Mobile Lithotripsy Services - 5 YR BPA - James H. Quillen VAMC

Form / Attachment / Pricing Sheet

This document is a certification form required for contractors to acknowledge and agree to comply with the Immigration and Nationality Act of 1952, as amended. It ensures that contractors will not knowingly employ illegal aliens or foreign nationals in violation of their visa status while providing services to the Department of Veterans Affairs (VA).

• Compliance with Immigration Laws: The contractor certifies adherence to all legal provisions of the Immigration and Nationality Act, as enforced by Homeland Security, Immigration and Customs Enforcement, and the U.S. Department of Labor.
• Prohibition of Illegal Employment: The contractor agrees not to employ illegal aliens or foreign nationals who are in violation of their U.S. admission status.
• E-Verify Requirements: The contractor must comply with "E-Verify" requirements per Executive Order 12989 and related amendments.
• Subcontractor Certification: The contractor must obtain similar certifications from its subcontractors.
• Consequences of Non-Compliance: Failure to comply may result in the prohibition of the non-compliant foreign national from working on VA-related contracts and may lead to contract termination for breach.
• Certification Fields: Includes spaces for signature, date, typed name and title, and company name.
• False Certification Warning: A statement warns that false certification may lead to prosecution under 18 U.S.C. 1001.

Bidders must complete and submit this certification to demonstrate their commitment to legal employment practices concerning foreign nationals. This is a mandatory requirement for participation in the contract and directly impacts compliance obligations during contract performance. Failure to provide this certification or to adhere to its terms can have significant consequences, including contract termination.

Form / Attachment / Pricing Sheet

This document outlines the Contractor Rules of Behavior required by the Department of Veterans Affairs (VA) for individuals accessing VA data, information systems, and sites while performing services under a contract. It details the terms and conditions for acceptable use and security practices.

• General Terms and Conditions: Covers user agreement, consent to monitoring and reviews by VA personnel, and acknowledgement of prohibited unauthorized access or misuse of Federal Government systems. It also outlines potential criminal, civil, or administrative penalties for violations.
• Rules of Behavior: Establishes standards for contractors, including:
  • Proper account access and usage.
  • Authorized use of systems, software, databases, and data.
  • Restrictions on using non-contractor owned equipment (OE) for VA sensitive information without approval.
  • Prohibition of exploiting system controls or accessing information beyond contract performance.
  • Limitations on overriding security controls.
  • Strict limitation of system, information, or site use to contract fulfillment; no personal use.
  • Requirements for granting access only to those with an official need-to-know.
  • Password protection and creation standards.
  • Protection of information and systems from unauthorized disclosure, use, modification, or destruction, including FIPS 140-2 validated encryption.
  • Compliance with VA Handbook 6500.1 for Electronic Media Sanitization.
  • Approval requirements for public dissemination of VA information.
  • Restrictions on hosting internet servers.
  • Protection of government property.
  • Authorized use of anti-virus, anti-spyware, and firewall software.
  • Reporting of software errors or alert messages.
  • Requirement for completing information security and privacy training.
• Additional Conditions for Non-VA IT Resources: Details requirements for direct connection to the VA network, approved remote access software, and prohibitions on remote access from public computers. It also addresses dual network connections and the responsibility of subcontractors.
• Statement on Litigation: Clarifies that the agreement does not create rights enforceable in litigation against the U.S. Government.
• Acknowledgement and Acceptance: Requires the contractor to acknowledge receipt, understanding, and acceptance of all terms and conditions.

This document is critical for bidders to understand the security and behavioral requirements they and their personnel must adhere to if awarded a contract. It highlights the strict protocols for data handling, system access, and reporting, which may influence resource allocation and training needs for proposal development and contract execution.

Form / Attachment / Pricing Sheet

This document, "ORGANIZATIONAL CONFLICTS OF INTEREST," outlines the requirements for bidders to address potential organizational conflicts of interest (OCI) related to the solicitation. It mandates the use of the form in APPENDIX A for providing the required response.

• OCI Definition: Explains what constitutes an organizational conflict of interest, including situations where impartiality or objectivity may be impaired, or an unfair competitive advantage may be gained.
• Bidder Statement Requirement: Requires Offerors to submit a concise statement with their offer detailing any past, present, or planned interests (financial, contractual, organizational) or actual/potential OCIs related to the services. This also applies to identified consultants and subcontractors.
• Mitigation: Offerors can provide information on how their organizational or management systems will avoid or mitigate potential OCIs.
• Contracting Officer Determination: The Contracting Officer will assess the provided information and may disqualify a contractor if an OCI exists and cannot be mitigated, or may seek a waiver.
• Consequences of Non-Disclosure: Failure to disclose or misrepresenting OCIs can lead to contract termination at no cost to the Government.
• APPENDIX A - Certification Statement: A form to be completed by the contractor, certifying that key personnel have no conflicts of interest, or providing a detailed statement if conflicts exist. It requires the contractor's name, solicitation number, and signature of a certifying official.

Bidders must carefully review this document and complete the provided certification statement (APPENDIX A) as part of their offer. Failure to properly address organizational conflicts of interest can result in disqualification or contract termination. This document is critical for ensuring compliance and a successful bid submission.

Statement of Work (SOW) / Performance Work Statement (PWS)

The James H. Quillen VA Medical Center (VAMC) requires a contractor to provide onsite Mobile Lithotripsy Services and Equipment, including specialized laser equipment and certified assistants.

• Provide specific laser equipment on an as-needed basis: Holmium Lasers (20W & 100W), GreenLight XPS Laser System (180W), Aura XP Laser System (15W), CO2 Flex Fiber Laser System (40W), and CO2 Laser System Free Beam.

• Provide a factory-trained, Certified Medical Laser Safety Officer (CLSO or CLSO-M) assistant for each laser system.

• The CLSO/CLSO-M assistant must operate the VA-owned Holmium Laser (100W) using VA-purchased fibers. If the VA laser is unavailable, the contractor's Holmium Lasers must be used with VA-purchased fibers. Third-party manufactured fibers are prohibited.

• Stand-by/cancellation charges apply if a VA physician determines laser use is not required after the assistant and laser are present.

• Personnel Qualifications: Laser assistants must be factory-trained, CLSO/CLSO-M certified, U.S. Citizens, proficient in English, and complete VA credentialing (including VETPRO enrollment). Qualifications are subject to VAMC Attending and Chief of Surgery approval.

• Onboarding: Personnel must complete VA credentialing, background investigations, and provide two proofs of identification. They must also self-enroll in the Talent Management System (TMS) and complete mandatory training modules.

• Urgent/Emergent Response: For off-duty hours or holidays, the contractor must respond telephonically within 15 minutes and be on-site within 2 hours.

• Quality Assurance: Services must meet or exceed The Joint Commission (TJC) standards. Contractor personnel must be technically proficient and adhere to VAMC policies.

• Infection Control: Personnel must provide proof of current TB testing (annual PPD or negative chest X-ray), and Rubella immunization/titer. Compliance with OSHA regulations for bloodborne pathogens is required.

• Conduct: Contractor personnel must adhere to federal personnel regulations and VAMC policies. Conduct jeopardizing patient care or VAMC operations is grounds for refusal.

• Equipment Inspection: VAMC Biomedical Engineering will inspect laser equipment before procedures. A current Preventative Maintenance (PM) inspection sheet must accompany the equipment.

• Identification: Contractors must wear a VAMC-issued ID badge with a picture at all times on VAMC grounds.

• No Smoking Policy: Strictly enforced within VAMC buildings and designated areas.

• PII: Contractor shall not remove Personal Identifiable Information from VAMC, except for limited invoicing details.

• Services to be provided at the James H. Quillen VA Medical Center, Mountain Home, TN 37684.

• Services to commence as soon as possible after contract award, pending credentialing.

Solicitation / RFP / RFQ

This is a combined synopsis/solicitation for commercial items to procure Onsite Mobile Lithotripsy Services for the James H. Quillen VA Medical Center. The solicitation is being conducted under simplified procedures.

• Furnish all personnel to provide Onsite Lithotripsy Services.

• Services must meet or exceed currently recognized standards of care.

• Contractor must have a certified Medical Laser Safety Officer-certified Laser Assistant candidate and required equipment.

• Personnel must be proficient in English and have relevant certifications and licenses.

• This RFQ will result in a Five (5) year Blanket Purchase Agreement (BPA) with five (5) one-year ordering periods.

• Anticipated Award Date: 05/01/2026.

• Period of Performance: 05/01/2026 through 04/30/2031.

• Firm-Fixed Price BPA.

• Includes 52.217-8 Option to Extend Services.

• Quotes are due no later than 10:00 A.M., Central Time, Tuesday, April 21, 2026.

• Quotes must be emailed directly to Rebecca.Espinoza@va.gov as a single searchable PDF, no more than 10 megabytes.

• Questions regarding the solicitation must be submitted via email by 10:00 A.M., Central Time, Monday, April 6, 2026.

• Evaluation will be based on comparative evaluation of Technical Expertise, Price, and Past Performance.

• The Government reserves the right to select a quote that provides the best benefits, even if it exceeds minimum requirements.

• Unrestricted.

• Contractors must be registered with the System for Award Management (SAM).

• Firms must have a Unique Entity Identifier (UEI).

• The following attachments are referenced: Performance Work Statement (D.1), Quality Assurance Surveillance Plan (D.2), Organizational Conflicts of Interest (D.3), Contractor Rules of Behavior (D.4), Schedule of Services (D.5), and Contractor Certification of Immigration (D.6).

• Supplemental insurance requirements include professional liability insurance of not less than $1,000,000.00 per individual and $3,000,000.00 per occurrence.

Form / Attachment / Pricing Sheet

This document, "ATTACHMENT D.5 - SCHEDULE OF SERVICES," outlines the specific services and associated estimated quantities for a Blanket Purchase Agreement (BPA). It details the items to be procured, including various types of lithotripsy laser equipment, laser systems, and related fibers, along with the required operating personnel and estimated case volumes or units.

• Item Number: Unique identifier for each service or supply.
• Description of Services: Specific details of the equipment, procedures, or supplies (e.g., Mobile Lithotripsy Laser Equipment, Holmium Laser Systems, Single use Holmium Fibers).
• Estimated Quantities: The anticipated number of units or cases required.
• Unit of Measure: The unit for the estimated quantity (e.g., CASE, EACH).
• Unit Price & Total Amount: Fields for pricing, to be filled in during the ordering process.
• Ordering Period: Specified as 05/01/2026 through 04/30/2031.
• Stand-by/Cancellation Charges: Details charges incurred if a laser and operator are present but not used.

This schedule is critical for bidders as it defines the specific products and services the government intends to purchase under the BPA. It provides estimated quantities and descriptions, allowing vendors to assess their capability to supply these items and to prepare pricing for individual Call Orders. The document also clarifies the ordering process, noting that it's a Fixed-Price BPA with funds obligated on individual Call Orders, each not exceeding a 12-month period.

Form / Attachment / Pricing Sheet

This document is the Quality Assurance Surveillance Plan (QASP) for the contract. It outlines the systematic method the Government will use to evaluate the contractor's performance, detailing what will be monitored, how monitoring will occur, who will conduct it, and how results will be documented. It clarifies that the QASP does not dictate how the contractor performs the work but rather how the Government will assess that performance against contract terms.

• Government Roles and Responsibilities: Identifies the Contracting Officer (CO) and Contracting Officer's Representative (COR), including their contact information and responsibilities.
• Contractor Representatives: Placeholder for contractor's primary and alternate program managers.
• Performance Standards: Defines the criteria and acceptable quality levels (AQLs) against which contractor performance will be measured. Key areas include Timeliness, Quality Care, Patient Safety, and Patient Satisfaction.
• Methods of QA Surveillance: Lists the methods the COR will use, such as Direct Observation, Periodic Inspection, Validated User/Customer Complaints, Random Sampling, and review of Contractor-provided documentation.
• CPAR Ratings: Explains the rating scale (Exceptional, Very Good, Satisfactory, Marginal, Unsatisfactory) used to assess performance against standards.
• Documenting Performance: Describes the process for documenting performance, including Contract Reports (CRs) for unacceptable performance and the contractor's responsibility for corrective action plans.
• Contract Report (CR) Form: A template for documenting specific issues, contractor responses, and government evaluation.

This QASP is crucial for bidders as it defines the performance standards and evaluation methods the Government will use to assess contractor performance throughout the contract lifecycle. Understanding these requirements will help bidders tailor their proposals to meet or exceed expectations and anticipate how their performance will be measured and rated, directly impacting past performance evaluations.