Q999--ME-Cryoablation Equipment Rental, Consumables, & Technician Support Services

SOURCES SOUGHT NOTICE This is a Sources Sought NOTICE (SSN) ONLY. The U.S. Government is conducting market research only to determine the availability of qualified sources capable of providing Cryoablation Equipment Rental and Consumables to include technician services at the VA Puget Sound Health Care System, Seattle, WA. Potential Contractors are invited to provide a response via e-mail to Contract Specialist at contact@example.gov by October 11, 2024, 12:00 noon (PT). Responses will be used to determine the appropriate strategy for a potential acquisition. Please clearly identify any information your company considers sensitive or proprietary. This notice is issued solely for information and planning purposes - it does not constitute a Request for Quotation (RFQ), or a promise to issue an RFQ in the future. This notice does not commit the U.S. Government to contract for any supply or service. Further, the U.S. Government is not seeking quotes, or proposals at this time and will not accept unsolicited quotes in response to this source sought synopsis. The U.S. Government will not pay for any information or administrative costs incurred in response to this notice. Submittals will not be returned to the responder. Not responding to this notice does not preclude participation in any future RFQ, if any is issued. BACKGROUND: The contractor shall provide all labor, materials, transportation, equipment, and supervision, in compliance with Federal, State, and local regulations, to provide cryoablation services and technical support for The Department of Veterans Affairs, Puget Sound Health Care System (PSHCS) on an as needed basis. The contract will require the contractor to provide cryoablation services with a minimum of a primary and back-up technician at the PSHCS. The VA estimates that there will be 1 patient per visit. The equipment must be prepared to perform the procedure at a mutually agreed upon time and continue to perform procedure until the Veteran patient is complete. There may be scheduled days that no procedures are needed, and the facility may cancel with the Contractor, with a minimum of 24 hours notice prior to the scheduled day with no charges to the Government. This contractor shall provide all services listed below to support VA in performing Cryoablation on our veteran s. NAICS: 621999, All Other Miscellaneous Ambulatory Health Care Services Interested potential Contractors please provide the following. 1) Company Name, address, point of contact, phone number, email address, and UEI Please indicate business size: Small Disadvantage Business (SDB)____ 8(a)____ Historically Underutilized Business Zone (HUBZone)____ Service-Disabled Veteran-Owned Small Business (SDVOSB)____ Veteran-Owned Small Business (VOSB)_____ Economically Disadvantaged Women-Owned Small Business (EDWOSB)_____ Women-Owned Small Business concerns (WOSB)_____ Small Business_____ Large Business_____ Please state if you possess a Federal Supply Schedule (FSS)______. Please state the Group your GSA FSS Schedule is under ________ 2) Please submit a brief capability statement (maximum three pages) with enough information to demonstrate to the Veterans Affairs that you have the resources, personnel, and experience to perform services pertaining to Cryoablation to include equipment and technician services as required in the attached Draft Statement of Work. **Draft Statement of Work STATEMENT OF WORK Cryoablation Equipment Rental & Technician Services The Department of Veterans Affairs Puget Sound Health Care System 1660 S. Columbian Way, Seattle, WA 98108 Contract Title. Cryoablation Machine rental & Technician Services Background. The Center's mission is to be able to treat veterans with Kidney and Renal tumors. Cryoablation is a less invasive way to treat tumors. Cryoablation is a process that uses extreme cold (cryo) to destroy or damage tissue (ablation). Cryoablation is used in a variety of clinical applications using hollow needles (cryoprobes) through which cooled, thermally conductive, fluids are circulated. Cryoprobes are inserted into or placed adjacent to tissue which is determined to be diseased in such a way that ablation will provide correction yielding benefit to the patient. When the probes are in place, the cryogenic freezing unit removes heat ("cools") from the tip of the probe and by extension from the surrounding tissues. Ablation occurs in tissue that has been frozen by at least three mechanisms: (1) formation of ice crystals within cells thereby disrupting membranes and interrupting cellular metabolism among other processes; (2) coagulation of blood thereby interrupting blood flow to the tissue in turn causing ischemia and cell death; and (3) induction of apoptosis, the so-called programmed cell death cascade. The most common application of cryoablation is to ablate solid tumors found in the lung, liver, breast, kidney, and prostate. The use in prostate and renal cryoablation are the most common. Although sometimes applied through laparoscopic or open surgical approaches, most often cryoablation is performed percutaneously (through the skin and into the target tissue containing the tumor) by a medical specialist, such as an interventional radiologist. Scope. The contractor shall provide all labor, materials, transportation, equipment, and supervision, in compliance with Federal, State, and local regulations, to provide cryoablation services and technical support for The Department of Veterans Affairs, Puget Sound Health Care System (PSHCS) on an as needed basis. The contract will require the contractor to provide cryoablation services with a minimum of a primary and back-up technician at the PSHCS. The VA estimates that there will be 1 patient per visit. The equipment must be prepared to perform the procedure at a mutually agreed upon time and continue to perform procedure until the Veteran patient is complete. There may be scheduled days that no procedures are needed, and the facility may cancel with the Contractor, with a minimum of 24 hours notice prior to the scheduled day with no charges to the Government. This contractor shall provide all services listed below to support VA in performing Cryoablation on our veteran s. 3.1 Definitions: The following terms when used in this Contract shall be defined as follows: 3.1.1 Acceptable Quality Level (AQL): The AQL is the maximum percent defective that, for purposes of sampling inspections can be considered satisfactory. 3.1.2 Contracting Officer (CO): A person duly appointed with the authority to enter into and administer contracts on behalf of the U.S. Government. Contracting officers are responsible for ensuring performance of all necessary actions for effective contracting, ensuring compliance with the terms of the contract, and safeguarding the interests of the United States in its contractual relationships. 3.1.3 Contracting Officer's Representative COR: An individual designated by the Contracting Officer to act as his/her representative to assist in administering a contract. The source and authority for a COR are contained in the written letter of designation. The Contracting Officer may delegate one or more VAMC employees who are responsible for monitoring the performance of the Contractor. 3.1.4 Customer Complaint: A means of documenting certain kinds of contract service problems. A government program that is explained to every organization that receives service under this contract, which is used to evaluate contractor s performance. 3.1.5 PSHCS: Puget Sound Health Care System 3.1.6 non-personal services contract: A contract under which the personnel rendering the services are not subject, either by the contract s terms or by the manner of its administration, to the supervision and control usually prevailing in relationships between the Government and its employees. 3.1.7 Performance Requirements Summary (PRS): Identifies the key service outputs of the contract that will be evaluated by the government to assure contract performance standards are met by the Contractor. 3.1.8 Quality Control: Those actions taken by a contractor to control the performance of services so that they meet the requirements of the PWS. 3.1.9 Quality Improvement (QI): The ongoing process of responding to data gathered through quality monitoring efforts, to improve the quality of health care delivered to individuals. This process involves follow-up studies of the measures taken to effect change in order to demonstrate that the desired change has occurred. 3.1.10 Quality Monitoring (QM): The ongoing process of assuring that the delivery of health care is appropriate, timely, accessible, available, medically necessary and in keeping with established guidelines and standards and reflective of the current state of medical knowledge. 3.1.11 Cryoablation: Cryoablation is a process that uses extreme cold (cryo) to destroy or damage tissue (ablation). Cryoablation is used in a variety of clinical applications using hollow needles (cryoprobes) through which cooled, thermally conductive, fluids are circulated. Cryoprobes are inserted into or placed adjacent to tissue which is determined to be diseased in such a way that ablation will provide correction yielding benefit to the patient. When the probes are in place, the cryogenic freezing unit removes heat ("cools") from the tip of the probe and by extension from the surrounding tissues. 3.1.12 JC: Joint Commission: An independent, not-for-profit organization, The Joint Commission accredits and certifies more than 18,000 health care organizations and programs in the United States. Joint Commission accreditation and certification is recognized nationwide as a symbol of quality that reflects an organization s commitment to meeting certain performance standards. 3.2 Specific Requirements: 3.2.1 The Contractor s technical personnel shall be certified, trained, and current in cryoablation and operation of the equipment units. The technician shall assist the attending physicians in the operating room in the operation of the equipment units. The technician may be required to operate the device and any related imaging equipment during the procedures. 3.2.2 The contractor shall provide a surgical laser or other Equipment along with a Technician for an operation. Technicians are non-physician and are unable to legally provide services on patients unless under supervision and control of a physician. 3.2.3 VA will use the equipment and supplies solely for the benefit of its patients or patients health organizations and entities that are subsidiaries of or affiliated with VA (collectively, the Affiliates). For purposes of this Agreement, affiliated with means a facility or entity that is controlled by VA. 3.2.4 The equipment must meet or exceed the following criteria Brand Name or Equal to: Galil Visual Ice Cryoablation system and needles. Must be compatible with the below specifications. Gas supplies furnished by VA. System Specifications: Operating Conditions Temperature: 10°C to 40°C Relative Humidity 30% to 75% Gas Supply Specifications: Argon Cylinder Purity Level: 99.998% or higher Solid particle size: <5 µm Helium Cylinder Purity Level: 99.995% or higher Solid particle size: <5 µm Gas Cylinder Specifications Maximum Pressure: 6000 psi Recommended Volume of Gas Cylinders: 42-50 L Connector Valve: CGA677 Consistent gas flow rates maintained. Software controls that optimize performance of simultaneous activation of multiple needles. Secondary internal gas dryers that produce consistent iceballs and boost freezing performance. Equipment shall be small and portable due to limited space in the OR. Multiple tumors- Multiple needles can be used simultaneously, independent needle control for up to 10 Needles. Large patient = at least 23cm shaft to accommodate deep lesions or tumor. Sharp Trocar Needle Tips for easy needle insertion in a range of configurations that produce various iceball sizes and shapes, allowing the clinician to match the needles to the desired ablation zone. Multi-Point Thermal Sensors (MTS) contain four sensor locations along the distal shaft of the needle to monitor temperature near the target site and adjacent critical structures. Cryoablation needles and MTS are supplied sterile in procedure kits or in needle kits. Equipment has Needle track ablation. Equipment has Cautery function. Equipment can be programed for freeze and thaw phases. 3.2.5 Additional materials and supplies, including consumables (i.e., electrodes), are necessary to conduct cryoablation procedures with the equipment units. 3.2.6 Maintenance of the devices to include service and preventative maintenance to ensure that the devices are in the highest level of functioning condition, with, as a minimum, maintenance performed at the manufacturer s preventative maintenance schedule. Maintenance logs or copies must always be available. Contractor shall be responsible for cleaning the machine after each use. 3.2.7 Assist in the education of each facility s personnel as it relates to cryoablation. 3.2.8 Be responsible for obtaining all necessary licenses, approvals, permits and be in compliance with all Federal, State, and local laws and regulations applicable to the devices and delivery of cryoablation related services provided for under the terms of this contract. 3.2.9 Delivery of all reports, digital, film and file records of all procedures performed with the devices to the Interventional Radiology staff. These medical records shall be the property of the Department of Veterans Affairs, PSHCS/663 facility. 3.2.10 The Contractor shall perform all services under this contract in accordance with any and all regulatory and accreditation standards applicable to the individual VA facility, including without limitations, those required by The Joint Commission (TJC) and/or Association of Acrreditation for Ambulatory Surgery Centers (AAA) certification for the State of Washington shall comply with all Veterans Health Administration (VHA) regulations and directives. Contractor shall provide consultation, if requested, in the development of protocols, utilization review, peer review, and risk management as required by regulatory bodies. 3.2.11 Equipment provided shall meet criteria, passes bio-medical check, and performs functions as designed. Equipment arrives to the Radiology Department (check-in) VA administrative staff will contact VA bio-med for safety check before entering Operating Room (OR). 3.2.12 Contractor shall arrive to the Radiology Department and check-in 1 hour prior to scheduled procedure time. Personnel. 4.1 Qualifications Contractor shall provide personnel under this contract with the following qualifications: Have an unrestricted license in a US state, territory or Commonwealth of the Untired States or District of Columbia. Able to read, write, speak, and understand the English language; and Be a US Citizen. 4.2. Citizenship Related Requirements: If technically qualified United States Citizens will be given preference over, non-citizens in accordance with current regulations. Non-citizens must provide proof of eligibility to work and an e-verify printout. 4.3. Contractor shall, without additional expenses to the Government, be responsible for obtaining all necessary licenses, approvals, and permits and be in compliance with all federal, state and local laws and regulations applicable to the Cryoablation related services provided for under this contract. The Contractor will be responsible for providing this information to the COR, if requested. 4.4. Contractor personnel shall be subject to the same quality assurance standards, meeting or exceeding current recognized national standards as all regular PSHCS employees. Contractor personnel shall perform the services in accordance with the ethical, professional, and technical standards of PSHCS. 4.5. Contractor shall immediately notify the Contracting Officer and COR anytime a Contractor employee(s) and/or facility are involved in malpractice actions or loss of certification. 4.6. Technical Proficiency: 4.6.1. All care provided to Veterans is expected to be of the highest quality and is subject to peer review, focused professional practice review, ongoing professional practice review, and quality assurance activities. 4.6.2. Adhere to PSHCS Rules and Regulations. 4.6.3. Participate, with PSHCS staff, in developing the patient s plan of care Provide feedback to the PSHCS staff as the plan of care is executed and coordinated revisions to the plan of care, if required. 4.6.4. The services to be performed: shall be performed in accordance with VA policies, procedures, and the regulations. The Government may evaluate the quality of professional and administrative service provided, but retains no control over the medical, professional aspects of services rendered (e.g., professional judgments, and/or diagnosis for specific medical treatment). 4.6.5. The services required in this awarded contract shall be performed in accordance with established principles and ethics of the profession. The quality of healthcare provided shall meet or exceed the current recognized standards established by the American Medical Association (AMA), http://www.amaassn.org/ Joint Commission (JC), http://www.jointcommission.org/standards/ and those of other professional associations, which specify standards of performance for the medical profession. 4.7. Conflict of Interest: See VHA Handbook 1660.3, Conflict of Interest; Aspects of Contracting for Scarce Medical Specialist Services; Enhanced Use Leases; Health Care Resource Sharing; Non-VA Purchased Care (Fee Basis); and Intergovernmental Personnel Action Agreements (IPAS). These publications and handbooks are available at: http://www1.va.gov/vhapublications/index.cfm 4.8. Citizenship Related Requirements: If technically qualified United States Citizens will be given preference over, non-citizens in accordance with current regulations. Non-citizens must provide proof of eligibility to work and an e-verify printout. 4.9. Office of Inspector General (OIG) Statement: The contractor is required to check the HHS Office of Inspector General List of excluded individuals/entities on the OIG Website (www.hhs.gov/oig) for each person providing services under this contract to ensure that the individuals providing services under the contract have not engaged in fraud or abuse regarding Sections 1128 and 1128A of the Social Security Act regarding federal health care programs. Further, the contractor is required to certify in its proposal that all persons listed in the contractor s proposal have been verified as not appearing on the OIG list. During the performance of this contract, the Contractor is prohibited from using any individual or business listed on the List of Excluded Individuals/Entities. 4.10. Technical Direction: 4.10.1. Submission: As part of the pre-award Contractor Responsibility determination and during the performance of the contract for the purpose of on-going Contractor competency evaluation, the VA will perform or require for evaluation, from the Offeror/Contractor one or more of the following: 4.10.1.1. Submission of information to allow evaluation of their qualifications and past performance. This information should be specific, concise, and complete and provide sufficient information to demonstrate the offeror s capacity to meet or exceed the requirements of the contract. 4.10.1.2 Submission of evidence of accomplishment of training and education that is required by the terms of the contract; and 4.10.1.3. Submission of evidence of experience and achievements in work similar to that required by the contract. Board certification or licensure that meets or exceeds standards relative to the industry being contracted. 4.11. Contractor will not refer a provider who has had a terminated license, registration or certification for cause, or if the provider voluntarily relinquished such license, registration or certification in any state after being notified in writing by a state of potential termination for cause. (The definition for cause is substandard care, professional misconduct, or professional incompetence. ) All providers assigned by the contractor shall have a current, full and unrestricted license to practice medicine in any State, Territory, or Commonwealth of the United States or in the District of Columbia. If required by the State of Licensure, current registration shall also be maintained. Invoices. Invoices shall be submitted monthly in arrears with the following information: Contract number and billing number Station ID (663) Dates of service and Patient s Medical Record Number Price Invoices will be billed as individual line items as they are listed in the price schedule. Monthly invoices will contain only those cases worked for that month. Previous invoiced caseload shall not be intermingled with current invoice. Invoices not received in proper format will be returned. PSHCS will not pay any hiring fees if the contract Cryoablation Technicians is hired for a permanent position. The Government agrees not to pursue contractor personnel to be hired permanently at the VA. Safety Requirements. 6.1. In the performance of this contract, the contractor shall take such safety precautions as the contracting officer Representative (COR), or his designee may determine to be reasonable and necessary to protect the lives and health of occupants of the building. The contracting officer Representative (COR) or his designee will notify the contactor of any non-compliance with the foregoing provisions and the action to be taken. The contractor shall after receipt of such notice, immediately correct the condition to which attention has been directed. Such notice, when served on the contractor or his representative at the site of the work, shall be deemed sufficient for the purpose aforesaid. If the contractor fails or refuses to comply promptly, the Contracting Officer may issue an order stopping all or any part of the work and hold the contractor in default. 6.2. Cryoablation Technicians are required to use universal precautions to guard against possibility of accidental exposure to blood-borne pathogens. PSHCS will provide appropriate Personal Protective Equipment (PPE). Cryoablation Technicians will follow the guidance provided in the PSHCS SOPs regarding Infection Control, Safety, and Hazardous Waste Management. NON- PERSONAL SERVICES: 7.1. It is expressly agreed and understood that this is a non-personal services contract, as defined in Federal Acquisition Regulation (FAR) 37.101, under which the professional services rendered by the Contractor, or its health-care providers are rendered in its capacity as an independent contractor. The Contractor and its health-care providers shall be liable for their liability-producing acts or omissions. The Contractor shall maintain or require all health-care providers performing under this contract to maintain, during the term of this contract, professional liability insurance issued by a responsible insurance carrier. However, if the Contractor is an entity or a subdivision of a State that either provides for self-insurance or limits the liability or the amount of insurance purchased by State entities, then the insurance requirement of this contract shall be fulfilled by incorporating the provisions of the applicable State law. 7.2. An apparently successful offeror, upon request of the Contracting Officer, shall, prior to contract award, furnish evidence of the insurability of the offeror and/or of all health-care providers who will perform under this contract. The submission shall provide evidence of insurability concerning the medical liability insurance required by paragraph (a) of this clause or the provisions of State law as to self-insurance, or limitations on liability or insurance. 7.3. The Contractor shall, prior to commencement of services under the contract, provide to the Contracting Officer Certificates of Insurance or insurance policies evidencing the required insurance coverage and an endorsement stating that any cancellation or material change adversely affecting the Government. 7.4. The Contractor shall notify the Contracting Officer if it, or any of the health-care providers performing under this contract, change insurance providers during the performance period of this contract. The notification shall provide evidence that the Contractor and/or health-care providers will meet all the requirements of this clause, including those concerning liability insurance and endorsements. These requirements may be met under either the new policy, or a combination of old and new policies, if applicable. 7.5. The Contractor shall insert the substance of this clause, including this paragraph (e), in all subcontracts for health-care services under this contract. The Contractor shall be responsible for compliance by any subcontractor or lower-tier subcontractor with the provisions set forth in paragraph 7.1 of this clause. 7.6. Non-Employee Status: The parties agree that such personnel working under this contract shall not be considered VA employees for any purpose and shall be considered employees of the Contractor. The relationship of the parties is not and shall not be construed or interpreted to be a partnership, joint venture, or agency. The relationship of the Parties is an independent contractor relationship. 7.7. Tort: Contractor employees are not covered by the Federal Tort Claims Act. When the Contractor or its employee has been identified as a provider in a tort claim, the Contractor is responsible for notifying the Contractor s legal counsel and/or insurance carrier. Any settlement or judgment arising from a Contractor or employee s action, or non-action is the responsibility of the Contractor and/or insurance carrier. The contractor shall provide a copy of current license and malpractice insurance certificate. KEY PERSONNEL AND EMERGENCY SUBSTITUTIONS: 8.1. The Contractor shall assign to this contract key personnel to include name/position/phone #: Name/Position/ phone #: To be determined. 8.2 The provider assigned by the contractor shall fall under all the existing PSHCS quality monitors relating to services provided such as, medical records review, Peer Review, Incident reporting, Infection Control, etc. 8.3. The Government reserves the right to refuse acceptance of a contractor, if personal or professional conduct jeopardizes patient care or interferes with the regular and ordinary operation of the facility. Breaches of conduct include intoxication or debilitation resulting from drug use, theft, patient abuse, dereliction, or negligence in performing directed tasks, or other conduct resulting in formal complaints by patient or other staff members to designated Government representatives. Standards for conduct shall mirror those prescribed by current federal personnel regulations. The Contracting Officer, Administrative Contracting Officer and Contracting Officer's Representative shall deal with issues raised concerning contract personnel's conduct. The final arbiter is the Contracting Officer. 8.4. The Contracting Officer Representative shall resolve complaints concerning Contractor relations with the Government employees or patients. In the event that the Contractor is involved and named in a validated patient complaint, and the Government is unable to resolve the issue the Government reserves the right to refuse acceptance of the services of such personnel. In the event of incidents involving physical or verbal abuse the contractor will be immediately removed from the facility and will not return until clearance is given by the Contracting Officer and the Facility Director. In the event any issues cannot be resolved the Contracting Officer is the final authority on validating complaints. 8.5. PSHCS personnel shall brief the Contractor on VAMC policies and procedures on the first scheduled duty day. HOURS OF OPERATION: Normal Clinic Hours are from 7:00 am to 5:00 pm. 9.1. Contractor s employee must be present at the VA facility during required hours and must be performing the required services identified in the Performance Work Statement to invoice for hours worked. The payments for holiday time (for work performed in the case of an emergency) and for any leave, including sick leave or vacation time is the responsibility of the contractor. The services covered by this contract shall be furnished by the Contractor during work hours as defined herein. 9.2. Any hours worked beyond the normally scheduled shifts shall be reviewed by the Chief of Staff and approved by the COR to determine appropriateness. Any time worked deemed unnecessary by the Chief of Staff will not be paid by the VA. 9.3. Work Schedule: Depending upon staffing levels the work hours will be: a. Regular Working Hours: Any time between 7:00 am and 5:00 pm, Monday through Friday that is not a Federal Holiday. b. Non-Working Hours: Any hours outside those shown as Regular Working Hours. Federal Holidays are considered Non-Working Hours. During Non-Working Hours the Contractor shall be available to respond to emergency situations arising at the VA WITHIN 60 MINUTES of notification; c. Federal Holidays: are those holidays observed by the United States Government: i.e., New Year's Day, Martin Luther King Day, President's Day, Memorial Day, Juneteenth, Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving Day, Christmas Day and any other day specifically declared by the President of the United States to be a Federal Holiday. 9.4. Cancellation Policy: Puget Sound VAMC reserves the right to withdraw any or all service requirements if they become available from other VAMC s or an Cryoablation Technician is hired at PSHCS. Any reduction in service requirements shall be at no charge to the Government. CONTRACTOR RESPONSIBILITIES: Services Required: This contract is to provide Cryoablation Technician services to PSHCS in accordance with Public Law 104-262 and 38 U.S.C.8153. 10.1. Standards of Practice: Contractor shall be responsible for meeting or exceeding VA and Joint Commission (or equivalent) standards. 10.2. The contractor shall be responsible for protecting the personnel furnishing services under this contract. To carry out this responsibility, the Contractor shall provide the following for these personnel: Worker s compensation. a. Professional liability insurance. b. Health examinations income tax withholding, and c. Social Security payments. 10.3. By signing this solicitation, the Contractor hereby acknowledges that it is and will continue to comply with State workers compensation laws that are applicable to the Contractor. While it is understood by the Federal government that workers compensation laws may not apply to a contractor with respect to that contractor s independent contractors and as such that contractor will not be required to make workers compensation premium payments for such independent contractors, it is wholly the burden and responsibility of the contractor to make such a determination pursuant to State workers compensation laws. The Federal government does not offer any legal advice on such a determination and contractors are encouraged to seek independent legal advice when making such a determination. 10.4. The Contractor shall comply with all current VHA policies. The Contractor is required to meet VHA performance and quality criteria and standards including, but not limited to, customer satisfaction, preventative index, chronic disease index and clinical guidelines. Performance and quality standards may change during the course of the contract. New or revised quality/performance criteria or standards will be provided to the contractor before their implementation date. Compliance with mandated performance is required as a condition of this contract. 10.5. The services required in this agreement shall be p...