Upgrade or replace one existing Transcranial Magnetic Stimulation Magstim Rapid2 Therapy System
Description This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, “Streamlined Procedures for Evalu... Description This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, “Streamlined Procedures for Evaluation and Solicitation for Commercial Items,” as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a written solicitation document will not be issued. This solicitation is issued as an RFQ. 36C25020Q0534 the solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular FAC 2020-05 effective 03-30-2020. This solicitation is Full and Open competition. The associated North American Industrial Classification System (NAICS) code for this procurement is 334510, with a small business size standard of 1,250 employees. The Louis Stokes Cleveland VAMC 10701 E Blvd Cleveland OH 44106 is seeking to purchase Multi-Wavelength Hair Removal System All interested companies shall provide quotations for the following: Supplies/Services Upgrade of current TMS equipment to a system capable of Express TMS and a Neuro Navigation system that shall be more accurate treatment of patients with Major Depressive Disorder. Line Item Description Quantity Unit of Measure Unit Price Total Price 1 UPGRADE Rapid System TMS to Horizon Performance. 1 2 StimGuide Upgrade for Horizon Performance. Neuro Navigation add on. 1 3 Warranty and or additional warranty 1 STATEMENT OF WORK As of 4/21/2020 Contracting Specialist Danielle.Bowman@va.gov Contract Title: Express TMS and Neuro Navigation System Background: The General Mental Health clinic at the Louis Stokes Cleveland VA medical center uses Transcranial Magnetic Stimulation (TMS) therapy to treat patients diagnosed with Major Depressive Disorder. Current equipment is a Rapid TMS system purchased from Magstim. The Rapid TMS delivers traditional TMS treatment protocol with a treatment run time of 20 minutes with a total appointment time of 1 hour to align treatment coil, prep patient, and provide treatment. Treatment requires multiple 1-hour visits and the clinic only has the capabilities to run one TMS machine. Subsequently, there is now a waitlist for TMS and some High-risk patients are unable to receive timely treatment that is even more scarce within the private sector. The other issue currently found with traditional TMS therapy is that the treatment must be applied to a precise location of the brain with each treatment for fully effective treatment within the least number of visits. The FDA has approved a rapid form of TMS with Theta Burst Stimulation (TBS) known as Express TMS. TBS treatment utilizes short bursts of stimulation at high frequencies that more closely mimics the natural rhythms of activity in the neurons of the brain than standard TMS therapy. Due to this technology, the treatment time is reduced from 20 minutes to only 3 minutes per treatment. Along with TBS there has been advancements in technology to locate and mark the exact location of the brain for efficacy in repeated treatments. Neuro Navigation systems are now available to deliver a precise and consistent treatment to patients. With the Neuro Navigation system, clinicians can locate and guide the treatment coil to a precise location time and time again ensuring each visit is delivering the most effective and consistent treatment to patients, reducing the number of visits needed while shortening prep time to manually locate treatment location in the brain. Upgrade of current TMS equipment to a system capable of Express TMS and a Neuro Navigation system will allow quicker, more accurate treatment of patients with Major Depressive Disorder. The result should be a treatment system that reduces treatment time, eliminates a back log of patients waiting for treatment, and offers a viable treatment option for patients opposed to the duration of traditional TMS. This will allow approximately 6 times as many patients to be treated and eliminate the wait-list improving access to care while aligning with Mission Act. Scope and Tasks: The Contractor will be required to upgrade or replace one existing Transcranial Magnetic Stimulation Magstim Rapid2 Therapy System (541 MX1779900) to deliver FDA approved Theta Burst Stimulation treatment and provide an FDA cleared Neuro Navigation system designed for a clinical setting. Result shall be FDA approved Express TMS Theta Burst stimulation capable equipment and Neuro Navigation system that are compatible from a single contractor. Contractor will be responsible for delivering, and installing any additional parts or equipment required to Louis Stokes Cleveland VA Medical Center room 1B-588. Contractor will provide warranty coverage to cover all supplies and services required to maintain equipment in operational status. Contractor will provide training on proper use and safety requirements to a minimum of 3 staff on proper use of all equipment. Equipment must have a treatment time of no more than 10 minutes to accomplish goals of clinic in reducing waitlist. Salient Characteristics: Requested item shall be: Be capable of having treatment run time of less than 10 minutes, but preferably 3. Be FDA cleared or approved for clinical treatment of Major Depressive Disorder Provide Express TMS through Theta Burst Stimulation Have extended warranty available Fit in current office setting with a footprint of 10ft x 12 ft with ceiling height of 8ft Run off existing 240V 20a electrical to prevent clinic downtime for electrical change over. Performance Monitoring: COR will conduct performance monitoring for the duration of the contract period. Security Requirements: None GFE/GFI: N/A Other pertinent Information or Special Considerations: Identification of Possible Follow-on work: NONE Identification of Potential Conflicts of Interest: NONE Identification of Non-disclosure Requirements: NONE Packaging, Packing and Shipping Instructions: NONE Inspection and Acceptance Criteria: The COR will monitor delivery and consult with local BioMedical staff to determine if the equipment received is suitable for use and meets the specifications of the SOW. Risk Control: Users will follow any safety recommendations given by the vendor for the equipment. Place of Performance Psychiatry Service General Mental Health Clinic Louis Stokes Cleveland VA Medical Center 10701 East Blvd Cleveland, OH 44106 Period of Performance: One Time Buy Delivery Schedule: Details of delivery to be finalized after award of the contract Delivery, FBO Destination, shall be provided no later than 30 days after receipt of order (ARO). Place of Performance/Place of Delivery Address: 10701 East Blvd. Cleveland, OH Postal Code: 44106 Country: UNITED STATES The full text of FAR provisions or clauses may be accessed electronically at http://acquisition.gov/comp/far/index.html. The following solicitation provisions apply to this acquisition: FAR 52.212-1, “Instructions to Offerors–Commercial Items” [March 2020] FAR 52.212-3, “Offerors Representations and Certifications–Commercial Items” [March 2020] Offerors must complete annual representations and certifications electronically via the System for Award Management (SAM) website located at https://www.sam.gov/portal in accordance with FAR 52.212-3, “Offerors Representations and Certifications–Commercial Items.” If paragraph (j) of the provision is applicable, a written submission is required. The following contract clauses apply to this acquisition: FAR 52.212-4, “Contract Terms and Conditions–Commercial Items” [Oct 2018] The following additional clauses apply: 52.232-40, 852.203-70, 852.219-10, 852.232-72, 852.246-71 FAR 52.212-5, “Contract Terms and Conditions Required to Implement Statutes or Executive Orders” [March 2020] The following subparagraphs of FAR 52.212-5 are applicable: 52.204-10. 52.209-6, 52.219-27, 52.219- 28, 52.222-3, 52.222-19, 52.222-21; 52.222-26, 52.222-36, 52.222-50, 52.223-18, 52.225-3 (iii) Alternate II; 52.225-13, 52.232-34 Vendor shall be an OEM, authorized dealer, authorized distributor or authorized reseller for the proposed medical supplies, medical equipment and/or services contracts for maintenance of medical equipment (i.e. replacement parts), verified by an authorization letter or other documents from the OEM, such that the OEM’s warranty and service are provided and maintained by the OEM. All software licensing, warranty and service associated with the medical supplies, medical equipment and/or services contracts for maintenance of medical equipment shall be in accordance with the OEM terms and conditions All quoters shall submit the following: Upgrade to TMS equipment to a system capable of Express TMS and a Neuro Navigation system. If unable to upgrade current system quoter shall provide quote for TMS equipment capable of Express TMS and a Neuro Navigation system with the above-mentioned characteristics. All quotes shall be sent to the Contracting Specialist Danielle Bowman at Danielle.Bowman@VA.GOV. Award will be based upon a comparative evaluation of quotes in accordance with the Simplified Acquisition Procedures of FAR 13. Comparative evaluation is the side by side pairwise comparison of quotes based on factors resulting in a Contracting Officer decision for the quote most favorable to the Government. The following are the decision factors: Ability to supply an upgrade to TMS equipment to a system capable of Express TMS and a Neuro Navigation system. If unable to upgrade current system supply TMS equipment capable of Express TMS and a Neuro Navigation system with the above-mentioned characteristics at the lowest price that is technically acceptable. The award will be made to the response most advantageous to the Government. Responses should contain your best terms, conditions. To facilitate the award process, all quotes must include a statement regarding the terms and conditions herein as follows: "The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition." OR "The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:" Quoters shall list exception(s) and rationale for the exception(s), if any. Submission of your response shall be received not later than April 28, 2020 11:59 p.m. EST. at Danielle.Bowman@VA.GOV . Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f). Any questions or concerns regarding this solicitation should be forwarded in writing via e-mail to the Point of Contact listed below. Point of Contact Contract Specialist Danielle Bowman, Danielle.Bowman@VA.gov , 216-447-8300 * 49577 Description This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, “Streamlined Procedures for Evaluation and Solicitation for Commercial Items,” as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a written solicitation document will not be issued. This solicitation is issued as an RFQ. 36C25020Q0534 the solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular FAC 2020-05 effective 03-30-2020. This solicitation is Full and Open competition. The associated North American Industrial Classification System (NAICS) code for this procurement is 334510, with a small business size standard of 1,250 employees. The Louis Stokes Cleveland VAMC 10701 E Blvd Cleveland OH 44106 is seeking to purchase Multi-Wavelength Hair Removal System All interested companies shall provide quotations for the following: Supplies/Services Upgrade of current TMS equipment to a system capable of Express TMS and a Neuro Navigation system that shall be more accurate treatment of patients with Major Depressive Disorder. Line Item Description Quantity Unit of Measure Unit Price Total Price 1 UPGRADE Rapid System TMS to Horizon Performance. 1 2 StimGuide Upgrade for Horizon Performance. Neuro Navigation add on. 1 3 Warranty and or additional warranty 1 STATEMENT OF WORK As of 4/21/2020 Contracting Specialist Danielle.Bowman@va.gov Contract Title: Express TMS and Neuro Navigation System Background: The General Mental Health clinic at the Louis Stokes Cleveland VA medical center uses Transcranial Magnetic Stimulation (TMS) therapy to treat patients diagnosed with Major Depressive Disorder. Current equipment is a Rapid TMS system purchased from Magstim. The Rapid TMS delivers traditional TMS treatment protocol with a treatment run time of 20 minutes with a total appointment time of 1 hour to align treatment coil, prep patient, and provide treatment. Treatment requires multiple 1-hour visits and the clinic only has the capabilities to run one TMS machine. Subsequently, there is now a waitlist for TMS and some High-risk patients are unable to receive timely treatment that is even more scarce within the private sector. The other issue currently found with traditional TMS therapy is that the treatment must be applied to a precise location of the brain with each treatment for fully effective treatment within the least number of visits. The FDA has approved a rapid form of TMS with Theta Burst Stimulation (TBS) known as Express TMS. TBS treatment utilizes short bursts of stimulation at high frequencies that more closely mimics the natural rhythms of activity in the neurons of the brain than standard TMS therapy. Due to this technology, the treatment time is reduced from 20 minutes to only 3 minutes per treatment. Along with TBS there has been advancements in technology to locate and mark the exact location of the brain for efficacy in repeated treatments. Neuro Navigation systems are now available to deliver a precise and consistent treatment to patients. With the Neuro Navigation system, clinicians can locate and guide the treatment coil to a precise location time and time again ensuring each visit is delivering the most effective and consistent treatment to patients, reducing the number of visits needed while shortening prep time to manually locate treatment location in the brain. Upgrade of current TMS equipment to a system capable of Express TMS and a Neuro Navigation system will allow quicker, more accurate treatment of patients with Major Depressive Disorder. The result should be a treatment system that reduces treatment time, eliminates a back log of patients waiting for treatment, and offers a viable treatment option for patients opposed to the duration of traditional TMS. This will allow approximately 6 times as many patients to be treated and eliminate the wait-list improving access to care while aligning with Mission Act. Scope and Tasks: The Contractor will be required to upgrade or replace one existing Transcranial Magnetic Stimulation Magstim Rapid2 Therapy System (541 MX1779900) to deliver FDA approved Theta Burst Stimulation treatment and provide an FDA cleared Neuro Navigation system designed for a clinical setting. Result shall be FDA approved Express TMS Theta Burst stimulation capable equipment and Neuro Navigation system that are compatible from a single contractor. Contractor will be responsible for delivering, and installing any additional parts or equipment required to Louis Stokes Cleveland VA Medical Center room 1B-588. Contractor will provide warranty coverage to cover all supplies and services required to maintain equipment in operational status. Contractor will provide training on proper use and safety requirements to a minimum of 3 staff on proper use of all equipment. Equipment must have a treatment time of no more than 10 minutes to accomplish goals of clinic in reducing waitlist. Salient Characteristics: Requested item shall be: Be capable of having treatment run time of less than 10 minutes, but preferably 3. Be FDA cleared or approved for clinical treatment of Major Depressive Disorder Provide Express TMS through Theta Burst Stimulation Have extended warranty available Fit in current office setting with a footprint of 10ft x 12 ft with ceiling height of 8ft Run off existing 240V 20a electrical to prevent clinic downtime for electrical change over. Performance Monitoring: COR will conduct performance monitoring for the duration of the contract period. Security Requirements: None GFE/GFI: N/A Other pertinent Information or Special Considerations: Identification of Possible Follow-on work: NONE Identification of Potential Conflicts of Interest: NONE Identification of Non-disclosure Requirements: NONE Packaging, Packing and Shipping Instructions: NONE Inspection and Acceptance Criteria: The COR will monitor delivery and consult with local BioMedical staff to determine if the equipment received is suitable for use and meets the specifications of the SOW. Risk Control: Users will follow any safety recommendations given by the vendor for the equipment. Place of Performance Psychiatry Service General Mental Health Clinic Louis Stokes Cleveland VA Medical Center 10701 East Blvd Cleveland, OH 44106 Period of Performance: One Time Buy Delivery Schedule: Details of delivery to be finalized after award of the contract Delivery, FBO Destination, shall be provided no later than 30 days after receipt of order (ARO). Place of Performance/Place of Delivery Address: 10701 East Blvd. Cleveland, OH Postal Code: 44106 Country: UNITED STATES The full text of FAR provisions or clauses may be accessed electronically at http://acquisition.gov/comp/far/index.html. The following solicitation provisions apply to this acquisition: FAR 52.212-1, “Instructions to Offerors–Commercial Items” [March 2020] FAR 52.212-3, “Offerors Representations and Certifications–Commercial Items” [March 2020] Offerors must complete annual representations and certifications electronically via the System for Award Management (SAM) website located at https://www.sam.gov/portal in accordance with FAR 52.212-3, “Offerors Representations and Certifications–Commercial Items.” If paragraph (j) of the provision is applicable, a written submission is required. The following contract clauses apply to this acquisition: FAR 52.212-4, “Contract Terms and Conditions–Commercial Items” [Oct 2018] The following additional clauses apply: 52.232-40, 852.203-70, 852.219-10, 852.232-72, 852.246-71 FAR 52.212-5, “Contract Terms and Conditions Required to Implement Statutes or Executive Orders” [March 2020] The following subparagraphs of FAR 52.212-5 are applicable: 52.204-10. 52.209-6, 52.219-27, 52.219- 28, 52.222-3, 52.222-19, 52.222-21; 52.222-26, 52.222-36, 52.222-50, 52.223-18, 52.225-3 (iii) Alternate II; 52.225-13, 52.232-34 Vendor shall be an OEM, authorized dealer, authorized distributor or authorized reseller for the proposed medical supplies, medical equipment and/or services contracts for maintenance of medical equipment (i.e. replacement parts), verified by an authorization letter or other documents from the OEM, such that the OEM’s warranty and service are provided and maintained by the OEM. All software licensing, warranty and service associated with the medical supplies, medical equipment and/or services contracts for maintenance of medical equipment shall be in accordance with the OEM terms and conditions All quoters shall submit the following: Upgrade to TMS equipment to a system capable of Express TMS and a Neuro Navigation system. If unable to upgrade current system quoter shall provide quote for TMS equipment capable of Express TMS and a Neuro Navigation system with the above-mentioned characteristics. All quotes shall be sent to the Contracting Specialist Danielle Bowman at Danielle.Bowman@VA.GOV. Award will be based upon a comparative evaluation of quotes in accordance with the Simplified Acquisition Procedures of FAR 13. Comparative evaluation is the side by side pairwise comparison of quotes based on factors resulting in a Contracting Officer decision for the quote most favorable to the Government. The following are the decision factors: Ability to supply an upgrade to TMS equipment to a system capable of Express TMS and a Neuro Navigation system. If unable to upgrade current system supply TMS equipment capable of Express TMS and a Neuro Navigation system with the above-mentioned characteristics at the lowest price that is technically acceptable. The award will be made to the response most advantageous to the Government. Responses should contain your best terms, conditions. To facilitate the award process, all quotes must include a statement regarding the terms and conditions herein as follows: "The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition." OR "The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:" Quoters shall list exception(s) and rationale for the exception(s), if any. Submission of your response shall be received not later than April 28, 2020 11:59 p.m. EST. at Danielle.Bowman@VA.GOV . Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f). Any questions or concerns regarding this solicitation should be forwarded in writing via e-mail to the Point of Contact listed below. Point of Contact Contract Specialist Danielle Bowman, Danielle.Bowman@VA.gov , 216-447-8300 * 49577
Data sourced from SAM.gov.
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