be implanted).

CONTRACTOR TRAINING: Any contractor who has access to VA Information and/or VA Information Systems shall complete the following: Contractor Rules of Behavior, VA Cyber Security Awareness and Rules of Behavior training, and VA Privacy Training. The contractor shall provide to the COR of this contract any applicable security training certificates and a signed copy of the VA s Contractor Rules of Behavior.

SECURITY REQUIREMENTS: (section subject to additional security requirements as outlined in VA Directive and Handbook 6500.6 Appendix A.)

Contractor's Personnel Security Requirements: All contractor employees who require access to the VA campus must follow the Medical Center Policy for those requesting access to the facilities listed above.

Background Investigation The level of background investigation commensurate with the required level of access is National Agency Check with Written Inquiries. Contractor's Responsibilities: (1) Shall prescreen all personnel to ensure they maintain a U.S. citizenship and are able to read, write, speak, and understand the English language.

Adhering to the policies and procedures regarding security and reporting any suspected violations and security.

Substitutions: The contractor is required to maintain regular delivery personnel for delivery of implants to the VA, however, when regular delivery personnel are substituted for any reason, the contractor is to notify the VA s appointed indefinite delivery agreement COR/POC within 24 hours before an actual delivery appointment.

COVID RESTRICTIONS: The contractor s appointed representative for deliveries shall provide the COR and /or Nurse Managers of proof of COVID-19 vaccination and booster shot before the representative is allowed access to CMCVAMC campus.

MINIMUM PAR - QUANTITY LEVELS: The contractor that provides the Sleep Remote for Upper Airway System can expect a minimum of three (3) orders placed per calendar year.

The contractor that provides the Next-Generation Implantable Pulse Generator (IPG) Model 3028 can expect a minimum of three (3) orders placed per calendar year.

The contractor that provides the Leadwire Model 4063 can expect a minimum of three (3) orders placed per calendar year.

The contractor that provides the Respiratory Sensing Lead can expect a minimum of three (3) orders placed per calendar year.
REQUEST FOR INFORMATION INSTRUCTIONS:

The information identified above is intended to be descriptive, not restrictive and to indicate the quality of the supplies/services that will be satisfactory. It is the responsibility of the interested source to demonstrate to the government that the interested parties can provide the supplies/services that fulfill the required specifications mentioned above.

Responses to this RFI should include company name, address, point of contact, phone number, and point of contact e-mail, UEI Number, Cage Code, size of business pursuant to North American Industrial Classification System (NAICS) 339112 (size standard of 1000 employees). Please answer the following questions:

Please indicate the size status and representations of your business, such as but not limited to: Service-Disabled Veteran Owned Small Business (SDVOSB), Veteran Owned Small Business (VOSB), Hubzone, Woman Owned Small Business (WOSB), Large Business, etc.)?

Is your company considered small under the NAICS code identified under this RFI?

Are you the manufacturer, distributor, or an equivalent solution to the items being referenced above?

If not, can you provide additional information shown below. This is to confirm compliance with the non-manufacturer rule IAW 13 CFR 121.406(b) Nonmanufacturers.

Does your company exceed 500 employees;

Primarily engaged in the retail or wholesale trade and normally sells the type of item being supplied;

Take ownership or possession of the item(s) with its personnel, equipment or facilities in a manner consistent with industry practice;

Obtained an individual or class waiver?

If you are a large business, do you have any designated distributors? If so, please provide their company name, telephone, point of Contact and size status (if available).

If you re a small business and you are an authorized distributor/reseller for the items identified above or an equivalent solution, do you alter; assemble; modify; the items requested in any way? If you do, state how and what is altered; assembled; modified?

If you intend to subcontract any work on this contract, what portion of the total cost will be self-performed/will be performed by your organization? Please provide estimated detailed percentage breakdowns related to subcontracted work and completion of job.

Does your company have an FSS contract with GSA or the NAC or are you a contract holder with any other federal contract? If so, please provide the contract number.

If you are an FSS GSA/NAC contract holder or other federal contract holder, are the items/solution you are providing information for available on your schedule/contract?

General pricing of your products/solution is encouraged. Pricing will be used for the purpose of market research only. It will not be used to evaluate for any type of award.

Please submit your capabilities in regard to the salient characteristics detailed above and any information pertaining to equal to items to establish capabilities for planning purposes?

Please review salient characteristics/statement of work (if applicable) and provide feedback or suggestions. If none, please reply as N/A.

Please provide your UEI number.

This RFI will be conducted in accordance with Federal Acquisition Regulation (FAR) Part 13. Telephone responses will not be accepted. Responses must be received via e-mail to andrew.taylor@va.gov no later than, 16:00 PM Eastern Time (ET) on June 16, 2023. This notice will help the VA in determining available potential sources only. Do not contact VA Medical Center staff regarding this requirement, as they are not authorized to discuss this matter related to this procurement action. All questions will be addressed by the Contracting Specialist, Andrew Taylor. Questions or responses will include the Source Sought number 36C24423Q0866 in the subject line.

All firms responding to this Request for Information are advised that their response is not a request for proposal, therefore will not be considered for a contract award.

Any interested business concern must submit a no longer that 10-page capability statement addressing its ability to meet the requirements listed above to Capability Statement shall include a statement regarding how the business concern is engaged in wholesale trade and normally sells the item being supplied and how the business concern will take ownership of the items being delivered. Vendors shall also provide certification, evidence that they are an authorized distributor of the Original Equipment Manufacturer.

If a solicitation is issued, information will be posted on the SAM web site for all qualified interested parties at a later date and interested parties must respond to the solicitation to be considered for award. This notice does not commit the government to contract for any supplies or services. The government will not pay for any information or administrative cost incurred in response to this Request for Information. Information will only be accepted in writing by e-mail to Contracting Officer at andrew.taylor3@va.gov include 36C24423Q0866 in the subject line.
DISCLAIMER
This RFI is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI.

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